[Federal Register Volume 83, Number 234 (Thursday, December 6, 2018)]
[Notices]
[Pages 62864-62866]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-26350]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[60Day-19-19BG; Docket No. CDC-2018-0102]
Proposed Data Collection Submitted for Public Comment and
Recommendations
AGENCY: Centers for Disease Control and Prevention (CDC), Department of
Health and Human Services (HHS).
ACTION: Notice with comment period.
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SUMMARY: The Centers for Disease Control and Prevention (CDC), as part
of its continuing effort to reduce public burden and maximize the
utility of government information, invites the general public and other
Federal agencies the opportunity to comment on a proposed and/or
continuing information collection, as required by the Paperwork
Reduction Act of 1995. This notice invites comment on a proposed
information collection project titled ``Web-based approaches to reach
black or African American and Hispanic/Latino MSM for HIV Testing and
Prevention Services.''
DATES: CDC must receive written comments on or before February 4, 2019.
ADDRESSES: You may submit comments, identified by Docket No. CDC-2018-
0102 by any of the following methods:
Federal eRulemaking Portal: Regulations.gov. Follow the
instructions for submitting comments.
Mail: Jeffrey M.Zirger, Ph.D., Information Collection
Review Office, Centers for Disease Control and Prevention, 1600 Clifton
Road NE, MS-D74, Atlanta, Georgia 30329.
Instructions: All submissions received must include the agency name
and Docket Number. CDC will post, without change, all relevant comments
to Regulations.gov.
Please note: Submit all comments through the Federal eRulemaking
portal (regulations.gov) or by U.S. mail to the address listed above.
FOR FURTHER INFORMATION CONTACT: To request more information on the
proposed project or to obtain a copy of the information collection plan
and instruments, contact Leroy A. Richardson, Information Collection
Review Office, Centers for Disease Control and Prevention, 1600 Clifton
Road NE, MS-D74, Atlanta, Georgia 30329; phone: 404-639-7570; Email:
[email protected].
SUPPLEMENTARY INFORMATION:
Under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-
3520), Federal agencies must obtain approval from the Office of
Management and Budget (OMB) for each collection of information they
conduct or sponsor. In addition, the PRA also requires Federal agencies
to provide a 60-day notice in the Federal Register concerning each
proposed collection of information, including each new proposed
collection, each proposed extension of existing collection of
information, and each reinstatement of previously approved information
collection before submitting the collection to the OMB for approval. To
comply with this requirement, we are publishing this notice of a
proposed data collection as described below.
The OMB is particularly interested in comments that will help:
1. 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;
[[Page 62865]]
2. Evaluate the accuracy of the agency's estimate of the burden of
the proposed collection of information, including the validity of the
methodology and assumptions used;
3. Enhance the quality, utility, and clarity of the information to
be collected; and
4. 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
submissions of responses.
5. Assess information collection costs.
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 a rapid HIV test kit and they will
report their results to the study. Men assigned to all study arms will
use the study app to complete study activities. All participants 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.
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; (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 will
require between 2 hours 53 minutes and 4 hours and 13 minutes of a
participant's time over the course of the entire study period.
The participation of respondents is voluntary. There is no cost to
the respondents other than their time. The total estimated annual
burden hours for the proposed project are 7,011 hours.
Estimated Annualized Burden Hours
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Number of
Number of responses per Average burden Total
Type of respondent Form name respondents respondent per per response ResponseBurden
year (in Hrs) (in Hrs)
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Potential participant......... Eligibility 10,000 18 10/60 1667
Consent.
Potential participant......... Eligibility 10,000 1 3/60 500
Screener.
Potential participant......... Study Consent... 4,000 1 10/60 667
Potential participant......... Registration 3,800 7 5/60 317
contact
information.
Enrolled participant.......... Baseline Survey. 3,600 110 30/60 1,800
Enrolled participant.......... HIV Test Result 3,000 10 5/60 250
Survey.
Enrolled participant.......... Follow-up Survey 3,000 120 30/60 1,500
Enrolled participant.......... HIV Test Result 3,000 10 5/60 250
Survey
(completion).
Enrolled participant.......... Product ordering 1,200 2 3/60 60
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Total..................... ................ .............. .............. .............. 7,011
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[[Page 62866]]
Jeffrey M. Zirger,
Acting Lead, Information Collection Review Office, Office of Scientific
Integrity, Office of Science, Centers for Disease Control and
Prevention.
[FR Doc. 2018-26350 Filed 12-4-18; 8:45 am]
BILLING CODE 4163-18-P