[Federal Register Volume 88, Number 176 (Wednesday, September 13, 2023)]
[Notices]
[Pages 62793-62795]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-19706]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[30Day-23-22GA]


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 ``Expanding PrEP in Communities of Color 
(EPICC)'' 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 June 13, 
2022, to obtain comments from the public and affected agencies. CDC 
received four 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

    Expanding PrEP in Communities of Color (EPICC)--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 36 months for a data collection 
titled, Expanding PrEP in Communities of Color (EPICC). 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: (1) increase provider knowledge of and comfort with 
preexposure prophylaxis (PrEP) modalities in clinical practice; and (2) 
improve PrEP adherence among young men who have sex with men (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 EPICC+ 
mobile app among YMSM on PrEP; and (4) evaluate the feasibility and 
acceptability of implementing a provider training.
    This study has two aims: In Aim 1, the study team will deliver 
training to health providers that will focus on implementation of 
evidence-based tools to enhance the providers' ability to engage in 
PrEP screening, counseling, initiation and to provide support for 
adherence and persistence. The study will utilize web-based computer-
assisted surveys to measure healthcare provider knowledge both pre- and 
post-training. Post-training and at three months, providers will 
complete a patient interaction assessment via teleconference and 
receive personalized feedback to assess and enhance their tailored 
motivational interviewing skills.
    For Aim 2a, the study will initiate an effectiveness-implementation 
trial with 400 YMSM to test the effectiveness of the EPICC+ 
intervention package in increasing PrEP adherence and persistence among 
YMSM. The intervention will utilize a mobile app-based platform, 
EPICC+, to support ongoing participant engagement and monitoring, as 
well as to provide additional adherence support. YMSM participants will 
complete quarterly web-based computerized assessments during the 18-
month follow up period. The assessments will measure PrEP knowledge, 
usage, and choice, and gather information about sexual behaviors, HIV 
status of partners, and substance use. YMSM participants will be mailed 
four dried blood spot collection kits to measure PrEP metabolites 
(baseline, six, 12, and 18 months). To further examine the participant 
experience and intervention satisfaction, a subset of YMSM participants 
(45) will be invited to participate in a web-based exit interview at 
the close of the follow up period (18 months). Additionally, study 
staff will collect data to measure mobile app use and conduct medical 
record abstractions three times during the follow up period (six, 12, 
and 18 months).
    In Aim 2b, the study team will conduct focus groups with health 
providers from the participating clinics to gather feedback on overall 
perceptions about the effectiveness of the intervention and the 
barriers and facilitators to implementation of the evidence-based tools 
(EBT) within their clinical site. Providers will complete a short web-
based computer-assisted pre-focus group survey prior to the virtual 
two-hour focus group. To describe PrEP services implementation at the 
facility level, each participating clinic will complete a web-based 
computer-assisted clinic assessment at six-month intervals during the 
three-year data collection period (baseline, six, 12, 18, 24, 30, and 
36 months).
    This study will be carried out in nine clinics located in Chicago, 
IL; Bronx, New York City, NY; Philadelphia, PA; Charlotte, NC; Raleigh, 
NC; Tuscaloosa, AL; Tampa, FL; Orlando, FL; and Houston, TX. Aim 1 will 
include healthcare providers from the nine clinic sites, all involved 
in the direct delivery of PrEP services. Providers may include but are 
not limited to medical doctors, nurses, adherence counselors, 
pharmacists, and social workers. Health providers will be recruited via 
staff

[[Page 62794]]

