Innovative e-Health interventions for HIV and substance use in women involved in the justice system
Integrated eHealth for HIV and Substance Use Disorders in Justice Involved Women
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 |
| Enrollment | 250 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Yale University Academic / other |
| Locations | 2 sites (Birmingham, Alabama and 1 other locations) |
| Trial ID | NCT05547048 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
Not a fit: Patients who are currently taking PrEP, pregnant, or breastfeeding may not receive benefit from this study.
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 performed: Other studies have shown success with integrated care approaches for similar populations, indicating potential for this innovative method.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * cis-women * 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 this trial is running
Birmingham, Alabama and 1 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.