[Federal Register Volume 88, Number 218 (Tuesday, November 14, 2023)]
[Notices]
[Pages 78043-78045]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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 www.reginfo.gov/public/do/PRAMain. 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
----------------------------------------------------------------------------------------------------------------
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