Proposed Data Collection Submitted for Public Comment and Recommendations, 56834-56836 [2023-17921]
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<![CDATA[
56834
Federal Register / Vol. 88, No. 160 / Monday, August 21, 2023 / Notices
ESTIMATED ANNUALIZED BURDEN HOURS—Continued
Average
burden per
response
(in hours)
Total burden
(in hours)
Form name
Fire Chiefs .........................................
Company Officers .............................
Survey ..............................................
Survey ..............................................
4,500
4,500
1
1
18/60
18/60
1,350
1,350
Total ...........................................
...........................................................
........................
........................
........................
4,050
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. 2023–17926 Filed 8–18–23; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[60Day–23–22FZ; Docket No. CDC–2023–
0072]
Proposed Data Collection Submitted
for Public Comment and
Recommendations
Centers for Disease Control and
Prevention (CDC), Department of Health
and Human Services (HHS).
ACTION: Notice with comment period.
AGENCY:
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 and/or continuing
information collection, as required by
the Paperwork Reduction Act of 1995.
This notice invites comment on a
proposed information collection project
titled mChoice: Improving PrEP Uptake
and Adherence among Minority MSM
through Tailored Provider Training and
Adherence Assistance in Two High
Priority Settings. The collection is part
of a research study designed to
implement and evaluate the
effectiveness of an intervention that
utilizes evidence-based education and
support tools to improve preexposure
prophylaxis (PrEP) adherence among
young men who have sex with men
(YMSM).
DATES: CDC must receive written
comments on or before October 20,
2023.
ADDRESSES: You may submit comments,
identified by Docket No. CDC–2023–
0072 by either of the following methods:
SUMMARY:
ddrumheller on DSK120RN23PROD with NOTICES1
Number of
responses per
respondent
Number of
respondents
Type of respondents
VerDate Sep<11>2014
18:17 Aug 18, 2023
Jkt 259001
b Federal eRulemaking Portal:
www.regulations.gov. Follow the
instructions for submitting comments.
b 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: omb@
cdc.gov.
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;
PO 00000
Frm 00043
Fmt 4703
Sfmt 4703
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
mChoice: Improving PrEP Uptake and
Adherence among Minority MSM
through Tailored Provider Training and
Adherence Assistance in Two High
Priority Settings—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
is requesting approval for 36 months of
data collection titled, ‘‘mChoice:
Improving PrEP Uptake and Adherence
among Minority MSM through Tailored
Provider Training and Adherence
Assistance in Two High Priority
Settings.’’ The purpose of this study is
to implement and evaluate the
effectiveness of a clinic-based
intervention that utilizes evidencebased education and support tools to
improve preexposure prophylaxis
(PrEP) adherence among young men
who have sex with men (YMSM). The
goals of this research study are to: (1)
improve the overall PrEP experience of
providers and YMSM patients; and (2)
increase our understanding of provider
and patient factors that influence the
choice of PrEP regimen by MSM in
clinical settings. This study will be
carried out in four clinics in New York,
NY (two clinics) and Birmingham, AL
(two clinics).
E:\FR\FM\21AUN1.SGM
21AUN1
56835
Federal Register / Vol. 88, No. 160 / Monday, August 21, 2023 / Notices
Aim 1 of the study will enroll 400
YMSM (ages 18–39) who identify as
male, non-binary, or genderqueer; were
assigned male sex at birth; are taking or
initiating PrEP; own a smartphone;
understand and read English or
Spanish; have a self-reported history of
sex with men in the past 12-months;
and live in the NYC or Birmingham, AL
areas. Participants may identify as any
race or ethnicity, but to ensure a diverse
sample comprised mainly of racial/
ethnic minority participants, the study
will utilize recruitment controls to
enroll at least 50% African American/
Black and/or Hispanic/Latino
participants. Patient participants will be
recruited to the study through a
combination of approaches including
flyers and social media, referral, inperson outreach, and through word of
mouth. Rolling enrollment will continue
until enrollment targets are reached;
each Aim 1 participant will be followed
for 12 months. All participants will
receive PrEP clinical services congruent
with CDC PrEP guidelines. Participants
using oral PrEP will receive CleverCap,
an electronic medication monitoring
device, that will track and support
medication adherence. At the 3-month
study visit, participants using oral PrEP
will receive the mChoice mobile phone
application, an evidence-based
intervention that supports PrEP use
through medication monitoring, study
staff interaction, and other resources.
