Notice2023-19706
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
September 13, 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 176 (Wednesday, September 13, 2023)</title>
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[Federal Register Volume 88, Number 176 (Wednesday, September 13, 2023)]
[Notices]
[Pages 62793-62795]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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 <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
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)
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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).
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[[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
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