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Active NON-SBIR/STTR RPGS NIH (US)

Promoting PrEP Adherence for Men Who Have Sex with Men of Color: More Options, Less Barriers

$10.38M USD

Funder NATIONAL CENTER FOR HIV, VIRAL HEPATITIS, STD AND TB PREVENTION
Recipient Organization University of North Carolina Chapel Hill
Country United States
Start Date Sep 01, 2021
End Date Aug 31, 2026
Duration 1,825 days
Number of Grantees 1
Roles Principal Investigator
Data Source NIH (US)
Grant ID 10488045
Grant Description

PROJECT SUMMARY Young men who have sex with men (YMSM) of color continue to experience disproportionate rates of HIV infection compared to other groups in the United States (US). Despite the availability of highly effective daily oral HIV pre-exposure prophylaxis (PrEP), uptake and adherence to PrEP among YMSM remains low. Data

support that YMSM show interest in exploring different dosing and delivery strategies which may translate into greater uptake of PrEP, particularly among those have not been successful adhering to a daily regimen. Evidence-based provider and patient education and support tools (EBT) are available but are not being

routinely used in clinical settings to increase PrEP screening, counseling, initiation, adherence, and persistence by YMSM. To date, there has been a lack of research on the impact that existing EBT have on PrEP provision, or how tailoring these materials to meet the needs of providers and YMSM from diverse

backgrounds could enhance their effects. Further, available EBT do not acknowledge or incorporate information about a growing arsenal of prevention products nor are they maximizing opportunities to engage in a shared decision-making (SDM) process about these products. Our interdisciplinary team of experts proposes

to adapt and enhance existing EBT to facilitate PrEP SDM, train providers on the use of the EBT and evaluate the impact within a longitudinal cohort of racially and geographically diverse YMSM. Our application relies upon the Exploration, Preparation, Implementation, and Sustainment (EPIS) model as the implementation framework

for studying the integration of these tools into real-world clinical settings. In aim 1, we will conduct an iterative formative assessment with providers and patients to inform adaptation and enhancement of existing patient and provider PrEP EBT. Findings will inform the adaptation and refinement of existing EBT which will be

iteratively reviewed with providers and YMSM through Consultative Workshops prior to implementation. In aim 2, we will train providers on use of newly developed EBT grounded in the Tailored Motivational Interviewing (TMI) training model, a scalable, centralized, culturally and developmentally tailored model that has

demonstrated impacts on autonomy supportive and stigma reducing communication. Providers at diverse clinical sites will participate in a virtual training workshop, followed by competency-based eCoaching. Training will focus on implementation of the EBT to ensure increases in their ability to engage in PrEP screening,

counseling, initiation, and provide support for adherence and persistence. In aim 3, we will test the newly developed/refined EBT through the conduct of a hybrid type 2 effectiveness-implementation pragmatic clinical trial (N=540 YMSM ages 18 to 39) to assess effectiveness and implementation outcomes. A fully-developed

and validated mobile app-based platform supports ongoing participant engagement and monitoring. Our study builds on our existing infrastructure that supports the rigorous clinical trials, mHealth tools, implementation science, and knowledge of, and linkages with, affected populations and community advocates.

All Grantees

University of North Carolina Chapel Hill

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