[Federal Register Volume 77, Number 96 (Thursday, May 17, 2012)]
[Notices]
[Pages 29350-29351]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-11878]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[30Day-12-12EL]


Agency Forms Undergoing Paperwork Reduction Act Review

    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 [email protected]. 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.

[[Page 29351]]



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                                                                                      Number      Average burden
          Type of respondent                    Form name            Number of     responses per  per respondent
                                                                    respondents     respondent       (in hours)
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Prospective Study Participant.........  Pre-Screening Form......             333               1            5/60
Prospective Study Participant.........  Full-Screening Form.....             172               1           10/60
Prospective Study Participant.........  Brief Locator Form......             172               1            5/60
Enrolled Study Participant............  Record Locator Form.....             146               1           10/60
Enrolled Study Participant............  Baseline Assessment.....             146               1               1
Enrolled Study Participant............  3-month Follow-up                    132               1               1
                                         Assessment.
Enrolled Study Participant............  6-month Follow-up                    117               1               1
                                         Assessment.
Enrolled Study Participant............  Participant Evaluation               146               6            5/60
                                         Forms.
Enrolled Study Participant............  Exit Survey.............             117               1           10/60
Enrolled Study Participant............  Exit Interview..........              10               1           30/60
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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]
BILLING CODE 4163-18-P