[Federal Register: March 28, 2003 (Volume 68, Number 60)]
[Notices]
[Page 15191-15196]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr28mr03-77]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[Program Announcement 03037]
Communication and Negotiation About Barrier Contraceptive Use
Among Young Adults at Risk; Notice of Availability of Funds
Application Deadline: May 27, 2003.
A. Authority
This program is authorized under sections 301(a) and 317(k)(2) of
the Public Health Service Act, [42 U.S.C. sections 247b(k)(2)], as
amended. The
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Catalog of Federal Domestic Assistance number is 93.283.
B. Purpose
The Centers for Disease Control and Prevention (CDC) announces the
availability of fiscal year 2003 funds for a cooperative agreement for
Communication and Negotiation About Barrier Contraceptive Use Among
Young Adults At Risk. This program addresses the ``Healthy People
2010'' focus areas family planning, HIV, and sexually transmitted
diseases.
The purpose of this program is to investigate the context within
which sexually active young adult African American and Latino women and
men (ages 18-25) communicate sexual values and negotiate about barrier
contraceptive use (use of male condoms, female condoms, or the
diaphragm). The program will develop, implement and evaluate case study
intervention models to encourage choices and effective negotiation
skills for prevention of HIV/STDs and unplanned pregnancies.
In Phase I, support will be provided for multi-method formative
approaches toward understanding communication between heterosexual
partners about sexual abstinence, monogamy, and barrier contraceptive
use and factors influencing implicit expectations (about gender roles,
reproductive ambivalence, competing contraceptive alternatives, power,
cultural values, social norms, etc.) and explicit negotiation
processes. This phase will culminate with the development of a plan for
an intervention model.
Phase II will support implementation of case studies of community-
based intervention models to facilitate communication about
reproductive decision making and barrier contraceptive use among young
adult women and men with their partners, using information gathered in
Phase I.
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): Support prevention research
to develop sustainable and transferable community-based behavioral
interventions.
C. Eligible Applicants
Applications may be submitted by public and private nonprofit
organizations and by governments and their agencies; that is,
universities, colleges, technical schools, research institutions,
hospitals, other public and private nonprofit organizations, community-
based organizations, faith-based organizations, state and local
governments or their bona fide agents, including the District of
Columbia, the Commonwealth of Puerto Rico, the Virgin Islands, the
Commonwealth of the Northern Mariana Islands, American Samoa, Guam, the
Federated States of Micronesia, the Republic of the Marshall Islands,
and the Republic of Palau, federally recognized Indian tribal
governments, Indian tribes, or Indian tribal organizations. 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.
D. Funding
Availability of Funds
Approximately $800,000 is available in FY 2003 to fund
approximately two awards. It is expected that the average award will be
$400,000, ranging from $300,000 to $450,000. It is expected that the
awards will begin on or about September 1, 2003 and will be made for a
12-month budget period within a total project period of five years; the
first phase will be for two-three years and the second phase will occur
during the subsequent two-three years. Awards for Phase II will be
subject to documented collaboration with community partner(s) and
availability of funds. Funding estimates may change.
Continuation awards within an approved project period will be made
on the basis of satisfactory progress as evidenced by required reports
and the availability of funds.
Recipient Financial Participation
No matching funds are required for this program.
Funding Priority
Priority will be given to projects that demonstrate access to and
propose to target young adult women and men at high risk for STDs,
including HIV, and unintended pregnancies. Communities in which
research is to be conducted, and interventions fielded, should be
predominately African American or Latino and disproportionately
affected by HIV and other STDs. Priority will be given to communities
with rates of chlamydia, gonorrhea, and teen pregnancy that are above
national average rates.
Funds may be awarded in such a way as to achieve geographic
distribution of funded projects.
E. Program Requirements
In conducting activities to achieve the purpose of this program,
the recipient will be responsible for activities listed under Recipient
Activities, and CDC will be responsible for activities listed under CDC
Activities.
Recipient Activities
The recipient will be responsible for conducting the research
outlined in Phase I, and using the formative research collected during
this Phase to develop an intervention plan and case study evaluation
for Phase II. Funding for Phase II will be contingent upon satisfactory
progress as evidenced by required reports, the intervention plan, the
documented establishment of a formal collaboration with a community-
based organization equipped to implement the intervention model, and
availability of funds. A complete description of the activities
required within Phase I and Phase II follows.