Aim 1 assessments include: a baseline
survey of self-reported demographic
factors, sexual and drug use behaviors,
and potential cofactors of sexual and
drug use behavior including attitudes,
beliefs, knowledge, traits, and other
psychosocial factors; follow-up surveys
at 3-, 6-, 9-, and 12-month study visits
which will assess experiences with
PrEP, PrEP adherence, and behavioral
and social factors; medication
adherence data from CleverCap;
participant use and voluntary selfreported adherence and HIV exposure
risk-related data from the mChoice app;
3 assessments include notes from
practice facilitation coaching sessions;
in-depth interviews of participating
providers exploring their experiences
with the intervention and thoughts
about providing PrEP clinical services;
and a clinic assessment completed by
clinic staff every six months to describe
the current implementation of PrEP
services at their clinical site. These data
will inform ongoing practice
improvement in PrEP clinical services
and increase understanding of provider
experiences with providing PrEP
clinical services.
It is expected that half of screened
persons will meet study eligibility. For
all aims we anticipate that screening
and completion of the locator form will
each take five minutes. Study staff will
assist Aim 1 participants with
onboarding the CleverCap device and
mChoice app, a process that will take 20
minutes. Aim 1 participants will
complete the baseline survey once
(anticipated 30 minutes completion
time) and the follow-up survey four
times (anticipated completion time 30
minutes each) over their 12-month
participation period. Total study
enrollment for Aim 1 is 400, over the 3year data collection period the
estimated annual enrollment is 134.
Aims 2 and 3 interviews will take 60
minutes to complete. For Aim 2, total
study enrollment is 30, over the 3-year
data collection period the estimated
annual enrollment is 10. For Aim 3,
total study enrollment is 20, over the 3year data collection period the
estimated annual enrollment is seven.
Additionally, a single Aim 3 participant
at each of the four participating clinic
sites will complete a clinic assessment
form every six months throughout the
study period.
There are no costs to the participants
other than their time. The total number
of burden hours is 1,323 across 36
months of data collection. The total
estimated annualized burden hours are
441.
PrEP clinical care data from clinic
electronic medical records; and urine
studies assessing PrEP adherence. The
information collected in Aim 1 will be
used to evaluate the effectiveness of the
mChoice intervention to improve PrEP
adherence and persistence, and to
increase understanding of PrEP
experiences and factors that influence
PrEP choices among MSM in clinical
settings.
Aim 2 of the study will enroll 30
YMSM who participated in Aim 1; 15
from New York and 15 from Alabama.
Participants will be recruited at Aim 1
study visits. Study staff will conduct indepth interviews with Aim 2
participants exploring their experiences
with PrEP, reasons for PrEP choices, and
thoughts about the mChoice
intervention. Data collected in Aim 2
will contribute to the evaluation of the
mChoice intervention, implementation,
and contribute to understanding factors
that influence PrEP choices by MSM in
clinical settings.
Aim 3 of the study will include 20
health care providers (10 from New
York and 10 from Alabama) involved in
the direct delivery of PrEP services at
participating clinical sites. Providers
may include nurse practitioners,
physicians, PrEP coordinators/
navigators, medical assistants, and other
cross-trained coordinators from the
participating clinics. Providers will be
recruited via flyers, emails to clinic
staff, and referrals. Providers will
receive education and training designed
to improve knowledge of PrEP options
and clinical recommendations and
enhance provider communications with
patients. Aim 3 includes practice
facilitation, an intervention that
includes identification of a clinic
champion who will engage other
providers in embracing PrEP
recommendations, as well as ongoing
support from a practice coach who will
offer tools, resources, hands-on
guidance, and content expertise to assist
the clinic team in developing strategies
to improve clinical PrEP services. Aim
ESTIMATED ANNUALIZED BURDEN HOURS
ddrumheller on DSK120RN23PROD with NOTICES1
Type of respondent
Aim 1 participants—YMSM;
public, adults.
