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Agency Forms Undergoing Paperwork Reduction Act Review

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Information about this document as published in the Federal Register.

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The Centers for Disease Control and Prevention (CDC) publishes a list of information collection requests under review by the Office of Management and Budget (OMB) in compliance with the Paperwork Reduction Act (44 U.S.C. chapter 35). To request a copy of these requests, call (404) 639-7570 or send an email to Send written comments to 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

Critical Thinking and Cultural Affirmation (CTCA): Evaluation of a Locally Developed HIV Prevention Intervention—New—National Center for HIV/AIDS, Viral Hepatitis, STD, TB Prevention (NCHHSTP), Centers for Disease Control and Prevention (CDC).

Background and Brief Description

In 2005, the Centers for Disease Control and Prevention (CDC) reported that 80,187 African Americans were diagnosed with HIV/AIDS, which represents 51% of persons diagnosed. African-American men with HIV/AIDS represented 44% of all cases among males (Centers for Disease Control and Prevention [CDC], 2005). These statistics have been consistently disproportional since the late 1990s, with African Americans bearing the greatest burden of new HIV cases in most regions of the United States. The Centers for Disease Control and Prevention estimates that at the end of 2006, Blacks were disproportionately affected by HIV. The 2006 HIV infection rate in Blacks was nearly twice the rate of Whites (92 out of every 100,000 Blacks compared to 48 per 100,000 Whites and 31 per 100,000 Hispanics). Among males, Black males accounted for the largest number of diagnosed HIV infections and have the highest HIV infection rate of any race/ethnicity group (144 per 100,000, compared to 94 per 100,000 for White males and 50 per 100,000 for Hispanic males

While many HIV prevention and intervention studies include samples of African-American men and African-American Men who have Sex with Men (AAMSM), beyond demonstrating disparities in seroprevalence between and among racial groups, few have been specifically designed and evaluated for efficacy among African American men. Because few HIV prevention interventions targeting AAMSM have been developed and rigorously evaluated, while their HIV infection rates remain disproportionately high and continue to rise, identifying effective interventions for AAMSM is a public health imperative.

The purpose of this project is to test the efficacy of an HIV transmission prevention intervention for reducing sexual risk among African American men who have sex with men in Chicago, Illinois. The intervention is a 3-day weekend retreat, group-level CTCA intervention that combines cultural affirmation with critical thinking and empowerment, to increase reasoning skill, problem solving capacity, self-protective behavior change, and well-being which facilitates the reduction of risky sexual behaviors. A convenience sample of 438 AAMSM will be recruited to participate in the study. We anticipate recruiting potential participants for the CTCA RCT through a variety of community venues, using both active (i.e., venue outreach) and passive (i.e., referral, flyers/handcards, Internet) recruitment techniques. The intervention will be evaluated using baseline, 3-month and 6-month follow up assessments. This project will also conduct exit surveys to identify men who were more favorable—men who agreed with positive comments about the intervention and those who were less favorable—men who disagreed with positive comments about the intervention. Exit interviews will be conducted with 15 favorable and 15 less favorable men identified by the Exit Survey to help understand participants' experiences with the CTCA intervention and their thoughts about the content of the intervention and ways in which it could be improved. Using the participant responses to the exit survey, we will categorize participants into two categories: Favorable (those men reporting a favorable reaction to the intervention) and unfavorable (those men reporting an unfavorable reaction to the intervention). Once we have 50 participants in each category, we will randomly select 15 participants from each group and invite them to participate in the exit interview. We anticipate that we will need to repeat these procedures and extend an invitation to at least 65 participants in order to reach and successfully interview 15 participants in each group.

CDC is requesting approval for a 3-year clearance for data collection. The data collection system involves a pre and full screening, brief locator information, record locator information, baseline assessment, 3-month follow-up assessment, 6-month follow-up assessment, participant evaluation forms, exit survey, and exit interviews. An estimated 1000 men will be pre-screened and 515 will be full-screened for eligibility in order to enroll 438 men. The baseline and follow up questionnaires will be administered electronically using audio computer assisted self-interview (ACASI). The ACASI interview includes 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 assessments are estimated to be 60 minutes; the exit survey 10 minutes; the exit interview 30 minutes; pre-screening form 5 minutes; full-screening form 10 minutes; brief locator information form 5 minutes; record locator information form 10 minutes; each participant evaluation survey 5 minutes.

There is no cost to participants other than their time. The total estimated annual burden hours are 527.

Type of respondentForm nameNumber of respondentsNumber responses per respondentAverage burden per respondent (in hours)
Prospective Study ParticipantPre-Screening Form33315/60
Prospective Study ParticipantFull-Screening Form172110/60
Prospective Study ParticipantBrief Locator Form17215/60
Enrolled Study ParticipantRecord Locator Form146110/60
Enrolled Study ParticipantBaseline Assessment14611
Enrolled Study Participant3-month Follow-up Assessment13211
Enrolled Study Participant6-month Follow-up Assessment11711
Enrolled Study ParticipantParticipant Evaluation Forms14665/60
Enrolled Study ParticipantExit Survey117110/60
Enrolled Study ParticipantExit Interview10130/60

Kimberly S. Lane,

Deputy Director, Office of Science Integrity, Office of the Associate Director for Science, Office of the Director, Centers for Disease Control and Prevention.

[FR Doc. 2012-11878 Filed 5-16-12; 8:45 am]