Phase I (Years One to Two or One to Three)
This program announcement seeks a multi-method approach toward
understanding the complexity of communication between partners: To what
extent does negotiation about sexual choices, including monogamy,
abstinence, and explicit barrier contraceptive use take place and by
whom; the nature of the actual communication processes; and the context
within which they lead to different outcomes. In this initial formative
phase of the project, applicants are encouraged to propose creative,
innovative data collection methods that will yield information about
individual, social, and cultural factors that affect contraceptive
decision making and behavior that may be used in the Phase II
intervention design.
Activities to be conducted are:
1. Clearly identify key research questions to be addressed
including, but not limited to:
a. How do young adult men and women make decisions about
abstinence, sexual initiation, and monogamy?
b. How do sexually active young adult men and women decide to use
barrier contraception and how are these choices negotiated? Or if not
directly negotiated, how do social roles, norms, and expectations
influence these decisions?
c. How are intimacy and commitment to mutual monogamy assumed,
expected, and communicated between partners, and how do couples that
perceive themselves as mutually monogamous communicate about barrier
methods?
d. Are power differentials between young adult men and women
perceived, and if so, how are they communicated (verbally or
nonverbally)?
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e. What are the tacit assumptions made or the explicit negotiation
strategies commonly used by young women and men and how do partners
respond to each approach (what contextual factors are important)?
f. Do young adult women and men use hierarchical strategies, if
they have multiple contraceptive methods available?
g. What social and cultural factors predict young adult men's
receptiveness to safe sex negotiation strategies offered by a female
partner? What social and cultural factors predict young adult men's
ability or willingness to negotiate?
h. How does marital and childbearing motivation, including cultural
expectations, ambivalence about pregnancy and perceptions of each
other's desires affect communication?
i. How do young adult men communicate their reproductive values to
their partners and what is the context in which this occurs?
j. How does communication about hormonal contraceptive use (e.g.,
oral contraceptives, implants, injectables, ring, patch) occur and what
is the context in which it occurs or what prompts it to occur?
2. Conduct comprehensive literature review related to identified
research questions.
3. Identify and recruit sexually active women and men, ages 18-25
from predominantly African American or Latino communities with
documented HIV/STD risk characteristics (rates of chlamydia, gonorrhea,
and teen pregnancy above national average rates).
4. Conduct formative research activities such as the following, but
not limited to:
a. Development of vignettes or scenarios depicting communication of
values and barrier negotiation strategies. Presentation of these
vignettes to young adult men and women (individually or in groups), and
assessment of their qualitative responses, similar experiences, and
further development of the situations (for intervention planning).
b. Mixed or same sex focus groups to explore cultural/environmental
influences and the role of peers in shaping attitudes toward
communication about sexual values and choices, including barrier
contraception. If focus groups are conducted, ensure that the
appropriate privacy concerns are addressed, as information provided
will be sensitive and confidential.
c. In-depth qualitative interviews with young adult men and women
who are sexually active. May consider their specific experiences with
barrier contraceptive use, including successful communication,
avoidance of use or dissuasion of a partner, partner responses, and
perceptions of partner attitudes, roles, and monogamy. May explore
implicit or explicit reproductive issues along with the context of
negotiating hormonal contraceptive use (including newer methods, such
as the contraceptive patch, ring, and emergency contraception).
d. Observational study of cohort of sexually active young adult men
and women provided with barrier contraceptives (male condom, female
condom, or diaphragm), trained in use of coital diaries (possibly a
software log), and interviewed at follow-up intervals to assess act-by-
act experiences with negotiation and partner communication (including
contextual factors).
5. Conduct analyses of data collected using, but not limited to,
these methods:
a. Identify the characteristics of different negotiation/
communication styles among young adult women and men.
b. Identify key influences on these negotiation and communication
styles.
c. Develop or identify existing quantitative measures of key
variables that could be used in Phase II and be hypothesized to predict
the behavior of women and men with different communication styles.
d. Collaborate with other recipients in the development and
measurement of a common core set of variables to permit comparative
analyses.
6. Develop a plan for using this formative research in the design
of a theory and evidence-based intervention model feasible for
implementation in a community-based case study.
a. Present relevant conceptual foundation for the model.
b. Integrate the results of the research with literature on
communication interventions and strategies. As part of this synthesis,
thoroughly document the intervention models and strategies that already
exist.
c. Based on formative research, theory and the review of the
intervention research, develop state-of-the-art recommendations on
intervention strategies to promote successful negotiation and
communication for young adult women and men at risk. These
interventions must consider the characteristics of the community and
cultural contexts of the participants' lives.
d. Collaborate with other recipients during development of design
and protocol.
