2014-09766. 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 404-639-7570 and send comments to Leroy Richardson, 1600 Clifton Road, MS-D74, Atlanta, GA 30333 or send an email 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

Community Context Matters Study—New—National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention (NCHHSTP), Centers for Disease Control and Prevention (CDC).

Background and Brief Description

The daily use of specific antiretroviral medications by persons without human immunodeficiency virus (HIV) infection, but at high risk of sexual or injection exposure to HIV has been shown to be a safe and effective HIV prevention method. The Food and Drug Administration approved the use of Truvada® for preexposure prophylaxis (PrEP) in July 2012 and CDC has issued clinical practice guidelines for its use. With approximately 50,000 new HIV infections each year, increasing rates of infection for young MSM, and continuing severe disparities in HIV infection among African-American men and women, incorporation of PrEP into HIV prevention is important. However, as a new prevention tool in very early stages of introduction and use, there is much we need to learn about how to implement PrEP in a real world setting and the need to develop and validate new measurement tools to capture this information.

CDC is requesting Office of Management and Budget (OMB) approval to collect data over a three-year period that will be used to (1) assess the utility of new measures developed or adapted to collect information related to this new intervention (PrEP) and (2) evaluate community contextual factors that may impact the acceptability and successful introduction of a new HIV prevention method. The project will be conducted in communities in each of four cities where PrEP has recently become available through a local community health center.

Once per year for three years, two surveys will be conducted: (1) A community-based survey to be administered to 40 persons per city approached in public venues in the catchment areas of the PrEP clinics, and (2) a key stakeholder survey to be administered to 10 community HIV leaders nominated by PrEP clinic staff and HIV community-based organizations in the clinic communities. Both surveys will collect data on the demographics of the participants, knowledge of PrEP, misinformation about PrEP, and attitudes about it. The neighborhood survey will also include questions about basic HIV knowledge, attitudes, and beliefs as well as information about sexual and drug use behaviors that are indications for PrEP use. For the stakeholder survey, additional questions will be included about type of organization where they work and organizational experience with PrEP.

Surveys will be administered face-to-face by trained, local interviewers.

There are no costs to respondents other than their time.

Estimated Annualized Burden Hours

Type of respondent	Form name	Number of respondents	Number of responses per respondent	Average hours per response	Total response burden (hours)
Neighborhood Survey Street Interview Participant	Neighborhood Interview Recruitment Script and Informed Consent	720	1	5/60	60
Key Stakeholder Participant	Key Stakeholder Telephone Recruitment Script and Informed consent	180	1	5/60	15
Street Interview Participant	Survey	480	1	20/60	160
Key Stakeholder Participant	Survey	120	1	20/60	40
Total					275

LeRoy Richardson,

Chief, Information Collection Review Office, Office of Scientific Integrity, Office of the Associate Director for Science, Office of the Director, Centers for Disease Control and Prevention.