Innovative e-Health interventions for HIV and substance use in women involved in the justice system
Official title: Integrated eHealth for HIV and Substance Use Disorders in Justice Involved Women
Run by Yale University · NCT05547048 · Data updated 2026-11-12
This study is testing a new online tool to help women in the justice system access HIV prevention and opioid treatment more easily, comparing it to a simpler version of the tool.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | Women only |
| Enrollment | 250 (estimated) |
| Sponsor | Yale University Academic / other |
| Locations | 2 sites (Birmingham, Alabama and 1 other locations) |
| Status | Recruiting |
| Started | July 25, 2023 |
| Main results expected | April 1, 2027 |
| Study ends | April 1, 2027 |
| Registry record updated | June 3, 2026 |
| Trial ID | NCT05547048 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are cis-women with opioid use disorder who have been involved in the criminal justice system and are HIV-negative.
✕Probably not a fit
Patients who are currently taking PrEP, pregnant, or breastfeeding may not receive benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study aims to test innovative interventions designed to reduce stigma and enhance access to pre-exposure prophylaxis (PrEP) and opioid use disorder (OUD) care for women involved in the criminal justice system. It evaluates a newly validated decision aid combined with eHealth for integrated PrEP and medication for OUD, comparing it to a decision aid-only approach. The study will randomize 250 eligible participants across two sites in Connecticut and Alabama, with follow-up assessments at 1, 3, and 6 months to measure engagement in care. Additionally, the research will explore the implementation of these interventions through stakeholder engagement and population modeling.
Why it matters
Potential benefit: If successful, this study could significantly improve access to lifesaving HIV prevention and treatment for women involved in the criminal justice system.
How similar studies have gone: Other studies have shown success with integrated care approaches for similar populations, indicating potential for this innovative method.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * woman * have access to a working mobile or landline phone * Lifetime CJ-involvement (probation, parole, intensive pretrial or community supervision, or release from prison/jail) * are confirmed HIV-negative by point-of-care 3rd generation HIV antibody test * meet clinical criteria for PrEP * have opioid use disorder (regardless of baseline treatment status) Exclusion Criteria: * unable or unwilling to provide informed consent * pregnant or breast-feeding * currently taking PrEP at the time of study enrollment * not comfortable conversing in English or Spanish.
Where it's running
-
University of Alabama in Birmingham
Birmingham, Alabama, United States Recruiting -
Yale University
New Haven, Connecticut, United States Recruiting
Study contacts
- Principal investigator: Jaimie P Meyer, MD, MS, FACP — Yale University
- Study coordinator: Adrienne L Marable
- Email: gcat5@yale.edu
- Phone: (203) 737-3393
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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HEAT telemedicine program for HIV and addiction care
This project will try a telemedicine program to deliver addiction treatment to adults living with HIV in Alabama who report opioid or stimulant misuse.
-
Improving HIV prevention for people who inject drugs on PrEP
This study is testing new ways to help people who inject drugs and are on HIV prevention medication to better understand and use information about staying safe from HIV.
-
CBD for Opioid Dependence and Pain on Buprenorphine
This study tests whether different doses of cannabidiol (CBD) can affect pain and opioid cravings in adults with opioid use disorder who are on buprenorphine, using a short, randomized, placebo-controlled setup.
-
Cebranopadol for opioid withdrawal in adults with chronic pain
This study tests whether cebranopadol can reduce withdrawal symptoms in adults with chronic pain who are physically dependent on prescribed opioids, compared with placebo.
-
emPath platform pilot to link and keep adults with opioid use disorder in care in Durham
This pilot tests a mobile app and telemedicine approach to help adults with opioid use disorder start and stay in MOUD through community outreach in Durham, NC.
-
Project SHIELD 2.0: Police Education to Support Public Health in Kentucky
Aimed at police in Kentucky, this program tests whether SHIELD training given to officers, with health workers helping deliver it, can reduce drug-related arrests and steer people who use drugs toward MOUD and other health services.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.