NCT05547048 Integrated e-Health (Electronic Health) for HIV and Substance Use Disorders in Justice Involved Women
| NCT ID | NCT05547048 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Yale University |
| Condition | HIV |
| Study Type | INTERVENTIONAL |
| Enrollment | 250 participants |
| Start Date | 2023-07-25 |
| Primary Completion | 2027-04-01 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 250 participants in total. It began in 2023-07-25 with a primary completion date of 2027-04-01.
⚠ 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
The purpose of this 2-site (CT, AL) study is to test innovative interventions to reduce stigma and improve the pre-exposure prophylaxis (PrEP) and opioid use disorder (OUD) care continua in women involved in the criminal justice system (WICJ). This study evaluates a newly validated PrEP decision aid and eHealth for integrated PrEP and MOUD compared to a decision aid-only for WICJ with OUD.
Eligibility 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.
Contact & Investigator
Carolina Price, MPA
STUDY DIRECTOR
Yale University
Frequently Asked Questions
Who can join the NCT05547048 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying HIV. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05547048 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT05547048 currently recruiting?
Yes, NCT05547048 is actively recruiting participants. Contact the research team at gcat5@yale.edu for enrollment information.
Where is the NCT05547048 trial being conducted?
This trial is being conducted at Birmingham, United States, New Haven, United States.
Who is sponsoring the NCT05547048 clinical trial?
NCT05547048 is sponsored by Yale University. The principal investigator is Carolina Price, MPA at Yale University. The trial plans to enroll 250 participants.
Related Trials
Related Intelligence Guides
In-depth guides covering this condition's trials, eligibility, and what to expect.