Integrated e-Health (Electronic Health) for HIV and Substance Use Disorders in Justice Involved Women
Recruiting · NCT05547048 · Interventional (participants receive a specific treatment) · Lead sponsor: Yale University
View the official record on ClinicalTrials.gov →Interventions studied
Athena strategyDecision Aid
What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
Female
Healthy volunteers
Yes - healthy volunteers may be accepted
Phase
Phase 4
Study type
Interventional (participants receive a specific treatment)
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 is running
2 locations listed across 2 US states.
- University of Alabama in Birmingham - Birmingham, Alabama, United States
- Yale University - New Haven, Connecticut, United States