NCT06439329Completed
STOP (Shared Decision Making to Treat Or Prevent) HIV in Justice Populations
Source: ClinicalTrials.gov · Last updated 17 Jul 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)
- Completed
- Study type
- Interventional
- Enrollment
- 40 (actual)
- First submitted
- 28 May 2024
- Start date
- 3 Oct 2024
- Primary completion date
- 31 Mar 2025
- Lead sponsor
- Yale University
- Diseases
- HIV
- NCT number
- NCT06439329
What you commit to
- Study type: Interventional
- Participants enrolled: 40
- From 3 Oct 2024 to the primary completion date, 31 Mar 2025
- 1 site 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
- Implementation portion/CAB members:
- 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 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 and have a viral load \>200 copies/mL 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 within 12 months prior to being in a controlled setting and/or in the last 6 months within the community
- Implementation portion/CAB members:
- able to provide written informed consent in English or Spanish;
- working with persons with a history of justice involvement and substance use in the areas targeted for this project
- PN Participants:
- able to provide written informed consent in English or Spanish;
- be employed at a project research site as a Patient Navigator
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| 135 College St., Suite 280 Coordinator of this site? Confirm its status | New Haven | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.