Shared decision-making to prevent or treat HIV for people with recent justice involvement
STOP (Shared Decision Making to Treat Or Prevent) HIV in Justice Populations
This project tests whether offering a shared decision-making 'patient choice' menu alongside standard patient navigation helps people with recent justice involvement start HIV prevention (PrEP) or treatment (ART) and begin substance use disorder care.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 400 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Yale University Academic / other |
| Locations | 4 sites (New Haven, Connecticut and 3 other locations) |
| Trial ID | NCT07223398 on ClinicalTrials.gov |
What this trial studies
This randomized R33 trial compares standard patient navigation (PN) to PN plus a Patient Choice (PC) shared decision-making menu across multiple U.S. sites. Eligible participants are people with justice involvement in the past six months who either have HIV and are not on ART or are HIV-negative and meet CDC PrEP criteria, and who report recent opioid or stimulant use. The primary outcomes are the proportions who initiate PrEP or ART and who start substance use/SUD treatment, and the study also measures implementation outcomes and costs. Study sites include Yale School of Medicine (CT), University of Kentucky (KY), and UT Southwestern Medical Center (Dallas, TX).
Who should consider this trial
Good fit: Adults living in the study regions with justice involvement within the past six months who report recent opioid or stimulant use, are willing to have HIV testing, and either are not currently on ART or are HIV-negative and meet CDC PrEP criteria are the intended participants.
Not a fit: People with severe medical or psychiatric conditions that make participation unsafe, those unable to give informed consent, those not living in the study catchment areas, or individuals already consistently taking ART or PrEP are unlikely to benefit from this intervention.
Why it matters
Potential benefit: If successful, this approach could increase uptake of PrEP/ART and substance use treatment among people re-entering the community after justice involvement, reducing HIV transmission risk and relapse.
How similar studies have performed: Prior work shows patient navigation can improve linkage to HIV care and treatment starts, but the shared decision-making 'patient choice' model in justice-involved populations has been less tested and is comparatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * able to provide written informed consent in English or Spanish; * living in the community of Western, CT, Dallas and Tarrant Counties in TX and Madison County, KY (potential for Fayette county as well); * Those with current justice involvement (with in the past 6 months) (e.g., prison, jail, community supervision); * willing to have HIV testing to determine negative or positive status; * persons with HIV who report not currently taking ART in past 6 months OR persons who test negative for HIV who report not taking PrEP that meet CDC PrEP eligibility criteria in past 6 months, including (i) condomless sexual intercourse; and/or (ii) sharing IDU equipment with HIV positive or unknown status partner; and/or (iii) bacterial STI and; * Having a history of opioid and/or stimulant use in the last 6 months within the community. Exclusion Criteria: * severe medical or psychiatric disability making participation unsafe; * unable to provide consent. * persons self-reporting pregnancy
Where this trial is running
New Haven, Connecticut and 3 other locations
- Yale School of Medicine — New Haven, Connecticut, United States (Recruiting)
- College of Medicine at the University of Kentucky — Lexington, Kentucky, United States (Recruiting)
- University of Texas Southwestern Medical Center (UTSW) — Dallas, Texas, United States (Recruiting)
- Texas Christian University's (TCU) School of Medicine — Fort Worth, Texas, United States (Recruiting)
Study contacts
- Principal investigator: Sandra Springer, MD — Yale University
- Study coordinator: Sandra Springer, MD
- Email: Sandra.springer@yale.edu
- Phone: 203-687-6680
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.