FR Doc 04-6283

[Federal Register: March 25, 2004 (Volume 69, Number 58)]
[Notices]
[Page 15439-15467]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr25mr04-134]

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Part II

Department of Health and Human Services

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Centers for Disease Control and Prevention

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Health Promotion and Disease Prevention Research Centers Special
Interest Projects Competitive Supplements; Notice

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

Health Promotion and Disease Prevention Research Centers Special
Interest Projects Competitive Supplements

Announcement Type: Competing Supplements.
Funding Opportunity Number: 04003-FY04 Comp Supp.
Catalog of Federal Domestic Assistance Number: 93.135.
Key Dates:
Letter of Intent Deadline: May 7, 2004.
Application Deadline: May 25, 2004.

I. Funding Opportunity Description

Authority: This program is authorized under sections 301(a),
317(k)(2) and 1706 [42 U.S.C. 241(a), 247b(k)(2) and 300 u-5] of the
Public Health Service Act, as amended.
Purpose: The purpose of the Prevention Research Centers (PRC)
program's Special Interest Projects (SIPs) is to support supplemental
projects in health promotion and disease prevention research that (1)
focus on the major causes of death and disability, (2) improve public
health practice within communities, and (3) cultivate effective state
and local public health programs. One of the major focuses of this
supplemental funding program is to design, test, and disseminate
effective prevention research strategies.
This program addresses the department-wide initiative, Steps to a
HealthierUS, which advances the HealthierUS goal of helping Americans
live longer, better and healthier lives by focusing on the importance
of prevention. The Steps focus areas supported by this program are the
following: Physical Activity and Fitness; Nutrition and Overweight;
Cancer; Diabetes; and other areas addressed by ``Healthy People 2010,''
such as Access to Quality Health Services, Disability and Secondary
Conditions, Educational and Community-Based Programs, and Health
Communications.
Measurable outcomes of the program will be in alignment with the
following performance goal for the National Center for Chronic Disease
Prevention and Health Promotion (NCCDPHP): to support prevention
research to develop sustainable and transferable community-based
behavioral interventions.
Research Objectives: Research objectives are described for each
special interest project in section IX of this announcement.
Recipient Activities: Awardee activities for this program are
described for each special interest project in section IX of this
announcement. Consistent with the nature of the cooperative agreement
funding mechanism, awardees are expected to collaborate with CDC staff
on research activities associated with these projects.
CDC Activities: CDC activities for this program are described for
each special interest project in section IX of this announcement.
Consistent with the nature of the cooperative agreement funding
mechanism, CDC staff is expected to be substantially involved in the
program activities, above and beyond routine grant monitoring. This may
include technical assistance in the design or direction of activities
to develop research protocols.

II. Award Information

Type of Award: Cooperative Agreement.
Fiscal Year Funds: 2004.
Approximate Total Funding: $18,000,000.
Approximate Number of Awards: 26 Special Interest Projects.
Approximate Average Award: $ Amount Varies (see each individual
special interest project description in section IX). Before application
submission, it is imperative that the Principal Investigator critically
evaluate whether the proposed budget is commensurable with the scope of
work and provide thorough justification for any amounts requested. If
CDC's Secondary Review Panel determines that funding discrepancies
exist for any approved SIP application, the panel will make funding
recommendations to the CDC/NCCDPHP Director for review.
Floor of Award Range: None.
Ceiling of Award Range: CDC will accept and review applications
with budgets greater than the ceiling of the award range.
Anticipated Award Date: September 15, 2004.
Budget Period Length: 12 months.
Project Period Length: Projects range in length from a minimum of 1
year to a maximum of 5 years. Throughout the project period, CDC's
commitment to continuation of awards will be as described below.

Continuation of Funding

Continuation of awards within an approved project period will be
conditioned on the availability of funds, evidence of satisfactory
progress by the recipient (as documented in required reports), and the
determination that continued funding is in the best interest of the
Federal Government.

Funding Preferences

If applicable for a particular special interest project, funding
preference will be based on maintaining an equitable geographic
distribution of centers and for the distribution of centers among areas
containing a wide range of population groups.

III. Eligibility Information

III.1. Eligible applicants: All applicants who have applied for and
have been considered eligible for Program Announcement 04003 may submit
an application for the special interest project competitive supplements
announcement.
Please note, however, only those applicants who have been selected
as Prevention Research Centers under Program Announcement 04003 will be
considered eligible to compete for the Special Interest Project
supplements funding. That is, only applicants who are selected to
receive a Notice of Grant award in September 2004 for Program
Announcement 04003 will be considered eligible to receive funding for
the special interest project competitive supplements.
III.2. Cost Sharing or Matching: Matching funds are not required
for this program.
III.3. Other Eligibility Requirements: Submission of a Letter of
Intent (LOI) on or before the LOI deadline.
III.4. Individuals Eligible to Become Principal Investigators:
Individuals with the skills, knowledge, and resources necessary to
conduct the proposed research are invited to work with their
institutions to develop an application. Individuals from
underrepresented racial or ethnic groups as well as individuals with
disabilities are always encouraged to apply for CDC programs.

Note: Title 2 of the United States Code section 1611 states that
an organization described in section 501(c)(4) of the Internal
Revenue Code that engages in lobbying activities is not eligible to
receive Federal funds constituting an award, grant, or loan.

IV. Application and Submission Information

IV.1. How to Obtain Application Forms and Form Instructions: To
apply for this funding opportunity, use application form PHS 398 (OMB
number 0925-0001 rev. 5/2001). Forms and instructions are available in
an interactive format on the CDC Web site, at the following Internet
address: http://www.cdc.gov/od/pgo/ forminfo.htm.

Forms and instructions are also available in an interactive format
on the

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National Institutes of Health (NIH) Web site at the following Internet
address: http://grants.nih.gov/grants/funding/ phs398/phs398.html.

Applicants that do not have access to the Internet or have
difficulty accessing the forms online can receive the application forms
through the mail by contacting the CDC Procurement and Grants Office
Technical Information Management Section (PGO-TIM) staff at (770) 488-
2700.
IV.2. Content and Form of Submission:
Letter of Intent (LOI): Potential applicants are required to send a
LOI stating intent to apply for a specific SIP. The LOI will be used to
gauge the level of interest in this program and help program prepare
for the Special Emphasis Panel. If an LOI is not received by the LOI
deadline, applicant will be considered ineligible for this
announcement.
The LOI must be written in the following format:
Maximum number of pages: one.
Font size: 12-point unreduced.
Double spaced.
Paper size: 8.5 by 11 inches.
Page margin size: One inch.
Printed only on one side of page.
Written in plain language, avoiding jargon.
The LOI must contain the following information:
Title and number of the Special Interest Project
applying for;
Name, address, E-mail address, and telephone
number of the Principal Investigator;
Participating institution or Prevention Research
Center.
Application: A separate application must be submitted for each SIP.
Applications must clearly indicate which SIP the applicant is applying
for.
Follow the PHS 398 application instructions for content and
formatting of the application. For assistance with the PHS 398
application form, contact PGO-TIM staff at (770) 488-2700, or contact
GrantsInfo at Telephone (301) 435-0714 or E-mail: GrantsInfo@nih.gov.
Applicants' research plan should address activities to be conducted
over the entire project period specified.
Applicants are required to have a Dun and Bradstreet Data Universal
Numbering System (DUNS) number to apply for a grant or cooperative
agreement from the Federal government. The DUNS number is a nine-digit
identification number, which uniquely identifies business entities.
Obtaining a DUNS number is easy and there is no charge. To obtain a
DUNS number, go online at http://www.dunandbradstreet.com or call 1-

866-705-5711.
For more information, see the CDC web site at http://www.cdc.gov/od/pgo/funding/pubcommt.htm.
Enter the DUNS number on line 11 of the

face page of the PHS 398 application form.
IV.3. Submission Dates and Times:
LOI Deadline Date: The LOI must be received by 4 p.m. Eastern Time,
May 7, 2004. Submit an electronic copy of the LOI to Jean Smith at e-
mail address JNSmith@cdc.gov.
Application Deadline Date: Applications for SIPs must be received
by CDC no later than 4 p.m. on May 25, 2004.
Explanation of Application Deadline: Applications must be received
in the CDC Procurement and Grants Office by 4 p.m. Eastern Time on the
deadline date. For applications sent via the U.S. Postal Service or
commercial delivery service, you must ensure that the carrier
guarantees delivery of the application by the closing date and time. If
CDC receives an application after the deadline due to (1) carrier error
(the carrier accepted the package with a guarantee for delivery by the
closing date and time) or (2) significant weather delays or natural
disasters, applicants will be given the opportunity to submit
documentation of the carrier's guarantee. If the documentation verifies
a carrier problem, CDC will consider the application as having been
received by the deadline.
This announcement is the definitive guide on application submission
address and deadline. It supersedes information provided in the
application instructions. If an application does not meet the deadline
above, it will not be eligible for review and will be discarded.
Applicants will be notified if an application did not meet the
submission requirements.
Otherwise, CDC will not notify applicant upon receipt of
application. For questions regarding application receipt, first contact
the carrier. If a question persists, contact the PGO-TIM staff at (770)
488-2700. To allow time for applications to be processed and logged,
please wait two to three days after the application deadline before
calling.
IV.4. Intergovernmental Review of Applications: Executive Order
12372 does not apply to this program.
IV.5. Funding restrictions: Restrictions that must be taken into
account in the budget should follow funding instructions provided for
each special interest project in section IX. Applicants requesting
indirect costs must include a copy of the indirect cost rate agreement.
If the indirect cost rate is a provisional rate, the agreement should
be less than 12 months old.
IV.6. Other Submission Requirements:
LOI Submission Address: Submit the LOI by e-mail to Jean Smith at
JNSmith@cdc.gov.

Application Submission Address: Submit the original and five copies
of the application by mail or express delivery service to Technical
Information Management--PA 04003, CDC Procurement and Grants
Office, 2920 Brandywine Road, Atlanta, GA 30341.
Applications may not be submitted electronically at this time.

V. Application Review Information

V.1. Criteria: Provide measures of effectiveness that will
demonstrate the accomplishment of the objectives of the cooperative
agreement; these measures will be an element of evaluation. Measures of
effectiveness must relate to the performance goals stated in the
Purpose section of this announcement. These measures must be objective,
quantitative, and appropriate for measuring the intended outcome.
Calculation of Scores: The reviewers will provide an overall score
for each application with 1=highest (best) and 5=lowest by using a 1 to
5 scale in increments of 0.1. The reviewers' scores for each
application will then be averaged and multiplied by 100 to obtain a
priority score for the application.

Evaluation Criteria: Non-Research SIPs

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(c) Are there adequate procedures in place for recruiting the
desired number of project participants? (if applicable)
(d) Does the proposed approach explain areas of flexibility as well
as procedures that would be used in responding to conditions that
require changes in methods or focus as needed?
(e) Does the applicant acknowledge potential problem areas and
consider alternative tactics?
(f) Is there an appropriate work plan and time line included?
(g) Does the project incorporate evaluation activities, including
measurement of progress toward achieving the stated objectives?
(h) Does the project include appropriate community involvement in
all phases of program development?
3. Innovation
(a) Are the aims clear?
(b) Is this work innovative or does it build upon previous work?
4. Staff
(a) Is there evidence that the proposed project director has
demonstrated knowledge, experience, and ability in planning and
managing projects that are similar to the proposed project in
complexity, scope, and participatory focus? (Ability includes the
percentage of time each person will devote to each project/activity.)
(b) Is there evidence that the proposed project staff has
demonstrated knowledge, experience, and ability in implementing similar
projects?
5. Environment/Collaborations
(a) Is there evidence that the proposed project will be conducted
through partnerships with representatives of community-based
organizations, private and public sector institutions, State and local
health departments, and/or academia, as appropriate?
(b) Does the project process allow for partners to apply their
knowledge and contribute to the project's planning, implementation, and
evaluation?
(c) Is there evidence of sufficient institutional support (e.g.,
space, equipment, support from senior faculty, etc.)?
(d) Is there an appropriate degree of commitment and cooperation of
potential partners as evidenced by letters detailing the nature and
extent of their involvement?
6. Target Population (Gender and Minorities)
(a) Are characteristics of the target population(s) well described?
(b) Are there adequate plans to included both genders, minorities,
and their subgroups as appropriate for the goals of the project?
(c) Are the plans for recruitment and retention of project
participants satisfactory?
7. Budget (Reviewed But Not Scored)
The extent to which the budget is clearly explained, adequately
justified, reasonable, sufficient for the proposed project activities,
and consistent with the intended use of the funding.

Evaluation Criteria: Research SIPs

The relative importance and applicability of any category will
differ by the focus of the project being solicited. Specific questions
listed below within each category serve as examples of the information
the applicant may wish to address.
1. Significance
(a) Does this project address an important public health problem?
(b) If the aims of the study are achieved, how will scientific
public health knowledge be advanced from the research proposed,
considering issues such as internal validity and generalizability?
(c) To what extent will the results of the study be useful in
promoting the adoption of effective public health prevention and
intervention programs and policies?
2. Approach
(a) Does the applicant demonstrate an understanding of the
community and cultural contexts, and current public health and other
scientific literature and theories as well as other information sources
relevant to the proposed project?
(b) Are the conceptual framework, design, methods, analyses, and
translation plan scientifically strong, well integrated, and
appropriate to achieve the aims of the project and to ensure the
sustainability of effective interventions?
(c) Does the proposed approach explain areas of flexibility as well
as procedures that would be used in responding to conditions that
require changes in research methods or focus as needed?
(d) Does the applicant acknowledge potential problem areas and
consider alternative tactics?
(e) Is there an appropriate work plan and time line included?
(f) Does the project incorporate evaluation activities, including
measurement of progress toward achieving the stated objectives?
(g) does the project include appropriate community involvement in
data collection, analyses, dissemination of results, and participation
in sustainable program development?
3. Innovation
(a) Are the aims clear?
(b) Is this work innovative or does it build upon previous work?
(c) Does the project challenge existing paradigms or develop new
methodologies or technologies?
(d) Does the applicant propose creative research translation
approaches or methods?
4. Investigators
(a) Is there evidence that the proposed project director has
demonstrated knowledge, experience, and ability in planning and
managing research projects that are similar to the proposed project in
complexity, scope, and participatory focus? (Ability includes the
percentage of time each person will devote to each project/activity.)
(b) Is there evidence that the proposed project staff has
demonstrated knowledge, experience, and ability in implementing the
proposed research?
(c) Is there evidence that prior research findings from
investigators have been translated and adopted into public health
practice or policy?
(d) Is there evidence that community-based staff has demonstrated
knowledge, experience, and ability to assist in the implementation of
the proposed research, develops relationships with community members,
and cultivates community participation?
5. Environment/Collaborations
(a) Is there evidence that proposed research and translation
activities will be conducted through partnerships with representatives
of community-based organizations, private and public sector
institutions, State and local health departments, and/or academia, as
appropriate?
(b) Does the research process allow for research partners to apply
their knowledge and contribute to the project's planning,
implementation, and evaluation?
(c) Is there evidence of sufficient institutional support (e.g.,
space, equipment, support from senior faculty, etc.)?
(d) Is there an appropriate degree of commitment and cooperation of
potential partners as evidenced by letters detailing the nature and
extent of their involvement?
6. Target Population (Gender and Minorities)
(a) Are characteristics of the target population(s) well described?

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(b) Are there adequate plans to include both genders, minorities,
and their subgroups as appropriate for the scientific goals of the
research?
(c) Are the plans for recruitment and retention of research
participants satisfactory?
(d) To what extent has the applicant met the CDC policy
requirements regarding the inclusion of women, ethnic, and racial
groups in the proposed research? This includes: (1) The proposed plan
for the inclusion of both sexes and racial and ethnic minority
populations for appropriate representation; (2) the proposed
justification when representation is limited or absent; (3) a statement
as to whether the design of the study is adequate to measure
differences when warranted; (4) a statement as to whether the plans for
recruitment and outreach for study participants include the process of
establishing partnerships with communities and recognition of mutual
benefits.
7. Budget (Reviewed But Not Scored)
The extent to which the budget is clearly explained, adequately
justified, reasonable, sufficient for the proposed project activities,
and consistent with the intended use of the funding.
8. Protection of Human Subjects From Research Risks
Does the application adequately address the requirements of title
45 CFR part 46 for the protection of human subjects? This will not be
scored; however, an application can be disapproved if the research
risks are sufficiently serious and protection against risks is so
inadequate as to make the entire application unacceptable.
9. Inclusion of Women and Minorities in Research
Does the application adequately address the CDC policy requirements
regarding the inclusion of women, ethnic, and racial groups in the
proposed research? This policy includes (1) The proposed plan for the
inclusion of both sexes and racial and ethnic minority populations for
appropriate representation; (2) The proposed justification when
representation is limited or absent; (3) A statement as to whether the
design of the study is adequate to measure differences when warranted;
and (4) A statement as to whether the plans for recruitment and
outreach for study participants include the process of establishing
partnerships with communities and recognition of mutual benefits.
V.2. Review and Selection Process: Applications will be reviewed
for completeness by the Procurement and Grants Office (PGO), and for
responsiveness by NCCDPHP. Incomplete applications and applications
that are non-responsive to the eligibility criteria will not advance
through the review process. Applicants will be notified that their
application did not meet submission requirements.
Applications that are complete and responsive will be evaluated for
scientific and technical merit by an appropriate peer review group or
charter study section convened by NCCDPHP in accordance with the
appropriate review criteria listed above. As part of the initial merit
review, all applications may:
Undergo a process in which only those
applications deemed to have the highest scientific merit, generally the
top half of the applications under review, will be discussed and
assigned a priority score.
Receive a written critique.
Receive a second level review by the NCCDPHP
Internal Review Panel.
Award Criteria: Criteria that will be used to make award decisions
include:
Scientific merit (as determined by peer review).
Availability of funds.
Programmatic priorities.
Specific language provided within each special
interest project description below.
V.3. Anticipated Announcement and Award Dates: September 15, 2004.