7. Establish and document formal collaboration with a community-
based organization(s) or partner qualified to carry out the work
proposed in Phase II.
Phase II (Years Three to Five or Four to Five)
Case Study: Community-Based Intervention Models
Project(s) in this phase would implement and conduct a feasibility
assessment of an intervention for facilitating reproductive decision-
making and effective barrier contraceptive negotiation by young adult
women and men based on the selected intervention plan. Proposed
interventions should address the subtle strategies and interpersonal
pathways to successful communication, the contextual (social normative,
etc.) factors that facilitate or constrain negotiation and
communication, and be designed to influence large numbers of young
adult men and women in a community. Applicant activities to be
conducted are:
1. Collaborate with community partners and members of the target
group to plan all phases of the project.
2. Identify a community site for implementation of the case study.
A comparison community may be used as part of a case study approach to
evaluation that includes extensive process evaluation, documenting all
aspects of program design and implementation.
3. Clearly state the objectives of the proposed intervention model.
4. Propose an intervention model that could be replicated in
community-based settings (a concept and preliminary approaches proposed
in this application must be fully developed based on Phase I: six a-d).
5. Develop and implement community-based intervention strategies
that have the potential for broad reach and high impact.
6. The cost effectiveness of the model as a public health
intervention must be addressed. Interventions that are costly and
logistically difficult for implementation in public health settings,
such as couples-based counseling interventions for young adults, will
not be supported by this announcement.
7. Collaborate with other recipients during the development and
implementation of the project evaluation.
CDC Activities
1. Host meetings each year to facilitate planning of the research
program and to promote progress toward meeting national health
objectives.
2. Provide technical assistance in the design and development of
the
[[Page 15194]]
formative research, scientific review and evaluation of measurement
strategies and instruments, and development of operational plans for
the protocols. Coordinate review of intervention plans and process
evaluation strategies.
3. Coordinate plans for data management and analysis of data from
Phase I and Phase II; assist with development of plan for, and
participation in analysis, preparation, and reporting of results.
4. Assist with development of a research protocol for Institutional
Review Board (IRB) review by all cooperating institutions participating
in the research project. Perform site visits to assess program progress
and to provide technical assistance.
F. Content
Letter of Intent (LOI)
A LOI is required for this program. The Program Announcement title
and number must appear in the LOI. The LOI narrative should be no more
than three pages, double-spaced, printed on one side, with one-inch
margins, and unreduced 12-point font. The LOI will be used to enable
CDC to determine the level of interest in the announcement and should
include the following information: Target group and site
characteristics, experience collaborating with relevant community
partner(s) and specific objectives to be addressed in the proposed
project.
Applications
Program announcement title and number must appear in the
application. Use the information in the Program Requirements, Other
Requirements, and Evaluation Criteria sections to develop the
application content. Your application will be evaluated on the criteria
listed, so it is important to follow them in laying out your program
plan. The application narrative should be no more than 25 pages single-
spaced, printed on one side, with one-inch margins, and unreduced 12-
point font.
The narrative should consist of a Background and Significance
section, a Plan, Objectives, Methods, a Research and Intervention
Capacity section, a Collaboration section, Evaluation, and Budget.
G. Submission and Deadline
Letter of Intent (LOI) Submission
On or before April 28, 2003. Submit the LOI to the Grants
Management Specialist identified in the ``Where to Obtain Additional
Information'' section of this announcement.
Application Forms
Submit the signed original and two copies of application form PHS
398. Forms are available at the following Internet address: http://www.cdc.gov/od/pgo/forminfo.htm
If you do not have access to the
Internet, or if you have difficulty accessing the forms on-line, you
may contact the CDC Procurement and Grants Office Technical Information
Management Section (PGO-TIM) at: 770-488-2700. Application forms can be
mailed to you.
Submission Date, Time, and Address
The application must be received by 4 p.m. Eastern Time May 27,
2003. Submit the application to: Technical Information Management-
PA 03037, Procurement and Grants Office, Centers for Disease
Control and Prevention, 2920 Brandywine Rd, Atlanta, GA 30341-4146.
CDC Acknowledgement of Application Receipt
A postcard will be mailed by PGO-TIM, notifying you that CDC has
received your LOI and application.
