NCT07223398

Shared Decision Making to Treat Or Prevent (STOP) HIV in Justice Populations (R33)

STOP (Shared Decision Making to Treat Or Prevent) HIV in Justice Populations

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 400 (estimated)
• Sponsor: Yale University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study seeks to compare the effectiveness of two Patient Navigation models of care to evaluate the proportion who initiate PrEP/ART and substance use/substance use disorder (SU/SUD) treatment. A standardized Patient Navigation (PN) arm will be compared with a shared decision-making model in the form of Patient Choice (PC) through the offer of a menu of existing community-based health service delivery options. This design will offer providers, correctional and public health authorities, payers and policy makers' timely and relevant data to assess the effectiveness of Patient Navigation and Patient Choice models of care as potentially useful re-entry and relapse prevention treatment options.

Detailed description

This study will be done in two phases. Aim 1, the R61 portion of the project will be a Pilot Study, and Aim 2, the R33 portion of the project will be a Randomized Controlled Trail informed by the pilot. The focus of this registration is Aim 2, the randomized controlled trial. The Aim 1 (R61) portion is registered with NCT06439329. In Aim 2 (R33), investigators will evaluate standard PN compared to PN+PC on participant outcomes, implementation outcomes and costs associated with implementing the study.

Conditions

• Substance Use Disorders

Interventions

Type	Name	Description
BEHAVIORAL	Standard PN	Standard of care
BEHAVIORAL	Patient Choice	Participants can select from a menu of options including brick and mortar services, Mobile Health Unit (MHU) or telehealth services.

Timeline

• Start date: 2025-11-24
• Primary completion: 2027-12-01
• Completion: 2028-06-01
• First posted: 2025-10-31
• Last updated: 2026-02-04

Locations

4 sites across 1 country: United States