Aim 1 participants—YMSM;
public, adults.
Aim 1 participants—YMSM;
public, adults.
Aim 1 participants—YMSM;
public, adults.
VerDate Sep<11>2014
Number of
respondents
Form name
Number of
responses per
respondent
Average
burden per
response
(in hr)
Total burden
(in hr)
General
Aim 1 Participant Eligibility Screener
268
1
5/60
22
General
Aim 1 Participant Locator Form .......
134
1
5/60
12
General
Aim 1 mChoice Onboarding Guide ..
134
1
20/60
45
General
Aim 1 Participant Baseline Survey ..
134
1
30/60
67
18:17 Aug 18, 2023
Jkt 259001
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Fmt 4703
Sfmt 4703
E:\FR\FM\21AUN1.SGM
21AUN1
56836
Federal Register / Vol. 88, No. 160 / Monday, August 21, 2023 / Notices
ESTIMATED ANNUALIZED BURDEN HOURS—Continued
Type of respondent
Aim 1 participants—YMSM; General
public, adults.
Aim 2 participants—YMSM; General
public, adults.
Aim 2 participants—YMSM; General
public, adults.
Aim 2 participants—YMSM; General
public, adults.
Aim 3 participants—providers; General public, adults.
Aim 3 participants—providers; General public, adults.
Aim 3 participants—providers; General public, adults.
Aim 3 participant—clinic staff respondent, 1 per clinic site; General public, adults.
Total ...........................................
4
30/60
268
Aim 2 Participant Eligibility Screener
20
1
5/60
2
Aim 2 Participant Locator Form .......
10
1
5/60
1
Aim 2 Participant Interview Guide ...
10
1
1.0
10
Aim 3 Participant Eligibility Screener
14
1
5/60
2
Aim 3 Participant Locator Form .......
7
1
5/60
1
Aim 3 Participant Interview Guide ...
7
1
1.0
7
Aim 3 Clinic Assessment .................
4
2
30/60
4
...........................................................
........................
........................
........................
441
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[60Day–23–1319; Docket No. CDC–2023–
0073]
Proposed Data Collection Submitted
for Public Comment and
Recommendations
Centers for Disease Control and
Prevention (CDC), Department of Health
and Human Services (HHS).
ACTION: Notice with comment period.
AGENCY:
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 continuing information collection, as
required by the Paperwork Reduction
Act of 1995. This notice invites
comment on a proposed information
collection project titled National
Surveillance of Community Water
Systems and Corresponding Populations
with the Recommended Fluoridation
Level. This surveillance collects the
fluoridation status of, and population
served by the nation’s 52,000
SUMMARY:
ddrumheller on DSK120RN23PROD with NOTICES1
Total burden
(in hr)
134
[FR Doc. 2023–17921 Filed 8–18–23; 8:45 am]
18:17 Aug 18, 2023
Average
burden per
response
(in hr)
Aim 1 Participant Follow-up Survey
Jeffrey M. Zirger,
Lead, Information Collection Review Office,
Office of Public Health Ethics and
Regulations, Office of Science, Centers for
Disease Control and Prevention.
VerDate Sep<11>2014
Number of
responses per
respondent
Number of
respondents
Form name
Jkt 259001
community water systems (CWS) which
serve the 50 States and the District of
Columbia.
DATES: CDC must receive written
comments on or before October 20,
2023.
ADDRESSES: You may submit comments,
identified by Docket No. CDC–2023–
0073 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: 404–639–7570; Email: omb@
cdc.gov.
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
PO 00000
Frm 00045
Fmt 4703
Sfmt 4703
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.
E:\FR\FM\21AUN1.SGM
21AUN1
]]>Agencies
[Federal Register Volume 88, Number 160 (Monday, August 21, 2023)]
[Notices]
[Pages 56834-56836]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-17921]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[60Day-23-22FZ; Docket No. CDC-2023-0072]
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.