Deadline
Letters of intent and applications shall be considered as meeting
the deadline if they are received before 4 p.m. Eastern Time on the
deadline date. Any applicant who sends their LOI or application by the
United States Postal Service or commercial delivery services must
ensure that the carrier will be able to guarantee delivery of the
application by the closing date and time. If an LOI or application is
received after closing due to (1) carrier error, when the carrier
accepted the package with a guarantee for delivery by the closing date
and time, or (2) significant weather delays or natural disasters, CDC
will upon receipt of proper documentation, consider the application as
having been received by the deadline.
Any LOI or application that does not meet the above criteria will
not be eligible for competition, and will be discarded. The applicant
will be notified of their failure to meet the submission requirements.
H. Evaluation Criteria
Application
Applicants are required to provide measures of effectiveness that
will demonstrate the accomplishment of the various identified
objectives of the grant or cooperative agreement. Measures of
effectiveness must relate to the performance goal stated in section
``B. Purpose'' of this announcement. Measures must be objective and
quantitative and must measure the intended outcome. These measures of
effectiveness shall be submitted with the application and shall be an
element of evaluation.
An independent review group appointed by CDC will evaluate each
application against the following criteria (in order of weight):
1. Methods (30 points)
The extent to which the design, methods, plans for instrument
development, data collection, and analysis for Phase I are
scientifically sound and capable of producing the intended results. The
extent to which the research is innovative and represents a new
approach by integrating new literature sources and using sophisticated
methodology to identify subtle or complex communication variables. The
extent to which the data synthesis process can be clearly used in a
timely manner for development of the Phase II intervention plan. The
extent to which the proposed intervention approaches for Phase II
represent a consideration of appropriate theoretically, empirically,
and programmatically justified intervention approaches which could
realistically be adapted using Phase I data. The proposed intervention
model should be feasible in community-based settings in which many
women and men might be influenced. The extent to which the applicant
describes a plan for process evaluation to be conducted during Phase
II.
2. Background and Significance (15 points)
The extent to which the applicant: Describes the background leading
to the application, including the theoretical or conceptual framework;
critically evaluates existing knowledge; specifically identifies gaps
that the Phase I project is intended to fill; and describes the target
population and the potential health impact of the research and
intervention.
3. Plan (15 points)
The quality of the justification for the theoretical, empirical and
programmatic focus of Phase I research and the approach proposed for
the Phase II intervention model (approaches and concepts considered for
design of Phase II are expected in the application; the proposed
intervention plan may be revised and will be fully developed at the end
of Phase I).
The extent to which the applicant describes the proposed research
plan for Phase I and the plan for establishing collaboration with a
community-based
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organization/partner qualified to carry out the work proposed in Phase
II. In Phase I, linkage between the research questions and the
formative research activities should be clearly presented. The extent
to which the applicant proposes a feasible case study plan for Phase
II.
The applicant must address the CDC Policy requirements regarding
the inclusion of women, ethnic, and racial groups in the proposed
research plan. 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 community(ies) and recognition of mutual benefits.
4. Objectives (10 points)
The extent to which the applicant describes the broad objectives
and the specific research questions this project is intended to address
in Phase I and II. The research questions must address multiple levels:
individual, partner, social, cultural, and other contextual variables.
The objectives must be quantifiable in terms of output and timeline.
5. Research and Intervention Capacity (10 points)
The extent to which the applicant provides an account of the
research team members' studies pertinent to the application that will
help establish the experience and competence of the team members to
pursue both phases of the proposed project. The extent to which the
applicant documents access to researchers with experience and training
in analysis of qualitative data, demonstrates the capacity to obtain
the participation of adequate numbers of male and female participants
from the proposed sites, and describes the adequacy of the staff (in
each phase) and facilities to feasibly carry out the project. Extent of
experience with formative research on this topic, experience conducting
community-based interventions addressing sexual risk behavior or
reproductive health, and experience implementing process evaluations.
6. Collaboration (10 points)
The extent to which the applicant describes how community partners
and members of the target group will be involved in Phase I and
potentially Phase II, defines the responsibilities of organizations in
the community on this project and highlights past involvement with
community-based organizations or partners (provides letters of
support).
7. Evaluation (10 points)
The methods by which the applicant proposes to measure progress in
meeting goals and objectives, and presents a reasonable plan for
collecting data, analyzing data, and reporting the results. Quality
assurance plan must be addressed.
8. Budget (reviewed but not scored)
The extent to which the budget and justification are consistent
with program objectives and purpose.