VI. Award Administration Information

VI.1. Award Notices: Successful applicants will receive a Notice of
Grant Award (NGA) from the CDC Procurement and Grants Office. The NGA
shall be the only binding, authorizing document between the recipient
and CDC. The NGA will be signed by an authorized Grants Management
Officer, and mailed to the recipient fiscal officer identified in the
application.
VI.2. Administrative and National Policy Requirements: 45 CFR part
74 and part 92.
For more information on the Code of Federal Regulations, see the
National Archives and Records Administration at the following Internet
address: http://www.access.gpo.gov/nara/ cfr/cfr-table-search.html.

The following additional requirements apply to this project:

AR-1 Human Subjects Requirements.
AR-2 Requirements for Inclusion of Women and Racial
and Ethnic Minorities in Research.
AR-8 Public Health System Reporting Requirements.
AR-9 Paperwork Reduction Act Requirements.
AR-10 Smoke-Free Workplace Requirements.
AR-11 Healthy People 2010.
AR-12 Lobbying Restrictions.
AR-22 Research Integrity.
Additional information on these requirements can be found on the
CDC web site at the following Internet address: http://www.cdc.gov/od/

pgo/funding/ARS.htm.
VI.3. Reporting Requirements: Funded applicants must provide CDC
with an original plus two copies of the following reports:
1. Interim progress report, (PHS 2590, OMB Number 0925-0001, rev.
5/2001) no less than 90 days before the end of the budget period.
The progress report will serve as a non-competing continuation
application.
It must contain the following elements:
a. Current Budget Period Activities Objectives.
b. Current Budget Period Financial Progress.
c. New Budget Period Program Proposed Activity Objectives.
d. Budget.
e. Additional Requested Information.
f. Measures of Effectiveness.
2. Financial status report, no more than 90 days after the end of
the budget period.
3. Final financial and performance reports, no more than 90 days
after the end of the project period.
These reports must be mailed to the Grants Management Specialist
listed in the ``Agency Contacts'' section of this announcement.

VII. Agency Contacts

For general questions about this announcement, contact: Technical
Information Management Section, CDC Procurement and Grants Office, 2920
Brandywine Road, Atlanta, GA 30341, Telephone: (770) 488-2700.
For financial, grants management, or budget assistance, contact:
Lucy Picciolo, Grants Management Specialist, CDC Procurement and Grants
Office, 2920 Brandywine Road, Atlanta, GA 30341, Telephone: (770) 488-
2683. e-mail: LPicciolo@cdc.gov.
For Program technical assistance, contact: Margaret Kaniewski,
Project Officer, Prevention Research Centers Office, National Center
for Chronic Disease Prevention and Health Promotion, Centers for
Disease Control and Prevention, 4770 Buford Highway, Northeast, MS K45,
Atlanta, GA 30341-3724, Telephone: (770) 488-5919, e-mail address:
MKaniewski@cdc.gov.

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VIII. Other Information

A forum for questions and answers between CDC and applicants during
the application process will be available as a LISTSERV, a system that
allows for creating, managing, and controlling mailing lists on a
network or the Internet. The mailing list, which will be titled PREV-
CENTERS is a closed list available only to persons and entities
associated with the application process for Announcement Number 04003.
To subscribe to the LISTSERV, the applicant must send an e-mail
message to LISTSERV@LISTSERV.CDC.GOV with the following command in the
body of the message: subscribe PREV-CENTERS. There is no need to write
a ``Subject'' or anything else in the message. The subscriber will then
receive a welcome e-mail message and instructions on how to use
commands for the LISTSERV. After the applicant is subscribed, questions
about this announcement and the special interest projects may be sent
to the following e-mail address: PREV-CENTERS@listserv.cdc.gov.
Do not post confidential information on the LISTSERV because all
members receive the messages and the replies. All confidential matters
should be conducted through direct e-mail, paper correspondence, or
telephone.
Please use the PREV-CENTERS LISTSERV exclusively for posting
questions about the application process for Announcement Number 04003.
Questions will be accepted until the application deadline. All
subscribers to the list will be deleted after the application due date.

IX. New Special Interest Projects (SIPs)

SIP 1-04

Project Title: Effectiveness of population-based interventions to
promote oral health.
Project Description: In 2002 the Task Force on Community Preventive
Services published a systematic review of the evidence of effectiveness
of selected population-based interventions to prevent oral diseases and
promote oral health, and identified gaps in knowledge for oral disease-
or condition-specific interventions. Population-based interventions can
bring about change by (1) providing information and education to
communities on current issues, such as prevention of dental caries
(tooth decay) and periodontal diseases; (2) changing laws and policies
to improve and protect health and well-being, such as mandatory
fluoridation laws; (3) altering the environment to enhance health and
encourage healthy behaviors, for example, through community water
fluoridation; (4) implementing health system changes, such as provider
reminder systems to reduce missed prevention opportunities; and (5)
making preventive services available in non-traditional settings, such
as schools, worksites, and community centers. The Task Force recognized
the need to develop and evaluate approaches that (a) influence
environments and behavior at the individual, family, organizational,
and community levels, and (b) consist of multiple components and
targets of change. Applicants are encouraged to review gaps in
knowledge for oral health promotion and disease prevention that were
identified by the Task Force. (See Truman BI, Gooch BF, Sulemana I, et
al. and the Task Force on Community Preventive Services. Reviews of
Evidence on Interventions to Prevent Dental Caries, Oral and Pharyngeal
Cancers, and Sport-Related Craniofacial Injuries. Am J Prev Med
2002;23(1s): 21-54. Available at: http://www.thecommunityguide.org/pubs/default.htm
). Applicants also are encouraged to review all

interventions recommended by the Task Force across a range of topics
(e.g., vaccine-preventable diseases, diabetes, physical activity) and
levels (e.g., policy/law, health care system, worksite, and general
population) to consider the applicability and feasibility of these
interventions for promoting oral health. (Summaries of recommended
interventions are available at: http://www.thecommunityguide.org/ pubs/

default.htm). These funds will not be used to support determinant
research (i.e., research that examines risk factors for oral diseases).
Consistent with CDC's priority to translate science into public
health practice, funds will be available to support applied research on
the effectiveness of interventions to reduce oral diseases and
conditions and promote oral health at the community or population
level. High priority will be placed on approaches that seek to reduce
disparities in oral health and improve quality of life among older
adults, the poor, and some members of racial and ethnic minority
groups. It is expected that the applicant will build on their effective
relationships with communities to develop investigator-initiated
research that reflects the health priorities of the communities they
serve and demonstrates community participation in the design, conduct,
and interpretation of the studies.
Project Activities: Applications should address the following:
1. Describe a study to assess the effectiveness of a well-defined
intervention or combination of interventions to promote oral health.
2. Show that the interventions are innovative and well supported by
promising findings in the health promotion literature.
3. Describe the proposed setting and study population. Ensure that
the study population has documented oral health needs.
4. Describe appropriate methods to assess the effectiveness of each
intervention or combination of interventions at the individual or
community level, as appropriate.
5. Provide evidence for the feasibility of the research design.
6. Ensure the suitability of the study design for assessing
effectiveness and consistency with design standards (i.e. concurrent or
before-after comparison) established by the Guide to Community
Preventive Services. (See Briss PA, Zasa S, Pappaioanou M, et al.
Developing an Evidence-based Guide to Community Preventive Services-
methods. Am J Prev Med 2000;18(1s):35-43. Available at: http://www.thecommunityguide.org/pubs/default.htm
).

7. Include specific, measurable time-framed objectives for the
three-year study period.
8. Identify key project staff. For each person describe their
demonstrated knowledge, experience, and ability in planning and
conducting intervention research of similar complexity and scope to
that described in this proposal.
9. Describe the established resources and expertise available to
the research staff for conducting intervention research in a timely
fashion.
10. Demonstrate that the project leverages the resources, central
research theme, and established linkages of the Prevention Research
Center.
Preference will be given to applicants who:
(1) Demonstrate experience in the area of analytical epidemiology
or community-based studies.
(2) Have completed earlier exploratory studies related to the
topic(s) of interest.
(3) Propose prospective measurement of exposure and outcome and
concurrent comparison group(s).
(4) Provide record of having published similar research in peer-
reviewed scientific journals.
(5) Implement the study in settings (e.g., workplaces, senior
centers, childcare centers) that reach at-risk populations.
Project Proposal Length and Supporting Material: Proposal
narratives are limited to 20 pages. Supporting materials included in
the appendices should not exceed 20 pages.

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Availability of Funds: Approximately $1,000,000 will be available
to fund up to four Prevention Research Centers for the first year of a
three-year funding period. Each award will be made for no more than
$250,000. Funding may vary and is subject to change.
Research Status: It is expected that these projects will be non-
exempt research. CDC staff will not serve as co-investigators on these
projects, but will provide technical assistance on activities such as
research design, data collection and analysis, and dissemination of
results. Applications should provide a federal wide assurance
registration number for each performance site included in the project.

SIP 2-04

Project Title: The feasibility of a population-based family cohort
study to assess the impact of familial and genomic factors on
population health
Project Description: The purpose of this project is to fund pilot
studies to assess the feasibility of assembling a state-based
representative sample of newborns and their families for the purpose
of:
(1) Using residual newborn blood spots (leftover blood spots from
newborn screening programs) from state programs to assess the
prevalence of selected genetic variants of public health significance
in the United States and among different racial/ethnic subgroups.
(2) Using newborn blood spots to assess the relationship between
genetic variants and selected childhood outcomes (e.g. birth defects,
low birth weight, infant mortality, developmental disabilities) by
linking to various state-based surveillance and information systems.
(3) Recruiting a family cohort composed of child, parents, and
grandparents to study the relation between genetic variation and the
prevalence of adult health outcomes and other risk factors.
(4) Using this family cohort to assess levels of familial risks for
selected chronic diseases based on a core family history tool and to
study associations between familial risks and prevalence of risk
factors and genetic variants.
(5) Recruiting this family cohort for a longitudinal study of
health and disease.
(6) Defining and studying the ethical, legal and social
implications of using newborn blood spots to assemble a cohort for
population-based family studies.
An immense gap currently exists between the scientific products of
the Human Genome Project and their application to the treatment and
prevention of disease. The challenge for public health is to translate
genomic research findings into information that can be used for more
effective health policies and programs. One priority for CDC and its
partners in the next 3-5 years is to conduct public health research to
better understand genomic factors in the health of populations.
Epidemiologic studies are needed of genotype prevalence, gene-disease
associations, and gene-environment interactions to examine individual
susceptibility to diseases related to infections, environmental
exposures, and behaviors. Knowing which subgroups or individuals in the
population are more likely to get sick may be useful for targeting
behavioral or pharmaceutical interventions and reducing the population
burden of various diseases. Understanding the population prevalence of
the thousands of genetic variants in different population groups and
geographic locations and their associations with health and disease is
crucial for planning screening programs and guiding future research.
Most discoveries of gene variants and their association with
disease are based on studies of a few high-risk families or selected
groups. Highly penetrant gene variants have been identified that are
transmitted through families in recognizable mendelian patterns
resulting in mostly rare diseases but also some common diseases like
breast and colorectal cancer (e.g., BRCA1 and APC). Fortunately, these
deleterious gene variants are rare in the population. For the majority
of families, genetic susceptibility is transmitted through many low
penetrant genes that interact with environmental factors to increase
the risk of disease. For example, polymorphisms for genes that code for
carcinogen metabolizing enzymes (e.g., NAT2 and MGMT) can increase the
risk of cancer. Population-based studies are needed to estimate the
frequency of gene variants, environmental exposures, and disease/
disability outcomes in different subgroups of the population and
explore the interactions between gene variants and exposures that
influence outcomes. Advantages of a cohort study design are the ability
to study rare exposures (gene variants); establish temporal
relationships between gene variants, environmental exposures and
disease; and study the multiple effects of a single gene variant or
exposure. A family-based study design will allow the study of three
generations and common age-associated diseases such as developmental
disabilities, heart disease, and Alzheimer's. This can be accomplished
in a shorter time frame than following individuals from birth through
the life stages. In addition, family-based studies can be used to
evaluate the clinical validity (predictive value) of family medical
history and can be used to determine the genetic etiology of certain
traits or diseases.
A large-scale family-based cohort study will be complex and
resource intensive so it is important that the feasibility of this
study design be determined first through smaller pilot studies. For
example, there are several options and methods for identifying and
recruiting the index child; blood spots from state newborn screening
programs could be used as the initial sampling frame or ongoing
population-based studies of newborns could be used as the foundation
for developing the family cohort. Additional issues to consider are:
The feasibility of identifying, locating, and
contacting parents and grandparents of the index child.
The feasibility of linking individuals with
existing administrative databases and obtaining information from
medical records.
Obstacles and incentives for participation in
research that includes DNA analysis.
Models for community participation and public
education about genomic studies.
Providing informed consent and assurances of
privacy and confidentiality.
Options and methods for biologic specimen
collection (DNA sources), processing, and storage.
Methods for selecting genes (and variants) to be
studied.
Options for laboratory and bioinformatics
technology for genotyping.
Project activities: Approximately 2 to 3 pilot studies will be
funded to address the feasibility of a collaborative family-based
cohort study as described by the six activities numbered above. Pilot
study activities might include the following:
1. Identifying a random sample of approximately 10,000 newborns
using residual newborn blood spots from state programs (options for
sample selection and over-sampling of minority groups or infants with
selected outcomes should be considered).
2. Assessing the prevalence of selected genetic variants from the
blood spots or other DNA sources.

[[Page 15446]]

3. Linking the newborn blood spots to state-based surveillance and
information systems.
4. Taking a 10% sample (1000) of the blood spots and contacting the
parents and grandparents about participating in a study.
5. Administering a questionnaire (risk factors and personal and
family medical history) and collecting buccal cells (cells scraped from
the inside of the cheek) from the parents and grandparents.
6. Obtaining health outcome information for participants from
medical records.
7. Following up study participants at 6 months and 1 year post-
enrollment.
8. Analyzing the questionnaire and DNA data.
Particular attention should be given to the ethical, legal, and
social implications of using newborn blood spots as the basis of a
family-based cohort study design; standardized and in-depth
documentation of reasons for non-participation; resources and effort
required to identify and contact parents and grandparents; ability to
re-contact and follow the cohort over time; technological and
laboratory issues concerning DNA collection, storage and processing;
and the application of the processes on a much larger scale.
Preference will be given to:
1. Collaborations between state health departments and academic
institutions;
2. Applicants who are knowledgeable and experienced in
Epidemiological and community-based research;
3. Applicants with the capacity for doing genomics research that
might include DNA banking, genetic-related IRB issues, and the use of
genetic epidemiological methods.
Project Proposal length and Supporting Materials: Proposed
narratives are limited to 20 pages. Supporting materials included in
the appendices should not exceed 30 pages.
Availability of Funds: Two to three Prevention Research Centers
will be funded at approximately $300,000-$400,000 per center per year
for three years. Funding may vary and is subject to change. Preference
will be given to funding applicants that will aid in providing
geographic diversity for the feasibility studies.
Research Status: It is expected that projects will be non-exempt
research. CDC staff will serve as co-investigators on these projects
and will provide technical assistance on activities such as research
design, data collection and analysis, and dissemination of results. It
is expected that this project will require CDC IRB approval. The CDC
IRB will review and approve the protocol initially and on an annual
basis until the research project is completed. Applications should
provide a federal wide assurance registration number for each
performance site included in the project.

SIP 3-04

Project Title: Healthy Passages: A Community-based Longitudinal
Study of Adolescent Health.
Project Description: Healthy Passages is a longitudinal study
conducted in three communities--Houston, Texas; Birmingham, Alabama;
and Los Angeles, California. Healthy Passages will help us understand
why some youth engage in healthful behaviors while others engage in
risky behaviors that affect their health, education, and social well
being. Funds are available to support implementation of the full study
among a cohort of 1,750 fifth-grade youth in each community.
A limited number of health risk behaviors, generally established
during childhood and adolescence, account for the overwhelming majority
of immediate and long-term morbidity, mortality, disability, and social
problems among adolescents and young adults. These behaviors include
carrying a weapon, physical fighting, attempted suicide, drinking when
driving, and unprotected sexual intercourse. In addition, use of
tobacco, unhealthy dietary behaviors, and physical inactivity,
behaviors also established during childhood and adolescence, contribute
substantially to morbidity and mortality in adulthood.
Previous and on-going longitudinal surveys and research studies
have made important contributions to understanding the association
between health risk behaviors and their determinants. However, these
studies are often limited in scope, limited in duration, or assess
participants at infrequent intervals. In addition, although previous
research has shown differences in health outcomes across racial and
ethnic groups of youth, the sources of those differences have yet to be
systematically investigated.
The objectives of the project are as follows:
Fund three Healthy Passages Research Centers
(HPRC) in geographically distinct metropolitan areas to (1) establish
and assess on a biennial basis a cohort of youth from age 10 (fifth
grade) through age 20; and (2) identify the etiological factors,
including individual, family, school, and community influences, that
predict health risk behaviors and related health outcomes and are
important for understanding disparities in health outcomes across
racially and ethnically diverse populations.
Implement a collaborative research study among
the funded HPRCs for implementation of the study design, development of
study instruments for each wave of data collection, and dissemination
of study results through peer reviewed publications and presentations
at scientific meetings.
Sustain the collaboration between the funded
HPRCs and CDC on the development and implementation of the study.
Participate in quarterly project meetings that
include key staff members from each HPRC and key CDC staff.
Project Activities: Applicants should address the following project
activities:
1. Significance:
Identify and justify the health risk behaviors
and health, educational, and social outcomes to be measured.
Identify and justify the etiologic factors
thought to influence health risk behaviors and health, educational, and
social outcomes. Etiologic factors should include factors at the
individual, family, school, and community levels.
Describe research goals, objectives, and
research questions.
Describe how study results can be used to
develop effective strategies for promoting adolescent health across a
broad range of social institutions.
Describe how study results will be important in
understanding disparities in health outcomes across racially and
ethnically diverse populations.
2. Approach:
Describe the conceptual framework and how the
framework incorporates health risk behaviors; health, educational, and
social outcomes; and etiological factors.
Describe plans for instrument development, data
collection, data management, and data analysis.
Describe the plans for training data collectors.
Describe the quality assurance evaluation and
monitoring for all research activities.
Describe plans for data handling and storage,
assurance of confidentiality, and linkage of data across occasions.
Describe the potential limitations of the study.
Identify the project work plan and timeline.
Describe the community involvement in the
research project.
Provide a clear dissemination plan to work
collaboratively with the other HPRCs and CDC to ensure that analysis
and production of peer-reviewed papers, presentations, and reports are
developed in a timely manner.

