[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]
=======================================================================
-----------------------------------------------------------------------
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
[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
[[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