emails. Aim 2a participants will include YMSM ages 18-39, inclusive. 
Participants will identify as a cisgender male; report sex with a man 
in the past 12 month; have an active prescription for PrEP; receive 
care at one of the nine participating study sites; provide a mailing 
address within the 50 states where packages can be received; have daily 
smartphone access; and be fluent in written/spoken English or Spanish. 
We will use purposive sampling to ensure at least 60% patient sample is 
African American or Black or Hispanic/Latino/Latinx. Patient 
participants will be recruited to the study using a combination of 
approaches including social media, referral and in-person outreach. Aim 
2b will include healthcare providers from the nine clinic sites, all 
involved in the direct delivery of PrEP services. Providers may include 
but are not limited to medical doctors, nurses, adherence counselors, 
pharmacists, and social workers. Health providers will be recruited via 
staff emails.
    Overall, this study will enroll up to 487 participants. Total study 
enrollment for Aim 1 is 30 healthcare providers; over the three-year 
study period (estimated annual enrollment is 10). Total enrollment for 
Aim 2a is 400 YMSM; over the three-year study period (estimated annual 
enrollment is 134). For Aim 2b, total study enrollment is 48 healthcare 
providers (estimated annual enrollment is 16). Additionally, a clinic 
staff member at each of the nine participating clinic sites will 
complete a clinic assessment form every six months throughout the study 
period.
    For the Aim 1 provider training, it is expected that 50% of 
providers screened will meet eligibility and decide to enroll in the 
study. We estimate that screening and the collection of contact 
information will each take five minutes. Pre-training and post-training 
surveys will take approximately 15 minutes each to complete. Patient 
interaction assessments delivered at baseline and three months will 
take approximately 15 minutes each to complete.
    For Aim 2a, the effectiveness-implementation trial, it is expected 
that 50% of YMSM screened will meet study eligibility. The initial 
screening will take approximately five minutes to complete. The 
collection of contact information and the completion of the HIPAA form 
will take approximately five minutes each to complete. The baseline 
assessment will take approximately 45 minutes to complete. The follow-
up assessments will take approximately 45 minutes to complete and will 
be administered quarterly for a total of six times during the 18-month 
follow up period. Study staff will assist participants during the 
EPICC+ app setup, a process that will take 30 minutes. The app setup is 
required of all participants but app use after the setup is voluntary. 
Participants will be mailed a dried blood spot (DBS) specimen 
collection kit that will take approximately 30 minutes to read, collect 
the specimen, and ship. The patient exit interview takes approximately 
60 minutes to complete and will be delivered one time to a subset (45) 
of YMSM participants. For the Aim 2b provider focus groups, it is 
expected that 50% of providers screened will meet eligibility and 
decide to enroll in the study. We estimate it will take approximately 
five minutes to conduct the screening, five minutes to collect contact 
information, and another five minutes to conduct the pre-focus group 
survey. Providers will attend one focus group that is expected to take 
120 minutes to complete. Clinic-level assessments will be completed by 
clinic staff. The baseline and study end assessments are estimated to 
take 120 minutes to complete. The assessments conducted at six-month 
intervals between the baseline and study end points are expected to 
take 90 minute to complete.
    CDC is requesting 3,535 total burden hours across 36-months of data 
collection. The total estimated annualized burden hours are 759. 
Participation of respondents is voluntary. There is no cost to 
participants other than their time.

                                        Estimated Annualized Burden Hours
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                                                                                                      Average
                                                                     Number of       Number of      burden per
          Type of respondents                   Form name           respondents    responses per   response (in
                                                                                    respondent        hours)
----------------------------------------------------------------------------------------------------------------
Health Practitioners..................  Aim 1 Provider Training               20               1               2
                                         Screener.
Health Practitioners..................  Aim 1 Provider Training               10               1               1
                                         Contact Information.
Health Practitioners..................  Aim 1 Provider Pre-                   10               1               3
                                         Training Survey.
Health Practitioners..................  Aim 1 Provider Post-                  10               1               3
                                         Training Survey.
Health Practitioners..................  Aim 1 Provider Patient                10               2               5
                                         Interaction.
General Public--Adults................  Aim 2a Cohort Screener..             267               1              22
General Public--Adults................  Aim 2a Cohort Contact                134               1              11
                                         Information.
General Public--Adults................  Aim 2a Cohort HIPAA Form             134               1              11
General Public--Adults................  Aim 2a Cohort Baseline               134               1             101
                                         Survey.
General Public--Adults................  Aim 2a Cohort Follow-Up              134               3             302
                                         Survey.
General Public--Adults................  Aim 2a Cohort App Setup.             134               1              67
General Public--Adults................  Aim 2a Cohort Blood                  134               2             134
                                         Collection Instructions.
General Public--Adults................  Aim 2a Cohort Exit                    15               1              15
                                         Interview.
Health Practitioners..................  Aim 2b Provider Focus                 32               1               3
                                         Group Screener.
Health Practitioners..................  Aim 2b Provider Focus                 16               1               1
                                         Group Contact
                                         Information.
Health Practitioners..................  Aim 2b Provider Pre-                  16               1               1
                                         Focus Group Survey.
Health Practitioners..................  Aim 2b Provider Focus                 16               1              32
                                         Group Guide.
Health Practitioners..................  Aims 1&2 Clinic                        9               1              18
                                         Assessment (Baseline
                                         and Final).
Health Practitioners..................  Aims 1&2 Clinic                        9               2              27
                                         Assessment (every 6
                                         months).
----------------------------------------------------------------------------------------------------------------



[[Page 62795]]

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. 2023-19706 Filed 9-12-23; 8:45 am]
BILLING CODE 4163-18-P