[[Page 15447]]

3. Innovation:
Describe how the proposed research builds upon
pilot studies.
Describe how the proposed research will
translate into the development of effective policies and programs.
4. Investigators:
Describe the research team and demonstrate that
the proposed research staff represent an interdisciplinary team of
behavioral and social scientists, epidemiologists, and statisticians
with the scientific training and previous scientific and practical
experience needed to conduct the research.
Provide evidence that the Principal Investigator
has successfully participated in collaborative, multicenter research
projects, longitudinal studies, and research studies related to the
health of youth.
Demonstrate the adequacy of the proposed staff
to carry out all project activities (i.e., sufficient in number,
percentage of time commitment to this and other projects, and
qualifications).
5. Environment and collaborations:
Describe the involvement of community-based
organizations and key members of the targeted population in a Community
Advisory Committee and provide letters of support describing their role
in the proposed research activities.
Describe facilities and systems for data
security and maintenance of participant confidentiality.
Describe institutional support in terms of
space, equipment, etc.
6.Target population:
Provide evidence of the ability to recruit and
enroll 1,750 10-year-old (fifth grade) children divided between at
least two of the three major race/ethnic groups (white, African-
American, and Hispanic).
Provide information on the sampling strategy to
assure appropriate representation by gender and race/ethnicity.
Describe plans to obtain participation of
adequate numbers of the targeted population.
Provide a detailed plan of the expected sample
attrition, how study participants will be tracked, and what strategies
will be used to increase retention.
7. Budget:
Provide a detailed line-item budget for year 1
that is adequately justified, sufficient for project activities, and
consistent with the intended use of the funds.
8. Human subjects:
Provide evidence that the applicant complies
with DHHS regulations regarding the protection of human subjects.
Preference will be given to applicants who:
1. Have extensive experience in conducting longitudinal studies
among children and adolescents;
2. Can demonstrate pilot studies to inform implementation of the
longitudinal study;
3 .Can provide a record of scientific publications from similar
studies.
Project Proposal Length and Supporting Materials: Proposal
narratives are limited to 20 pages. Supporting materials included in
appendices should include survey instruments and consent forms for year
1 data collection, biographical sketches, and letters of support.
Availability of Funds: Approximately $3,600,000 is available to
fund up to three Prevention Research Centers in the first year of a 5-
year project period. Individual awards are expected to range from
$1,100,000 to $1,300,000. Funding may vary and is subject to change.
Research Status: Healthy Passages is non-exempt research. CDC staff
will serve as co-investigators on these projects and will provide
technical assistance on activities such as research design, data
collection and analysis, and dissemination of results. Healthy Passages
has CDC IRB approval. The CDC IRB reviews and approves the protocol on
an annual basis until the project is completed. As applicable,
applicants should provide a federal-wide assurance registration number.

SIP 4-04

Project Title: Evaluation of abstinence-only and abstinence-plus
programs to prevent HIV, STD, and pregnancy among middle school
students.
Project Description: Beginning in the 1990s, the prevalence of
sexual intercourse decreased among high school students, particularly
among males, African Americans, and whites. In addition, the number of
adolescents using condoms at last intercourse increased. Despite these
improvements, adolescents continue to be at risk for HIV infection,
other sexually transmitted diseases (STD), and pregnancy. Between 1994
and 2000, 14% of HIV cases were diagnosed among youth aged 13-24; one
in every four cases of STD diagnosed annually in the United States
occurs among teenagers; and in 1997, 840,000 pregnancies occurred among
15 to 19 year olds in the United States.
Starting in the 1990s, major legislative initiatives have funded
both abstinence-only and abstinence-plus programs to prevent HIV, STD,
and pregnancy among adolescents. The efficacy of both kinds of programs
and their role in the decrease in sexual risk behaviors among youth has
been debated. Further studies are necessary to explore the relative
efficacy of these approaches. Funds are available to support a five-
year evaluation project to test the efficacy of an abstinence-only
sexual risk reduction program for middle school students relative to a
comparable abstinence-plus program and relative to standard care.
For purposes of this announcement, abstinence-only programs
emphasize sexual abstinence (that is, refraining from vaginal, oral,
and anal sexual activity). Abstinence interventions should address all
of the following elements; however, programs need not place equal
emphasis on each of the following: (1) Teaches abstinence from sexual
activity outside of marriage as the expected standard for all school
age children; (2) teaches that abstinence is the only certain way to
avoid out-of-wedlock pregnancy, STD, and other health problems; (3)
teaches that a monogamous relationship in context of marriage is the
expected standard of human sexual activity; (4) teaches that sexual
activity outside of marriage is likely to have harmful effects; (5)
teaches that bearing children out-of-wedlock is likely to have harmful
consequences; (6) teaches young people how to avoid sexual advances and
how alcohol and drug use increases vulnerability to sexual advances;
(7) teaches the importance of attaining self-sufficiency before
engaging in sexual activity; and (8) teaches the gains to be realized
by abstaining from sexual activity. (See http://www.mchb.hrsa.gov/programs/adolescents/statefs.htm
for information on Title V Abstinence

Education criteria and for ordering information for the Title V
guidance.)
Abstinence-plus programs include information and skills related to
abstinence, condom and other barrier use, and contraception.
Abstinence-plus programs address avoiding or reducing sexual risk
behaviors and address specific antecedents of sexual risk behaviors
such as reducing social pressures to engage in sexual activity; or
increasing negotiation and communication skills. Abstinence-plus
programs, for purposes of this announcement, do not include clinically-
based programs, or programs that focus on offering clinical services to
adolescents.
Project Activities: Applicants should address the following:
1. Describe a study that includes a developmental phase in which
known, effective interventions are adapted and pilot-tested for use in
equivalent

[[Page 15448]]

abstinence-only and abstinence-plus arms of the study, and a comparison
or standard care intervention is specified. This study may include, but
is not limited to: (a) Adapting existing interventions based on sound
behavior change theory or from empirically supported interventions for
middle school students. The proposed interventions may be adapted to
become equivalent school-based abstinence-only and abstinence-plus
interventions. The proposed interventions may include multiple booster
sessions. Interventions may include innovative components such as
parent or family involvement, youth asset development, community
service learning, or mentoring by youth or adults. Interventions should
be targeted toward youth in communities disproportionately affected by
HIV, STD, or unintended pregnancy; (b) Convening panels consisting of
individuals from participating communities, and programmatic and
evaluation experts experienced in abstinence-only and abstinence-plus
interventions to provide input on the content, and assessment of, the
developed interventions; (c) Pilot-testing interventions and data
collection instruments among youth comparable to those proposed as
participants in the evaluation study.
2. Describe a study that includes an evaluation phase to test the
efficacy of these interventions relative to a standard care control or
comparison group. This portion of the study may include, but is not
limited to: (a) Designing and conducting a longitudinal experimental or
quasi-experimental study with follow-up of participants for short
period of time (e.g. minimum of 24 months), including clear
conceptualization of the control or comparison group consisting of
standard care in schools or a standard control intervention; (b)
Proposing a population of middle-school students in communities
disproportionately affected by HIV, STD, or teen pregnancy to
participate in the study; (c) Determining the primary outcomes of the
study that include, but are not limited to, sexual risk behaviors,
intentions to engage in sexual risk behaviors, and biological markers
for STD; (d) Determining secondary outcomes of the study that would
include psychosocial outcomes (such as self-efficacy, attitudes,
normative beliefs), and knowledge; intervening variables that may
identify sub-populations for whom the interventions have particular
impact; and unique outcomes appropriate to intervention components; (e)
Outlining plans to sustain interventions in the target community that
are found to be efficacious; and (f) Outlining plans to disseminate
research results.
In addition, applicants should address the following issues:
1. Significance: Describe the extent to which the proposed research
addresses important public health issues, and how it will advance
knowledge about sexual risk interventions through generalizable and
internally valid research.
2. Approach: Describe the following: the proposed interventions to
be adapted and the process of adaptation and consultation, including
community input in all phases of the proposed research; the proposed
evaluation design including a conceptual framework based on behavior
change theory or empirical findings, and a description of the sample
size, matching or randomization plan, statistical power, longitudinal
data management plan, and statistical analyses; anticipated problems
and methods used to respond to them; plans to sustain efficacious
programs; plans to disseminate findings; and a proposed work plan and
timeline.
3. Innovation: Describe the following: how the proposed research
builds upon prior research and what innovative programmatic and
research components are proposed, including creative program adaptation
approaches and methods.
4. Investigators: Describe the following: experience of proposed
staff in program adaptation and in conducting all phases of behavioral
intervention evaluations for adolescents; experience in working with
schools and school-based interventions; current commitments of proposed
staff and the percent of time that each staff member will devote to the
project; prior experience in working with community members and program
staff and researchers who represent a broad spectrum of policy outlooks
and programmatic approaches.
5. Environment/Collaborations: Describe the following: experience
in forming partnerships with community members; experience in forming
partnerships with programmatic staff and researchers who are
experienced with abstinence-only and abstinence-plus research; evidence
of support for the proposed research from community, programmatic, and
research collaborators; methods to create and maintain productive
collaboration; institutional support including resources such as space
and equipment; letters of support from proposed collaborators.
6. Target Population: Describe the following: demographic
characteristics and sexual risk behaviors among the proposed
intervention participants, and disproportionate impact of HIV, other
STD, or pregnancy on the proposed community; plan to include both
genders and ethnic minorities as appropriate to the proposed research;
plans to recruit and retain participants; plans to longitudinally link
participants' responses; and plans to meet CDC policy requirements
regarding the inclusion of women and ethnic and racial groups.
7. Budget: Provide a clear budget, and provide a narrative that
adequately justifies expenditures as reasonable, sufficient for the
proposed project activities, and consistent with the intended use of
the funding.
Project Proposal Length and Supporting Material: Applications
should not exceed 20 pages, and appendices should not exceed 30 pages;
the appendices should include biographic sketches, position
descriptions of staff (if needed), letters of support, proposed
membership lists of panels, and other evidence as consistent with the
proposal.
Availability of Funds: Approximately $1,000,000 is available to
fund one Prevention Research Center in the first year of a 5-year
project. Funding may vary and is subject to change.
Research Status: This project is anticipated to be non-exempt
research. CDC staff will serve as co-investigators on this project and
will provide technical assistance on activities such as research
design, data collection and analysis, and dissemination of results.
This project will require CDC Institutional Review Board (IRB)
approval. The CDC IRB reviews and approves the protocol on an annual
basis until the project is completed. As applicable, applicants should
provide a federal-wide assurance registration number. Additional
clearances, such as certificates of confidentiality, may also be
needed.

SIP 5-04

Project Title: Establishment of a Physical Activity Policy Research
Network (PAPN)--Participating Network Center.
Project Description: Significant improvements in public health have
been achieved through health policy interventions in areas such as
tobacco control and injury prevention. Currently, research is being
conducted through the Prevention Research Centers (PRC) addressing
physical activity. However this research has a primary focus on
identifying environmental, social or individual correlates of
participation in physical

[[Page 15449]]

activity where physical activity or disease endpoints are the outcome
measures. The Physical Activity and Health Branch, Division of
Nutrition and Physical Activity, National Center for Chronic Disease
Prevention and Health Promotion seeks to support the creation of a
Physical Activity Policy Research Network to foster understanding of
the effectiveness of health policies related to increasing physical
activity in communities. The network, which would have long-term
sustainability for physical activity policy research, will have one
lead center and several participating centers. This particular project
is for the participating centers only.
PRCs are housed within schools of public health, medicine, or
osteopathy, which primarily work with stakeholders within those
traditional fields of public health. This current structure poses a
barrier to the potential non-traditional, transdisciplinary nature of
physical activity policy research. In addition to traditional public
health partnerships, this proposed network would establish active and
productive collaborations with non-traditional partners including
researchers and practitioners in political science, law, architecture,
and urban planning and design. The network will rely on cross-
disciplinary collaboration to achieve its objectives.
Recently, accomplishments have been made toward developing a
framework for physical activity public health policy research. This
framework was developed through a series of three CDC workshops that
gathered information and opinions from national experts. During these
workshops, the following priorities were identified as critical to
future physical activity policy research: (1) Schools; (2) Worksites;
(3) Parks and Public Spaces; (4) Walkability; (5) Safety and Crime; (6)
Economic Factors; and (7) Liability. Participants also concluded that
policy research involves more than just understanding whether or not a
policy is effective. Policy research can involve (1) identifying
policies that affect physical activity levels; (2) identifying
determinants of why some policies are adopted and others are not; (3)
research on how to implement a policy so that it is effective; and (4)
the outcomes of policy implementation. Research is lacking on
understanding the contribution of health policies to increasing
community physical activity levels.
Project Activities: Applicants should address the following:
1. Discuss how the center would collaborate with the PAPN Lead
Coordinating Center and CDC to advance a physical activity research
policy agenda.
2. Identify resources in areas relevant to public health and
physical activity within or available to your PRC. Discuss how these
resources could be involved in and enhanced through the proposed
network. Discuss the potential and need for collaboration with
community-based organizations and public health departments to enhance
dissemination and impact of policy research.
3. Document that your center will work with the other PAPN network
centers in prioritizing and choosing topics for research, intervention
or translation.
4. Describe how your center will work with the PAPN network and
other partners to develop evidence-based interventions that can be
implemented in communities.
Centers are expected to actively participate in the network and to
identify and develop one pilot project in physical activity policy.
Applicants should develop collaborative projects for creation and
evaluation of physical activity policy frameworks in one or more of the
following policy research areas:
1. Transportation planning and urban design models that incorporate
valid measures of active transport such as walking, bicycling, and
other forms of physical activity.
2. Links between transportation and urban design policies and
community levels of physical activity.
3. Surveillance techniques to assess and track key indicators of
policies that promote or inhibit physical activity.
4. Case studies of school setting within a community and the effect
on physical activity and correlates (e.g., community, social
interaction, transportation, health, and economic impact).
5. Detailed review and analysis of the economic impact of smart
growth and traditional neighborhood design as they relate to physical
activity.
The project results are expected to include the following:
1. Development of a multidisciplinary physical activity policy
research network.
2. Satisfactory progress in each of the five areas of interest
outlined above.
3. Communication of progress and findings through meetings and
publications.
4. Plans for network sustainability and growth.
Research results should help inform activities of CDC-funded state
programs for promoting physical activity. Issues related to diversity,
social equity, and health disparities should be built into the core
policy agenda. Multiple traditional and non-traditional partnerships
necessary for a successful project should be addressed.
Preference will be given to applicants that document or demonstrate
the ability to establish formal working agreements with multiple
disciplines such as law, economics, political science, architecture,
and urban design and that include a state health department as part of
the project team.
Project Proposal Length and Supporting Material: Application
proposals should not exceed 20 pages, excluding appendices and
supporting materials. Appendices should not exceed a total of 30 pages.
Availability of Funds: Three to five centers will receive funding
to be part of the physical activity policy network. Funding will be up
to $60,000 per center, per year for a period of three years. The
composition of the working group and the individual projects proposed
by the sites cannot be known in advance; therefore, some sites may be
asked to revise their scope of work so that (1) two or more sites
collaborate on a policy research project and/or (2) policy research
areas deemed a priority by the network and CDC are assigned to at least
one PRC. Funding may vary and is subject to change.
Research Status: The operations of the network itself will not
involve research on human subjects. However, the pilot projects chosen
may involve IRB review. CDC staff will assist network centers in making
human subject determinations.

