Attachment 2 60-day FRN 6

Billing Code: 4163-18-P

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[60Day-11-XXXX]

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 and send comments to Daniel L. Holcomb, CDC Reports Clearance Officer, 1600 Clifton Road, MS-D74, Atlanta, GA 30333 or send an email to [email protected].

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

Evaluating Locally-Developed HIV Prevention Interventions for African-American MSM in Los Angeles - New - National Center for HIV/AIDS, Viral Hepatitis, STD, 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 3-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 will be evaluated using baseline, 3 month and 6 month follow up assessments. This project will also conduct in-depth qualitative interviews with 36 men in order to assess the experiences with the intervention, elicit recommendations for improving the intervention, and to better understand the factors that put young African American MSM at risk for HIV.

CDC is requesting approval for a 3-year clearance for 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 700 men will be screened for eligibility in order to enroll 528 men. The baseline and follow up questionnaires contain questions about participants’ socio-demographic information, health and healthcare, sexual activity, substance use, and other psychosocial issues. The duration of each baseline, 3-month, and 6-month questionnaires are estimated to be 60 minutes; the 36 Success Case Study interviews 90 minutes; Outreach Recruitment Assessment 5 minutes; limited locator information form 5 minutes; participant contact information form 10 minutes; each client satisfaction survey 5 minutes.

There is no cost to participants other than their time.

Type of Respondent	Form Name	No. of Respondents	No. Responses Per Respondent	Average Burden Per Respondent (in hours)	Total Annual Burden in Hours
Prospective Participant	Outreach Recruitment Assessment (screener)	700	1	5/60	58
Prospective Participant	Limited Locator Information	700	1	5/60	58
Enrolled Participant	Participant Contact Information Form	528	1	10/60	88
Enrolled Participant	Baseline Questionnaire	528	1	1	528
Enrolled Participant	Client Satisfaction Survey	224	3	5/60	56
Enrolled Participant	3 month follow up Questionnaire	420	1	1	420
Enrolled Participant	6 month follow up Questionnaire	400	1	1	400
Enrolled Participant	Success Case Study Interview	36	1	1.5	54
Total					1662

DATE:

__________________________________

Daniel L. Holcomb, B.S.

Chief Reports Clearance Officer

Centers for Disease Control and Prevention