Integrated e-Health (Electronic Health) for HIV and Substance Use Disorders in Justice Involved Women
NCT ID: NCT05547048
Last Updated: 2025-05-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE4
250 participants
INTERVENTIONAL
2023-07-25
2027-04-01
Brief Summary
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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.
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Detailed Description
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Purpose: This study uses a newly validated decision aid and eHealth to remotely deliver integrated PrEP and MOUD to community-based WICJ with OUD in New Haven, Connecticut (CT) and Birmingham, Alabama (AL).
Methods: 250 PrEP-eligible WICJ with OUD will undergo randomization to: a) the "Athena" strategy, which includes the decision aid + eHealth for remote integrated PrEP/MOUD with a provider using outputs from the decision aid; or b) decision aid-only with referral to community-based PrEP/MOUD. Randomization will be stratified by site; past 6-month use of any stimulants; and baseline receipt of MOUD. Follow-up study assessments occur at months 1, 3, and 6. To understand implementation, the investigators will conduct population modeling and engage with relevant stakeholders through focus groups using nominal group technique and in-depth individual interviews.
Aims: The Aims of the project are: 1) To compare the Athena strategy to decision aid-only in terms of patient-level engagement in the PrEP and OUD care continua, considering key site differences; and 2) To assess scale-up potential of the Athena strategy in terms of modelled long-term outcomes and how stakeholders interact with eHealth for integrated PrEP/MOUD in WICJ in two diverse epidemiological and implementation contexts (CT and AL), using standardized definitions of implementation outcomes.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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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
Athena strategy
eHealth for integrated PrEP/medications for opioid use disorder + decision aid
Decision Aid
Decision aid for PrEP tailored for justice-involved women with opioid use disorder
Decision Aid
Decision aid for PrEP tailored for justice-involved women with opioid use disorder
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
* 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
* pregnant or breast-feeding
* currently taking PrEP at the time of study enrollment
* not comfortable conversing in English or Spanish.
18 Years
FEMALE
Yes
Sponsors
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National Institute on Drug Abuse (NIDA)
NIH
Yale University
OTHER
Responsible Party
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Principal Investigators
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Carolina Price, MPA
Role: STUDY_DIRECTOR
Yale University
Jaimie P Meyer, MD, MS, FACP
Role: PRINCIPAL_INVESTIGATOR
Yale University
Locations
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University of Alabama in Birmingham
Birmingham, Alabama, United States
Yale University
New Haven, Connecticut, United States
Countries
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Central Contacts
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Facility Contacts
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References
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Meyer JP, Brunson S, Price CR, Mulrain M, Nguyen J, Altice FL, Kyriakides TC, Cropsey K, Eaton E. 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. Addict Sci Clin Pract. 2025 Jan 17;20(1):4. doi: 10.1186/s13722-024-00534-x.
Other Identifiers
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2000033006
Identifier Type: -
Identifier Source: org_study_id
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