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
Abstract Background Women 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...
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BMC
2025-01-01
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| Series: | Addiction Science & Clinical Practice |
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| Online Access: | https://doi.org/10.1186/s13722-024-00534-x |
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| author | Jaimie P. Meyer Stacey Brunson Carolina R. Price Morgan Mulrain Julie Nguyen Frederick L. Altice Tassos C. Kyriakides Karen Cropsey Ellen Eaton |
| author_facet | Jaimie P. Meyer Stacey Brunson Carolina R. Price Morgan Mulrain Julie Nguyen Frederick L. Altice Tassos C. Kyriakides Karen Cropsey Ellen Eaton |
| author_sort | Jaimie P. Meyer |
| collection | DOAJ |
| description | Abstract Background Women 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. Methods We 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 registration Clinicaltrials.gov (NCT05547048). Registered September 15, 2022. https://clinicaltrials.gov/study/NCT05547048?term=NCT05547048&rank=1 . |
| format | Article |
| id | doaj-art-5afd575688dc49999615980fea7f70cb |
| institution | Kabale University |
| issn | 1940-0640 |
| language | English |
| publishDate | 2025-01-01 |
| publisher | BMC |
| record_format | Article |
| series | Addiction Science & Clinical Practice |
| spelling | doaj-art-5afd575688dc49999615980fea7f70cb2025-01-19T12:34:20ZengBMCAddiction Science & Clinical Practice1940-06402025-01-0120111210.1186/s13722-024-00534-xRationale 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 studyJaimie P. Meyer0Stacey Brunson1Carolina R. Price2Morgan Mulrain3Julie Nguyen4Frederick L. Altice5Tassos C. Kyriakides6Karen Cropsey7Ellen Eaton8Yale School of Medicine, Section of Infectious DiseasesYale School of Medicine, Section of Infectious DiseasesYale School of Medicine, Section of Infectious DiseasesUniversity of Alabama at Birmingham School of MedicineUniversity of Alabama at Birmingham School of MedicineYale School of Medicine, Section of Infectious DiseasesYale Center for Analytical Sciences, Yale School of Public HealthUniversity of Alabama at Birmingham School of MedicineUniversity of Alabama at Birmingham School of MedicineAbstract Background Women 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. Methods We 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 registration Clinicaltrials.gov (NCT05547048). Registered September 15, 2022. https://clinicaltrials.gov/study/NCT05547048?term=NCT05547048&rank=1 .https://doi.org/10.1186/s13722-024-00534-xHIV preventionWomen involved in criminal legal systems (WICL)Pre-exposure prophylaxis (PrEP)Medications for opioid use disorder (MOUD)Opioid use disorder (OUD) |
| spellingShingle | Jaimie P. Meyer Stacey Brunson Carolina R. Price Morgan Mulrain Julie Nguyen Frederick L. Altice Tassos C. Kyriakides Karen Cropsey Ellen Eaton 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 Addiction Science & Clinical Practice HIV prevention Women involved in criminal legal systems (WICL) Pre-exposure prophylaxis (PrEP) Medications for opioid use disorder (MOUD) Opioid use disorder (OUD) |
| title | 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 |
| title_full | 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 |
| title_fullStr | 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 |
| title_full_unstemmed | 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 |
| title_short | 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 |
| title_sort | 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 |
| topic | HIV prevention Women involved in criminal legal systems (WICL) Pre-exposure prophylaxis (PrEP) Medications for opioid use disorder (MOUD) Opioid use disorder (OUD) |
| url | https://doi.org/10.1186/s13722-024-00534-x |
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