Shared Decision Making to Treat Or Prevent (STOP) HIV in Criminal Legal Involved Populations

This study is looking at two ways to help people with substance use disorders who have been involved with the criminal justice system to prevent or treat HIV. We are comparing "Standard PN" (Patient Navigation), which is the usual care, with "Patient Choice." Patient Choice lets you pick from different services like in-person clinics, a Mobile Health Unit, or telehealth. The goal is to see how many people start or restart PrEP (medication to prevent HIV) or ART (medication to treat HIV) within 6 months. We are also looking at how many people get treatment for substance use. You can join if you are 18 or older, live in specific areas of Connecticut, Texas, or Kentucky, and have been involved with the justice system in the last year. The study is currently recruiting 400 participants.

Study design: This is an interventional study comparing two different approaches to patient navigation. It plans to enroll 400 participants.
What's involved: Not specified in the trial record.
Compensation: Not stated in the trial record.
Follow-up: The main outcomes are measured at 6 months after starting the study interventions.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

Shared Decision Making to Treat Or Prevent (STOP) HIV in Criminal Legal Involved Populations (R33)

Recruiting

NAAges 18+InterventionalTreatment

Yale University

~400 participants

Updated 2026-06-25 on ClinicalTrials.gov

What's tested:Standard PNPatient Choice

At a glance

Recruiting sites

4 of 4 listed sites are recruiting right now

RecruitingSuspended, closed, or not yet open

What they're measuring

Percentage of participants who initiate or re-initiate PrEP

Measured over 6 months

+1 more outcome measured

Conditions

Substance Use Disorders

Where it's being run

4 sites across 3 states

Texas2

Connecticut1

Kentucky1

Study leadership

Sandra Springer, MD · PRINCIPAL_INVESTIGATOR · Yale University

Who to contact

Sandra Springer, MD

[email protected]

203-687-6680

Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

severe medical or psychiatric disability making participation unsafe;

unable to provide consent.

persons self-reporting pregnancy

What this trial measures

Percentage of participants who initiate or re-initiate PrEP6 months
Percentage of participants not living with HIV who initiate or re-initiate PrEP within the 6-month intervention period by self report
Percentage of participants who initiate or re-initiate ART6 months
Percentage of participants living with HIV who initiate or re-initiate ART within the 6-month intervention period by self report

Trialytics