9. Human Subjects Involvement (reviewed but not scored)
The extent to which the applicant addresses the requirements of 45
CFR part 46 for the protection of human subjects. Not 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.
10. Performance Goals (reviewed but not scored)
The extent to which the applicant addresses the relevant
Performance goals. The relevant goals include (timeline may vary):
Year 1: Design the formative research component, including
literature review, methods, sampling frame, data collection
instruments, and IRB package.
Year 2: Conduct data collection and prepare a detailed analysis and
publication plan.
Year 3: Analyze the data, synthesize data with review of literature
on communication interventions and strategies, prepare a report and
develop an intervention and evaluation plan.
Year 4: Pending approval and funds, implement the intervention and
prepare an interim process evaluation report.
Year 5: Evaluate the intervention and prepare a final report
summarizing results of the case study and recommendations for
technology transfer.
I. Other Requirements
Technical Reporting Requirements
Provide CDC with original plus two copies of:
1. An interim progress report. The interim progress report will be
due on the 15th of March each year through 2008. This interim progress
report will serve as your non-competing continuation application. A
second report is due 90 days after the end of each budget period. These
reports must include the following elements:
a. A succinct description of the program accomplishments and
progress made in meeting each Current Budget Period Activities
Objectives during the previous six months of the budget period.
b. A succinct description of the program accomplishments/narrative
and progress made in meeting each Current Budget Period Activities
Objectives during the previous six months of the budget period.
c. The reason(s) for not meeting established program objectives and
strategies to be implemented to achieve unmet objectives.
d. Current Budget Period Financial Progress.
e. New Budget Period Proposed Activities and Objectives.
f. Detailed Line-Item Budget and Justification.
g. For all proposed contracts, provide the name of contractor,
method of selection, period of performance, scope of work, and itemized
budget and budget justification. If the information is not available,
please indicate ``To Be Determined'' until the information becomes
available; it should be submitted to CDC Procurement and Grants
Management Office contact identified in this program announcement.
2. Financial status report, no more than 90 days after the end of
the budget period. The financial status report should include an
attachment that identifies unspent balances for each program component.
3. Final financial and performance reports, no more than 90 days
after the end of the project period.
Send all reports to the Grants Management Specialist identified in
the ``Where to Obtain Additional Information'' section of this
announcement.
Additional Requirements
The following additional requirements are applicable to this
program. For a complete description of each, see Attachment I of the
program announcement as posted on the CDC Web site.
AR-1 Human Subjects Requirements
AR-2 Requirements for Inclusion of Women and Racial and Ethnic
Minorities in Research
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AR-5 HIV Program Review Panel Requirements
AR-7 Executive Order 12372 Review
AR-9 Paperwork Reduction Act Requirements
AR-10 Smoke-Free Workplace Requirements
AR-11 Healthy People 2010
AR-12 Lobbying Restrictions
J. Where To Obtain Additional Information
This and other CDC announcements, the necessary applications, and
associated forms can be found on the CDC Web site, Internet address:
http://www.cdc.gov.
Click on ``Funding'' then ``Grants and Cooperative Agreements''.
For general questions about this announcement, contact: Technical
Information Management, CDC Procurement and Grants Office, 2920
Brandywine Rd, Room 3000, Atlanta, GA 30341-4146, Telephone: 770-488-
2700.
For business management and budget assistance, in the states,
contact: LaKassa Wyatt, Procurement and Grants Office, Centers for
Disease Control and Prevention, 2920 Brandywine Road, Room 3000,
Atlanta, GA 30341-4146, Telephone: 770-488-2728, E-mail address:
Lwyatt@cdc.gov. For business management and budget assistance in the territories,
contact: Charlotte Flitcraft, Centers for Disease Control and
Prevention, 2920 Brandywine Road, Room 3000, Atlanta, GA 30341-4146,
Telephone: 770-488-2632, E-mail address: caf5@cdc.gov. For program technical assistance, contact: Rebecca Cabral, Ph.D.,
Division of Reproductive Health, Centers for Disease Control and
Prevention, 4770 Buford Hwy, NE., Atlanta, GA 30341, Telephone: 770-
488-6399, E-mail address: Rcabral@cdc.gov.
Dated: March 24, 2003.
Sandra R. Manning,
Director, Procurement and Grants Office, Centers for Disease Control
and Prevention.
[FR Doc. 03-7452 Filed 3-27-03; 8:45 am]
BILLING CODE 4163-18-P