Agency Forms Undergoing Paperwork Reduction Act Review

The Centers for Disease Control and Prevention (CDC) has submitted the following information collection request to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act of 1995. The notice for the proposed information collection is published to obtain comments from the public and affected agencies.

Written comments and suggestions from the public and affected agencies concerning the proposed collection of information are encouraged. Your comments should address any of the following: (a) Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility; (b) Evaluate the accuracy of the agencies estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (c) Enhance the quality, utility, and clarity of the information to be collected; (d) Minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology, e.g., permitting electronic submission of responses; and (e) Assess information collection costs.

To request additional information on the proposed project or to obtain a copy of the information collection plan and instruments, call (404) 639-7570 or send an email to omb@cdc.gov. Written comments and/or suggestions regarding the items contained in this notice should be directed to the Attention: CDC Desk Officer, Office of Management and Budget, Washington, DC 20503 or by fax to (202) 395-5806. Written comments should be received within 30 days of this notice.

Proposed Project

Understanding Barriers and Facilitators to HIV prevention for Men Who Have Sex with Men (MSM)—Pulse 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 National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention (NCHHSTP)/Division of HIV/AIDS Prevention (DHAP) is requesting a one-year approval for a study-related data collection entitled, “Understanding Barriers and Facilitators to HIV prevention for Men Who Have Sex with Men (MSM).” The purpose of this study is to conduct primarily qualitative research with most at risk HIV-negative MSM.

There are four goals to this study: (1) Understand issues surrounding HIV risk for MSM; (2) learn more about how gay community or peer norms, and community identification influence risk behaviors; (3) understand individual HIV risk management, such as having an HIV-positive partner with suppressed viral load, barriers and facilitators for use of biomedical interventions (i.e., pre-exposure prophylaxis (PrEP), non-occupational post-exposure prophylaxis (nPEP); and (4) understand factors that promote resiliency among HIV-negative MSM.

The present research will be conducted in the top five Southern metropolitan areas in the United States with the highest HIV diagnoses for MSM-Atlanta, Georgia; Jackson, Mississippi; Miami, Florida; and New Orleans and Baton Rouge, Louisiana. These cities rank among those in the South with the highest prevalence and incidence of HIV and STIs among black/African American and Hispanic/Latino MSM.

The study population will consist of black/African-American and Hispanic/Latino (1) male adolescents who are attracted to men and report they are HIV negative or have not been tested and (2) adult MSM who are recently tested and verified as HIV-negative. All study participants will be 13 years of age or older. Participants will be recruited in the selected cities through referrals from Health Departments, clinics and community based organizations (CBOs).

For the purposes of this study, we will use a primarily qualitative research design and will include a brief quantitative survey to reduce participant burden where possible (for example, when we do not need to know an in-depth answer for socio-demographics, HIV testing history, housing status, health insurance status). The first portion of the interview instrument consists of brief structured demographic questions to characterize the respondents. The second portion of the instrument consists of open-ended in-depth qualitative questions. This research design was chosen based on the exploratory nature of our study purpose. All interviews will be conducted by trained personnel. The data collection will take place at a time and place that is convenient to the respondent. Locations will be private. Data collection may be audio-recorded and transcribed with the consent of the respondent.

Recruitment will consist of health departments and CBOs who conduct testing to give HIV negative males who meet the recruiting eligibility criteria the study flyer following post-result counseling.

We estimate one minute for the flyer distribution. We anticipate screening a total of 300 respondents, at various locations, and anticipate the screening process to take five minutes per respondent for a total of 26 burden hours. Of the 300 respondents screened, we anticipate a 50% response rate. We anticipate that recording a participant's contact information to take one minute per respondent for a total of three burden hours for the 150 participants.

We will conduct a one-hour in depth interview for HIV-negative MSM (minors and adults) that will take a total of 150 burden hours for all 150 study participants.

The total number of burden hours is 184.