ArticleAddiction science & clinical practice2025
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.
Article in Addiction science & clinical practice, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05547048 (Integrated eHealth for HIV and Substance Use Disorders in Justice Involved Women), which is not on this map. Cited by 2 papers.
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The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Integrated eHealth for HIV and Substance Use Disorders in Justice Involved Women
Who cites it
2 citing papers in PubMed.
- HIV Prevention for People Releasing from Incarceration: A Qualitative Pre-implementation Study.Journal of general internal medicine · 2025Article
- Advancing pre-exposure prophylaxis (PrEP) implementation for people who use drugs: an introduction to and lessons from the special series.Addiction science & clinical practice · 2025Article
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Authors and funding
9 authors.
Funding
Abstract
backgroundWomen involved in the criminal legal system have elevated rates of opioid use disorder, which is treatable, and HIV, which is preventable with pre-exposure prophylaxis (PrEP). There are significant social and structural barriers to integrated delivery of PrEP and medications for opioid use disorder (MOUD), limiting women's ability to access these life-saving interventions. In a two parallel-arm randomized controlled trial, we are assessing an innovative eHealth delivery model that integrates PrEP with MOUD and is tailored to meet the specific needs of women involved in the criminal legal system.
methodsWe will recruit and enroll 250 women involved in the criminal legal system with opioid use disorder across two diverse settings (New Haven, CT and Birmingham, AL). Participants will be randomized to (a) the "Athena strategy," which includes a PrEP decision aid and integrated PrEP/MOUD delivery via eHealth; or (b) enhanced standard of care (SOC) that includes a decision aid-only. During 6-month follow-up, we will assess PrEP initiation as the primary clinical outcome and implementation outcomes that include acceptability, adoption, feasibility, fidelity, implementation cost, and sustainability. DISCUSSION: Results could help determine if reducing the social and structural barriers to PrEP and MOUD for women involved in the criminal legal system will facilitate engagement in treatment and prevention services, thus alleviating health disparities.
trial registrationClinicaltrials.gov (NCT05547048). Registered September 15, 2022. https://clinicaltrials.gov/study/NCT05547048?term=NCT05547048&rank=1 .
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