Clinical trial Recruiting at 1 site Interventional Ages 18 and up Women only

See if PrEP for WINGS helps with starting and sticking to PrEP among women in community supervision programs

Official title: 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

Run by Columbia University · NCT06853314 · Data updated 2026-11-12

This study tests PrEP for WINGS plus PrEP compared with PrEP alone to see if it increases PrEP initiation and adherence among cisgender women in CSPs who use alcohol hazardously and may face IPV and HIV risk.

Quick facts

Study typeInterventional
Ages18 Years and up
SexWomen only
Enrollment307 (estimated)
SponsorColumbia University
Academic / other
Locations1 site (New York, New York)
StatusRecruiting
StartedApril 9, 2026
Main results expectedJune 1, 2027
Study endsJune 1, 2027
Registry record updatedJune 22, 2026
Trial IDNCT06853314 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Cisgender women aged 18 or older who have prior engagement with the criminal legal system or child protective services, report hazardous alcohol use, recent IPV, and recent HIV risk exposure, and are HIV-negative.

Probably not a fit

Individuals who do not use PrEP or do not pursue HIV risk-reducing behaviors may experience little to no benefit.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a hybrid Type 1 effectiveness and implementation trial conducted in New York City to evaluate an m-Health syndemic intervention that combines PrEP for WINGS with a PrEP decision aid. The study will measure initiation and adherence to PrEP over six months using self-reports and medical records, and will also examine changes in intimate partner violence, hazardous drinking, recidivism, and HIV risk. Subgroup analyses will explore moderation by race/ethnicity, sexual orientation, age, education, incarceration history, IPV severity, substance use disorders, digital access, housing stability, and medical mistrust. The trial targets cisgender women in community supervision programs, including probation, parole, and ATI settings, who report hazardous drinking and HIV risk exposure. Eligible settings include CSPs in NYC, with Columbia University as lead sponsor and NIH/NIAAA collaborators.

Why it matters

Potential benefit: If successful, the approach could increase PrEP uptake and adherence among women in CSPs, potentially reducing HIV risk and related health disparities.

How similar studies have gone: Previous mixed-methods PrEP interventions have shown promise in increasing uptake, but few have targeted women in CSPs or integrated m-Health supports for this population.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

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 Criteria:

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)

Where it's running

  • The Columbia Community Partnership for Health
    New York, New York, United States
    Recruiting

Study contacts

Similar studies

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.