Recruiting

Observational Study

Sponsor:

Yale University

Code:

NCT05547048

Conditions

HIV

Opioid Use Disorder

eHealth

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Accepted

Interventions

Decision Aid

Athena strategy

Study Details

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.

Conditions

HIV

Opioid Use Disorder

eHealth

Study ID

NCT05547048

Start date

Jul 25, 2023

Status verified date

Jun, 2026

Completion date

Apr 1, 2027

Anticipated

Primary completion date

Apr 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

250 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Athena Strategy

Virtual care model that includes direct synchronous videoconferencing with a provider, telephone/ texting communication, electronic health records, e-prescribing for the purposes of delivering PrEP and medications for opioid use disorder. This is combined with a decision aid for PrEP

active comparator: Decision Aid

Decision aid for PrEP tailored for justice-involved women with opioid use disorder

Interventions

Decision Aid

Decision aid for PrEP tailored for justice-involved women with opioid use disorder

Athena strategy

eHealth for integrated PrEP/medications for opioid use disorder + decision aid

Primary outcome measure

  • Number of participants who initiate PrEP [ Time Frame: up to 6 months ]

Central Contacts and Locations

Central contacts

Adrienne L Marable

(203) 737-3393gcat5@yale.edu

Locations

University of Alabama in Birmingham

Recruiting

Birmingham, Alabama, United States, 35294

Contacts

Ellen Eaton

205-934-3411eeaton@uabmc.edu

Principal Investigator:

Ellen Eaton, MD

Yale University

Recruiting

New Haven, Connecticut, United States, 06519

Contacts

Carolina Price, MPA

203-499-8075carolina.price@yale.edu

Principal Investigator:

Jaimie P Meyer, MD, MS, FACP

More Information

Sponsor

Yale University

Last update posted

Jun 3, 2026

Last verified

Jun, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Yale University on 2026-06-03.