[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]]
-----------------------------------------------------------------------
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