Actively Recruiting

Phase 4
Age: 18Years +
FEMALE
Healthy Volunteers
NCT05547048

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

Led by Yale University · Updated on 2025-05-16

250

Participants Needed

2

Research Sites

192 weeks

Total Duration

On this page

Sponsors

Y

Yale University

Lead Sponsor

N

National Institute on Drug Abuse (NIDA)

Collaborating Sponsor

AI-Summary

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
FEMALE
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Participants must be cisgender women
  • Must have access to a working mobile or landline phone
  • Must have lifetime involvement in the criminal justice system (including probation, parole, intensive pretrial or community supervision, or release from prison/jail)
  • Must be confirmed HIV-negative by a point-of-care 3rd generation HIV antibody test
  • Must meet clinical criteria for PrEP eligibility
  • Must have opioid use disorder regardless of current treatment status
Not Eligible

You will not qualify if you...

  • Unable or unwilling to provide informed consent
  • Pregnant or breastfeeding at the time of enrollment
  • Currently taking PrEP at the time of study enrollment
  • Not comfortable communicating in English or Spanish

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 2 locations

1

University of Alabama in Birmingham

Birmingham, Alabama, United States, 35294

Actively Recruiting

2

Yale University

New Haven, Connecticut, United States, 06519

Actively Recruiting

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Research Team

A

Adrienne L Marable

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

2

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