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Integrated e-Health (Electronic Health) for HIV and Substance Use Disorders in Justice Involved Women

NCT05547048 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 250

Last updated 2026-05-20

No results posted yet for this study

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

Interventions

COMBINATION_PRODUCT

Athena strategy

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

BEHAVIORAL

Decision Aid

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

Sponsors & Collaborators

  • National Institute on Drug Abuse (NIDA)

    collaborator NIH

  • Yale University

    lead OTHER

Principal Investigators

  • Carolina Price, MPA · Yale University

  • Jaimie P Meyer, MD, MS, FACP · Yale University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-07-25
Primary Completion
2027-06-01
Completion
2027-06-30
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05547048 on ClinicalTrials.gov