NCT07223398 Shared Decision Making to Treat Or Prevent (STOP) HIV in Criminal Legal Involved Populations (R33)
| NCT ID | NCT07223398 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Yale University |
| Condition | Substance Use Disorders |
| Study Type | INTERVENTIONAL |
| Enrollment | 400 participants |
| Start Date | 2025-11-24 |
| Primary Completion | 2027-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 400 participants in total. It began in 2025-11-24 with a primary completion date of 2027-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
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
Contact & Investigator
Sandra Springer, MD
PRINCIPAL INVESTIGATOR
Yale University
Frequently Asked Questions
Who can join the NCT07223398 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Substance Use Disorders. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07223398 currently recruiting?
Yes, NCT07223398 is actively recruiting participants. Contact the research team at Sandra.springer@yale.edu for enrollment information.
Where is the NCT07223398 trial being conducted?
This trial is being conducted at New Haven, United States, Lexington, United States, Dallas, United States, Fort Worth, United States.
Who is sponsoring the NCT07223398 clinical trial?
NCT07223398 is sponsored by Yale University. The principal investigator is Sandra Springer, MD at Yale University. The trial plans to enroll 400 participants.