[Federal Register: December 2, 2008 (Volume 73, Number 232)]
[Notices]
[Page 73332-73333]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr02de08-79]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[60Day-09-09AG]
Proposed Data Collections Submitted for Public Comment and
Recommendations
In compliance with the requirement of Section 3506(c)(2)(A) of the
Paperwork Reduction Act of 1995 for opportunity for public comment on
proposed data collection projects, the Centers for Disease Control and
Prevention (CDC) will publish periodic summaries of proposed projects.
To request more information on the proposed projects or to obtain a
copy of the data collection plans and instruments, call 404-639-5960 or
send comments to Maryam Daneshvar, Acting CDC Reports Clearance
Officer, 1600 Clifton Road, MS-D74, Atlanta, GA
[[Page 73333]]
30333 or send an e-mail to omb@cdc.gov.
Comments are invited on: (a) Whether the proposed collection of
information is necessary for the proper performance of the functions of
the agency, including whether the information shall have practical
utility; (b) the accuracy of the agency's estimate of the burden of the
proposed collection of information; (c) ways to enhance the quality,
utility, and clarity of the information to be collected; and (d) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques or other
forms of information technology. Written comments should be received
within 60 days of this notice.
Proposed Project
An Assessment of the Acceptability of Pre-exposure Prophylaxis
(PrEP) Among Inner City Persons At Risk for HIV/AIDS--New--National
Center for HIV, Viral Hepatitis, STD, and TB Prevention (NCHHSTP),
Centers for Disease Control and Prevention (CDC).
Background and Brief Description
New HIV infections, both in the U.S. and globally are continuing at
an unacceptably rapid rate and are rising in some sites and sub-
populations. Despite the many behavioral interventions available, it is
necessary to develop additional highly effective prevention modalities,
including biomedical ones if we are to significantly reduce the number
of new HIV infections. Pre-exposure prophylaxis (PrEP) is currently
under intense investigation as a potential biomedical intervention for
the prevention of HIV acquisition. Clinical trials are underway in
populations at high risk of acquiring HIV in Asia (injection drug
users), Africa (heterosexuals and discordant couples), Latin America
(men who have sex with men [MSM]), and among MSM in the United States.
Based on the high efficacy shown with antiretroviral prophylaxis for
the prevention of HIV transmission to infants during pregnancy, birth,
and breastfeeding; and on the protection against vaginal or rectal
exposure prophylaxis studies with non-human primates, it is likely that
one of more of these human trials will show efficacy.
The purpose of the proposed study is to conduct a preliminary
assessment of attitudes about, preferences for programmatic
introduction of, and anticipated changes in risk behaviors resulting
from PrEP among young adults in neighborhoods and social networks where
risk behaviors are likely to lead to HIV exposure. An early
understanding of the perspective of intended users is critical to
planning for possible use of PrEP.
Investigators at Georgia State University, in collaboration with
NCHHSTP, will conduct 20 focus groups in the first year, and 50
ethnographic individual interviews in the second year, with a largely
African-American population of young adults, ages 18-24. Study
participants will be recruited from the 10 zipcodes in Atlanta, GA with
the highest HIV/STD prevalence. The focus group and interview guides
will cover six major areas: (1) Healthcare access and use; (2) risk
perception in their social network; (3) knowledge and understanding of
HIV transmission; (4) positive and negative attitudes toward a clinic-
based HIV prevention program that involves daily doses of an
antiretroviral with periodic HIV testing and risk counseling; (5)
preferences for the design of such a program (e.g., where would it best
be located); (6) whether they anticipate any changes in their risk
behavior if engaged in such a program. In the second year, rapid HIV
testing will be offered to individual interview participants, with
referrals for prevention or treatment services as indicated by test
results.
There is no cost to respondents other than their time.
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Number of Average burden
Types of data collection Number of responses per per response Total burden
respondents respondent (in hours) (in hours)
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Focus Group Participants........................ 160 1 2 320
Ethnographic Interviews......................... 50 1 2 100
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Total....................................... .............. .............. .............. 420
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Dated: November 21, 2008.
Maryam I. Daneshvar,
Acting Reports Clearance Officer, Centers for Disease Control and
Prevention.
[FR Doc. E8-28552 Filed 12-1-08; 8:45 am]
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