# STOP (Shared decision making to Treat Or Prevent) HIV in Justice Populations

> **NIH NIH R61** · YALE UNIVERSITY · 2024 · $759,241

## Abstract

Project Summary/Abstract
The U.S. Ending the HIV Epidemic (EHE) plan aims to reduce new HIV infections by 90% by 2030 through
providing pre-exposure prophylaxis (PrEP) for those at risk for HIV and antiretroviral therapy (ART) for those
with HIV. The EHE does not integrate substance use disorder (SUD) assessments and treatments nor provide
implementation strategies on providing PrEP/ART for persons who use drugs (PWUD) involved in the justice
system, a critically underserved population. In response to RFA-DA-24: Ending the HIV Epidemic: Focus on
Justice Populations with SUD (R61/R33), our proposed study titled STOP (Shared decision making to Treat Or
Prevent) HIV in Justice Populations is a 5-year project; the first year (R61) is dedicated to a single site pilot study
in CT, followed by a 4-year, 4 site (CT, KY, and 2 in TX) type 3 hybrid implementation-effectiveness study (R33).
We build on existing partnerships between our multi-disciplinary research teams, justice and community
agencies, and stakeholders with lived experience, to develop and assess a patient-centered approach to access
PrEP/ART/SUD services. Following a differentiated service delivery model implementation approach, we focus
on incorporating (1) risk assessments conducted by patient navigators (PN) and (2) providing patient choice
(PC) options for services delivery methods (e.g., brick and mortar clinic, telehealth, mobile health unit) to access
PrEP/ART/SUD; this enhanced implementation approach will be compared to routine PN alone and include
implementation and participant outcomes. Aim 1 (R61) is to develop and pilot test the PN+PC menu of options
of PrEP/ART and SUD treatment services for justice-involved PWUD compared to established PN in CT, which
will be achieved by meeting the following milestones: (1) build upon established collaborations to include multiple
service delivery models and the perspectives of persons with lived experience; (2) curate a menu of PC options
to access PrEP/ART and SUD services; (3) conduct a pilot study that includes among N=30 adults with recent
justice system involvement with DSM-5 SUD at risk or living with HIV, randomized 1:1 to PN vs. PN+PC to assess
acceptability, feasibility, and proportion who (a) access a clinician and (b) receive treatment (ART, PrEP, SUD,
harm reduction); (4) seek guidance from the Patient Engagement Resource Center to inform the final
implementation model of the R33; (5) develop a common set of R33 measures; and (6) obtain R33 IRB/OHRP
approval. Aim 2 (R33) will use R61 data to inform our type 3 hybrid implementation-effectiveness study of PN
vs PN+PC in 4 communities (CT, 2 in TX, KY) using the R61 eligibility criteria, with Aim 2. 1 evaluating patient-
level outcomes (proportion accessing clinicians and treatment) and Aim 2.2 assessing system-level
implementation outcomes (acceptability, adoption, penetration), sustainment, and costs of implementing both
PN and PN+PC approaches. This study has the potential to be...

## Key facts

- **NIH application ID:** 10908913
- **Project number:** 1R61DA060625-01
- **Recipient organization:** YALE UNIVERSITY
- **Principal Investigator:** KEVIN KNIGHT
- **Activity code:** R61 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2024
- **Award amount:** $759,241
- **Award type:** 1
- **Project period:** 2024-05-15 → 2025-04-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10908913

## Citation

> US National Institutes of Health, RePORTER application 10908913, STOP (Shared decision making to Treat Or Prevent) HIV in Justice Populations (1R61DA060625-01). Retrieved via AI Analytics 2026-05-25 from https://api.ai-analytics.org/grant/nih/10908913. Licensed CC0.

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