An Effectiveness Trial of the PrEP for WINGS Study
An Effectiveness Trial of WINGS+PrEP: a Syndemic mHealth Intervention to Increase PrEP Uptake Among Women Impacted by Heavy Alcohol Use and Partner Violence in the Criminal Legal System
Columbia University
307 participants
Mar 28, 2026
INTERVENTIONAL
Conditions
Summary
(Effectiveness Aim 1) To test the comparative effectiveness of PreP for WINGS versus PrEP alone on primary outcomes of increasing PrEP initiation measured by self-report/medical records, recent adherence and longer-term adherence by self-report/medical records over the 6-month follow-up; and secondary outcomes of decreasing IPV, hazardous drinking, recidivism, and HIV risks. (Moderation Aim 2) To test if the effectiveness of WINGS+PrEP on study outcomes is moderated by key participant subgroups based on race/ethnicity, sexual orientation, age, education, incarceration history, IPV severity, substance use disorders (SUDs), digital access and literacy, housing stability, and medical mistrust.
Eligibility
Inclusion Criteria2
- Identify as a cis-gender woman Aged 18 or older HIV-negative Previous engagement with the criminal legal system or child protective services.
- Meet criteria for hazardous alcohol use Previous experience of intimate partner veiolence Report not taking PrEP in the past 90 days Recent experiences of HIV risk due to HIV risk exposure
Exclusion Criteria2
- Ability to speak and understand English is not sufficient to participate in assessments or intervention sessions.
- Inability to complete informed consent process due to a psychiatric or cognitive impairment (assessed by the Mini Folstein exam)
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Interventions
The PrEP for WINGS intervention involves three sessions of a self-paced and self-directed intervention delivered via a mobile health platform. Session 1 will focus on HIV risk reduction and provide the PrEP Decision Aid, where participants will learn information about PrEP to help them decide if it is appropriate for them. Sessions 2-3 will involve integrated Screening, Brief Intervention, Referral to Treatment (SBIRT) modules focused on IPV and alcohol reduction. The PrEP for WINGS intervention will also involve peer navigation sessions with Community Health Advocates to help intervention participants trouble shoot any barriers to achieving goals they set during the self-paced sessions. The PrEP for WINGS intervention will take place over a 30 day period and Sessions 2-3, and the peer navigation sessions may be delivered using smart phones or using tablets available at study data collection sites.
The PrEP Decision Aid will be delivered to participants in the control condition, and focus on helping study participants decide if they should initiate PrEP. This single session will focus on HIV risk reduction, and then launch the patient-centered PrEP Decision Aid. This individual session will be identical to the first session of the PrEP for WINGS three session intervention, and will also be delivered through an online survey platform. In addition, study participants in the control condition will also have one peer navigation session with a Community Health Advocate at the end of the self-paced session to help facilitate linkage to care.
Locations(1)
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NCT06853314