Clinical Trial

Shared Decision Making to Treat Or Prevent (STOP) HIV in Criminal Legal Involved Populations (R33)

Recruiting
View on ClinicalTrials.gov →
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.
Protocol Amendment History 3 amendments
This ClinicalTrials.gov record has been amended 3 times since 2025-10-30; most recent amendment 2026-06-22.
Status change: Not Yet Recruiting → Recruiting 2026-02-02
Trial Details
NCT Number NCT07223398
Lead Sponsor Yale University
Collaborators: National Institute on Drug Abuse (NIDA)
Conditions Substance Use Disorders
Enrollment 400 participants
Start Date 2025-11-24
Primary Completion 2027-12 (estimated)
Study Completion 2028-06 (estimated)
Updated on ClinicalTrials.gov 2026-06-25