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

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.

Study Overview

• Status: Recruiting
• Conditions: HIV; Opioid Use Disorder; eHealth
• Intervention / Treatment: Combination product: Athena strategy; Behavioral: Decision Aid

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.

• Study Type: Interventional
• Enrollment (Estimated): 250
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Adrienne L Marable; Phone Number: (203) 737-3393; Email: gcat5@yale.edu

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35294
      • Recruiting
      • University of Alabama in Birmingham
      • Contact: Ellen Eaton; Phone Number: 205-934-3411; Email: eeaton@uabmc.edu
      • Principal Investigator: Ellen Eaton, MD
      • Sub-Investigator: Karen Cropsey, PsyD
  • Connecticut
    • New Haven, Connecticut, United States, 06519
      • Recruiting
      • Yale University
      • Contact: Carolina Price, MPA; Phone Number: 203-499-8075; Email: carolina.price@yale.edu
      • Principal Investigator: Jaimie P Meyer, MD, MS, FACP
      • Sub-Investigator: Fredrick L Altice, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 49 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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	Combination product: Athena strategy; eHealth for integrated PrEP/medications for opioid use disorder + decision aid
Active Comparator: Decision Aid; Decision aid for PrEP tailored for justice-involved women with opioid use disorder	Behavioral: Decision Aid; Decision aid for PrEP tailored for justice-involved women with opioid use disorder

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants who initiate PrEP	PrEP in initiation will be determined using dates of prescription and pharmacy fill and medication type (brand/generic)	up to 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants who are adherent to PrEP	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.	up to 6 months
Number of participants who engage in opioid use disorder treatment	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.).	up to 6 months

Collaborators and Investigators

• Sponsor: Yale University
• Collaborators: National Institute on Drug Abuse (NIDA)
• Investigators: Study Director: Carolina Price, MPA, Yale University; Principal Investigator: Jaimie P Meyer, MD, MS, FACP, Yale University

Publications and helpful links

General Publications

• Meyer JP, Brunson S, Price CR, Mulrain M, Nguyen J, Altice FL, Kyriakides TC, Cropsey K, Eaton E. Rationale and design of a randomized clinical trial of integrated eHealth for PrEP and medications for opioid use disorders for women in the criminal legal system. The Athena study. Addict Sci Clin Pract. 2025 Jan 17;20(1):4. doi: 10.1186/s13722-024-00534-x.

Study record dates

Study Major Dates

• Study Start (Actual): July 25, 2023
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): April 1, 2027

Study Registration Dates

• First Submitted: September 15, 2022
• First Submitted That Met QC Criteria: September 15, 2022
• First Posted (Actual): September 21, 2022

Study Record Updates

• Last Update Posted (Actual): June 3, 2026
• Last Update Submitted That Met QC Criteria: June 1, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Narcotic-Related Disorders; Mental Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Opioid-Related Disorders; Investigative Techniques; Decision Support Techniques
• Other Study ID Numbers: 2000033006; 1R01DA057342-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes