Integrated e-Health (Electronic Health) for HIV and Substance Use Disorders in Justice Involved Women
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Decision Aid, Athena strategy.
- Who it may be relevant to
- Registry conditions: HIV, Opioid Use Disorder, eHealth. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Integrated eHealth for HIV and Substance Use Disorders in Justice Involved Women
Overview
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.
Interventions
- 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
Primary outcome measures
- Number of participants who initiate PrEP [Time frame: up to 6 months]
Secondary outcome measures (2)
- Number of participants who are adherent to PrEP [Time frame: up to 6 months]
- Number of participants who engage in opioid use disorder treatment [Time frame: up to 6 months]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Prevention
Study locations
United States · 2 centers
- University of Alabama in Birmingham — Birmingham
- Yale University — New Haven
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. PMID 39825419
Identifiers
NCT: NCT05547048 · 2000033006 · 1R01DA057342-01