Notice2022-12697
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
June 13, 2022
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 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).
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<title>Federal Register, Volume 87 Issue 113 (Monday, June 13, 2022)</title>
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[Federal Register Volume 87, Number 113 (Monday, June 13, 2022)]
[Notices]
[Pages 35781-35783]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-12697]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[60Day-22-22FZ; Docket No. CDC-2022-0075]
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 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 August 12, 2022.
ADDRESSES: You may submit comments, identified by Docket No. CDC-2022-
0075 by either of the following methods:
<bullet> Federal eRulemaking Portal: <a href="http://www.regulations.gov">www.regulations.gov</a>. Follow
the instructions for submitting comments.
<bullet> 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
[[Page 35782]]
(<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#88e7e5eac8ebeceba6efe7fe"><span class="__cf_email__" data-cfemail="aec1c3cceecdcacd80c9c1d8">[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 (NCHHSTP) is requesting approval for 36 months of data
collection entitled, ``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 located in New York, NY (NYC)
(two clinics) and Birmingham, AL (two clinics).
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 three-
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
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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 three-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 three-year data collection period the
estimated annual enrollment is 10. For Aim 3, total study enrollment is
20, over the three-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.
The total number of burden hours is 1,323 across 36 months of data
collection. The total estimated annualized burden hours are 441. There
are no costs to the participants other than their time to participate.
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.
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 Scientific
Integrity, Office of Science, Centers for Disease Control and
Prevention.
[FR Doc. 2022-12697 Filed 6-10-22; 8:45 am]
BILLING CODE 4163-18-P
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