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

Yale University

Status and phase: Enrolling; Phase 4

Conditions: eHealth; Opioid Use Disorder; HIV

Treatments: Behavioral: Decision Aid; Combination Product: Athena strategy

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05547048

2000033006

1R01DA057342-01 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 250 estimated patients

Sex: Female

Ages: 18 to 59 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• cis-women
• 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

• 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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

250 participants in 2 patient groups

Athena Strategy

Experimental group

Description:

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

Treatment:

Combination Product: Athena strategy

Decision Aid

Active Comparator group

Description:

Decision aid for PrEP tailored for justice-involved women with opioid use disorder

Treatment:

Behavioral: Decision Aid