-----------------------------------------------------------------------
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 and/or
continuing information collection, as required by the Paperwork
Reduction Act of 1995. This notice invites comment on a proposed
information collection project titled mChoice: Improving PrEP Uptake
and Adherence among Minority MSM through Tailored Provider Training and
Adherence Assistance in Two High Priority Settings. The collection is
part of a research study designed to implement and evaluate the
effectiveness of an intervention that utilizes evidence-based education
and support tools to improve preexposure prophylaxis (PrEP) adherence
among young men who have sex with men (YMSM).
DATES: CDC must receive written comments on or before October 20, 2023.
ADDRESSES: You may submit comments, identified by Docket No. CDC-2023-
0072 by either of the following methods:
[square] Federal eRulemaking Portal: www.regulations.gov. Follow
the instructions for submitting comments.
[square] 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
mChoice: Improving PrEP Uptake and Adherence among Minority MSM
through Tailored Provider Training and Adherence Assistance in Two High
Priority Settings--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 is requesting approval for 36 months of data collection
titled, ``mChoice: Improving PrEP Uptake and Adherence among Minority
MSM through Tailored Provider Training and Adherence Assistance in Two
High Priority Settings.'' 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 improve preexposure
prophylaxis (PrEP) adherence among young men who have sex with men
(YMSM). The goals of this research study are to: (1) improve the
overall PrEP experience of providers and YMSM patients; and (2)
increase our understanding of provider and patient factors that
influence the choice of PrEP regimen by MSM in clinical settings. This
study will be carried out in four clinics in New York, NY (two clinics)
and Birmingham, AL (two clinics).
[[Page 56835]]
Aim 1 of the study will enroll 400 YMSM (ages 18-39) who identify
as male, non-binary, or genderqueer; were assigned male sex at birth;
are taking or initiating PrEP; own a smartphone; understand and read
English or Spanish; have a self-reported history of sex with men in the
past 12-months; and live in the NYC or Birmingham, AL areas.
Participants may identify as any race or ethnicity, but to ensure a
diverse sample comprised mainly of racial/ethnic minority participants,
the study will utilize recruitment controls to enroll at least 50%
African American/Black and/or Hispanic/Latino participants. Patient
participants will be recruited to the study through a combination of
approaches including flyers and social media, referral, in-person
outreach, and through word of mouth. Rolling enrollment will continue
until enrollment targets are reached; each Aim 1 participant will be
followed for 12 months. All participants will receive PrEP clinical
services congruent with CDC PrEP guidelines. Participants using oral
PrEP will receive CleverCap, an electronic medication monitoring
device, that will track and support medication adherence. At the 3-
month study visit, participants using oral PrEP will receive the
mChoice mobile phone application, an evidence-based intervention that
supports PrEP use through medication monitoring, study staff
interaction, and other resources. Aim 1 assessments include: a baseline
survey of self-reported demographic factors, sexual and drug use
behaviors, and potential cofactors of sexual and drug use behavior
including attitudes, beliefs, knowledge, traits, and other psychosocial
factors; follow-up surveys at 3-, 6-, 9-, and 12-month study visits
which will assess experiences with PrEP, PrEP adherence, and behavioral
and social factors; medication adherence data from CleverCap;
participant use and voluntary self-reported adherence and HIV exposure
risk-related data from the mChoice app; PrEP clinical care data from
clinic electronic medical records; and urine studies assessing PrEP
adherence. The information collected in Aim 1 will be used to evaluate
the effectiveness of the mChoice intervention to improve PrEP adherence
and persistence, and to increase understanding of PrEP experiences and
factors that influence PrEP choices among MSM in clinical settings.
Aim 2 of the study will enroll 30 YMSM who participated in Aim 1;
15 from New York and 15 from Alabama. Participants will be recruited at
Aim 1 study visits. Study staff will conduct in-depth interviews with
Aim 2 participants exploring their experiences with PrEP, reasons for
PrEP choices, and thoughts about the mChoice intervention. Data
collected in Aim 2 will contribute to the evaluation of the mChoice
intervention, implementation, and contribute to understanding factors
that influence PrEP choices by MSM in clinical settings.
