Notice2023-25081
Agency Forms Undergoing Paperwork Reduction Act Review
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
November 14, 2023
Issuing agencies
Health and Human Services DepartmentCenters for Disease Control and Prevention
Full Text
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<title>Federal Register, Volume 88 Issue 218 (Tuesday, November 14, 2023)</title>
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[Federal Register Volume 88, Number 218 (Tuesday, November 14, 2023)]
[Notices]
[Pages 78043-78045]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2023-25081]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[30Day-24-22FZ]
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 ``mChoice: Improving PrEP Uptake and
Adherence among Minority MSM through Provider Training and Adherence
Assistance in Two High Priority Settings'' 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 August 21, 2023, to obtain comments from
the public and affected agencies. CDC received three comments 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. Comments and recommendations for the proposed
information collection should be sent within 30 days of publication of
this notice to <a href="http://www.reginfo.gov/public/do/PRAMain">www.reginfo.gov/public/do/PRAMain</a>. Find this particular
information collection by selecting ``Currently under 30-day Review--
Open for Public Comments'' or by using the search function. 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
mChoice: Improving PrEP Uptake and Adherence among Minority MSM
through Provider Training and Adherence Assistance in Two High Priority
Settings--New--National Center for HIV, Viral Hepatitis, STD, TB
Prevention (NCHHSTP), Centers for Disease Control and Prevention (CDC).
Background and Brief Description
The CDC is requesting approval for three years for a data
collection titled mChoice: Improving PrEP Uptake and Adherence among
Minority MSM through Provider Training and Adherence Assistance in Two
High Priority Settings. The purpose of the information collection is to
implement and evaluate the effectiveness of mChoice, a clinic-based
intervention designed to improve HIV preexposure prophylaxis (PrEP)
adherence and persistence among young men who have sex with men (YMSM).
The intervention targets both health providers and PrEP patients by
providing evidence-based training for health providers to improve
clinical knowledge and enhance provider communications with patients,
and CleverCap, an electronic medication monitoring device and mobile
phone application that provides health information and medication and
appointment reminders for patients undergoing PrEP treatment.
Data collected through this study will be used to evaluate the
mChoice intervention for YMSM. The information collected in this study
will be used to: (1) describe real-world PrEP use including factors
influencing selection and change of PrEP regimens; (2) understand and
describe barriers and facilitators impacting the implementation of new
PrEP modalities in clinical practice; (3) evaluate the feasibility and
acceptability of the CleverCap mobile app among YMSM on PrEP; and (4)
evaluate the feasibility and acceptability of implementing provider
PrEP training.
The study will be carried out in four clinics in two locations, New
York City, NY (2), and Birmingham, AL (2). For the cohort, convenience
and referral-based sampling techniques will be used to identify and
recruit participants. Participants will be young men between the ages
of 18 and 39 who have sex with men; are using or initiating PrEP; and
live in the New York City or Birmingham, AL area. Recruitment controls
will ensure enrollment of at least 50% Black or African American or
Hispanic or Latino men. Cohort participants will be recruited using a
combination of approaches including print media posted in clinic
waiting rooms, social media, referral, and in-person outreach.
[[Page 78044]]
For the provider training, convenience and referral-based sampling
techniques will be used to identify and recruit a total of 20
healthcare providers from the four participating clinics. Providers
will include, but are not limited to, medical doctors, nurse
practitioners, physician associates, nurses, adherence counselors,
pharmacists, and social workers. A provider can include any employee
who discusses PrEP treatment with patients. Providers will be recruited
using email invitations and flyers posted at the clinic sites.
To evaluate the effectiveness of the mChoice clinic intervention to
increase PrEP adherence and persistence among YMSM, we will conduct a
hybrid type II trial. Participants will be asked to complete computer
assisted surveys at baseline and quarterly in-person visits. The
surveys will assess participant attitudes, knowledge, behavior, and
experiences related to PrEP, and risk factors for HIV acquisition.
Participants will be given a CleverCap device to track medication
dispensed from their prescription PrEP bottle. Participants will also
be asked to download the companion CleverCap smartphone application.
The application is designed to support PrEP adherence by providing
health information, appointment reminders, medication reminders and
other supportive information. Data collected from the app will include
prescription adherence data from CleverCap and paradata to describe
overall app use and use of app components. Data will also be collected
from urine specimens and from electronic health records to describe the
PrEP prescription regimen and any changes in PrEP regimen, evaluate
PrEP adherence, and assess sexual risk through HIV and STI test
results. To further examine the participant experience and intervention
satisfaction, a subset of the cohort will be invited to participate in
in-depth interviews. During the in-person interviews, participants will
be asked to elaborate on intervention satisfaction; communications with
providers; PrEP choices, switching and decision making; CleverCap and
app use and acceptability; and PrEP knowledge.
