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PrEP Point-of-Care Brief-Intervention for Adherence among Young Men Who Have Sex with Men (PrEP2-BAY Study)

Award Number: K23MH122286
ORGANIZATION: NATIONAL INSTITUTE OF MENTAL HEALTH
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: TRAINING/TRAINEESHIP
PERIOD OF PERFORMANCE START DATE: 01/24/2020
PERIOD OF PERFORMANCE END DATE: 12/31/2024

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PrEP Point-of-Care Brief-Intervention for Adherence among Young Men Who Have Sex with Men (PrEP2-BAY Study) - PROJECT SUMMARY/ABSTRACT Young men who have sex with men (YMSM; ages 18-29 years) have rising HIV incidence in the United States. Pre-exposure prophylaxis (PrEP) is a highly effective medication prevent HIV infection, both at the individual and population level. However, in several clinical trials and demonstration projects among YMSM, a majority of participants had adherence to PrEP sufficiently low to compromise efficacy throughout the study. Unfortunately, pill-counts and self-reported adherence have limitations in this population, and therapeutic drug monitoring using previously available methods requires expensive equipment and specialized staff, meaning it cannot be implemented at the point-of-care (POC). We have developed a novel POC test to measure urine drug-levels to PrEP for the first time, providing the opportunity to target and enhance adherence counseling during a routine clinical visit. Substantial knowledge gaps on the correct counseling approach and framing of the drug-level feedback message must be addressed to use this strategy to improve adherence among YMSM. The proposed training and research plan for this K23 application will allow Matthew Spinelli, MD to acquire the necessary skills to achieve his career goal of becoming an NIH-funded independent clinical investigator with expertise in designing interventions to improve antiretroviral adherence among men who have sex with men (MSM). Under the guidance of a dedicated mentoring team, Dr. Spinelli will use a mixed methods approach to test the central hypothesis that an intervention leveraging a POC urine bioassay to detect PrEP adherence can both target and enhance adherence counseling. Brief interventions are a motivational interviewing (MI) counseling approach with wide uptake by primary care providers for substance use prevention and medical therapy adherence. Dr. Spinelli proposes a brief intervention be used as the framework for POC drug-level feedback among YMSM using PrEP at the San Francisco City Clinic (SFCC). SFCC is the municipal sexually- transmitted disease clinic for San Francisco and has a high-volume PrEP program, facilitating recruitment. Building on the candidate's prior research in PrEP care outcomes and adherence diagnostics, this proposal will address the following specific aims: (1) identify behavioral targets for PrEP adherence amenable to counseling specific to YMSM; (2) develop the POC bioassay-enhanced adherence brief intervention through in-depth interview feedback from PrEP users and providers; (3) test the acceptability, feasibility, and preliminary impact on long-term adherence, measured through hair tenofovir levels, of the brief intervention in a pilot randomized controlled trial among YMSM. This proposed research plan has the goal of optimizing PrEP's impact through a novel adherence support and is aligned with Dr. Spinelli's career development plan to gain expertise in intervention design, qualitative research, and behavioral trial design and evaluation. The findings of this proposal will lead to a R01 application to test a POC bioassay-enhanced adherence brief intervention among YMSM in a multi-city trial, with the goal of reducing the burden of HIV among MSM.


Issue Date FY	Funding FY	Legal Entity Name	Legal Entity Address	Legal Entity City	Legal Entity State	Legal Entity Zip Code	Legal Entity COUNTY	Legal Entity COUNTRY	Assistance Listing	Award Code	Budget Year	Action Date	Action Type	Action Amount

Issue Date FY: 2025 ( Subtotal = -$182 )
2025	2024	REGENTS OF THE UNIVERSITY OF CALIFORNIA, SAN FRANCISCO, THE	1855 FOLSOM ST STE 425	SAN FRANCISCO	CA	94103	SAN FRANCISCO	USA	Mental Health Research Grants	000	5	6/20/2025	NON-COMPETING CONTINUATION	-$182
														Subtotal = -$182

Issue Date FY: 2024 ( Subtotal = $169,884 )
2024	2024	REGENTS OF THE UNIVERSITY OF CALIFORNIA, SAN FRANCISCO, THE	1855 FOLSOM ST STE 425	SAN FRANCISCO	CA	94143	SAN FRANCISCO	USA	Mental Health Research Grants	002	5	12/14/2023	NON-COMPETING CONTINUATION	$183,456
2024	2023	REGENTS OF THE UNIVERSITY OF CALIFORNIA, SAN FRANCISCO, THE	1855 FOLSOM ST STE 425	SAN FRANCISCO	CA	94143	SAN FRANCISCO	USA	Mental Health Research Grants	001	4	11/14/2023	NON-COMPETING CONTINUATION	-$1,005
2024	2023	REGENTS OF THE UNIVERSITY OF CALIFORNIA, SAN FRANCISCO, THE	1855 FOLSOM ST STE 425	SAN FRANCISCO	CA	94143	SAN FRANCISCO	USA	Mental Health Research Grants	000	4	10/31/2023	NON-COMPETING CONTINUATION	-$12,567
														Subtotal = $169,884

Issue Date FY: 2023 ( Subtotal = $210,600 )
2023	2023	REGENTS OF THE UNIVERSITY OF CALIFORNIA, SAN FRANCISCO, THE	1855 FOLSOM ST STE 425	SAN FRANCISCO	CA	94143	SAN FRANCISCO	USA	Mental Health Research Grants	000	4	12/21/2022	NON-COMPETING CONTINUATION	$210,600
														Subtotal = $210,600

Issue Date FY: 2022 ( Subtotal = $210,600 )
2022	2022	REGENTS OF THE UNIVERSITY OF CALIFORNIA, SAN FRANCISCO, THE	1855 FOLSOM ST STE 425	SAN FRANCISCO	CA	94143	SAN FRANCISCO	USA	Mental Health Research Grants	000	3	12/22/2021	NON-COMPETING CONTINUATION	$210,600
														Subtotal = $210,600

Issue Date FY: 2021 ( Subtotal = $210,600 )
2021	2021	REGENTS OF THE UNIVERSITY OF CALIFORNIA, SAN FRANCISCO, THE	1855 FOLSOM ST STE 425	SAN FRANCISCO	CA	94143	SAN FRANCISCO	USA	Mental Health Research Grants	000	2	1/25/2021	NON-COMPETING CONTINUATION	$210,600
														Subtotal = $210,600

Issue Date FY: 2020 ( Subtotal = $210,600 )
2020	2020	REGENTS OF THE UNIVERSITY OF CALIFORNIA, SAN FRANCISCO, THE	1855 FOLSOM ST STE 425	SAN FRANCISCO	CA	94143	SAN FRANCISCO	USA	Mental Health Research Grants	000	1	1/24/2020	NEW	$210,600
2020	2020	REGENTS OF THE UNIVERSITY OF CALIFORNIA, SAN FRANCISCO, THE	1855 FOLSOM ST STE 425	SAN FRANCISCO	CA	94143	SAN FRANCISCO	USA	Mental Health Research Grants	001	1	7/28/2020	NEW	$0
														Subtotal = $210,600

Grand Total All Awards = $1,012,102

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PrEP Point-of-Care Brief-Intervention for Adherence among Young Men Who Have Sex with Men (PrEP2-BAY Study)

Award Number: K23MH122286

ORGANIZATION: NATIONAL INSTITUTE OF MENTAL HEALTH

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

AWARD ACTIVITY TYPE: TRAINING/TRAINEESHIP

PERIOD OF PERFORMANCE START DATE: 01/24/2020

PERIOD OF PERFORMANCE END DATE: 12/31/2024

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