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

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Yale University
Study ID
NCT05547048
Phase
PHASE4
Status
Recruiting
Apply to this trial

Conditions

  • HIV
  • Opioid Use Disorder
  • eHealth

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Decision Aid — BEHAVIORAL
    Decision aid for PrEP tailored for justice-involved women with opioid use disorder
  • Athena strategy — COMBINATION_PRODUCT
    eHealth for integrated PrEP/medications for opioid use disorder + decision aid

Study Details

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.

Key Dates

Start date
Jul 25, 2023
Status verified
Jun 2026
Primary completion
Apr 1, 2027
Completion
Apr 1, 2027

Study Design

Enrollment
250 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

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

Primary Outcome Measure

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

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
University of Alabama in BirminghamBirminghamAlabama35294
Ellen Eaton
[email protected]
205-934-3411
Ellen Eaton, MD (PRINCIPAL_INVESTIGATOR)
Karen Cropsey, PsyD (SUB_INVESTIGATOR)
Yale UniversityNew HavenConnecticut06519
Carolina Price, MPA
[email protected]
203-499-8075
Jaimie P Meyer, MD, MS, FACP (PRINCIPAL_INVESTIGATOR)
Fredrick L Altice, MD (SUB_INVESTIGATOR)

Find similar trials in Birmingham, AL

By condition
HIV
By specialty
Infectious disease
By research site
University of Alabama in Birmingham· Birmingham, ALYale University· New Haven, CT

Related Studies