SIP 6-04

Project Title: Establishment of a Physical Activity Policy Research
Network (PAPN)--Lead Coordinating Center.
Project Description: Significant improvements in public health have
been achieved through health policy interventions in areas such as
tobacco control and injury prevention. Currently, research is being
conducted through the Prevention Research Centers (PRC) addressing
physical activity. However this research has a primary focus on
identifying environmental, social or individual correlates of
participation in physical activity where physical activity or disease
endpoints are the outcome measures. The Physical Activity and Health
Branch, Division of Nutrition and Physical Activity, National Center
for Chronic Disease Prevention and Health Promotion seek to support the
creation of a Physical Activity Policy Research Network designed to
foster advances in understanding the effectiveness of health policies
related

[[Page 15450]]

to increasing physical activity in communities and with long-term
sustainability for physical activity policy research. This Special
Interest Project would provide the funding necessary for one PRC to
take the leadership responsibility in coordinating the Physical
Activity Policy Research Network described in SIP 5-04.
PRCs are housed within schools of public health, medicine, or
osteopathy, which primarily work with stakeholders within those
traditional fields of public health. This current structure poses a
barrier to the potential non-traditional, transdisciplinary nature of
physical activity policy research. In addition to traditional public
health partnerships, this proposed network would establish active and
productive collaborations with non-traditional partners including
researchers and practitioners in political science, law, architecture,
urban planning and design. The network will rely on cross-discipline
collaboration to achieve this objective.
Recently, substantial accomplishments have been made toward
developing a preliminary framework for physical activity public health
policy research. This framework was developed through a series of three
CDC workshops that gathered information and opinions from national
experts. During these workshops, the following priorities were
identified as critical to future physical activity policy research: (1)
Schools; (2) Worksites; (3) Parks and Public Spaces; (4) Walkability;
(5) Safety and Crime; (6) Economic Factors; and (7) Liability.
Participants also concluded that policy research involves more than
just understanding whether or not a policy is effective. Policy
research can involve: (1) Identifying policies that affect physical
activity levels; (2) identifying determinants of why some policies are
adopted and others are not; (3) research on how to implement a policy
so that it is effective; and (4) the outcomes of policy implementation.
Research is lacking on understanding the contribution of health
policies to increasing community physical activity levels.
Project Activities: Applicants should address the following:
1. Explain the organization and interaction of the Coordinating and
Collaborating centers. Discuss the relationship with relevant CDC
activities. Define performance expectations for the network.
2. Explain how the proposed PAPN would draw on community
collaborations to enhance physical activity public health policy
research. Discuss additional partners who may have a stake in the work.
Address the dissemination of relevant information beyond the scientific
literature, specifically to communities.
3. Describe how the network Coordinating Center will provide
leadership in fostering and growing the network. Indicate how this
growth will be assessed and monitored during the project period.
4. Describe how the Coordinating Center will represent and promote
the PAPN and its member centers within the PRCs and to external
partners.
5. Describe how the Coordinating Center will participate as a
general member of the PAPN, including identifying established resources
in areas relevant to public health and physical activity within or
available to the PRC, and how you will work with the other network
centers to prioritize topics for research and intervention development.
6. Describe the process by which each member center's
contributions, including individual roles and responsibilities for the
projects and activities, will be determined.
Preference for the Coordinating Center will be given to: Applicants
who can document or demonstrate the ability to (1) manage multi-
discipline, multi-site initiatives and (2) establish formal working
agreements with disciplines such as law, economics, political science,
and architecture and urban design and that include a state health
department as part of the project team. The Coordinating Center will be
expected to coordinate the PAPN, document network results, and plan and
coordinate a meeting at which the work of other network members will be
presented. The Coordinating Center will also coordinate any activities
undertaken with partners external to the network. Working with CDC, the
Coordinating Center will divide the work among the members of the
network.
Project Proposal Length and Supporting Material: Application
proposals should not exceed 20 pages, excluding appendices and
supporting materials. Appendices should not exceed a total of 30 pages.
Availability of Funds: Approximately $30,000 is available to
support one Lead Coordinating Center per year for a three-year period.
Applicants applying for this SIP 6-04 as the Coordinating Center must
apply as a PAPN participating center under SIP 5-04. The applicant
selected as the Coordinating Center will have an approximate total
budget of $90,000 annually ($30,000 for leadership and coordination;
$60,000 for network member activities). The composition of the working
group and the individual projects proposed by the sites cannot be known
in advance; therefore, some sites may be asked to revise their scope of
work so that (1) two or more sites collaborate on a policy research
project and/or (2) policy research areas deemed a priority by the
network and CDC are assigned to at least one PRC. Funding may vary and
is subject to change.
Research Status: The operations of the network itself will not
involve research on human subjects. However, the pilot projects chosen
may involve IRB review. CDC staff will assist network centers in making
human subject determinations.

SIP 7-04

Project Title: Investigation of the role of school-based physical
activity on indicators of academic performance among elementary school
children
Project Description: Schools are a natural environment for physical
activity promotion. Most children are enrolled in schools where
facilities and infrastructure exist to help promote physical activity.
Recent successes in improving physical education training and delivery
for elementary school children are examples of what is possible in
targeting schools for physical activity programs.
The literature on the role that physical activity may play in
academic achievement is sparse. Academic achievement can be assessed in
a variety of ways, including distal outcomes for standardized test
scores, or more proximal outcomes such as acute learning, time-on-task,
disruptive behavior, daily attendance, etc. School-based physical
activity need not be limited to only physical education curriculum, but
should also include multiple inputs such as environmental supports
(equipment and infrastructure), classroom activities, after-school
activities and intramural/interscholastic activities. The intent of
this project is to seek to study the effects on the role physical
activity may play in academic or classroom settings.
Project Activities: The overall objective of this project is to
support the design, conduct, and evaluation of an experimental
investigation into the role that physical activity may play in academic
performance and its associated indicators among elementary school
children.
Preference will be given to applicants with demonstrated experience
in school based physical activity interventions. An adequate cross-
section of grade levels in elementary schools is desired. Applicants
should take a broad

[[Page 15451]]

approach to defining key outcomes of interest of academic achievement
and include both distal and proximal variables. Physical activity
efforts should focus not only on physical education, but other
potential exposures as well such as classroom, after-school, recess,
and sports participation.
It is expected that applicants/investigators will design, conduct,
and evaluate an experimental investigation into the role that physical
activity may play in academic performance and its associated indicators
among elementary school children. All aspects of the design, including
conceptualization, sample size estimation, intervention design, data
collection and analysis, and reporting will be the responsibility of
the applicant/investigator(s). Design characteristics should include
the ability to evaluate a dose-response effect if one exists.
Project Proposal Length and Supporting Material: Application
proposals should not exceed 20 pages, excluding appendices and
supporting materials. Appendices should not exceed a total of 30 pages.
Availability of Funds: It is anticipated that $400,000-$450,000 per
year for up to three years will be available to fund one Prevention
Research Center for this project. Funding may vary and is subject to
change.
Research Status: It is expected that this will be non-exempt
research. CDC staff will not serve as co-investigators on this project
but will provide technical assistance on activities such as research
design, data collection and analysis, and dissemination of results. As
applicable, applications should provide a federal wide assurance
registration number for each performance site included in the project.

SIP 8-04

Project Title: Development of a Brief Physical Activity Assessment
Tool for Use in Medical Settings as a Patient Chart Variable.
Project Description: Despite recommendations for health care
providers to counsel patients to be physically active (including
Healthy People 2010 health objectives for the nation), there are few
health care settings with physical activity chart variables or
recordkeeping systems to evaluate or track patients' physical activity
habits. Such information may be beneficial for physicians and other
health care providers to identify patients at risk from inactivity, or
with health conditions (e.g., obesity, hypertension, hyperlipdemia,
cardiovascular disease, diabetes, low/abnormal bone density levels,
etc.) that may be improved by increased participation in physical
activity. A physical activity chart variable may also yield data that
health plans can use to determine the economic burden of physical
inactivity specific to their own patient population. Furthermore, a
physical activity chart variable may serve as a catalyst for
physicians/providers to triage patients' to obtain an in-depth physical
activity assessment or to physical activity program. Although protocols
are available to assist health care providers do physical activity
assessment and counseling, these standardized procedures are perceived
by some in the health care field to be too lengthy for use during
routine medical care practice. Thus, there is a need for physicians and
other health care providers to rapidly assess a patient's physical
activity level, and at minimum, provide a patient with a recommendation
to increase physical activity when warranted.
The purpose of the proposed funding is to support the development
of a ``rapid assessment'' physical activity tool that can be used as a
chart variable. It can be incorporated into a health care system
infrastructure to allow for the assessment and tracking of patients'
physical activity behaviors, prompt provider recommendations to
patients to be active, and monitoring economic factors of economic.
Project Activities: Funding will be awarded to develop a valid and
reliable rapid assessment tool to be used as a physical activity
patient chart variable, with patients 18 years and older. An empirical
or intuitive approach to item development may be used. Year 1
activities are to (1) develop an assessment tool (chart variable), and
(2) plan and conduct a study to determine the validity and reliability
of the item(s)/assessment tool. Year 2 activities are to plan and
conduct a feasibility study using the item(s)/assessment tool in
clinical settings. These activities will result in the following study
outcomes: (1) The PI will take the lead on the development and
feasibility testing of a valid and reliable physical activity chart
variable that can be used in standard medical care practice (including
publication of scientific articles). (2) A physical activity chart
variable will be available for use in health care settings (a) to
monitor the physical activity behavior of patients and prompt
recommendations for patients to increase physical activity, and (b) to
link a physical activity chart variable to health, medical care
utilization, and medical expenditure outcomes.
Project Proposed Length and Supporting Materials: Application
proposals should not exceed 15 pages excluding appendices and
supporting materials. Appendices should not exceed a total of 10 pages.
Availability of Funds: One PRC will be funded for this project, for
a two-year period. Approximately $232,750 is available for the two-year
period. It is anticipated that year one costs may be lower than year
two costs, both years totaling to $232,750.
Research Status: It is expected that this will be non-exempt
research. CDC staff will not serve as co-investigators on this project
but will provide technical assistance on activities such as research
design, data collection and analysis, and dissemination of results.
Applications should provide a federal wide assurance registration
number for each performance site included in the project.

SIP 9-04

Project Title: Investigation of Pedometers and Step Counters for
Physical Activity Promotion.
Project Description: Physical activity levels in the U.S. currently
are measured with national surveys (telephone or interview) that
require respondents to characterize their usual level of leisure time,
occupational, household and transportation related physical activity.
Respondents are further asked to characterize the intensity of
participation (moderate or vigorous). Data from these national surveys
indicate fewer than 50% of U.S. adults are currently active at levels
thought to promote and maintain health.
Walking is the most frequently reported source of physical activity
among U.S. adults. Recently, community and individual physical activity
promotion programs have emerged that rely on the accumulation of daily
steps toward a target goal as a prime physical activity strategy. These
programs rely on either a static daily goal (e.g., 10,000 steps each
day) or on a progressive goal (e.g., an additional 2,000 steps each day
from baseline). Regardless of the program, electronic pedometers and
step counters are used to help participants monitor their daily step
accumulation and as a behavioral tool for prompting and goal setting.
Despite recent studies, there are few health outcomes data on which
to base daily step recommendations. More specifically, there is a
paucity of information on how (or if) step counters and pedometers can
be used to promote congruence with physical activity recommendations
based on scientific evidence of their relation to health outcomes
(e.g., CDC/ACSM physical activity recommendations). Existing

[[Page 15452]]

step accumulation programs do not specifically promote intensity (e.g.,
at least moderate-intensity) or duration (e.g., at least 8-10 minute
continuous bouts); both of which are central tenets of evidence-based
public health recommendations for physical activity promotion. The
purpose of this project is to generate scientific research to help
understand the role that step counters and pedometers play in helping
to promote existing physical activity recommendations.
Project Activities: The overall objective of the project is to
support the design, conduct, and evaluation of scientific assessments
of the utility of electronic step counters and pedometers in helping to
promote physical activity recommendations for adults. Investigators on
the project, working closely with CDC staff, will design evaluation
studies to meet this objective.
Preference will be given to applicants who have documented skills
in physical activity promotion programs which include step counters
and/or pedometers. Proposals should consider aspects of both physical
activity intensity and duration as they may relate to daily
accumulation of steps. Aspects of the uses of electronic step counters
and pedometers for population physical activity assessment and
individual interventions should be considered.
All aspects of the design, including conceptualization, sample size
estimation, intervention design, data collection and analysis, and
reporting will be the responsibility of the investigators. An adequate
cross-section of a variety of settings is desirable as is diversity in
age, gender, and race or ethnicity of the populations examined. Design
characteristics should include the ability to evaluate a dose-response
effect if one exists. Also of interest are behavioral aspects of
pedometer use and potential health outcomes associated with their use
as physical activity promotion tools.
Project Proposal Length and Supporting Material: Application
proposals should not exceed 20 pages, excluding appendices and
supporting materials. Appendices should not exceed a total of 30 pages.
Availability of Funds: It is anticipated that up to $200,000 per
year for 3 years will be available to fund one Prevention Research
Center. Funding may vary and is subject to change.
Research Status: It is anticipated that this project will be non-
exempt research. Human subject research will be involved and CDC IRB
approval will be required. CDC staff will serve as a co-investigator on
this project and will provide technical assistance on activities such
as research design, data collection and analysis, and dissemination of
results. Applications should provide a federal wide assurance
registration number for each performance site included in the project.

SIP 10-04

Project Title: Center of Excellence in Public Health Training and
Intervention Research Translation: WISEWOMAN and Obesity Prevention
Programs.
Project Description: The intent of the special interest project is
to develop a Center of Excellence in Public Health Training and
Intervention Research Translation. The Center will address training and
intervention research translation needs of two CDC programs funded
through the Division of Nutrition and Physical Activity: the WISEWOMAN
program and the Obesity Prevention Program. The Center will begin by
addressing the component needs of the programs described below. The
Center will likely expand its activities in the future and serve as a
model for other Centers of Excellence in Public Health Research
Translation and Training.
Little is known about effective obesity and chronic disease
interventions, especially those interventions addressing disparities.
The public will benefit: (1) By having services provided by a well-
trained public health professional staff in the areas of obesity,
cardiovascular health, and other chronic diseases and (2) from the
translation of effective preventive health programs that will meet
their particular needs in addressing obesity, cardiovascular and other
chronic diseases.

CDC Program Descriptions

WISEWOMAN Program: WISEWOMAN funds 14 projects throughout the
United States that provide low-income, underinsured, or uninsured 40 to
64 year old women, with the knowledge, skills, and opportunities needed
to improve diet, physical activity, and other life habits to prevent,
delay, or control cardiovascular and other chronic diseases. The
projects provide these services to women from various racial and ethnic
groups who live in both urban and rural settings. More information on
this program can be found at http://www.cdc.gov/wisewoman.

Obesity Prevention Program: The purpose of the program is to
prevent and control obesity and other chronic diseases by supporting
States in the development, implementation, and evaluation of science-
based nutrition and physical activity interventions. Funds have been
awarded to 20 states to address the obesity epidemic in the US. The
goals of the program are to: (1) Decrease levels of obesity or reduce
the rate of growth of obesity in communities reached through
interventions; (2) Increase physical activity and better dietary
behaviors in communities reached through interventions; (3) Increase
the number of effective obesity prevention interventions using
nutrition and physical activity that are implemented and evaluated; (4)
Increase the number of communities that implement a nutrition and
physical activity plan for the prevention and control of obesity and
other chronic diseases; (5) Increase the number of state or community
nutrition and physical activity policies, environmental supports, and/
or legislative actions that are planned, initiated, or modified for the
prevention or control of obesity and other chronic diseases. More
information about this program can be found at http://www.cdc.gov/nccdphp/dnpa/obesityprevention.htm
.

Component 1: Center of Excellence in Public Health Training and
Intervention Research Translation

Objective: To develop the Center of Excellence model There is a
need to coordinate training and translation activities into Centers for
Excellence for both the WISEWOMAN and Obesity Prevention programs. Both
programs address similar risk factors including obesity, poor
nutrition, and physical inactivity. By October 2004, CDC expects to
have recommendations for creating Centers of Excellence for WISEWOMAN.
The awardee will focus on the development of one Center of Excellence
based on these recommendations. The Center may become a model for
future Centers.
Activity 1: Review the WISEWOMAN recommendations for the
establishment of a Center for Excellence and discuss implementation
issues with a CDC workgroup that includes WISEWOMAN team members and
representatives of funded states.
Activity 2: Conduct research as necessary to further elucidate the
recommendations made in the plan for the establishment of a Center of
Excellence to meet both WISEWOMAN and Obesity Prevention Program needs.
Activity 3: Develop a plan and timetable for the establishment of
the Center of Excellence.
Activity 4: Establish a Center of Excellence by the end of the
third year of funding.

[[Page 15453]]

Activity 5: Develop a monograph documenting and describing the
development of the Center of Excellence and how coordination of
training and translation has been achieved.
Funding: Year 1: $105,000; Years 2-5: $130,000 annually.

Component 2: Training

Part 1 Objective: To fund the continuation and expansion of
Nutrition and Public Health, A Course for Community Practitioners.
A course titled, `Nutrition and Public Health, A Course for
Community Practitioners' (NPH) was developed and conducted for public
health practitioners, particularly WISEWOMAN staff responsible for
planning and implementing WISEWOMAN projects. This course was developed
using the socioecological model and MATCH \1\, multi-level approaches
toward community health, as theoretical models to provide public health
practitioners with the skills necessary to address lifestyle
intervention planning and implementation at multiple levels of
influence. The planning and implementation of NPH will continue under
this special interest project. More information about NPH can be
obtained at http://www.hpdp.unc.edu/nph/.

Activity 1: Plan and conduct NPH annually starting in fiscal Year
2005.
Activity 2: Make course revisions and updates based on soon to be
completed training needs assessment, annual course evaluations, and
input from course advisory committee and CDC.
Activity 3: Assess the training course to determine if participant
needs are met and the extent to which participants apply the knowledge
in public health practice.
Activity 4: Explore delivery and expansion options for NPH.
Activity 5: Develop a 5 year training plan based on the
recommendations in the soon to be completed training needs assessment.
Activity 6: Develop and implement at least one additional training
annually based on the soon to be completed training needs assessment
and the 5-year training plan developed under this SIP.
Funding: Years 1-5: $175,000 annually.
Part 2 Objective: To fund the development and implementation of
training for public health professionals addressing obesity prevention.
Activity 1: Review the recommendations made in the soon to be
completed training needs assessment for the Obesity Prevention Program.
Activity 2: Discuss the training needs assessment with CDC staff to
reach consensus on methods of implementing the recommendations reached
in the assessment.
Activity 3: Develop a five-year training plan to address the
recommendations made in the training needs assessment with a continuous
process for gathering CDC and state input.
Activity 4: Plan, develop and implement training based on the five-
year plan.
Activity 5: Assess the developed trainings to determine if
participant needs are met and, the extent to which participants apply
the knowledge in public health practice.
Funding: Years 1-5: $135,000 annually.

Component 3: Translation

Objective: This component will provide an understanding of how to
translate efficacious interventions into the public health setting.
WISEWOMAN has been engaged in these activities since its inception and
CDC has been supporting the development and translation of new
community and clinical guidelines for the prevention and control of
obesity. The newly funded Center will evaluate current translation
efforts for the purpose of maximizing their public health impact. A
theoretical framework such as RE-AIM \2\ might be used. Also, the
Center will identify other efficacious interventions that may be
translated into the public health setting. The key components of the
efficacious interventions will be identified and translated
appropriately for various populations and settings including
underserved populations, preschool and young children, families,
worksites, community-based settings, and diverse ethnic/racial groups.
Appropriate evaluation of interventions can assist public health
professionals in making decisions about adopting interventions for
implementation in their communities.