Aim 3 of the study will include 20 health care providers (10 from
New York and 10 from Alabama) involved in the direct delivery of PrEP
services at participating clinical sites. Providers may include nurse
practitioners, physicians, PrEP coordinators/navigators, medical
assistants, and other cross-trained coordinators from the participating
clinics. Providers will be recruited via flyers, emails to clinic
staff, and referrals. Providers will receive education and training
designed to improve knowledge of PrEP options and clinical
recommendations and enhance provider communications with patients. Aim
3 includes practice facilitation, an intervention that includes
identification of a clinic champion who will engage other providers in
embracing PrEP recommendations, as well as ongoing support from a
practice coach who will offer tools, resources, hands-on guidance, and
content expertise to assist the clinic team in developing strategies to
improve clinical PrEP services. Aim 3 assessments include notes from
practice facilitation coaching sessions; in-depth interviews of
participating providers exploring their experiences with the
intervention and thoughts about providing PrEP clinical services; and a
clinic assessment completed by clinic staff every six months to
describe the current implementation of PrEP services at their clinical
site. These data will inform ongoing practice improvement in PrEP
clinical services and increase understanding of provider experiences
with providing PrEP clinical services.
It is expected that half of screened persons will meet study
eligibility. For all aims we anticipate that screening and completion
of the locator form will each take five minutes. Study staff will
assist Aim 1 participants with onboarding the CleverCap device and
mChoice app, a process that will take 20 minutes. Aim 1 participants
will complete the baseline survey once (anticipated 30 minutes
completion time) and the follow-up survey four times (anticipated
completion time 30 minutes each) over their 12-month participation
period. Total study enrollment for Aim 1 is 400, over the 3-year data
collection period the estimated annual enrollment is 134. Aims 2 and 3
interviews will take 60 minutes to complete. For Aim 2, total study
enrollment is 30, over the 3-year data collection period the estimated
annual enrollment is 10. For Aim 3, total study enrollment is 20, over
the 3-year data collection period the estimated annual enrollment is
seven. Additionally, a single Aim 3 participant at each of the four
participating clinic sites will complete a clinic assessment form every
six months throughout the study period.
There are no costs to the participants other than their time. The
total number of burden hours is 1,323 across 36 months of data
collection. The total estimated annualized burden hours are 441.
Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
Average
Number of Number of burden per Total burden
Type of respondent Form name respondents responses per response (in (in hr)
respondent hr)
----------------------------------------------------------------------------------------------------------------
Aim 1 participants--YMSM; Aim 1 268 1 5/60 22
General public, adults. Participant
Eligibility
Screener.
Aim 1 participants--YMSM; Aim 1 134 1 5/60 12
General public, adults. Participant
Locator Form.
Aim 1 participants--YMSM; Aim 1 mChoice 134 1 20/60 45
General public, adults. Onboarding
Guide.
Aim 1 participants--YMSM; Aim 1 134 1 30/60 67
General public, adults. Participant
Baseline Survey.
[[Page 56836]]
Aim 1 participants--YMSM; Aim 1 134 4 30/60 268
General public, adults. Participant
Follow-up
Survey.
Aim 2 participants--YMSM; Aim 2 20 1 5/60 2
General public, adults. Participant
Eligibility
Screener.
Aim 2 participants--YMSM; Aim 2 10 1 5/60 1
General public, adults. Participant
Locator Form.
Aim 2 participants--YMSM; Aim 2 10 1 1.0 10
General public, adults. Participant
Interview Guide.
Aim 3 participants--providers; Aim 3 14 1 5/60 2
General public, adults. Participant
Eligibility
Screener.
Aim 3 participants--providers; Aim 3 7 1 5/60 1
General public, adults. Participant
Locator Form.
Aim 3 participants--providers; Aim 3 7 1 1.0 7
General public, adults. Participant
Interview Guide.
Aim 3 participant--clinic Aim 3 Clinic 4 2 30/60 4
staff respondent, 1 per Assessment.
clinic site; General public,
adults.
---------------------------------------------------------------
Total..................... ................ .............. .............. .............. 441
----------------------------------------------------------------------------------------------------------------
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. 2023-17921 Filed 8-18-23; 8:45 am]
BILLING CODE 4163-18-P
