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NCT Number: NCT05547048

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

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.

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Key information

Conditions

HIV Chemically-Induced Disorders Mental Disorders Narcotic-Related Disorders Opioid Use Disorder Opioid-Related Disorders Substance-Related Disorders eHealth

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

University of Alabama in Birmingham, Birmingham, Alabama, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • woman
  • 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.

Treatment and study plan

Decision aid

Behavioral

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

Athena strategy

Combination Product

eHealth for integrated PrEP/medications for opioid use disorder + decision aid

Primary outcomes

  1. Number of participants who initiate PrEP

    Time frame: up to 6 months

    PrEP in initiation will be determined using dates of prescription and pharmacy fill and medication type (brand/generic)

Secondary outcomes

  1. Number of participants who are adherent to PrEP

    Time frame: up to 6 months

    PrEP adherence will be assessed using a urine assay for measuring tenofovir levels (single point of care qualitative immunoassay reflecting past 48-hour adherence), where a positive test results indicates adherence.

  2. Number of participants who engage in opioid use disorder treatment

    Time frame: up to 6 months

    The opioid use disorder treatment cascade engagement is composed of and defined by: 1) initiation of medications for opioid use disorder (or other evidence-based treatment); 2) 6-month retention on treatment; and 3) remission. The study will assess for complexity of substance use disorder treatment (e.g., court mandated vs. voluntary, behavioral vs. MOUD, residential vs. outpatient, detoxification program, etc.).

Study contacts

Contact information is provided by the study sponsor or research team.

Adrienne L Marable

CONTACT

[email protected]

(203) 737-3393

Sponsors and collaborators

Lead sponsor

Yale University

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
Sep 21, 2022
Registry last updated
Jun 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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