Actively Recruiting
Shared Decision Making to Treat Or Prevent (STOP) HIV in Justice Populations (R33)
Led by Yale University · Updated on 2026-04-30
400
Participants Needed
4
Research Sites
131 weeks
Total Duration
On this page
Sponsors
Y
Yale University
Lead Sponsor
N
National Institute on Drug Abuse (NIDA)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Shared Decision Making to Treat Or Prevent (STOP) HIV in Justice Populations (R33)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able to provide written informed consent in English or Spanish
- Living in the community of Western Connecticut, Dallas and Tarrant Counties in Texas, or Madison County, Kentucky (potential for Fayette County as well)
- Current justice involvement within the past 6 months (such as prison, jail, or community supervision)
- Willing to have HIV testing to determine negative or positive status
- Persons with HIV not currently taking ART in past 6 months OR persons who test negative for HIV who meet CDC PrEP eligibility criteria and not taking PrEP in past 6 months, including condomless sexual intercourse; sharing injection drug use equipment with HIV positive or unknown status partner; or bacterial STI
- History of opioid and/or stimulant use in the last 6 months within the community
You will not qualify if you...
- Severe medical or psychiatric disability making participation unsafe
- Unable to provide consent
- Persons self-reporting pregnancy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 4 locations
1
Yale School of Medicine
New Haven, Connecticut, United States, 06510
Actively Recruiting
2
College of Medicine at the University of Kentucky
Lexington, Kentucky, United States, 40506
Actively Recruiting
3
University of Texas Southwestern Medical Center (UTSW)
Dallas, Texas, United States, 75390
Actively Recruiting
4
Texas Christian University's (TCU) School of Medicine
Fort Worth, Texas, United States, 76109
Actively Recruiting
Research Team
S
Sandra Springer, MD
CONTACT
A
Alysse Schultheis, MA
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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