Activities

(1) Identify efficacious studies related to improved nutrition and
physical activity, obesity prevention and weight management for
translation into a variety of public health settings.
(2) Describe the key components of the intervention that relate to
its efficacy.
(3) Use or develop a model for translating the key components into
public health settings.
(4) Develop a method for assessing whether current or future
translation activities achieve maximum public health impact to include
the reach, efficacy, adoption, implementation, and sustainability of
the intervention.
(5) Develop training that provides health professionals and
partners with the necessary skills for effective translation of
interventions in their local settings.
(6) Provide technical assistance to health professionals in
translating interventions in their setting.
(7) Continually review the literature to identify new efficacious
studies appropriate for translation, inform CDC, and work with CDC to
decide their relevance for WISEWOMAN and the Obesity Prevention
Programs.
Funding: Year 1: $195,000; Years 2-5: $260,000 annually.
Preference will be given to applicants who:
(1) Demonstrate understanding and experience with both WISEWOMAN
and Obesity Prevention Programs, and
(2) demonstrate expertise and experience in:
(a) Developing, planning, implementing, and evaluating public
health nutrition and obesity training in a variety of delivery modes,
(b) Conducting and evaluating public health interventions to
prevent and control obesity and other chronic diseases,
(c) Evaluating revising and training to meet the needs of
participants,
(d) Assessing efficacy studies related to improved nutrition,
physical activity, and other positive health behaviors to identify key
components for translation into the public health setting,
(e) Tailoring these key components for effectiveness in various
populations including underserved midlife women, preschool and young
children, families, worksites, community-based settings, various
racial/ethnic backgrounds, and those that are financially
disadvantaged,
(f) Developing a method for public health translation,
(g) Evaluating public health interventions for reach, efficacy,
adoption, implementation, and maintenance
(h) Ongoing assessment of training needs of public health
professionals
Project proposal and length: The application narrative should not
exceed 25 pages, exclusive of appendices. The appendices should not
exceed 15 pages.
Availability of Funds: Year 1: Total budget of $610,000; Years 2-5:
Total budget of $700,000 annually. Funding may vary and is subject to
change.
Research Status: This project will not involve human subject
research and therefore, should not require CDC IRB approval. The CDC
staff will serve as technical consultants.

[[Page 15454]]

References:
1. Simons-Morton DG, Simons-Morton BG, Parcel GS, Bunker JF:
Influencing personal and environmental conditions for community health:
A multilevel intervention model. Fam. Community Health 1988; 11(2): 25-
35.
2. Glasgow RE, Vogt TM, Boles SM: Evaluating the public health
impact of health promotion interventions: The RE-AIM framework. Am J
Public Health. 1999; 89: 1322-1327.

SIP 11-04

Project Title: Development and Evaluation of Messages to Address
Safety and Adverse Event Concerns about Influenza Vaccination among
Adults.
Project Description: Although an effective vaccine against
influenza is available and covered by Medicare, only two thirds of
persons 65 and over are vaccinated each year. In addition, only one
third of high-risk adults 18 to 65 are vaccinated. At present the
leading reason for non-vaccination among 65 and older is concern about
the vaccine, specifically the belief that the vaccine causes illness.
Concern about the vaccine is also a leading reason among those 18-65.
Funds will be available to support sound research on developing
effective messages to reduce such concerns and overcome this barrier to
vaccination.
Data from Medicare's Current Beneficiary Survey have shown that
almost half of unvaccinated seniors give reasons related to concerns
about the vaccine for not being vaccinated, including that it causes
disease, causes side effects, and is not effective at preventing
influenza. About a third give as main reasons for non-vaccination
reasons related to not knowing they should be vaccinated. Preliminary
data from a survey of Medicare beneficiaries suggest that concerns
about the vaccine are more prevalent among African Americans than among
whites. African Americans are less likely to be vaccinated than whites
(50% and 69%, respectively in 2002), and remain less likely to be
vaccinated even after taking into account differences in demographic
factors and access to care.
Previous research suggests that a physician's recommendation can
overcome patient concerns about the influenza vaccine, however not all
patients are swayed by a provider recommendation. The type of
information or messages needed to reduce concerns about influenza
vaccine in general and to help convince those for whom physician
recommendation is not sufficient to overcome concerns is unknown.
Research is needed to identify messages and methods that will
reduce concerns of patients about influenza vaccination, and to
determine whether different messages are needed for racial/ethnic
subgroups, with an emphasis on African American patients. The results
of this project should lead to increased understanding of the kind of
information that helps to convince people that the influenza vaccine
does not cause illness and to identify the best channel to deliver such
information.
Project Activities: Applications should address the following:
Objective 1: Message development (Year 1).
Develop an approach to message development that
will allow for identifying the need for different messages for
different racial ethnic groups. A possible approach might be to conduct
focus groups of persons who have been offered vaccination but elected
not to be vaccinated because of concerns about the vaccine (groups
segmented by race/ethnicity)
Determine setting, methods, feasibility of
message development protocol prior to implementation. The setting
should provide access to a substantial proportion of African American
patients.
Identify key staff and established resources/
expertise available to conduct this project. Staff qualifications
should be based on demonstrated knowledge of message development.
Objective 2: Message testing/evaluation (Year 2, during influenza
vaccination season).
Develop an approach for testing the message
against a control message (for example a pre and post intervention
survey).
Develop an approach to determining which channel
(e.g. pamphlet, doctor, nurse, peer educator) is the most effective or
preferred channel for receiving such information (again, for example, a
pre and post intervention survey addressing issues such as trust of the
information, overall satisfaction, and beliefs about the flu vaccine).
Determine setting, methods, feasibility of
message testing/evaluation protocol prior to implementation. The
setting should provide access to a substantial proportion of African
American patients.
Identify key staff and established resources/
expertise available to conduct this project. Staff qualifications
should be based on demonstrated knowledge of message development.
Preference will be given to applicants who:
1. Can demonstrate they have participated in prior research related
to message development and evaluation.
2. Can provide a record of publishing similar research.
3. Can demonstrate access to working with substantial numbers of
African American adults.
Project Proposal Length and Supporting Material: Proposal
narratives are limited to 15 pages. Supporting materials included in
appendices should not exceed 20 pages.
Availability of Funds: Approximately $300,000 is available to fund
up to 2 Prevention Research Centers in the first of a 2-year project
period. No individual award will exceed $150,000. Funding may vary and
is subject to change.
Research Status: It is expected that this project will be non-
exempt research. CDC staff will serve as co-investigators on these
projects and will provide technical assistance on activities such as
research design, data collection and analysis, and dissemination of
results. This project will require CDC IRB approval. As applicable,
applicants should provide a federal wide assurance number for each
performance site included in the project.

SIP 12-04

Project Title: Provider and public health input for vaccine policy
decisions.
Project Description: Vaccination is considered one of the top ten
public health achievements in the 20th century. Despite the power of
this prevention tool, however, vaccine coverage with all recommended
vaccines remains below national goals for both children and adults.
Many factors play a role in immunization uptake, but evidence has shown
that provider recommendations and practices are very influential.
Further, a number of evidence-based strategies for raising and
sustaining high coverage levels among children, adolescents, and adults
include interventions to be carried out at the provider level. State
and public health officials are important partners to immunization
providers, monitoring provider practices and providing technical
assistance, particularly regarding childhood immunization.
Implementation of recommendations for new vaccines and recommended
strategies for vaccination requires several critical components: (1) An
understanding of potential barriers and concerns perceived by providers
and by state and local public health officials, (2) measurement of the
extent of knowledge and misperceptions that

[[Page 15455]]

private and public sector staff have about new recommendations and
strategies, and (3) the ability to test potential messages among both
groups. Further, data from these inquiries should be collected using
scientifically sound methods. Ample response rates to present
generalizable results and the findings should be available for broad
dissemination in a timely fashion.
The purpose of this project is to develop a collaborative mechanism
with an academic researcher to obtain such input from providers and
state and local public health officials in a timely fashion. Based on
prior experience, staff at CDC's National Immunization Program
anticipate a need to carry out multiple inquiries during each year of
the three year project period.
This project should assist in making policy recommendations
regarding new vaccines, strategies to improve immunization coverage,
contingency plans to address urgent problems such as vaccine supply
shortages. In addition, these data will be used to test and refine
messages for immunization providers and their state and local public
health collaborators.
Project Activities: Applications should address the following:
1. A multidisciplinary study team, including:
Individuals experienced in the conduct of health
services research specifically related to childhood and adult
immunization.
Individuals with experience conducting and
analyzing quantitative and qualitative (e.g., focus groups, key
informant interviews) studies.
Individuals able to support necessary
statistical analyses.
Individuals to support research activities such
as sampling from national databases, data collection, data entry,
database management, and programming.
2. A process for working with CDC staff to identify, prioritize,
and devise timelines for multiple inquiries per year, including the
ability to modify priorities/timelines as needed.
3. A process for working with CDC staff (and outside public health/
researchers as appropriate) to develop and refine study objectives,
methods, and instruments.
4. Approaches for collecting data in areas relevant to this
project, including:
Awareness, agreement, and adoption of new
recommendations and factors influencing these outcomes;
Issues affecting private provider adoption of
strategies designed to raise immunization coverage, such as the use of
reminder/recall systems, Assessment, Feedback, and Information eXchange
(AFIX), and immunization registries;
Response to and feedback to potential
recommendations or communications.
Preference will be given to applicants who:
1. Can demonstrate that they have participated in rapid (2-6
months) assessments of provider and public health official perceptions,
barriers, and reaction to potential recommendations, using both
qualitative and quantitative methods.
2. Can provide a record of publishing such research.
3. Can demonstrate ability to obtain high response rates (50-70%)
in such research.
4. Can conduct a minimum of four inquiries per year during each
year of the three-year project period.
Project Proposal Length and Supporting Material: Proposal
narratives are limited to 15 pages. Supporting materials included in
appendices should not exceed 20 pages.
Availability of funds: Approximately $300,000 is available to fund
1 Prevention Research Center in the first of a 3-year project period.
Funding may vary and is subject to change.
Research Status: It is expected that this project will involve
multiple components, most of which are exempt research. CDC staff will
participate as co-investigators on project activities including
research design, data collection and analysis, and co-authoring
manuscripts. It is expected that this project will require CDC IRB
approval of exempt research status. As applicable, applications should
provide a federal wide assurance registration number for each
performance site included in the project.
References: Centers for Disease Control and Prevention. Ten great
public health achievements--United States, 1900-1999. MMWR 1999;
48:241-3.
Task Force on Community Preventive Services. Recommendations
regarding interventions to improve vaccination coverage in children,
adolescents, and adults. American Journal of Preventive Medicine.
2000;18(1S):92-96.

SIP 13-04

Project Title: Prevention Research Centers' Healthy Aging Research
Network (HAN)--Participating Network Center.
Project Description: The Health Care and Aging Studies Branch,
Division of Adult and Community Health, National Center for Chronic
Disease Prevention and Health Promotion, CDC, is seeking to support the
infrastructure and activities of a network formed around ``healthy
aging.'' Of particular interest is a network that draws on the
community collaborations characteristic of the PRCs and provides a
framework to translate research into practice and policy.
Consistent with the vision and mission of the PRCs, the proposed
network will conduct the following types of activities: (1) Synthesis
of scientific information on the determinants of healthy aging,
intervention research, and/or translation research for programs in
healthy aging; (2) research on the effectiveness of community-based
interventions for which evidence is insufficient to justify a CDC
recommendation; (3) research on mechanisms to disseminate and implement
evidenced-based interventions into communities by public health and
aging services network organizations; (4) evaluation of the
implementation and effectiveness of community-based programs; and (5)
development and dissemination of training products for the public
health and aging networks.
Although the core function of this special interest project is to
provide the necessary funding to organize and operate a network of PRCs
focused on healthy aging, the network would be expected to identify a
topic area of focus and participate in activities that address gaps in
the knowledge; assist in the translation of research into practice; and
contribute to the development of evidence-based intervention that can
be implemented into community practice.
Project Activities: Applications should address the following:
1. Define how the center would collaborate with the Coordinating
Center and CDC to advance a prevention research agenda for public
health and aging.
2. Identify established resources in areas relevant to public
health and aging within or available to your PRC. Discuss how these
resources could be enhanced through the proposed network. Define the
potential for collaboration with academic and community-based resources
in aging.
3. Describe how your center would contribute to facilitating the
translation of research into practice. Discuss the areas where your
center could play a leadership role and those areas where your
contributions would be more of a supporting role. What other partners
need to be involved and how do you propose to include them in
activities?
4. Explain how your center will work with the other HAN network
centers in prioritizing and choosing topics for research, intervention
or translation.

[[Page 15456]]

5. Describe how your center will work with the HAN network and
other partners to develop evidence-based interventions that can be
implemented in communities.
Preference will be given to applicants who have:
(1) Demonstrated experience in health issues for older adults;
(2) Experience working within a network construct; and
(3) Basic knowledge about the organization and capacity of the
aging services network (i.e. the formal network established through the
Older Americans Act of 1965 which includes the U.S. Administration on
Aging, state units on aging, local area agencies on aging, and local
community aging service providers which provides health and social
services to older adults).
Project Proposal Length and Supporting Materials: Proposal
narratives are limited to 20 pages. Supporting materials included as
appendices should not exceed 40 pages, including publications.
Availability of Funds: Approximately $210,000-$300,000 is available
to support six participating network centers (ranging from $35,000-
$50,000/center) for the first year of a five-year project. Funding may
vary and is subject to change.
Research Status: The operations of the network itself will not
involve research on human subjects. However, the pilot projects chosen
may involve IRB review. CDC technical monitors will assist network
centers in making human subject determinations.

SIP 14-04

Project Title: Prevention Research Centers' Healthy Aging Research
Network (HAN)--Lead Coordinating Network Center.
Project Description: The Health Care and Aging Studies Branch,
Division of Adult and Community Health, National Center for Chronic
Disease Prevention and Health Promotion, CDC is seeking to support the
infrastructure and activities of a network formed around ``healthy
aging.'' Of particular interest is a network that draws on the
community collaborations characteristic of the PRCs and provides a
framework to translate research into practice. This network would serve
as a model for a PRC-directed collaboration to address a CDC priority
population. This Special Interest Project (SIP) would provide the
funding necessary for one PRC to take the leadership responsibility in
coordinating the Healthy Aging Research Network's (HAN) activities.
Consistent with the vision and mission of the PRCs, the proposed
network will conduct the following types of activities: (1) Synthesis
of scientific information on the determinants of healthy aging,
intervention research, and/or translation research for programs in
healthy aging; (2) research on the effectiveness of community-based
interventions for which evidence is insufficient to justify a CDC
recommendation; (3) research on mechanisms to disseminate and implement
evidenced-based interventions into communities by public health and
aging services network organizations; (4) evaluation of the
implementation and effectiveness of community-based programs; and (5)
development and dissemination of training products for the public
health and aging networks.
Although the core function of this special interest project is to
provide the necessary funding to organize and operate a network of PRCs
focused on healthy aging, the network would be expected to identify a
topic area of focus and participate in activities that address gaps in
the knowledge; assist in the translation of research into practice; and
contribute to the development of evidence-based interventions that can
be implemented into community practice.
Project Activities: Applications should address the following:
1. Explain the organization and interaction of the Coordinating and
Collaborating centers. Discuss the relationship with relevant CDC
activities and staff. Define performance expectations for the network.
2. Explain how the proposed HAN network would draw on community
collaborations to enhance older consumers' ability to lead healthier
and more satisfying lives. Discuss additional partners who may have a
stake in the work taking place. Address the dissemination of relevant
information beyond the scientific literature, specifically to
communities.
3. Describe how the HAN network would facilitate translation of
research into practice. Provide a description of a project that would
be developed and initiated within the first year of the project period
related to the prior efforts of the HAN.
4. Define how training needs in public health and aging for public
health practitioners will be identified and addressed.
5. Describe how the network Coordinating Center will provide
leadership in fostering and growing the network. Indicate how this
growth will be assessed and monitored during the project period.
Measures may include but are not limited to: (1) The number of
intervention and dissemination research projects that have been funded;
or (2) the variety of governmental, foundation, and non-profit sources
of funding.
6. Describe how the Coordinating Center will represent and promote
the PRC Healthy Aging Research Network and its member centers within
the PRCs and to external partners.
7. Describe how the Coordinating Center will participate as a
member of the Healthy Aging Research Network including contributing to
the facilitation of translating research into practice; identifying
established resources in areas relevant to public health and aging
within or available to its PRC; and how the Coordinating Center will
work with the other network centers to prioritize topics for research
and intervention development.
8. Describe the process by which each member center's contributions
including individual roles and responsibilities to the projects and
activities of the HAN will be determined.
Preference will be given to an applicant who:
(1) Has demonstrated experience in health issues for older adults;
(2) Has experience in organizing and leading a group of academic
institutions around a common agenda or theme;
(3) Has experience in working within a network construct;
(4) Has letters of support from current member centers of the PRC
Healthy Aging Research Network that define each PRC's role and
responsibilities; and
(5) Has basic knowledge about the organization and capacity of the
aging services network (i.e., the formal network established through
the Older Americans Act of 1965 which includes the U.S. Administration
on Aging, state units on aging, local area agencies on aging, and local
community aging service providers which provides health and social
services to older adults).
Project Proposal Length and Supporting Materials: Proposal
narratives are limited to 20 pages. Supporting materials included as
appendices should not exceed 40 pages, including publications.
Availability of Funds: Approximately $185,000-$200,000 ($150,000
for leadership and coordination; $35,000-$50,000 for network
activities) is available to support one Coordinating Center for the
first year of a five year project. Applicants must apply as a Healthy
Aging Research Network (SIP 13-04) center to apply for the Coordinating
Center funding. Funding may vary and is subject to change.

[[Page 15457]]

Research Status: The operations of the network itself will not
involve research on human subjects. However, the pilot projects chosen
may involve IRB review. CDC staff will assist network centers in making
human subject determinations.

