[Federal Register Volume 79, Number 227 (Tuesday, November 25, 2014)]
[Notices]
[Pages 70190-70192]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-27851]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[30Day-15-0913]
Agency Forms Undergoing Paperwork Reduction Act Review
The Centers for Disease Control and Prevention (CDC) has submitted
the following information collection request to the Office of
Management and Budget (OMB) for review and approval in accordance with
the Paperwork Reduction Act of 1995. The notice for the proposed
information collection is published to obtain comments from the public
and affected agencies.
Written comments and suggestions from the public and affected
agencies concerning the proposed collection of information are
encouraged. Your comments should address any of the following: (a)
Evaluate whether the proposed collection of information is necessary
for the proper performance of the functions of the agency, including
whether the information will have practical utility; (b) Evaluate the
accuracy of the agencies estimate of the burden of the proposed
collection of information, including the validity of the methodology
and assumptions used; (c) Enhance the quality, utility, and clarity of
the information to be collected; (d) Minimize the burden of the
collection of information on those who are to respond, including
through the use of appropriate automated, electronic, mechanical, or
other technological collection techniques or other forms of information
technology, e.g., permitting electronic submission of responses; and
(e) Assess information collection costs.
To request additional information on the proposed project or to
obtain a copy of the information collection plan and instruments, call
(404) 639-7570 or send an email to [email protected]. Written comments and/or
suggestions regarding the items contained in this notice should be
directed to the Attention: 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.
[[Page 70191]]
Proposed Project
Evaluating Locally-Developed HIV Prevention Interventions for
African-American MSM in Los Angeles (OMB No. 0920-0913, expires 01/15/
2015)--[Extension]--National Center for HIV/AIDS, Viral Hepatitis, STD,
and 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.
As of November 7, 2014, 888 men were screened using the eligibility
screener, 711 were eligible, and 520 men were consented, enrolled, and
completed the baseline assessment. There are a total of 227 men who
completed 3-month follow-up and 193 men who completed 6-month follow-
up. Each enrolled participant completed a client satisfaction survey
for each of the three intervention sessions they attended. Finally,
twenty-two men consented for and completed qualitative interviews.
There were unanticipated delays in getting our initial OMB approval and
delays in enrollment which prevented the study from reaching the
desired sample size of 528 and completing data collection within the
original 3-year timeframe. When the current information collection
request (ICR) expires on January 31st, 2015, we will need to enroll,
consent, and baseline approximately 10 more participants. To reach
these additional 10 participants, we anticipate having to screen
approximately more 20 men. During this extended period, an additional
185 men will complete the 3-month assessment, 225 men will complete the
6-month follow-up questionnaires, and 14 men will consent for and
complete the success case study qualitative interviews. We anticipate
that all data collection activities will be completed by the end of
2015.
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 is being evaluated using baseline, 3
month and 6 month follow up assessments. This project is also
conducting in-depth qualitative interviews with a total of 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 1-year clearance to complete 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 20 men
will be screened for eligibility in order to enroll 10 additional men
to reach the desired sample size of 528. 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 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. The total
estimated annual burden hours are 459.
Estimated Annualized Burden Hours
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Number of Average burden
Type of respondent Form name Number of responses per per respondent
respondents respondent (in hours)
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Prospective Participant............... Outreach Recruitment 20 1 5/60
Assessment (screener).
Prospective Participant............... Limited Locator Form.... 20 1 5/60
Enrolled Participant.................. RCT Informed Consent 10 1 10/60
Form.
Enrolled Participant.................. Participant Contact 10 1 10/60
Information Form.
Enrolled Participant.................. Baseline Questionnaire.. 10 1 1
Enrolled Participant.................. Client Satisfaction 30 3 5/60
Survey.
Enrolled Participant.................. 3 month follow up 185 1 1
Questionnaire.
Enrolled Participant.................. 6 month follow up 225 1 1
Questionnaire.
Enrolled Participant.................. Success Case Study 14 1 10/60
Informed Consent Form.
Enrolled Participant.................. Success Case Study 14 1 1.5
Interview.
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[[Page 70192]]
Leroy A. Richardson,
Chief, Information Collection Review Office, Office of Scientific
Integrity, Office of the Associate Director for Science, Office of the
Director, Centers for Disease Control and Prevention.
[FR Doc. 2014-27851 Filed 11-24-14; 8:45 am]
BILLING CODE 4163-18-P