Integrated e-Health (Electronic Health) for HIV and Substance Use Disorders in Justice Involved Women
Purpose
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
- HIV
- Opioid Use Disorder
- eHealth
Eligibility
- Eligible Ages
- Between 18 Years and 59 Years
- Eligible Genders
- Female
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- cis-women - have access to a working mobile or landline phone - CJ-involved (currently on probation, parole, intensive pretrial or community supervision, or are within 12 months after 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
- unable or unwilling to provide informed consent - pregnant or breast-feeding - currently taking PrEP at the time of study enrollment - not comfortable conversing in English or Spanish.
Study Design
- Phase
- Phase 3
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Intervention Model Description
- This study will compare the Athena strategy to a decision aid-only intervention.
- Primary Purpose
- Prevention
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
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 |
|
Recruiting Locations
Birmingham, Alabama 35294
More Details
- Status
- Recruiting
- Sponsor
- Yale University
Detailed Description
Problem: There is urgent need to reach women involved in criminal justice (WICJ) for lifesaving, evidence-based PrEP and medications for OUD (MOUD), using innovative healthcare delivery models that surmount existing social and structural barriers to engagement. 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.