[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
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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