CDC will also conduct a PrEP training for 20 healthcare providers
from the four participating clinic sites. The provider training will
include education on available PrEP modalities and will be aligned with
the most recent CDC PrEP guidelines. To evaluate the training,
providers will complete computer assisted self-administered pre- and
post-training assessments to identify the potential impact of the
training module on PrEP knowledge, attitudes, and practice. Six-months
after completing the training, providers will be asked to complete a
post-implementation interview to assess the impact of the intervention
on the provider's work and interactions with their patients.
Information to be collected from the interviews will include training
satisfaction and opinions about the effect of the training on clinic
operations, staff procedures, and client/patient responses; barriers to
PrEP care; and attitudes and perceptions about PrEP. Healthcare
providers will have the option to complete their interview in-person or
using a web-based HIPAA-compliant platform. In addition to the training
and provider-level assessments, at six-month intervals, clinic staff at
each of the four participating clinic sites will complete a computer
assisted clinic assessment to describe PrEP services implementation at
the facility level. Information collected from the assessments will
include facility hours and scheduling; patient services; PrEP services;
PrEP prescribing information; and available PrEP options.
For the patient trial, we will enroll a total of 400 YMSM; over the
three-year data collection period the estimated annual enrollment will
be 134. It is expected that 50% of YMSM screened will meet study
eligibility criteria and agree to join the study; therefore, we expect
to screen 267 YMSM annually. The collection of initial screening
information will take approximately 10 minutes to complete. Once
enrolled, the collection of locator information will take an additional
10 minutes to complete. Participants will complete a baseline
assessment which will take approximately 45 minutes to complete
Participants will also complete follow-up assessments at 3-, 6-, 9-,
12- and 18-month time points. The follow-up assessments will take
approximately 45 minutes to complete. Participants will receive their
CleverCap and be asked to install the CleverCap app on their mobile
phones. We estimate the CleverCap onboarding process will take
approximately 10 minutes to complete. Use of the app after the initial
install will be optional. A subset (30 total) of the YMSM participants
will be invited to participate in an in-depth interview. The interview
will take approximately 90 minutes to complete.
For the healthcare provider training, we will enroll a total of 20
healthcare providers. Over the 3-year data collection period, the
estimated annual enrollment will be seven providers. It is expected
that 50% of healthcare providers screened will meet study eligibility
criteria and agree to join the study. Thus, we expect to screen 14
providers annually. The collection of initial screening information
from the 14 providers will take approximately 10 minutes to complete.
The collection of locator information from enrolled participants will
take an additional 10 minutes to complete. Provider participants will
be asked to complete an assessment before and after the PrEP training.
Each assessment will take approximately 30 minutes to complete.
Providers will also be asked to take part in a 60-minute interview.
To evaluate the impact of the intervention at the facility level,
every six months during the 36-month data collection period, each of
the four participating clinic sites will complete the clinic assessment
tool to describe PrEP services implementation at the facility level.
The clinic assessment will be completed by a single member of the
clinic staff at each clinic (four respondents total). Clinic-level
assessments at baseline and study end are estimated to take 120 minutes
to complete. Clinic-level assessments conducted at six-month intervals
between the baseline and study end points are expected to take 90
minutes to complete.
CDC is requesting OMB approval for 2,210 total burden hours across
three years of data collection. Participation of respondents is
voluntary. There are no costs to the respondents other than their time.
Estimated Annualized Burden Hours
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Number of Average
Type of respondents Form name Number of responses per burden per
respondents respondent response
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General Public--Adults................ Patient Screener........ 267 1 10/60
General Public--Adults................ Patient Locator Form.... 134 1 10/60
General Public--Adults................ Patient Baseline 134 1 45/60
Assessment.
[[Page 78045]]
General Public--Adults................ Patient Quarterly 134 3 45/60
Assessment.
General Public--Adults................ CleverCap App Setup..... 134 1 10/60
General Public--Adults................ Patient Interview Guide. 10 1 90/60
Health Practitioners.................. Provider Screener....... 14 1 10/90
Health Practitioners.................. Provider Locator Form... 7 1 10/90
Health Practitioners.................. Provider Pre-Training 7 1 30/60
Assessment.
Health Practitioners.................. Provider Post-Training 7 1 30/60
Assessment.
Health Practitioners.................. Provider Interview Guide 7 1 60/60
Health Practitioners.................. Clinic Assessment 4 1 120/60
Baseline and Final.
Health Practitioners.................. Clinic Assessment Every 4 2 90/60
Six Months.
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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. 2023-25081 Filed 11-13-23; 8:45 am]
BILLING CODE 4163-18-P
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