[Federal Register Volume 88, Number 122 (Tuesday, June 27, 2023)]
[Notices]
[Pages 41623-41625]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-13570]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[60Day-23-22GA; Docket No. CDC-2023-0053]


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 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 increase provider knowledge and improve PrEP adherence.

DATES: CDC must receive written comments on or before August 28, 2023.

ADDRESSES: You may submit comments, identified by Docket No. CDC-2023-
0053 by either of the following methods:
     Federal eRulemaking Portal: www.regulations.gov. Follow 
the instructions for submitting comments.
     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 www.regulations.gov.
    Please note: Submit all comments through the Federal eRulemaking 
portal (www.regulations.gov) 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: [email protected].

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

    Expanding PrEP in Communities of Color (EPICC)--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 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).
    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. 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 also 
utilize a mobile app-based platform, HealthMPowerment (HMP) to support 
ongoing participant engagement and monitoring, as well as to provide 
additional adherence support. In Aim 2b, the study team will conduct 
focus groups with providers to gather feedback on overall perceptions 
of the barriers and facilitators to implementation of evidence-based 
tools (EBT) within their clinical site.
    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 will be carried out in 10 clinics located in Chicago, 
IL; New York City, NY; Philadelphia, PA; Charlotte, NC; Raleigh, NC; 
Tuscaloosa, AL; Montgomery, AL; Tampa, FL; Orlando, FL; and Houston, 
TX. Aim 1 will include 30 health care providers from the 10 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.
    Aim 2a participants will include 400 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 ten

[[Page 41624]]

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.
    Quantitative and qualitative assessments will be used to collect 
information from providers and YMSM participants. For the Aim 1 
provider training, assessments will include pre, post, 3-month, and 6-
month surveys to evaluate provider information retention. Providers 
will also be asked to complete a brief survey at baseline, 3- and 6-
months to assess their new patient interaction skills. For Aim 2a, YMSM 
participants will be asked to complete a baseline assessment and 
quarterly assessments at 3, 6, 9, 12, 15, and 18 months to assess PrEP 
adherence; PrEP knowledge, usage and choice; sexual risk behaviors; HIV 
status of partners); and substance use assessment. A subset of YMSM 
participants from Aim 2a will be asked to complete an exit interview 
that will focus on understanding factors that influenced participants' 
selection of PrEP regimens, changes and/or discontinuations, as well as 
perceptions of the counseling they received by providers at PrEP 
initiation and follow-up, receipt of tools or materials that influenced 
choice and feasibility/acceptability of the HMP app. We will also 
conduct focus groups with providers in Aim 2b to gather feedback on 
overall perceptions of the barriers and facilitators to EBT 
implementation within their clinical site. The study will also collect 
data through from electronic health records; biological specimens 
collected at quarterly intervals; and a clinic assessment tool 
delivered every six months.
    For the Aim 1 provider training, we estimate the collection of 
contact information will take five minutes. Pre-training, baseline and 
follow up surveys at three and six months will take approximately 15 
minutes each to complete. Patient interaction assessments delivered at 
baseline, three and six months will take approximately 15 minutes each 
to complete. For Aim 2a, the effectiveness-implementation trail, it is 
expected that 50% of YMSM screened will meet study eligibility. The 
initial screening will take five minutes to complete and the collection 
of contact information to take five minutes. The baseline assessment 
will take approximately 45 minutes to complete. The follow up 
assessments will take 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 to setup the HMP app, a 
process that will take 30 minutes.. The patient exit interview takes 
approximately 60 minutes to complete and will be delivered one time to 
a subset of 48 YMSM participants. For the Aim 2b provider focus groups, 
we estimate it will take approximately 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.
    Total study enrollment for Aim 1 is 30, over the three-year study 
period the estimated annual enrollment is 10. Total enrollment for Aim 
2a is 400, over the three-year study period the estimated annual 
enrollment is 134. For the Aim 2a exit interview, 45 will participate 
for an annual enrollment of 15. For Aim 2b, total study enrollment is 
48 and the estimated annual enrollment is 16. Additionally, a clinic 
staff member at each of the ten participating clinic sites will 
complete a clinic assessment form every six months throughout the study 
period. The total estimated annualized burden hours are 685. There is 
no cost to respondents other than their time to participate.

                                        Estimated Annualized Burden Hours
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                                                                     Number of    Average burden
      Type of respondent            Form name        Number of     responses per   per response    Total burden
                                                    respondents     respondent        (in hr)         (in hr)
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General Public--Adults........  Aim 1 Provider                10               1            5/60               1
                                 Contact
                                 Information.
General Public--Adults........  Aim 1 Provider                10               4           15/60              10
                                 Training Survey.
General Public--Adults........  Aim 1 Patient                 10               3           15/60               8
                                 Interaction
                                 Assessment.
General Public--Adults........  Aim 2a                       268               1            5/60              23
                                 Participant
                                 Eligibility
                                 Screener.
General Public--Adults........  Aim 2a                       134               1            5/60              12
                                 Participant
                                 Contact
                                 Information.
General Public--Adults........  Aim 2a Baseline              134               1           45/60             101
                                 Assessment.
General Public--Adults........  Aim 2a Quarterly             134               4           45/60             402
                                 Assessments.
General Public--Adults........  Aim 2a HMP App               134               1           30/60              67
                                 Setup.
General Public--Adults........  Aim 2a Exit                   15               1               1              15
                                 Interview.
General Public--Adults........  Aim 2b Provider               16               1            5/60               2
                                 Focus Group
                                 Contact
                                 Information.
General Public--Adults........  Aim 2b Provider               16               1            5/60               2
                                 Focus Group
                                 Survey.
General Public--Adults........  Aim 2b Provider               16               1             2.0              32
                                 Focus Group
                                 Guide.
General Public--Adults........  Clinic                        10               2           30/60              10
                                 Assessment.
                                                 ---------------------------------------------------------------
    Total.....................  ................  ..............  ..............  ..............             886
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[[Page 41625]]

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. 2023-13570 Filed 6-26-23; 8:45 am]
BILLING CODE 4163-18-P