Notice2023-17921
Proposed Data Collection Submitted for Public Comment and Recommendations
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
August 21, 2023
Issuing agencies
Health and Human Services DepartmentCenters for Disease Control and Prevention
Abstract
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 mChoice: Improving PrEP Uptake and Adherence among Minority MSM through Tailored Provider Training and Adherence Assistance in Two High Priority Settings. The collection is part of a research study designed to implement and evaluate the effectiveness of an intervention that utilizes evidence-based education and support tools to improve preexposure prophylaxis (PrEP) adherence among young men who have sex with men (YMSM).
Full Text
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<title>Federal Register, Volume 88 Issue 160 (Monday, August 21, 2023)</title>
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[Federal Register Volume 88, Number 160 (Monday, August 21, 2023)]
[Notices]
[Pages 56834-56836]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2023-17921]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[60Day-23-22FZ; Docket No. CDC-2023-0072]
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 mChoice: Improving PrEP Uptake
and Adherence among Minority MSM through Tailored Provider Training and
Adherence Assistance in Two High Priority Settings. The collection is
part of a research study designed to implement and evaluate the
effectiveness of an intervention that utilizes evidence-based education
and support tools to improve preexposure prophylaxis (PrEP) adherence
among young men who have sex with men (YMSM).
DATES: CDC must receive written comments on or before October 20, 2023.
ADDRESSES: You may submit comments, identified by Docket No. CDC-2023-
0072 by either of the following methods:
[square] Federal eRulemaking Portal: <a href="http://www.regulations.gov">www.regulations.gov</a>. Follow
the instructions for submitting comments.
[square] Mail: Jeffrey M. Zirger, Information Collection Review
Office, Centers for Disease Control and Prevention, 1600 Clifton Road
NE, MS H21-8, Atlanta, Georgia 30329.
Instructions: All submissions received must include the agency name
and Docket Number. CDC will post, without change, all relevant comments
to <a href="http://www.regulations.gov">www.regulations.gov</a>.
Please note: Submit all comments through the Federal eRulemaking
portal (<a href="http://www.regulations.gov">www.regulations.gov</a>) 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 Jeffrey M. Zirger, Information Collection
Review Office, Centers for Disease Control and Prevention, 1600 Clifton
Road NE, MS H21-8, Atlanta, Georgia 30329; Telephone: 404-639-7118;
Email: <a href="/cdn-cgi/l/email-protection#cea1a3ac8eadaaade0a9a1b8"><span class="__cf_email__" data-cfemail="2847454a684b4c4b064f475e">[email protected]</span></a>.
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;
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;
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; and
5. Assess information collection costs.
Proposed Project
mChoice: Improving PrEP Uptake and Adherence among Minority MSM
through Tailored Provider Training and Adherence Assistance in Two High
Priority Settings--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 National Center for HIV/AIDS, Viral Hepatitis, STD and TB
Prevention is requesting approval for 36 months of data collection
titled, ``mChoice: Improving PrEP Uptake and Adherence among Minority
MSM through Tailored Provider Training and Adherence Assistance in Two
High Priority Settings.'' The purpose of this study is to implement and
evaluate the effectiveness of a clinic-based intervention that utilizes
evidence-based education and support tools to improve preexposure
prophylaxis (PrEP) adherence among young men who have sex with men
(YMSM). The goals of this research study are to: (1) improve the
overall PrEP experience of providers and YMSM patients; and (2)
increase our understanding of provider and patient factors that
influence the choice of PrEP regimen by MSM in clinical settings. This
study will be carried out in four clinics in New York, NY (two clinics)
and Birmingham, AL (two clinics).
[[Page 56835]]
Aim 1 of the study will enroll 400 YMSM (ages 18-39) who identify
as male, non-binary, or genderqueer; were assigned male sex at birth;
are taking or initiating PrEP; own a smartphone; understand and read
English or Spanish; have a self-reported history of sex with men in the
past 12-months; and live in the NYC or Birmingham, AL areas.
Participants may identify as any race or ethnicity, but to ensure a
diverse sample comprised mainly of racial/ethnic minority participants,
the study will utilize recruitment controls to enroll at least 50%
African American/Black and/or Hispanic/Latino participants. Patient
participants will be recruited to the study through a combination of
approaches including flyers and social media, referral, in-person
outreach, and through word of mouth. Rolling enrollment will continue
until enrollment targets are reached; each Aim 1 participant will be
followed for 12 months. All participants will receive PrEP clinical
services congruent with CDC PrEP guidelines. Participants using oral
PrEP will receive CleverCap, an electronic medication monitoring
device, that will track and support medication adherence. At the 3-
month study visit, participants using oral PrEP will receive the
mChoice mobile phone application, an evidence-based intervention that
supports PrEP use through medication monitoring, study staff
interaction, and other resources. Aim 1 assessments include: a baseline
survey of self-reported demographic factors, sexual and drug use
behaviors, and potential cofactors of sexual and drug use behavior
including attitudes, beliefs, knowledge, traits, and other psychosocial
factors; follow-up surveys at 3-, 6-, 9-, and 12-month study visits
which will assess experiences with PrEP, PrEP adherence, and behavioral
and social factors; medication adherence data from CleverCap;
participant use and voluntary self-reported adherence and HIV exposure
risk-related data from the mChoice app; PrEP clinical care data from
clinic electronic medical records; and urine studies assessing PrEP
adherence. The information collected in Aim 1 will be used to evaluate
the effectiveness of the mChoice intervention to improve PrEP adherence
and persistence, and to increase understanding of PrEP experiences and
factors that influence PrEP choices among MSM in clinical settings.
