2014-19827. Proposed Data Collections Submitted for Public Comment and Recommendations

The Centers for Disease Control and Prevention (CDC), as part of its continuing effort to reduce public burden, invites the general public and other Federal agencies to take this opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995. To request more information on the below proposed project or to obtain a copy of the information collection plan and instruments, call 404-639-7570 or send comments to Leroy A. Richardson, 1600 Clifton Road, MS-D74, Atlanta, GA 30333 or send an email to [e-mail].

Comments submitted in response to this notice will be summarized and/or included in the request for Office of Management and Budget (OMB) approval. 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;(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; and (e) estimates of capital or start-up costs and costs of operation, maintenance, and purchase of services to provide information. Burden means the total time, effort, or financial resources expended by persons to generate, maintain, retain, disclose or provide information to or for a Federal agency. This includes the time needed to review instructions; to develop, acquire, install and utilize technology and systems for the purpose of collecting, validating and verifying information, processing and maintaining information, and disclosing and providing information; to train personnel and to be able to respond to a collection of information, to search data sources, to complete and review the collection of information; and to transmit or otherwise disclose the information. Written comments should be received within 60 days of this notice.

Proposed Project

Evaluating Locally-Developed HIV Prevention Interventions for African-American MSM in Los Angeles (OMB Control No. 0920-0913, expires 01/15/2015)—Extension — National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention (NCHHSTP), Centers for Disease Control and Prevention (CDC).

Background and Brief Description

Data on HIV cases reported in 33 U.S. states with HIV reporting indicate the burden of HIV/AIDS is most concentrated in the African-American population compared to other racial/ethnic groups. Of the 49,704 African-American males diagnosed with HIV between 2001 and 2004, 54% of these cases were among men who have sex with men (MSM). In Los Angeles County (LAC), the proportion of HIV/AIDS cases among African-American males attributable to male-to-male sexual transmission is even greater (75%).

In the absence of an effective vaccine, behavioral interventions represent one of the few methods for reducing high HIV incidence among African American MSM (AAMSM). Unfortunately, in the third decade of the epidemic, very few of the available HIV-prevention interventions for African-American populations have been designed specifically for MSM. In fact, until very recently, none of CDC's evidence-based HIV-prevention interventions had been specifically tested for efficacy in reducing HIV transmission among MSM of color. Given the conspicuous absence of (1) evidence-based HIV interventions and (2) outcome evaluations of existing AAMSM interventions, our collaborative team intends to address a glaring research gap by implementing a best-practices model of comprehensive program evaluation.

The purpose of this project is to test, in a real-world setting, the efficacy of an HIV transmission prevention intervention for reducing sexual risk among African-American men who have sex with men in Los Angeles County. The intervention is a three-session, group-level intervention that will provide participants with the information, motivation, and skills necessary to reduce their risk of transmitting or acquiring HIV.

The intervention is being evaluated using baseline, 3-month and 6-month follow up assessments. This project also intends to conduct in-depth qualitative interviews with a total of 36 men in order to assess the experiences with the intervention, elicit recommendations for improving the intervention, and to better understand the factors that place young African American MSM at risk for HIV.

CDC is requesting approval for a 1-year clearance to complete data collection. The data collection system involves screenings, limited locator information, contact information, baseline questionnaire, client satisfaction surveys, 3-month follow-up questionnaire, 6-month follow-up questionnaire, and case study interviews.

An estimated 160 men will be screened for eligibility in order to enroll 80 additional men to reach the desired sample size of 528. The baseline and follow up questionnaires contain questions about participants' socio-demographic information, health and healthcare, sexual activity, substance use, and other psychosocial issues.

There is no cost to participants other than their time.

Estimated Annualized Burden Hours

Type of respondent	Form name	Number of respondents	Number responses per respondent	Average burden per respondent (in hours)	Total annual burden (in hours)
Prospective Participant	Outreach Recruitment Assessment (screener)	160	1	5/60	13
Prospective Participant	Limited Locator Form	160	1	5/60	13
Enrolled Participant	RCT Informed Consent Form	80	1	10/60	13
Enrolled Participant	Participant Contact Information Form	80	1	10/60	13
Enrolled Participant	Baseline Questionnaire	80	1	1	80
Enrolled Participant	Client Satisfaction Survey	40	3	5/60	10
Enrolled Participant	3-month follow up Questionnaire	100	1	1	100
Enrolled Participant	6-month follow up Questionnaire	170	1	1	170
Enrolled Participant	Success Case Study Informed Consent Form	10	1	10/60	2
Enrolled Participant	Success Case Study Interview	10	1	1.5	15
Total					429

Leroy A. 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.