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
- Substance Use Disorders
At a glance
- Phase
- Phase not stated
- Study type
- Interventional
- Sponsor
- Yale University
- Enrolment target
- 400
- Started
- 24 November 2025
- Main results due
- 30 December 2027
- Study sites
- 4
- Registry updated
- 29 September 2026
Can you take part?
- Aged 18 years and over.
- Open to any sex.
- You need the condition being studied — healthy volunteers are not accepted.
These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.
Read the full eligibility 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 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. Exclusion Criteria: * severe medical or psychiatric disability making participation unsafe; * unable to provide consent. * persons self-reporting pregnancy
What this study is about
In the sponsor’s own words, from the registry.
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.
Study sites(4)
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
Showing 4 of 4 sites. 4 of the 4 sites on this study are recruiting right now — a site can stop enrolling while the study as a whole is still open.
Source: ClinicalTrials.gov record NCT07223398. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.
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