[Federal Register Volume 77, Number 39 (Tuesday, February 28, 2012)]
[Notices]
[Pages 12057-12059]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-4566]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[60Day-12-12EL]


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 404-639-7570 
and send comments to Kimberly S. Lane, CDC Reports Clearance Officer, 
1600 Clifton Road, MS-D74, Atlanta, GA 30333 or send an email to 
<a href="/cdn-cgi/l/email-protection#b9d6d4dbf9daddda97ded6cf"><span class="__cf_email__" data-cfemail="0c63616e4c6f686f226b637a">[email protected]</span></a>.
    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

[[Page 12058]]

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

    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. Data collection will begin November 2012 and end January 
2015. 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 700 men will be pre-screened and 500 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 assessment 
is 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.

----------------------------------------------------------------------------------------------------------------
                                                                      Number      Average burden   Total annual
      Type of respondent            Form name        Number of     responses per  per respondent     burden in
                                                    respondents     respondent       (in hours)        hours
----------------------------------------------------------------------------------------------------------------
Prospective Study Participant.  Pre-Screening                700               1            5/60              58
                                 Form.
Prospective Study Participant.  Full-Screening               515               1           10/60              86
                                 Form.
Prospective Study Participant.  Brief Locator                515               1            5/60              43
                                 Form.
Enrolled Study Participant....  Record Locator               438               1           10/60              73
                                 Form.
Enrolled Study Participant....  Baseline                     438               1               1             438
                                 Assessment.
Enrolled Study Participant....  3-month Follow-              395               1               1             395
                                 up Assessment.
Enrolled Study Participant....  6-month Follow-              350               1               1             350
                                 up Assessment.
Enrolled Study Participant....  Participant                  438               6            5/60             219
                                 Evaluation
                                 Forms.
Enrolled Study Participant....  Exit Survey.....             350               1           10/60              58
Enrolled Study Participant....  Exit Interview..              30               1           30/60              15
                                                                                 -------------------------------

[[Page 12059]]

 
    Total.....................  ................  ..............  ..............  ..............            1735
----------------------------------------------------------------------------------------------------------------


Kimberly S. Lane,
Reports Clearance Officer, Centers for Disease Control and Prevention.
[FR Doc. 2012-4566 Filed 2-27-12; 8:45 am]
BILLING CODE 4163-18-P


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