E8-28552. 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 30333 or send an e-mail to [e-mail].

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.

Estimate of Annualized Burden Table

Types of data collection	Number of respondents	Number of responses per respondent	Average burden per response (in hours)	Total burden (in hours)
Focus Group Participants	160	1	2	320
Ethnographic Interviews	50	1	2	100
Total				420

Dated: November 21, 2008.

Maryam I. Daneshvar,

Acting Reports Clearance Officer, Centers for Disease Control and Prevention.