SIP 15-04

Project Title: Prevention Research Centers' Healthy Aging Research
Network (HAN)--Defining the Public Health Role in Depression and
Depressive Disorders for Older Adults.
Project Description: Several areas of interest in healthy aging
research are emerging for which no defined public health role has been
established. Among these areas of interest are health conditions such
as depression, dementia, Alzheimer's disease, and Parkinson's disease.
Mental health illnesses, such as depression, can be debilitating
for older adults. Older adults commonly have multiple chronic
conditions. Due to physical difficulties resulting from chronic
disease, older adults may find traveling difficult and are, therefore,
often physically isolated from family and friends. Social isolation can
lead to feelings of despair and depression, which when combined with
physical inactivity, can bring about a decline in both physical and
mental health functioning.
Chronic illnesses, such as heart disease, stroke, diabetes, and
cancer often co-exist with depression. Because many older adults face
these illnesses as well as various social and economic difficulties,
health care professionals may mistakenly conclude that depression is a
normal consequence of these problems'an attitude often shared by
patients themselves. These factors together contribute to the
underdiagnosis and undertreatment of depressive disorders in older
people.
About 58% of those ages 65 and older believe
that it is ``normal'' for people to be ``depressed'' as they grow
older. It is estimated that only half of older adults who acknowledge
mental health problems actually receive treatment from any health care
provider.
Major depression affects 5-10% of older adults
who visit their primary care provider (Blazer D.G. Depression in Late
Life: Review and Commentary. J of Gerontology: Medical Sciences. 2003;
58A(3), pp. 249-265.).
The prevalence of clinically significant
depressive symptoms for community-dwelling older adults ranges from
approximately 8% to 16% (Blazer D.G. Depression in Late Life: Review
and Commentary. J of Gerontology: Medical Sciences. 2003; 58A(3), pp.
249-265.).
The identification and refinement of public health prevention
opportunities in addressing depression and depressive disorders or the
co-morbidities associated with depression among older adults are of
particular interest.
Project Activities: Applications should address the following:
1. Describe the review team. This should include but not be limited
to: (a) Selection of the HAN network center participants; (b) role of
the coordinating center (applicant); and (c) selection and expertise of
review team members and roles and responsibilities of the team members.
Letters of support, identifying the roles and support of the project
should be provided from all identified team members. Indicate how this
activity relates to the mission and activities of the PRC Healthy Aging
Network.
2. Provide a detailed description of how the review team plans to
conduct a systematic review of the literature. The purpose of the
systematic literature review is to identify effective interventions for
preventing or addressing depression or depressive disorders, and, in
particular, those strategies that could be made available to older
adults through the public health and aging services network. As part of
the review, the review team should also identify strategies for
assessing mental health in older adults, such as screening instruments
for depressive symptoms.
3. Describe the methods that will be employed to execute the
review, including the databases to be searched, and potential search
terms. Indicate how the applicant will develop or refine a conceptual
approach to assist with defining the scope and organization of the
review. If the framework developed by the Healthy Aging Research
Network through SIP 13-04 is refined from other work on mental health,
such as the Guide to Community Preventive Services, indicate how such a
model will be applied to older adults.
4. Describe the criteria that will be used to classify articles as
eligible or ineligible for the review, as well as the process through
which data will be abstracted from articles, including training of the
reviewers and measurement of inter-rater reliability.
5. Describe how the team will assess and define the effectiveness
of interventions that address depression and depressive disorders for
older adults for the public health system and the aging services
network (i.e. the formal network established through the Older
Americans Act of 1965 which includes the U.S. Administration on Aging,
state units on aging, local area agencies on aging, and local community
aging service providers which provides health and social services to
older adults).
6. Describe how the network would work with CDC, including the CDC
Mental Health Workgroup and the Guide to Community Preventive Services
(http://www.thecommunityguide.org/mental/default.htm), to frame the

public health role and parameters for interventions and outcomes,
including health outcomes and costs, related to depression and
depressive disorders for older adults.
Preference will be given to an applicant who:
(1) Is a funded member of the PRC Healthy Aging Research Network
through SIP 13-04;
(2) Explicitly partners with one or more other members of the
current PRC Healthy Aging Research Network;
(3) Has demonstrated letters of support from contributing member
centers of the current PRC Healthy Aging Research Network that define
each center's role and responsibilities; and
(4) Has demonstrated research experience in the area of depression
and depressive disorders for older adults. The anticipated activities
will be conducted in collaboration with staff from CDC, including
representatives from the Division of Adult and Community Health,
National Center for Chronic Disease Prevention and Health Promotion,
who are members of the CDC Mental Health working group and a
representative from the mental health chapter of the Guide to Community
Preventive Services.
Project Proposal Length and Supporting Materials: Proposal
narratives are limited to 20 pages. Supporting materials included as
appendices should not exceed 40 pages, including publications.
Availability of Funds: Approximately $200,000 is available to
support a project on depression and depressive disorders in older
adults for the PRC Healthy Aging Research Network for the first year of
a two-year project. Applicants must also apply and be funded as a
Healthy Aging Research Network center to apply for this funding.
Funding may vary and is subject to change.
Research Status: The project will not involve research on human
subjects.

SIP 16-04

Project Title: Prevention Research Centers' Cancer Prevention and
Control Research Network (CPCRN).
Project Description: Funds are available for Prevention Research

[[Page 15458]]

Centers (PRCs) to become members of the Cancer Prevention and Control
Research Network (CPCRN). The vision of the CPCRN is communities and
researchers work together to significantly reduce the burden of cancer,
especially among those disproportionately affected. Its mission is to
conduct cancer prevention and control research that (1) extends the
knowledge base, (2) addresses critical gaps, and (3) leads to adoption,
replication, implementation and diffusion of successful programs in
communities. This research is carried out both by each member center
through local networks and by the CPCRN as a larger network of member
centers following the work in the Community Guide to Preventive
Services (Guide).
The Guide provides public health decision makers with
recommendations regarding population-based interventions to promote
health and to prevent disease, injury, disability, and premature death,
appropriate for use by communities and health care systems. The Guide
provides an assessment of the evidence of intervention effectiveness
and makes two types of recommendations: (1) Where the evidence is
insufficient to recommend the adoption of an intervention, the Guide
identifies areas for further research; and (2) where evidence of
intervention effectiveness is sufficient, the Guide recommends adoption
of that intervention. CDC and the National Cancer Institute are
collaborating to develop and/or disseminate several chapters of the
Guide related to cancer control, including the Cancer Chapter and the
Tobacco Control Chapter. For more information on the Guide to Community
Preventive Services, applicants may refer to http://www.thecommunityguide.org
or see: Am J Prev Med 2000; 18 (1S): 18-26

and Am J Prev Med 2000;18(1S):35-43.
For more information about the CPCRN, see http://ukprc.uky.edu/CPCRN/home.htm.
Also, please see the related Special Interest Project

17-04 which requests proposals for a Coordinating Center for the Cancer
Prevention and Control Network.
Project Activities: The objective of this project is to support the
work of the CPCRN in expanding community-based intervention research on
cancer prevention and control and facilitating the translation of
effective interventions into practice. This project is to establish or
maintain the infrastructure necessary for an individual Center's local
network and for the larger CPCRN to conduct community-based
participatory research which will contribute to extending the knowledge
base, addressing critical gaps in evidence for a particular
intervention strategy, evaluate specific intervention, and leading to
adoption, replication, implementation and diffusion of successful
interventions in communities. Such an infrastructure would allow
individual Centers and the larger CPCRN to compete successfully for
research projects, including multi-center projects, from a wide variety
of sources.
Applicants should address the following issues:
1. Describe how your center will contribute to vision, mission, and
objectives of the CPCRN.
a. Provide a description of prior research, practice and evaluation
experiences in intervention and dissemination research (provide
examples of your achievements in the appendices, including peer-
reviewed articles, grants received, etc).
b. Describe your particular experiences with cancer prevention and
control research.
c. Describe your particular experience with community-based
participatory research, specifically with regard to health intervention
programs that involve partnerships with community-based organizations.
d. Given that this center would be part of the CPCRN, describe your
experiences of collaboration or describe how the project staff could
collaborate with other centers in the network.
2. Identify the key staff who will be devoted to this project.
a. For each person describe his or her demonstrated knowledge,
experience, and ability in planning and conducting research that is
similar in complexity, scope and focus to the types proposed here. If
there is a position that is yet to be filled, provide a position
description in the appendix. Include the percentage of time each person
will devote to project activities.
b. Of the named staff, provide evidence of the interdisciplinary
nature of the key center leadership and experiences in conducting and
being funded for intervention research, community-based participatory
research, and translation of research into practice.
3. Provide evidence that the proposed project activities will be
conducted through partnerships with cancer prevention and control
experts in the community, state, and/or region.
a. Provide evidence of links to other cancer control research and
practice centers, such as comprehensive cancer control centers, special
population networks, transdisciplinary tobacco use research centers,
and the current PRC Cancer Prevention and Control Research Network.
b. Describe the methods that will be used to maintain these
partnerships. Provide evidence of commitment and cooperation of
potential partners (e.g., recent letters of support, memoranda of
understanding, and documented examples of prior collaboration).
c. Describe the methods that will be used to establish and maintain
new partnerships, as needed.
d. Describe how you will involve various community representatives
in the proposed project.
e. Indicate the leadership responsibilities, roles, and
relationship of community representatives to the larger CPCRN team.
4. Provide evidence of sufficient institutional support for this
project (e.g., support from PRC leadership, space, equipment, etc).
Describe the established resources and expertise available to your
staff (e.g., intervention research, health services research,
community-based participatory research, behavioral sciences,
statistical expertise for randomized trials, research dissemination,
program evaluation, public health, economics, communication theory and
practice, etc).
5. State the proposed evaluation strategies and measures at three
and five years that can be used to indicate the effectiveness of the
local network and provide information needed for refinement and growth
of the local network. Measures might include: (1) The number of
intervention and dissemination research projects that have been funded,
conducted and published which might be used to inform subsequent Guide
recommendations; (2) the number of such research efforts that have been
awarded from a variety of governmental, foundation, and non-profit
sources; and (3) the number of collaborative research efforts that have
been initiated between the member center and other NCI-supported cancer
research centers/networks.
Preference will be given to applicants who:
1. Demonstrate the capacity to publish and/or be funded for
community intervention research, particularly in cancer prevention and
control.
2. Provide evidence of successful experiences in conducting
research on dissemination processes, dissemination of specific
research, or community-based participatory research with underserved
populations.
3. Represent diverse populations and are geographically distributed
throughout the United States.

[[Page 15459]]

Project Proposal Length and Supporting Material: Proposal
narratives are limited to 20 pages. Supporting materials included in
the appendices should not exceed 30 pages. The appendices should
include the requested materials above, including the 2-page
biographical sketches, position descriptions of faculty and staff (if
needed), letters of support, membership lists of community advisory
board, etc.
Availability of Funds: Approximately $1,500,000 is available to
fund 5 Prevention Research Centers for the first year of a 5-year
project period. The average award is expected to range from $300,000 to
$350,000 per year. Budgets should include costs for travel for two
persons to an annual meeting of the full Network. For budgetary
purposes, use Atlanta as the site of such annual meetings. Funding may
vary and is subject to change.
Research Status: This project is to establish or maintain
infrastructure of the CPCRN, and will not involve human subject
research.

SIP 17-04

Project Title: Coordinating Center, Prevention Research Centers'
Cancer Prevention and Control Network.
Project Description: Funds are available to support a Coordinating
Center for the Prevention Research Centers' (PRC's) Cancer Prevention
and Control Network. The Coordinating Center serves as the focal point
for (1) guiding network discussions related to the development of
research expertise in community interventions for cancer prevention and
control, (2) organizing collaborative activities with network members
and their various collaborating partners (e.g., state/local health
departments, community groups, and cancer control research and practice
centers), (3) facilitating linkages among network members and national/
state/local partners to ensure network objectives are being achieved,
and (4) coordinating evaluation of network activities. For further
detail on the objectives and activities of the Cancer Prevention and
Control Network, please see the Special Interest Project 16-04.
Project Activities: Applicants should address the following:
1. Describe the proposed process for serving as the coordinating
arm for the development of a PRC Cancer Prevention and Control Network,
including but not limited to the following items:
a. Description of the resources and processes that will facilitate
linkages and activities among the Cancer Prevention and Control
Research Network, such as coordination of conference calls and
dissemination of information;
b. Description of the processes through which network research
projects would be selected and pursued by network centers or subgroups;
and
c. Description of the process for identifying, collecting, and
disseminating products and results from network members.
2. Propose an external evaluation process to indicate the
effectiveness of the network and to provide information needed for
refinement and growth of the network. Indicate how and when the
evaluation results will be shared with the network members and other
partners, including the PRC program.
3. Identify the proposed staff who will work on coordinating center
activities. Provide their relevant experience, a description of their
roles, and the proportion of time each will spend on coordinating
center activities. Examples of these personnel may include an
administrator, project manager, and others.
Preference will be given to applicants who demonstrate experience
in:
1. Coordinating and conducting multicenter research;
2. Collaborative planning using participatory methods; and
3. Conducting community-based intervention research, participatory
research, dissemination research, and program evaluation.
Project Proposal Length and Supporting Material: Proposal
narratives are limited to 20 pages. Supporting materials included in
the appendices should not exceed 30 pages; the appendices should
include the above-requested materials, 2-page biographical sketches,
position descriptions of staff (if needed), recent letters of support,
membership lists of community advisory board, and other evidence as
consistent with the proposal.
Availability of Funds: Approximately $300,000 is available to fund
one Prevention Research Center in the first year of a 5-year project
period to act as the Coordinating Center. Funding may vary and is
subject to change. Applicant must apply and receive funding as a
Prevention Research Centers' Cancer Prevention and Control Research
Network (SIP 16-04) to be eligible to receive Coordinating Center
funding.
Research Status: The Coordinating Center does not conduct research,
but monitors the network infrastructure only. This project will not
involve research on human subjects.

SIP 18-04

Project Title: Trial of interventions to increase utilization of
colorectal cancer screening and promote informed decision making about
colorectal screening among Hispanic women and men.
Project Description: Colorectal cancer is the second leading cause
of cancer death in the United States. Strong scientific evidence has
shown that screening for colorectal cancer saves lives. However,
studies have demonstrated that most eligible persons are still not
meeting the screening recommendations for colorectal cancer and that
screening rates are especially low among Hispanic men and women in the
United States. Few intervention studies have examined methods to
increase colorectal cancer screening, or to promote informed decision
making about colorectal cancer screening, and even fewer studies have
focused on Hispanic persons. As such, effective intervention materials
that are culturally appropriate and available in English and Spanish
are needed to promote colorectal cancer screening among Hispanic
adults.
Informed decision making about colorectal cancer screening includes
making informed choices between screening options. The interventions
tested for effectiveness should target Hispanic men and women aged 50
years older (including those who are at average risk and those who have
a modest family history of colorectal cancer). The interventions
developed as part of this project should be consistent with the U.S.
Preventive Services Task Force (USPSTF) recommendations regarding
colorectal cancer screening and informed decision-making.
The available evidence regarding the effectiveness of specific
client-oriented interventions and provider-oriented interventions for
colorectal cancer screening is not currently sufficient to justify a
Guide to Community Preventive Services recommendation (http://www.thecommunityguide.com
). Where evidence is sufficient for a

recommendation, there is a need for replication studies to examine the
applicability of the interventions to other populations such as
Hispanic men and women. Most studies of informed decision making for
cancer screening have focused on prostate or breast cancer screening,
and few studies on informed decision making for cancer screening have
included Hispanic persons.
This project seeks to develop and examine the effectiveness of an
intervention to increase colorectal screening and promote informed
decision making about colorectal cancer screening among Hispanic men
and women (for example, Mexican

[[Page 15460]]

Americans), via a community-based intervention trial and participatory
research methods.
Project Activities: Applications should address the following:
1. Explain how intervention materials will be developed and tested
to increase routine colorectal screening and to promote informed
decision making about colorectal cancer screening among Hispanic women
and men.
2. Explain how the above intervention materials will fit into an
intervention strategy for increasing informed decisions regarding
colorectal cancer screening.
3. Describe how a pilot of the intervention strategy will be
conducted, including revisions based upon the pilot.
4. Describe how a community-based intervention trial will be
conducted including the: background and rationale, methods (including a
description of the intervention materials that will be developed and
tested), sample size estimates, desired outcome measures, the plan for
analysis, and human subjects considerations.
5. Outline plans for engaging Hispanic community partners in all
aspects of this study.
6. Describe the collaborative relationships between the university,
representatives of the community partners, the relevant state and local
health departments, and a major provider of health care services for
the target population.
Preference will be given to applicants who:
1. Demonstrate prior experience conducting community-based,
participatory research involving Hispanic communities.
2. Propose a community-based intervention trial that would be
conducted by a Prevention Research Center, in partnership with a
university medical center or other major health care provider and their
community partners.
3. Propose an intervention study consisting of a randomized
preventive trial or one which has a quasi-experimental design,
following guidelines for rigorous research identified by the Guide to
Community Preventive Services (http://www.thecommunityguide.com).

4. Demonstrate that research participants who have a positive
colorectal cancer screening test will have access to follow-up care and
treatment, as appropriate.
Project Proposal Length and Supporting Material: Proposal
narratives are limited to 20 pages. Supporting materials in appendices
should not exceed 20 pages.
Availability of Funds: Approximately $350,000 is available to fund
1 Prevention Research Center in the first year of a 4-year project
period. Funding may vary and is subject to change.
Research Status: It is expected that the project will be non-exempt
research. CDC staff will serve as co-investigators on this project and
will provide technical assistance on activities such as research
design, data collection and analysis, and dissemination of results. It
is expected that the project will require CDC IRB approval or approval
of deferral to the local IRB. As applicable, applications should
provide a federal wide assurance registration number for each
performance site included in the project.

