2014-20103. 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 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

HIV Prevention among Latino MSM: Evaluation of a Locally Developed Intervention (OMB No. 0920-0942, expires 06/30/2015)—Extension—National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention (NCHHSTP), Centers for Disease Control and Prevention (CDC).

Background and Brief Description

Latinos are the largest and fastest growing ethnic minority group in the U.S. and have the second highest rate of HIV/AIDS diagnoses of all racial/ethnic groups in the country. From the beginning of the epidemic through 2007, Latinos accounted for 17% of all AIDS cases reported to the CDC. Among Latino males, male-to-male sexual contact is the single most important source of HIV infection, accounting for 46% of HIV infections in U.S.-born Latino men from 2001 to 2005, and for more than one-half of HIV infections among South American, Cuban, and Mexican-born Latino men in the U.S. (CDC, 2007a; 2007b). In 2006, male-to-male sex accounted for 72% of new HIV infections among Latino males. Relative to other men who have sex with men (MSM), the rate of HIV infection among Latino MSM is twice the rate recorded among whites (43.1 vs. 19.6 per 100,000).

Despite the high levels of infection risk that affect Latino MSM, no efficacious behavioral interventions to prevent infection by HIV and other sexually transmitted diseases (STDs) are available for this vulnerable population. CDC's Prevention Research Synthesis group, whose role is to identify HIV prevention interventions that have met rigorous criteria for demonstrating evidence of efficacy, has not identified any behavioral interventions for Latino MSM that meet current efficacy criteria, and no such interventions are listed in CDC's 2011 update of its Compendium of Evidence-Based HIV Behavioral Interventions (http://www.cdc.gov/​hiv/​topics/​research/​prs/​compendium-evidence-based-interventions.htm). There is an urgent need for efficacious, culturally congruent HIV/STD prevention interventions for Latino MSM.

The purpose of this project is to test the efficacy of an HIV prevention intervention for reducing sexual risk among Latino men who have sex with men in North Carolina. The HOLA en Grupos intervention is a Spanish-language, small-group, 4-session intervention that is designed to increase consistent and correct condom use and HIV testing among Latino MSM and to affect other behavioral and psychosocial factors that can increase their vulnerability of HIV/STD infection. This study is using a randomized controlled trial design to assess the efficacy of the HOLA en Grupos intervention compared to a general health comparison intervention.

CDC is requesting a one-year extension to the existing Information Collection Request in order to collect information from 50 study participants. This will terminate data collection for the study. During the requested extension period, a six-month follow-up assessment will be administered to a total 50 study participants. Information collection during the extension period will make it possible to measure intervention and comparison participants' socio-demographic characteristics, health seeking actions, HIV/STD and substance use-related risk behaviors, and psychosocial factors 6 months after they receive the HOLA en Grupos and comparison interventions, respectively, and to test the efficacy of the HOLA en Grupos intervention. Collection of the six-month follow-up assessment information will require about one hour per study participant.

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
Enrolled Study Participant	6-month follow-up assessment (att 3)	50	1	1	50
Total					50

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.