Aim 2 of the study will enroll 30 YMSM who participated in Aim 1;
15 from New York and 15 from Alabama. Participants will be recruited at
Aim 1 study visits. Study staff will conduct in-depth interviews with
Aim 2 participants exploring their experiences with PrEP, reasons for
PrEP choices, and thoughts about the mChoice intervention. Data
collected in Aim 2 will contribute to the evaluation of the mChoice
intervention, implementation, and contribute to understanding factors
that influence PrEP choices by MSM in clinical settings.
Aim 3 of the study will include 20 health care providers (10 from
New York and 10 from Alabama) involved in the direct delivery of PrEP
services at participating clinical sites. Providers may include nurse
practitioners, physicians, PrEP coordinators/navigators, medical
assistants, and other cross-trained coordinators from the participating
clinics. Providers will be recruited via flyers, emails to clinic
staff, and referrals. Providers will receive education and training
designed to improve knowledge of PrEP options and clinical
recommendations and enhance provider communications with patients. Aim
3 includes practice facilitation, an intervention that includes
identification of a clinic champion who will engage other providers in
embracing PrEP recommendations, as well as ongoing support from a
practice coach who will offer tools, resources, hands-on guidance, and
content expertise to assist the clinic team in developing strategies to
improve clinical PrEP services. Aim 3 assessments include notes from
practice facilitation coaching sessions; in-depth interviews of
participating providers exploring their experiences with the
intervention and thoughts about providing PrEP clinical services; and a
clinic assessment completed by clinic staff every six months to
describe the current implementation of PrEP services at their clinical
site. These data will inform ongoing practice improvement in PrEP
clinical services and increase understanding of provider experiences
with providing PrEP clinical services.
It is expected that half of screened persons will meet study
eligibility. For all aims we anticipate that screening and completion
of the locator form will each take five minutes. Study staff will
assist Aim 1 participants with onboarding the CleverCap device and
mChoice app, a process that will take 20 minutes. Aim 1 participants
will complete the baseline survey once (anticipated 30 minutes
completion time) and the follow-up survey four times (anticipated
completion time 30 minutes each) over their 12-month participation
period. Total study enrollment for Aim 1 is 400, over the 3-year data
collection period the estimated annual enrollment is 134. Aims 2 and 3
interviews will take 60 minutes to complete. For Aim 2, total study
enrollment is 30, over the 3-year data collection period the estimated
annual enrollment is 10. For Aim 3, total study enrollment is 20, over
the 3-year data collection period the estimated annual enrollment is
seven. Additionally, a single Aim 3 participant at each of the four
participating clinic sites will complete a clinic assessment form every
six months throughout the study period.
There are no costs to the participants other than their time. The
total number of burden hours is 1,323 across 36 months of data
collection. The total estimated annualized burden hours are 441.
Estimated Annualized Burden Hours
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Average
Number of Number of burden per Total burden
Type of respondent Form name respondents responses per response (in (in hr)
respondent hr)
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Aim 1 participants--YMSM; Aim 1 268 1 5/60 22
General public, adults. Participant
Eligibility
Screener.
Aim 1 participants--YMSM; Aim 1 134 1 5/60 12
General public, adults. Participant
Locator Form.
Aim 1 participants--YMSM; Aim 1 mChoice 134 1 20/60 45
General public, adults. Onboarding
Guide.
Aim 1 participants--YMSM; Aim 1 134 1 30/60 67
General public, adults. Participant
Baseline Survey.
[[Page 56836]]
Aim 1 participants--YMSM; Aim 1 134 4 30/60 268
General public, adults. Participant
Follow-up
Survey.
Aim 2 participants--YMSM; Aim 2 20 1 5/60 2
General public, adults. Participant
Eligibility
Screener.
Aim 2 participants--YMSM; Aim 2 10 1 5/60 1
General public, adults. Participant
Locator Form.
Aim 2 participants--YMSM; Aim 2 10 1 1.0 10
General public, adults. Participant
Interview Guide.
Aim 3 participants--providers; Aim 3 14 1 5/60 2
General public, adults. Participant
Eligibility
Screener.
Aim 3 participants--providers; Aim 3 7 1 5/60 1
General public, adults. Participant
Locator Form.
Aim 3 participants--providers; Aim 3 7 1 1.0 7
General public, adults. Participant
Interview Guide.
Aim 3 participant--clinic Aim 3 Clinic 4 2 30/60 4
staff respondent, 1 per Assessment.
clinic site; General public,
adults.
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Total..................... ................ .............. .............. .............. 441
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Jeffrey M. Zirger,
Lead, Information Collection Review Office, Office of Public Health
Ethics and Regulations, Office of Science, Centers for Disease Control
and Prevention.
[FR Doc. 2023-17921 Filed 8-18-23; 8:45 am]
BILLING CODE 4163-18-P
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