SIP 19-04

Project Title: Assessing the reliability and validity of core
questions to measure colorectal cancer screening behaviors.
Project Description: Colorectal cancer (CRC) is the second leading
cause of cancer death. Screening has been demonstrated to be effective
in reducing death from colorectal cancer, but the prevalence of
colorectal cancer screening among adults is extremely low. The Task
Force on Community Preventive Services has concluded that there is
insufficient evidence concerning the effectiveness of interventions to
increase screening for CRC. The recently published Institute of
Medicine report, Fulfilling the Potential of Cancer Prevention and
Early Detection (Curry SJ, Byers T, Hewitt M (eds.) Fulfilling the
Potential of Cancer Prevention and Early Detection. Washington, DC: The
National Academies Press, 2003.) called for the development,
implementation and evaluation of ``comprehensive community-based
programs in cancer prevention and early detection.'' Additional
research is likely to be undertaken in the next several years to
address the effectiveness of different types of interventions to
increase CRC screening. Central to any program evaluation are valid and
reliable measures of outcome.
For measures of CRC screening behaviors, core questions recently
have been developed by a working group of experts which was sponsored
by the National Cancer Institute (NCI) (A manuscript describing this
effort has been prepared and is expected to be published within the
next year.) These core questions were based on questions that had been
used in national surveys or in survey instruments for intervention
studies of colorectal cancer screening. Cognitive testing was performed
on these questions in May 2002. As the next step, the working group has
recommended ``studies to assess the reliability and validity of the
questions in different subgroups of the population.'' To date, this
research has not been conducted. In other words, there is no evidence
regarding the reliability or validity of commonly used measures of
colorectal screening behavior.
The establishment of reliable and valid measures of colorectal
cancer screening behaviors would be of enormous value to a variety of
surveillance and intervention activities. These activities would enable
decision makers to have a greater confidence in data which are based on
reliable and valid measures. Measures of colorectal cancer screening
are used to evaluate the effectiveness of interventions, compare the
effectiveness of different types of interventions with each other, and
track changes in screening behavior over time. The value of research
studies on intervention effectiveness and surveillance efforts are
highly dependent on the quality of the outcome measures used.
The purpose of this funding would be to conduct studies using the
core questions to measure colorectal cancer screening behaviors that:
(1) Measure the reliability or consistency of responses to questions
following repeat administration; and/or (2) measure the validity of
responses to the core questions. The results of the research to be
supported through this project should contribute substantially toward
the establishment of reliable and valid measures for colorectal cancer
screening behavior.
Project Activities: Applicants should address the following:
1. Clarify the specific research question(s) to be addressed. The
research question(s) should consider measures of reliability and
validity of the core CRC screening behavior questions. The specific
research question(s) may be refined depending on the method of
administration (mail, telephone, or face-to-face) and the population to
be included.
2. Describe a study to address the research question to be
addressed, including a description of the proposed population, setting
and methods.
3. Provide a description of prior research to justify the proposed
study population and study approach.
4. Provide an explanation of the basis for the proposed sample size
and anticipated participation rates.

[[Page 15461]]

5. Describe the estimated timetable for the study.
6. Provide evidence of support from institutions and other
stakeholders to carry out this research.
7. Identify the key staff who will be devoted to the project and
their respective roles and time commitments. For each person, describe
their demonstrated knowledge, experience, and ability in planning and
conducting this type of research.
Preference will be given to applicants who:
1. Can demonstrate that they have participated in previous research
related to tests of the reliability or validity of outcome measures
used in questionnaires.
2. Have extensive experience in conducting research in community or
clinic settings.
Project Proposal Length and Supporting Material: Proposal
narratives are limited to 15 pages. Supporting materials included in
appendices should not exceed 20 pages.
Availability of Funds: Approximately $250,000 is available to fund
one Prevention Research Center in the first year of a 2-year project
period. Funding may vary and is subject to change.
Research Status: It is expected that this project is non-exempt
research. CDC staff will not serve as co-investigators on this project
but will provide technical assistance on activities such as research
design, data collection and analysis, and dissemination of results.

SIP 20-04

Project Title: Trial of interventions to increase utilization of
colorectal cancer screening among women and men.
Project Description: Colorectal cancer is the second leading cause
of cancer death in the United States. Strong scientific evidence has
shown that screening for colorectal cancer saves lives. However,
studies have demonstrated that most eligible persons are still not
meeting the screening recommendations for colorectal cancer. In
addition, few intervention studies have examined methods to increase
colorectal cancer screening.
The available evidence regarding the effectiveness of specific
client-oriented interventions and provider-oriented interventions for
colorectal cancer screening is not currently sufficient to justify a
Guide to Community Preventive Services recommendation (http://www.thecommunityguide.com
). Where evidence is sufficient for a

recommendation, there is a need for replication studies to examine the
applicability of the interventions to other populations.
This project seeks to develop and examine the effectiveness of an
intervention to increase colorectal screening among men and women, via
a community-based intervention trial and participatory research
methods.
The interventions should be tested for effectiveness that target
men and women aged 50 years of older (including those who are at
average risk and those who have a modest family history of colorectal
cancer). The interventions developed as part of this project should be
consistent with the U.S. Preventive Services Task Force (USPSTF)
recommendations regarding colorectal cancer screening.
Project Activities: Applications should address the following:
1. Explain how intervention materials will be developed and tested,
to increase routine colorectal screening among women and men.
2. Explain how the above intervention materials will fit into an
intervention strategy for increasing colorectal cancer screening.
3. Describe how a pilot of the intervention strategy will be
conducted, including revisions based upon the pilot.
4. Describe how a community-based intervention trial will be
conducted including the: background and rationale, methods (including a
description of the intervention materials that will be developed and
tested), sample size estimates, desired outcome measures, the plan for
analysis, and human subjects considerations.
5. For all aspects of this study, outline plans for engaging
community partners in implementing the study.
6. Identify a collaborative relationship between the university,
representatives of the target population, the relevant state and local
health departments, and a major provider of health care services for
the target population.
Preference will be given to applicants who:
1. Demonstrate prior experience conducting community-based,
participatory research involving communities.
2. Propose a community-based intervention trial that would be
conducted by a Prevention Research Center, in partnership with a
university medical center or other major health care provider and
community partners.
3. Propose an intervention study consisting of a randomized
preventive trial or one which has a quasi-experimental design,
following guidelines for rigorous research identified by the Guide to
Community Preventive Services (http://www.thecommunityguide.com).

SIP 21-04

Project Title: Community Interventions in Non-medical Settings to
Increase Informed Decision Making (IDM) for Prostate Cancer Screening.
Project Description: The purpose of this project is to provide
evidence contributing to recommendations made in The Guide to Community
Preventive Services (Guide). The Guide provides evidence-based
recommendations on the effectiveness of community interventions to
promote health and prevent disease, disability and premature death.
Guide recommendations are provided for use by communities, public
health agencies, and health care systems. For more information see
http://www.thecommunityguide.org or Am J Prev Med 2000; 18 (1S). In a

recently published review of evidence on the effectiveness of community
interventions to promote IDM for cancer screening, the Guide found
insufficient evidence to make a recommendation about the effectiveness
of these interventions (Am J Prev Med Jan. 2004). While the Guide found
evidence that such interventions increased individuals' knowledge, too
few studies examined whether the interventions resulted in individuals'
participating in decision making at their desired levels or whether
decisions were consistent with individuals' values and preferences. The
Guide recommended

[[Page 15462]]

additional research focusing on participation in decision making and on
the how to effectively incorporate individual values and preferences in
decision making. Given the lack of research in non-medical settings and
in diverse populations, additional research is needed on how to perform
effective and cost-effective IDM interventions in non-clinical settings
and on how to implement these interventions in diverse populations,
particularly in populations that include non-white or less advantaged
groups. Interventions for use in non-clinical settings are particularly
needed because of the limited time primary care providers have
available to provide preventive services. Applicants may refer to http:
//http://www.thecommunityguide.org for the Guide IDM review and

recommendations and for copies of other relevant Guide publications.
Evidence on the effectiveness of prostate cancer screening and on
the balance of benefits and harms from screening is summarized by the
U.S. Preventive Services Task Force (USPSTF) http://www.ahrq.gov/clinic/cps3dix.htm#screening.
There is good evidence that prostate

specific antigen (PSA) screening can detect early-stage prostate cancer
but mixed and inconclusive evidence that early detection improves
health outcomes. Screening is associated with important harms,
including unnecessary anxiety, biopsies, and complications of treatment
of some prostate cancers that may never have affected a patient's
health. It is unclear whether the benefits outweigh the harms. Given
the uncertainty regarding the balance of benefits and harms from
prostate cancer screening, the CDC supports informed decision making as
a public health approach to prostate cancer screening (http://www.cdc.gov/cancer/prostate/
).

The objective of this funding is to support research on the
effectiveness of community interventions in non-medical settings to
promote informed decision making for prostate cancer screening,
conducted in collaboration with appropriate community and research
partners.
Project Activities: Applicants should address the following:
1. How the proposed study design and methods of implementation meet
quality criteria for inclusion in evidence reviews conducted by the
Guide;
2. How the research will provide evidence of the effectiveness of
the community intervention in promoting IDM as defined by the Guide;
3. How the information component of the proposed intervention (the
knowledge provided) is consistent with USPSTF on prostate cancer
screening effectiveness and on the balance of benefits and harms from
prostate cancer screening;
4. How the intervention will be developed and evaluated for use in
non-clinical settings, such as workplaces or with voluntary
associations or community organizations;
5. How the intervention will be developed and evaluated for use
among men from a range of diverse backgrounds, including non-white and/
or Hispanic populations and men with blue collar occupations and/or
lower incomes;
6. How the intervention will be developed and evaluated for effects
on men's participation in screening decisions at their desired level;
7. How the interventions will be developed and evaluated for
incorporation of individuals' values and preferences in decision-
making;
Preference will be given to proposals that demonstrate the
following:
1. The ability to address each of the project activities listed
above, particularly with regard to consistency with the Guide and the
USPSTF evidence reviews and recommendations;
2. The applicants' abilities to successfully complete the research;
3. A history of extramural funding for related research and of
publications from that research;
4. Evidence that the community interventions can be made available
in a format that will allow them to be easily used by public health
agencies and community groups to promote informed decision making for
prostate cancer in community settings; and
5. Use materials and methods previously developed and evaluated
through formative research and piloting in the planned setting with the
proposed populations.
Project Proposal Length and Supporting Material: Proposal
narratives are limited to 25 pages. Supporting materials included in
the appendices should not exceed 40 pages; the appendices should
included the materials supportive of ability to successfully conduct
the research described above, 2-page biographical sketches, position
descriptions of staff (if needed), any needed letters of support, and
other evidence as consistent with the proposal.
Availability of Funds: Approximately $1,275,000 is available to
fund two applications ($637,500 per applicant) in the first year of a
3-year project period. Funding may vary and is subject to change.
Applicants must apply for and receive funding as a PRC Cancer
Prevention and Control Research Network Center to be eligible to
receive funding for this project. (See SIPs 16-04 and 17-04 on the
Prevention Research Centers Cancer Prevention and Control Network).
Research Status: CDC staff will serve as co-investigators on these
projects and will provide technical assistance on activities such as
research design, data collection and analysis, and co-authoring
manuscripts. It is anticipated that these projects will need approval
by the IRB at the recipient institution and that CDC IRB approval or
deferral to the recipient IRB will be required. The CDC IRB reviews
projects annually. Applicants should provide a federal wide assurance
registration number for each performance site included in this project.

SIP 22-04

Project Title: Validating the Educational Effectiveness of
Professional Education on Informed Decision Making for Prostate Cancer
Screening.
Project Description: A key element in the Community Guide to
Preventive Services analytic framework for interventions to promote
informed decision making about prostate cancer screening is providers'
knowledge, attitudes, intentions, and efficacy. For more information
about the Community Guide, see http://www.thecommunityguide.org or Am J

Prev Med 2000; 18 (1S). The intent of this project is to support
methodologically sound initial evaluation studies of professional
medical education training materials and curricula on informed decision
making. Curricula to be evaluated should promote:
Doctor-patient communication about prostate
cancer screening and informed decision making
Physician's knowledge and understanding of the
clinical evidence related to prostate cancer screening, including the
harms and benefits
Physicians' skills in relating and explaining
the current recommendations related to prostate cancer screening
Physicians' understanding of racial, ethnic and
cultural differences related to prostate cancer epidemiology and the
use of medical services.
These projects should evaluate training materials and curricula
which have been fully developed but have not been tested to address
initial validation questions such as: Do physicians who complete the
professional education curriculum acquire the knowledge or
interpersonal skills that the training

[[Page 15463]]

intends? The project may support up to two validation studies of
comprehensive professional medical education programs through the
Cancer Prevention and Control Research Network.
Although prostate cancer is an important cause of death and
disability among men in the United States, screening for prostate
cancer is controversial. Because of the growing use of screening in
spite of uncertainty about the balance between its harms and benefits,
many organizations encourage informed decision making to assist men
with understanding complex screening issues and making decisions which
are consistent with their personal values, beliefs, and preferences.
Informed decision making is a complex process designed to assist a
patient with understanding the nature of prostate cancer; understanding
the preventive service (in this case, prostate cancer screening)
including risks, limitations, benefits, alternatives, uncertainties;
identifying preferences and values; choosing a level of participation
in decision making with which he is comfortable; and making (or
deferring) a decision based on his preferences and values. The process
of informed decision making involves, at some point, an active
discussion between the individual and his health care provider, usually
his primary care physician. Like their patients, physicians need to be
prepared to be effective participants in the informed decision making
dialogue. At the level of the individual physician, this translates
into very practical questions about what exactly should be said during
the clinical visit, how should relevant aspects of risk and benefit be
communicated, or how to respond to asymptomatic men who request a
screening test with obviously incomplete or incorrect information.
It is well accepted that patients defer to their physicians when
faced with complicated medical decisions. Physicians and other health
care providers must not only understand the facts of prostate cancer
screening but also be able to assist the patient with actively
participating in the informed decision making process. Specific
professional medical education and informed decision making for
prostate cancer screening is necessary. Projects funded through this
proposal will evaluate the effectiveness of existing professional
education materials and programs for teaching providers the knowledge,
interpersonal skills, and cultural sensitivity needed to participate in
informed decision making. Training packages should include training on
doctor-patient communication; information on the clinical evidence
related to prostate cancer screening, including the harms and benefits;
information on racial, ethnic and cultural differences related to
prostate cancer epidemiology and the use of medical services; and
specific skills training for relating and explaining the current
recommendations related to prostate cancer screening.
Project activities: Applications should address the following:
1. Describe a study to assess the potential effectiveness of a
well-defined and replicable professional education training program
designed to promote competent physician participation in informed
decision making for prostate cancer screening;
2. Provide a description of prior research and examples of success
with conducting experimental intervention research (e.g., resulting
scientific publications in peer-reviewed journals);
3. Provide a description of the proposed setting, methods, and
training materials;
4. Provide evidence for the feasibility of the training methods and
materials;
5. Describe how the study design is consistent with design
standards established by the Guide to Community Preventive Services. [A
detailed description of Community Guide standards can be found at:
http://www.thecommunityguide.org];

6. Identify the key project staff and their roles. For each person,
describe their demonstrated knowledge, experience, and ability in
planning and conducting research on professional education;
7. Describe the established resources and expertise available to
the research staff for conducting intervention research in a timely
fashion;
8. Provide evidence of sufficient institutional and other necessary
support for carrying out this project.
Preference will be given to applicants who:
1. Have developed the educational materials and procedures to be
used in this project;
2. Can demonstrate that they have participated in previous research
related to informed decision making;
3. Can provide a record of publishing similar research;
4. Have extensive experience in conducting intervention research in
community or clinical settings;
5. Are part of, or actively collaborate with a member of, the
Cancer Prevention and Control Research Network;
6. Develop their project using an existing professional education
program designed specifically to address provider participation in
informed decision making. No support will be provided for new
development of training materials.
Project Proposal Length and Supporting Material: Proposal
narratives are limited to 15 pages. Supporting materials included in
appendices should not exceed 30 pages. Supporting materials should
provide information sufficient to evaluate the content and
comprehensiveness of the training, biographical sketches of key
investigators, position descriptions of staff (if needed), and letters
of support from collaborators.
Availability of Funds: Approximately $150,000 per year per project
for up to two projects per year is available for over a three-year
period. Funding may vary and is subject to change. The applicant funded
through this announcement will not be eligible for funding under SIP
23-04.
Research Status: It is expected that this project will be exempt
research. CDC staff will provide technical assistance but will not
serve as co-investigators. CDC staff will not have significant input on
project activities including study design, methods, sampling, and data
analysis.

