Clinical trial NCT05547048: Integrated e-Health (Electronic Health) for HIV and Substance Use Disorders in Justice Involved Women
Official title: Integrated eHealth for HIV and Substance Use Disorders in Justice Involved Women
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: HIV
Opioid Use Disorder
eHealth
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2022-09-21
Enrollment: 250
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This study will compare the Athena strategy to a decision aid-only intervention.
Primary purpose: PREVENTION

Brief 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Number of participants who initiate PrEP
timeFrame: up to 6 months
Secondary outcomes:
measure: Number of participants who are adherent to PrEP
timeFrame: up to 6 months
measure: Number of participants who engage in opioid use disorder treatment
timeFrame: up to 6 months
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama in Birmingham
state: Alabama
city: New Haven
country: United States
facility: Yale University
state: Connecticut
Study officials:
affiliation: Yale University
name: Carolina Price, MPA
role: STUDY_DIRECTOR
affiliation: Yale University
name: Jaimie P Meyer, MD, MS, FACP
role: PRINCIPAL_INVESTIGATOR
References: