[Federal Register Volume 78, Number 213 (Monday, November 4, 2013)]
[Notices]
[Pages 66008-66009]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-26277]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[60Day-14-14BB]


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 or 
send comments to LeRoy Richardson, 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 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:
    Evaluation of Rapid HIV Home-Testing among MSM Trial--New--National 
Center for HIV/AIDS, Viral Hepatitis, STD, TB Prevention (NCHHSTP), 
Centers for Disease Control and Prevention (CDC).

Background and Brief Description

    Innovative testing strategies are needed to reduce levels of 
undiagnosed Human immunodeficiency virus (HIV) infection and increase 
early access to treatment. Rapid home HIV tests may play an important 
role in efforts to reduce both HIV morbidity and mortality. Given the 
unrelenting HIV crisis among men who have sex with men (MSM) and the 
release into the market of a rapid HIV test for at-home use, it is 
necessary to evaluate the impact of providing rapid HIV home-test kits 
on repeat HIV testing, linkage to care, partner testing, serosorting, 
and HIV sexual risk behaviors among MSM. This information will assist 
the Division of HIV/AIDS Prevention (DHAP) in developing 
recommendations, future research and program needs concerning home-
testing for MSM.

Specific Aims

    This study is a randomized trial which aims to evaluate the use and 
effectiveness of home-test kits as a public health strategy for 
increasing testing among MSM. A secondary aim of the randomized trial 
is to evaluate the extent to which MSM (both HIV-negative and HIV-
positive) distribute HIV home-test kits to their social and sexual 
networks.
    The population for the randomized trial will be men over the age of 
18 years who self-report that they have had anal sex with at least one 
man in the past year. We will recruit approximately 3,200 men who 
report their HIV status to be negative or who are unaware of their HIV 
status and 300 men who self-report that they are HIV-positive. Men will 
be recruited from the 12 cities: Atlanta, Georgia; Baltimore, Maryland; 
Chicago, Illinois; Dallas, Texas; District of Columbia; Houston, Texas; 
Los Angeles, California; Miami, Florida; New York City, New York; 
Philadelphia, Pennsylvania; San Francisco, California; and San Juan, 
Puerto Rico. We will ensure that at least 20% of participants are black 
and at least 15% are Hispanic. Recruitment will be conducted through 
banner advertisements displayed on social networking sites such as 
Facebook and dating and sex-seeking sites such as Manhunt and 
Adam4Adam.
    This study also has a qualitative component that aims to examine 
the experiences of participants in the randomized control trial (RCT). 
Participants for the qualitative data collection will be drawn from the 
randomized control trial. Two data collection techniques will be used: 
focus group discussions (FGD) (both online and in-person) and 
individual in-depth interviews (IDIs).
    CDC is requesting approval for a 3-year clearance for data 
collection. All participant consenting and data collection for the RCT 
will be completed using an online reporting system. Data will be 
collected using an eligibility screener, an online study registration 
process, a baseline survey, HIV test results reporting system, and 
follow-up surveys. Men will be asked to use the study Web site or 
download and access a secure cell phone application prior to enter 
results of their rapid HIV home-tests that they receive and conduct at 
home and to take the follow-up surveys which will collect information 
on HIV

[[Page 66009]]

testing results and behaviors and sexual activities. Focus group 
discussions and in-depth interviews will be used to examine experiences 
of participants in the RCT.
    The duration of the eligibility screener is estimated to be 5 
minutes; the study registration process 5 minutes; the baseline survey 
15 minutes; the reporting of home-test results 5 minutes; the follow-up 
surveys 10 minutes; the focus group discussion 1 hour and 30 minutes; 
and the in-depth interviews 1 hour and 15 minutes.
    There is no cost to participants other than their time.

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                                                                     Number of
      Type of respondent            Form name        Number of     responses per   Average hours  Total response
                                                    respondents     respondent     per response   burden (hours)
----------------------------------------------------------------------------------------------------------------
Prospective Participant.......  Eligibility               24,000               1            3/60           1,200
                                 Screener.
Enrolled participant..........  Study                     14,000               1            5/60           1,167
                                 Registration.
Enrolled participant..........  Baseline Survey            3,200               1           15/60             800
                                 for RCT.
Enrolled participant..........  Baseline Survey              300               1           15/60              75
                                 for HIV-
                                 positive group.
Enrolled participant..........  Reporting of               1,600               3            5/60             400
                                 Home-test
                                 Results during
                                 study.
Enrolled participant..........  Follow-up                  3,200               4           10/60           2,133
                                 Surveys for RCT.
Enrolled participant..........  Follow-up                    300               2           10/60             100
                                 Surveys for HIV
                                 positive group.
Enrolled participants.........  Reporting of               3,200               1            5/60             267
                                 Home-test
                                 Results at
                                 completion of
                                 study.
Enrolled participant..........  Focus group                  216               1             1.5             324
                                 discussion.
Enrolled participant..........  Individual in-                30               1             1.5              45
                                 depth interview
                                 guide.
                                                 ---------------------------------------------------------------
    Total.....................  ................  ..............  ..............  ..............           6,511
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Leroy 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. 2013-26277 Filed 11-1-13; 8:45 am]
BILLING CODE 4163-18-P