SIP 23-04

Project Title: Evaluating the Effect of Professional Education on
Provider Interventions for Informed Decision Making about Prostate
Cancer Screening.
Project Description: A key element in the Community Guide to
Preventive Services analytic framework for interventions to promote
informed decision making about prostate cancer screening is providers'
knowledge, attitudes, intentions, and efficacy. For more information
about the Community Guide, see http://www.thecommunityguide.org or Am J Prev

Med 2000; 18 (1S).
The objective of this project is to support methodologically sound
research evaluating the effectiveness of professional medical education
designed to shape health care providers' interventions with patients
for promoting informed decision making about prostate cancer screening.
A comprehensive program should provide, at a minimum, training on:
Doctor-patient communication about prostate
cancer screening and informed decision making;
Physician's knowledge and understanding of the
clinical evidence related to prostate cancer screening, including the
harms and benefits;
Physician's skills in relating and explaining
the current

[[Page 15464]]

recommendations related to prostate cancer screening; and
Physicians' understanding of racial, ethnic and
cultural differences related to prostate cancer epidemiology and the
use of medical services.
The project will support one investigation of a comprehensive
professional medical education program through the Cancer Prevention
and Control Research Network. The research should be designed to
evaluate differences in outcomes for patients who participate in
informed decision making with trained providers compared to those who
participate in informed decision making with providers who have not
received the training.
Although prostate cancer is an important cause of death and
disability among men in the United States, screening for prostate
cancer is controversial. Because of the growing use of screening in
spite of uncertainty about the balance its harms and benefits, many
organizations encourage informed decision making to assist men with
understanding complex screening issues and making decisions which are
consistent with their personal values, beliefs, and preferences.
Informed decision making is a complex process designed to assist a
patient with understanding the nature of prostate cancer; understanding
the preventive service (in this case, prostate cancer screening)
including risks, limitations, benefits, alternatives, and
uncertainties; identifying preferences and values; choosing a level of
participation in decision making with which he is comfortable; and
making (or deferring) a decision based on his preferences and values.
The process of informed decision making involves, at some point, an
active discussion between the individual and his health care provider,
usually his primary care physician. Like their patients, physicians
need to be prepared to be effective participants in the informed
decision making dialogue. At the level of the individual physician,
this translates into very practical questions about what exactly should
be said during the clinical visit, how relevant aspects of risk and
benefit should be communicated, or how responses should be made to
asymptomatic men who request a screening test with obviously incomplete
or incorrect information.
It is well accepted that patients defer to their physicians when
faced with complicated medical decisions. Physicians and other health
care providers must not only understand the facts of prostate cancer
screening but also be able to assist the patient with actively
participating in the informed decision making process. Training
materials have been developed to assist physicians with participating
in informed decision making, including 4 developed through DCPC
cooperative agreements and a slide show developed by DCPC. However,
there has been no research on the effectiveness of these materials for
promoting decision making by improving practitioners' knowledge and
skill.
Projects funded through this proposal should evaluate the
effectiveness of existing professional education materials and programs
for enhancing competent provider participation in informed decision
making in real-world, clinical settings. Competence should be measured
in terms of both changed provider behavior and successful completion of
the informed decision making process by the patient. Training packages
should include training on doctor-patient communication; information on
the clinical evidence related to prostate cancer screening, including
the risks and benefits; information on racial, ethnic and cultural
differences related to prostate cancer epidemiology and the use of
medical services; and specific skills training for relating and
explaining the current recommendations related to prostate cancer
screening. Training materials and procedures used in the project should
have received an initial evaluation demonstrating educational
effectiveness.
Project activities: Applications should address the following:
1. Describe a study to assess the effectiveness of a well-defined
and replicable professional education training program designed to
promote competent physician participation in informed decision making
for prostate cancer screening.
2. Provide a description of prior research and examples of success
with conducting experimental intervention research (e.g., resulting
scientific publications in peer-reviewed journals);
3. Provide a description of the proposed setting, methods, and
training materials;
4. Provide a summary of the initial evaluation results for the
training methods and materials;
5. Provide evidence for the feasibility of the research design;
6. Describe how the study design is consistent with design
standards established by the Guide to Community Preventive Services. [A
detailed description of Community Guide standards can be found at:
http://www.thecommunityguide.org];

7. Identify the key staff who will be devoted to the project. For
each person describe their demonstrated knowledge, experience, and
ability in planning and conducting research on professional education;
8. Describe the established resources and expertise available to
the research staff for conducting intervention research in a timely
fashion;
9. Provide evidence of sufficient institutional and other necessary
support for carrying out this project.
Preference will be given to applicants who:
1. Have developed and pre-tested the educational materials and
procedures to be used in this project;
2. Can demonstrate that they have participated in previous research
related to informed decision making;
3. Can provide a record of publishing similar research;
4. Have extensive experience in conducting intervention research in
community or clinical settings;
5. Are part of, or actively collaborate with a member of the
Prevention Research Centers' Cancer Prevention and Control Research
Network, SIP 16-04 and SIP 17-04.
Project Proposal Length and Supporting Material: Proposal
narratives are limited to 15 pages. Supporting materials included in
appendices should not exceed 30 pages. Supporting materials should
provide information sufficient to evaluate the content and
comprehensiveness of the training, biographical sketches of key
investigators, position descriptions of staff (if needed), and letters
of support from collaborators.
Availability of Funds: Approximately $400,000 per year is available
to fund one project for up to 4 years. Funding may vary and is subject
to change. Each applicant should develop their project using an
existing professional education. No support will be provided for new
development of training materials. The applicant funded for this
project will not be eligible for funding under SIP 22-04.
Research Status: It is expected that this project will be exempt
research. CDC staff will provide technical assistance but will not
serve as co-investigators. CDC staff will not have significant input on
project activities including study design, methods, sampling, and data
analysis.

SIP 24-04

Project Title: Analysis of ovarian cancer surgeries using state
hospital discharge data.
Project Description: Existing data have shown that cancer staging
and

[[Page 15465]]

cytoreduction performed by gynecologic oncologists has a significant,
positive impact on survival (Nguyen, et al. 1993; Mayer, et al. 1992;
Puls et al. 1997). It is likely that these specialists perform the most
surgeries and practice in high-volume hospitals. A recent study in
Canada (Elit et al. 2002) used hospitalization data to evaluate the
effect of hospital type, hospital volume, and surgical specialty on
ovarian cancer re-operation rates and mortality rates. This study found
that patients were less likely to have a repeat operation if the
initial operation was done in a high-or intermediate-volume hospital,
in a hospital with a gynecologic oncologist, or performed by a
gynecologic oncologist, gynecologist, or high-volume surgeon. The study
also found that the adjusted survival was improved when the initial
surgery was done by a gynecologic oncologist. In addition, a Maryland
study using hospital discharge data has shown that most ovarian cancer
surgeries in that state continue to be performed in low-volume
hospitals by low-volume surgeons (Bristow, et al., in press).
Additional information is needed in the United States to assess what
proportion of ovarian cancer patients are being surgically evaluated in
low-volume hospitals and by surgeons with a low operating volume.
CDC is committed to better understanding the current patterns of
care in women being evaluated or treated for ovarian cancer. In the
majority of cases, ovarian cancer is diagnosed at a late stage when 5-
year survival rates are very low. Without a screening test,
opportunities for improving survival depend upon identification of
modifiable factors during the diagnosis or initial treatment of ovarian
cancer that may decrease the stage at diagnosis or increase disease
free survival time. If a large proportion of women are receiving their
primary surgical care from low-volume hospitals and surgeons,
opportunities can be identified for improving initial surgical staging
and treatment, as well as survival in these women. Women and general
surgeons should be educated that survival from ovarian cancer is
improved when these surgeries are performed by gynecologic oncologists
and in high volume hospitals.
Project Activities: Applicants should address the following:
1. Describe a study which uses appropriate hospital discharge data
to learn more about the medical setting where the primary surgical
management of ovarian cancer is taking place. Activities might include:
a. Determining and evaluating the patterns of primary surgical care
of ovarian cancer by hospital volume and individual surgeon volume; and
b. Assessing changes in patterns of surgical care over time.
2. Describe the methods which will be used to obtain and analyze
the data.
3. Identify key staff who will be devoted to the project. Describe
each person's demonstrated knowledge, experience, and ability in
analyzing data for this study.
4. Provide evidence of sufficient institutional and other necessary
support for carrying out this project.
5. Describe how the information gained from this study will be made
available to improve the health and survival of persons diagnosed with
ovarian cancer.
Preference will be given to applicants who:
1. Describe a project which will incorporate data from multiple
states, as well as from rural and urban hospitals.
2. Can provide a record of publishing similar research.
Project Proposal Length and Supporting Material: Proposal
narratives are limited to 15 pages. Supporting materials included in
appendices should not exceed 20 pages.
Availability of Funds: Approximately $175,000 is available to fund
one Prevention Research Center in the first year of a 1-year project
period. Funding may vary and is subject to change.
Research Status: It is expected that this project will be exempt
research. This project will involve the study of existing data that are
publicly available for a fee. The data will be recorded in a manner in
which the individual subjects cannot be identified, directly or though
identifiers linked to the subjects. CDC staff will serve as co-
investigators and provide input into the design, methodology, and
analysis of the data; however, CDC will not receive the data. It is
expected that this project will require CDC IRB approval of exempt
research status.

SIP 25-04

Project Title: A Prospective Study on the Effect of Treatment on
Health-Related Quality of Life for Men with Localized Prostate Cancer.
Project Description: More than 220,000 men will be diagnosed with
prostate cancer in 2003. Eighty six percent of these individuals will
be diagnosed with localized disease. Patients with newly diagnosed,
early stage prostate cancer have a number of treatment choices,
including watchful waiting, surgical resection, brachytherapy, and
external beam radiation. These treatment choices are associated with
significant morbidity and side effects, which affects men's health-
related QOL. Currently there is no clinical consensus regarding the
optimal medical management of early stage prostate cancer, and given
the protracted natural history of the disease, it is not possible to
differentiate tumors that behave aggressively from those that remain
indolent during a man's lifetime. Lacking comparative data from
controlled studies and divergent clinical opinions about the benefits
and harms of each treatment option, men with prostate cancer face
difficult choices about their care. As an important measure of health
outcome, QOL following screening, diagnosis, and treatment for prostate
cancer may provide important information to guide patients' decisions
regarding available treatment choices.
A major portion of treatment decisions take place at home, that is,
within the context of family. However, existing studies have not
credited family as a major player in the prostate cancer treatment
decision making process. In this study, we hypothesize that treatment
choices regarding prostate cancer will inevitably be influenced by
three decision makers: the patient, their physician, and (when present)
the patient's family or caregiver. To date, no prospective study has
examined the influence of this ``triangle'' of decision makers on
treatment decisions.
While shared decision making is vital in prostate cancer, it is
inevitable that knowledge about the myriad of outcomes that are related
to each treatment choice (e.g., side effects, impact on chances of
cancer recurrence, etc.), as well as preferences regarding the many
outcomes corresponding to each treatment will differ among decision
makers. Facilitating shared decision making among all those involved is
likely to improve satisfaction with care and outcomes for prostate
cancer treatment.
The purpose of this project is to support studies that measure
prostate cancer-specific and general health-related quality of life
(QOL) from the perspective of the patient, their caregiver and the
physician directing care before, during, and after treatment. The goal
is to better understand the patient's QOL following prostate cancer
treatment and to correlate the patient's self-reported QOL with that
reported by the caregiver and the attending physician. The objective of
this study is to develop a better understanding of patient, physician,
and caregiver perceptions of the costs, benefits, and

[[Page 15466]]

QOL associated with each prostate cancer treatment option.
Project Activities: Applicants should address the following issues:
1. Demonstrate a conceptual framework, design, methods, and
analyses appropriate to the aims of the project. Applicants should:
a. Demonstrate knowledge of available treatments for prostate
cancer and issues related to the evaluation of health-related quality
of life and differences in perceptions of QOL.
b. Demonstrate knowledge of recent literature and explain how the
proposed research could further what is already known.
c. Demonstrate access to substantial patient population and provide
plans for patient retention.
d. Include policies, criteria, and processes for selecting
candidates, including special efforts to recruit minorities.
e. Address potential problem areas and consider alternative
tactics.
2. Provide evidence of infrastructure suitable to their study.
Applicants should:
a. Describe the scientific environment in which the work will be
conducted.
b. Describe nature of infrastructure or partnership.
c. Provide evidence of commitment and cooperation of potential
partners (e.g., recent letters of support, memoranda of understanding,
and documented examples of prior collaboration).
3. Identify the key staff who will be devoted to this project.
a. For each person describe their demonstrated knowledge,
experience, and ability in planning, implementation, conducting, and
management of research that is similar to that proposed here in
complexity, scope and focus. If there is a position that is yet to be
filled, provide a position description in the appendix. Include the
percentage of time each person will devote to project activities.
b. Of the named staff, provide evidence of the nature of their
experience in conducting and being funded for intervention research,
community-based participatory research, and translation of research
into practice.
4. Provide evidence of sufficient institutional support (e.g.,
space, equipment, etc.). Describe the established resources and
expertise available to your member center staff (e.g., intervention
research, health services research, community-based participatory
research, behavioral sciences, communication theory and practice,
etc.).
2. Include specific, measurable, time-framed objectives for a
three-year funding period.
Preference will be given to applicants who:
1. Demonstrate past publication history or literature reviews in
this area.
2. Demonstrate the ability to manage multi-site initiatives.
3. Consider a national, multi-site sampling scheme.
Project Proposal Length and Supporting Material: Proposal
narratives are limited to 20 pages. Supporting materials included in
the appendices should not exceed 30 pages. The appendices should
include the requested materials above, including the 2-page
biographical sketches, position descriptions of faculty and staff (if
needed), letters of support, etc.
Availability of Funds: Approximately $290,000 is available to fund
one Prevention Research Center for the first year of a 3-year project
period. Funding may vary and is subject to change.
Research Status: It is expected that this project will be non-
exempt research. CDC staff will serve as co-investigators on this
project and will provide technical assistance on activities such as
research design, data collection and analysis, and dissemination of
results. It is expected that the project will require CDC IRB approval
and local IRB approval. As applicable, applicants should provide a
federal wide registration number for each performance site included in
the project.
References.
Sommers and Ramsey. A review of quality-of-life evaluations in
prostate cancer. Pharmacoeconomics 16:127-40. 1999.
Schapira MM, Lawrence WF, Katz DA, McAuliffe TL, Nattinger AB.
Effect of treatment on quality of life among men with clinically
localized prostate cancer. Medical Care. 39(3):243-53, 2001 Mar.
Litwin MS et al. Urinary function and bother after radical
prostatectomy or radiation for prostate cancer: a longitudinal
multivariate quality of life analysis from the Cancer of the Prostate
Strategic Urologic Research Endeavor. J Urology 164:1973-77. 2000.
Lubeck DP et al. Changes in health-related quality of life in the
first year after treatment for prostate cancer: results from CaPSURE.
Urology 53:180-86. 1999.
Lubeck DP et al. Health related quality of life differences between
black and white men with prostate cancer: results from CaPSURE. J
Urology 166:2281-85. 2001.

SIP 26-04

Project Title: HIV Infection and Breastfeeding: Interventions for
Maternal and Infant Health.
Project Description: With levels of HIV seroprevalence in pregnant
women in parts of sub-Saharan Africa approaching 30%, the potential
impact of HIV/AIDS on maternal morbidity and mortality must be
considered. Preliminary data from a study conducted in Nairobi
indicates that HIV-infected women who breastfed experienced an increase
in mortality as compared to HIV-infected women who did not. Not only
are these women HIV-infected and mothers, but many may suffer from
malnutrition and have very limited access to health care. This nexus of
factors demands a careful examination of the impact of breastfeeding by
HIV positive mothers on maternal morbidity and mortality.
Many antiretroviral (ARV) regimens that administer the ARVs to
pregnant women and neonates result in substantial reduction in vertical
transmission at birth. However, in the absence of interventions to
prevent postnatal infection due to HIV transmission through breast
milk, many infants will be infected during the breastfeeding period.
There are no safe alternatives to breastfeeding in many less developed
countries. Many interventions for reduction of HIV transmission through
breastfeeding are currently being explored including formula feeding
(WHO), exclusive breastfeeding, early weaning, treatment of subclinical
mastitis, antiretroviral treatment of the mother, antiretroviral
prophylaxis for the infant, or enhancement of protective anti-HIV
immunity in either mother or infant. The implications of these options
for maternal and infant health remain unexplored.
The purpose of this project is to support studies that explore
interventions to reduce maternal morbidity and HIV transmission during
breastfeeding. It would be most advantageous to link this study with an
ongoing intervention to reduce maternal to child transmission of HIV
(e.g. short course ZDV in late pregnancy and labor or nevirapine in
labor).
Project Activities: Activities that meet the objectives of the
project may include:
1. Describe the benefit of nutritional supplementation given to
women during breastfeeding.
Data would be collected prospectively on 2,000-3,000 breastfeeding
HIV-infected mothers from delivery to at least 6 months post-partum.
Follow-up

[[Page 15467]]

measurements would include, but not be limited to, maternal mortality,
HIV viral load, CD4 counts, AIDS-related illness, anthropometric
measurements, and maternal micronutrient levels.
2. The benefit and safety of antiretroviral medications given
either to infants or to their mothers to prevent HIV transmission
during breastfeeding.
Interventions to reduce HIV transmission during breastfeeding
should be provided in the form of antiretrovirals to infants born to
breastfeeding HIV-infected mothers who participate in the prospective
study listed above in an effort to reduce maternal to child
transmission of HIV. For antiretroviral drugs provided as prophylaxis
for breastfeeding infants, issues of dosing schedule, pediatric
formulation, safety, necessary U.S. and host country regulatory
approvals, and sustainability need to be considered.
3. The feasibility of exclusive breastfeeding followed by early,
rapid breastfeeding cessation. In facilitation of this, a suitable
alternative to formula will be used as a replacement food for breast
milk after 6 months.
Applications should also address the following:
1. Identify key staff who will be devoted to the project. For each
person describe their demonstrated knowledge, experience, and ability
in planning and conducting intervention research that is described
above in complexity, scope and focus.
2. Provide evidence of sufficient institutional and other necessary
support for carrying out this project.
3. Describe the established resources and expertise available to
the research staff for conducting intervention in a timely fashion.
4. Identify specific methods that will be used to assess the
individual components as well as the intervention components of the
intervention.
5. Provide evidence of feasibility of the research.
Preference will be given to applicants who:
1. Have obtained information on food security, acceptability of
food supplementation, use of supplementation in pregnancy and
postnatally, issues around sharing of supplementation with family
members, typical weaning diets and the acceptability of early
breastfeeding cessation.
2. Can demonstrate that they have participated in previous research
related to informed consent process.
3. Have piloted a suitable informed consent process.
4. Have experience in conducting intervention research in community
or clinic settings.
5. Can demonstrate ability to recruit at least 60 HIV-infected
mothers and their infants per month.
6. Have demonstrated clinical experience in prescribing ARV
regimens in resource-limited settings.
Project Proposal Length and Supporting Material: Proposal
narratives are limited to 10 pages. Supporting materials included in
the appendices should not exceed 35 pages.
Availability of Funds: Up to $1,500,000 is available to support one
Prevention Research Center for the first year of a five-year project
period. Funding may vary and is subject to change.
Research Status: It is expected this project will involve non-
exempt research as it will require obtaining clinical and behavioral
information from human subjects. This project involves a protocol which
requires IRB review by all institutions participating in the research
project. CDC staff will serve as co-investigators on this project and
will provide technical assistance on activities such as research
design, data collection and analysis, and dissemination of results. The
CDC IRB will review and approve the protocol on an annual basis until
the project is completed. Applications should provide a federal wide
assurance registration number for each performance site included in the
project.

Dated: March 15, 2004.
Edward Schultz,
Acting Director, Procurement and Grants Office, Centers for Disease
Control and Prevention.
[FR Doc. 04-6283 Filed 3-24-04; 8:45 am]

BILLING CODE 4163-18-P