82 FR 16403 - Agency Forms Undergoing Paperwork Reduction Act Review

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention

Federal Register Volume 82, Issue 63 (April 4, 2017)

[Federal Register Volume 82, Number 63 (Tuesday, April 4, 2017)]
[Notices]
[Pages 16403-16404]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2017-06577]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[30Day-17-17AX]


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.

Proposed Project

    Mobile Messaging Intervention to Present New HIV Prevention Options 
for Men Who have Sex with Men (MSM) Study--New--National Center for 
HIV/AIDS, Viral Hepatitis, STD, and TB Prevention (NCHHSTP), Centers 
for Disease Control and Prevention (CDC).

Background and Brief Description

    Public health approaches to HIV prevention and control are 
increasingly complex for men who have sex with men (MSM), a population 
with a disproportionately high burden of HIV infection. In addition to 
the established biomedical treatments for HIV-positive MSM, and 
behavioral strategies to reduce the risk of transmitting or contracting 
HIV, current recommendations incorporate the breakthrough biomedical 
risk reduction

[[Page 16404]]

strategy of pre-exposure prophylaxis (PrEP) for HIV-negative MSM who 
are at high risk of contracting HIV. For maximum efficacy, health 
communications about HIV prevention and control should be delivered to 
MSM according to their HIV serostatus and risk category.
    The National Center for HIV/AIDS, Viral Hepatitis, STD and TB 
Prevention is requesting approval to evaluate the efficacy of a 
smartphone-based HIV prevention intervention for MSM, known as M\3\(M-
Cubed) that has been designed to deliver targeted messages in six 
intervention domains: HIV testing, sexually transmitted infection (STI) 
testing, PrEP, antiretroviral (ARV) treatment, Condoms, and Engagement 
in Care. The smartphone and tablet application includes 36 core 
messages and 12 videos that were developed based on CDC-sponsored 
iterative formative research (OMB No. 0920-0840) and a review of HIV 
health communications literature. Messages will be delivered to each 
participant's device. The proposed study will assess whether exposure 
to the message-delivery platform results in improvements in 
participants' self-reported sexual health and HIV prevention behaviors, 
beliefs and attitudes. Information will be collected at baseline and 3-
month, 6-month, and 9-month follow-ups.
    The study population will include 1,206 adult MSM living in 
Atlanta, GA, Detroit, MI and New York City, NY. These study sites were 
selected not only because they have high rates of HIV, but also because 
significant disparities in HIV among men who have sex with men (MSM) 
have been observed by race/ethnicity and age. Study participants will 
be sexually active MSM at least 18 years in age who own and use and 
Android and iOS smartphone. Study participants will be stratified by 
risk category: HIV positive (one third) and HIV negative (one third 
each: condomless anal sex in past three months; no condomless anal sex 
past three months). Across the three sites, we will ensure that at 
least 40% of participants are people of color (non-white or Hispanic) 
by quota sampling. Participants will be recruited to the study through 
a combination of approaches, including online advertisement, 
traditional print advertisement, referral, in-person outreach, and 
through word of mouth. Participants will be randomly assigned to an 
intervention group or a waitlist control group. The control group will 
receive the intervention after the study has been completed.
    A quantitative assessment questionnaire will be administered online 
at four points in time. The assessment will be used to measure changes 
in condom use behavior, number of sex partners, HIV testing, sexually 
transmitted disease (STD) testing, health care engagement, pre-exposure 
prophylaxis uptake and adherence, and antiretroviral therapy uptake and 
adherence following completion of the intervention. Participants will 
complete the assessment in-person at baseline and 9-months, using a 
computer in a private location, and remotely via their personal 
computer or tablet device at the 3-month and 6-month follow-ups. The 
same information will be collected from all participants. The burden 
per response for each assessment is 1.5 hours.
    It is expected that 50% of men screened will meet study eligibility 
and provide contact information, that 75 percent will schedule and show 
up for an in-person appointment, and that 95 percent of these men will 
remain eligible after reverification. We expect the initial screening 
to take approximately four minutes to complete, that providing contact 
information will take 1 minute, and the rescreening prior to study 
enrollment to take another four minutes.
    OMB approval is requested for two years. Participation is voluntary 
and there are no costs to the respondents other than their time. The 
total estimated annual burden is 3,787 hours.

                                        Estimated Annualized Burden Hours
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                                                                                                      Average
                                                                     Number of       Number of      burden per
         Type of respondent                   Form name             respondents   responses  per   response  (in
                                                                                     respondent       hours)
----------------------------------------------------------------------------------------------------------------
Men >= 18 Years of Age Who Have Sex  Participant Screening                 1,693               1            4/60
 With Men.                            (Eligibility).
                                     Contact Information Form...             847               1            1/60
                                     Participant Screening                   635               1            4/60
                                      (Verification).
                                     Assessment.................             603               4             1.5
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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. 2017-06577 Filed 4-3-17; 8:45 am]
 BILLING CODE 4163-18-P