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NCT05547048

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

Recruiting now Phase 4 Last updated 16 May 2025
What this trial tests

Phase 4 trial testing Decision Aid in HIV in 250 participants. Currently enrolling.

Timeline
25 July 2023
Primary endpoint
1 April 2027
1 April 2027

Quick facts

Lead sponsorYale University
PhasePhase 4
StatusRecruiting now
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingnone
Primary purposeprevention
Enrollment250
Start date25 July 2023
Primary completion1 April 2027
Estimated completion1 April 2027
Sites2 locations across United States

Drugs / interventions tested

Conditions studied

Sponsor

Yale University

Who can join

18 and older, female only, with HIV or Opioid Use Disorder. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Rationale and design of a randomized clinical trial of integrated eHealth for PrEP and medications for opioid use disorders for women in the criminal legal system. The Athena study.
    Meyer JP, Brunson S, Price CR, Mulrain M, et al · · 2025 · cited 2× · PMID 39825419 · DOI 10.1186/s13722-024-00534-x

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Other trials of Decision Aid

Trials testing the same drug.

Other recruiting trials for HIV

Currently open trials in the same condition.

Other Yale University trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

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Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing