NCT07223398Recruiting
Shared Decision Making to Treat Or Prevent (STOP) HIV in Criminal Legal Involved Populations (R33)
STOP (Shared Decision Making to Treat Or Prevent) HIV in Criminal Legal Involved Populations
Source: ClinicalTrials.gov · Last updated 20 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 400 (estimated)
- First submitted
- 30 Oct 2025
- Start date
- Nov 2025
- Primary completion date
- Dec 2027
- Lead sponsor
- Yale University
- Diseases
- HIV
- NCT number
- NCT07223398
What you commit to
- Study type: Interventional
- Planned participants: 400
- From Nov 2025 to the primary completion date, Dec 2027
- 4 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- severe medical or psychiatric disability making participation unsafe;
Other
- unable to provide consent.
- persons self-reporting pregnancy
Who the study is looking for
- 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 12 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 have a PrEP indication in past 12 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 12 months within the community.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (4)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Texas Southwestern Medical Center (UTSW) Coordinator of this site? Confirm its status | Dallas | United States | Recruiting |
| Texas Christian University's (TCU) School of Medicine Coordinator of this site? Confirm its status | Fort Worth | United States | Recruiting |
| College of Medicine at the University of Kentucky Coordinator of this site? Confirm its status | Lexington | United States | Recruiting |
| Yale School of Medicine Coordinator of this site? Confirm its status | New Haven | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.