NCT05547048

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

Integrated eHealth for HIV and Substance Use Disorders in Justice Involved Women

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 250 (estimated)
• Sponsor: Yale University · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

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.

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.

Conditions

• HIV
• Opioid Use Disorder
• eHealth

Interventions

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

Timeline

• Start date: 2023-07-25
• Primary completion: 2027-04-01
• Completion: 2027-04-01
• First posted: 2022-09-21
• Last updated: 2025-05-16

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study