[Federal Register Volume 79, Number 49 (Thursday, March 13, 2014)]
[Notices]
[Pages 14252-14253]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-05482]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[30-Day-14-14BB]


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

    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 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 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, Baltimore, Chicago, Dallas, 
the District of Columbia, Houston, Los Angeles, Miami, New York City, 
Philadelphia, San Francisco, and San Juan. 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. 
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 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 RCT consent 10 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 
and individual interview consents 10 minutes each; 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. The total 
estimated annual burden hours are 7,085.

                                        Estimated Annualized Burden Hours
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                                                                                    Number of
         Type of respondent                   Form name             Number of     responses per   Average hours
                                                                   respondents     respondent      per response
----------------------------------------------------------------------------------------------------------------
Prospective Participant............  Eligibility Screener......          24,000               1           3/60
Enrolled participant...............  Study Registration........          14,000               1           5/60
Enrolled participant...............  Consent for RCT...........           3,200               1          10/60
Enrolled participant...............  Baseline Survey for RCT...           3,200               1          15/60
Enrolled participant...............  Baseline Survey for HIV-               300               1          15/60
                                      positive group.
Enrolled participant...............  Reporting of Home-test               1,600               3           5/60
                                      Results during study.
Enrolled participant...............  Follow-up Surveys for RCT.           3,200               4          10/60
Enrolled participant...............  Follow-up Surveys for HIV              300               2          10/60
                                      positive group.
Enrolled participants..............  Reporting of Home-test               3,200               1           5/60
                                      Results at completion of
                                      study.

[[Page 14253]]

 
Enrolled participant...............  Focus group consent.......             216               1          10/60
Enrolled participant...............  Focus group discussion....             216               1              1.5
Enrolled participant...............  Individual in-depth                     30               1          10/60
                                      interview guide consent.
Enrolled participant...............  Individual in-depth                     30               1              1.5
                                      interview guide.
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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. 2014-05482 Filed 3-12-14; 8:45 am]
BILLING CODE 4163-18-P