Notice2023-13570
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 27, 2023
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 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.
Full Text
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<title>Federal Register, Volume 88 Issue 122 (Tuesday, June 27, 2023)</title>
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[Federal Register Volume 88, Number 122 (Tuesday, June 27, 2023)]
[Notices]
[Pages 41623-41625]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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:
<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 (<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#0a6567684a696e69246d657c"><span class="__cf_email__" data-cfemail="3a5557587a595e59145d554c">[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
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.
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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
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