Shared Decision Making to Treat Or Prevent (STOP) HIV in Criminal Legal Involved Populations (R33)
Start Date
11/24/2025
Completion Date
6/1/2028
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.
Eligibility Criteria
Age Range: 18 years to No maximum
Interventions
Standard PN
Patient Choice
Conditions
Locations
Yale School of Medicine
New Haven, Connecticut 06510
United States
College of Medicine at the University of Kentucky
Lexington, Kentucky 40506
United States
University of Texas Southwestern Medical Center (UTSW)
Dallas, Texas 75390
United States
Texas Christian University's (TCU) School of Medicine
Fort Worth, Texas 76109
United States