[Federal Register Volume 84, Number 132 (Wednesday, July 10, 2019)]
[Notices]
[Pages 32918-32919]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-14681]



[[Page 32918]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[30Day-19-19BG]


Agency Forms Undergoing Paperwork Reduction Act Review

    In accordance with the Paperwork Reduction Act of 1995, the Centers 
for Disease Control and Prevention (CDC) has submitted the information 
collection request titled ``Web-based approaches to reach black or 
African American and Hispanic/Latino MSM for HIV Testing and Prevention 
Services'' to the Office of Management and Budget (OMB) for review and 
approval. CDC previously published a ``Proposed Data Collection 
Submitted for Public Comment and Recommendations'' notice on December 
6, 2018 to obtain comments from the public and affected agencies. CDC 
received one substantive comment related to the previous notice. This 
notice serves to allow an additional 30 days for public and affected 
agency comments.
    CDC will accept all comments for this proposed information 
collection project. The Office of Management and Budget is particularly 
interested in comments that:
    (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]. Direct written comments 
and/or suggestions regarding the items contained in this notice to the 
Attention: CDC Desk Officer, Office of Management and Budget, 725 17th 
Street NW, Washington, DC 20503 or by fax to (202) 395-5806. Provide 
written comments within 30 days of notice publication.

Proposed Project

    Web-based approaches to reach black or African American and 
Hispanic/Latino MSM for HIV Testing and Prevention Services--New--
National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention 
(NCHHSTP), Centers for Disease Control and Prevention (CDC).

Background and Brief Description

    The goal of this study is to evaluate the effectiveness of mailing 
out rapid HIV home-testing kits and additional testing promotion 
components to increase HIV testing among black/African-American or 
Hispanic/Latino MSM. The findings from this research will assist local 
and state health departments, and community based organizations in 
making decisions on how to improve HIV testing and linkage to HIV 
prevention services for black/African American and Hispanic/Latino men 
who have sex with men.
    The research study is a randomized control trial and all survey 
data will be collected over the internet. There will not be any in-
person surveys. We will advertise the study on internet websites 
frequented by black and Hispanic MSM. People will click on a banner ad 
and will be taken to a study website that provides a brief overview of 
the study. Those who are interested in participating will complete a 
brief survey to determine their eligibility. Men who are eligible will 
complete registration information and then download a study phone app 
onto their smartphone. The app will allow them to complete a baseline 
survey. After completing the baseline survey, they will be randomized 
into one of three conditions.
    All participants will be sent up to four rapid HIV test kits for 
their use and to give to their friends (hereafter referred to as 
``guests'') and they will report their results to the study. 
Participants will use the study app to complete study activities. All 
participants and guests will have access to web-based HIV counseling 
upon request. Participants who report a positive HIV test result will 
be offered web-based HIV counseling if they have not previously 
requested counseling. Men assigned to the control arm will only have 
access to the study app and web-based counseling. Men assigned to one 
intervention arm will also be able to access another smartphone app 
(HealthMindr) that will allow them to engage in additional study 
activities. Men assigned to the second intervention arm will have 
access to a web-based forum (HealthEmpowerment) covering HIV prevention 
and not the HealthMindr app. At four months after enrollment, all 
participants will complete an online survey and will be offered 
additional HIV testing materials to complete. Guests who receive a 
study HIV self-test kit will be able to report the result online.
    The subpopulation are individuals who: (1) Identify as African-
American/black or Hispanic/Latino; (2) report their HIV status as 
negative or report being unaware of their HIV status; (3) are not 
currently using PrEP or participating in other HIV testing prevention 
studies; (4) have had anal intercourse with another man in the past 12 
months; (5) reside in one of the study states and not planning to move 
out of the state in the next 4 months; (6) Are 18 years or older; (7) 
born male; and (8) identify as male. We will evaluate the comparative 
effectiveness of the HIV home-testing kits and additional testing 
promotion components with respect to linkage of participants to 
appropriate services (HIV treatment, PrEP, STI testing, additional 
prevention and social services). These analyses will determine whether 
any such differences are significant within and across study arms, and 
by race/ethnicity.
    Depending on the study arm to which participants are assigned 
filling out data collection forms, engaging with testing promotion 
components, and completing and submitting at-home HIV testing this will 
require between two hours 25 minutes and three hours and 45 minutes of 
a participant's time over the course of the entire study period. Guests 
who receive an HIV self-test from a study participant will take up to 
37 minutes to complete the testing activities.
    The total annual burden hours are 1,517. There are no other costs 
to respondents other than time.

[[Page 32919]]



                                        Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
                                                                                     Number of
                                                                     Number of     responses per  Average burden
          Type of respondent                    Form name           respondents   respondent per   per response
                                                                                       year          (in hrs)
----------------------------------------------------------------------------------------------------------------
Potential participant.................  Eligibility Consent.....           3,333               3            2/60
Potential participant.................  Eligibility Screener....           3,333              20            2/60
Potential participant.................  Study Consent...........           1,333               2            4/60
Potential participant.................  Registration contact               1,267               7            2/60
                                         information.
Enrolled participant..................  Baseline Survey.........           1,200             107           20/60
Enrolled participant..................  Initial HIV Test Result            1,000              43            5/60
                                         Survey.
Enrolled participant..................  Follow-up Survey........           1,000             187           30/60
Enrolled participant..................  Final HIV Test Result              1,000              18            5/60
                                         Survey.
Enrolled participant..................  Product ordering........             400              12            3/60
Guest.................................  Guest Consent...........             667               1            2/60
Guest.................................  Guest HIV Test Result                667              24            5/60
                                         Survey.
----------------------------------------------------------------------------------------------------------------


Jeffrey M. Zirger,
Lead, Information Collection Review Office, Office of Scientific 
Integrity, Office of Science, Centers for Disease Control and 
Prevention.
[FR Doc. 2019-14681 Filed 7-9-19; 8:45 am]
 BILLING CODE 4163-18-P