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Recruiting
NCT06853314
An Effectiveness Trial of the PrEP for WINGS Study
Conditions: HIV Infections, Alcohol Use Disorder, Violence, Gender-Based
Sex: Female
Ages: 18 Years – N/A
Healthy volunteers: Yes
Phase: NA
Enrollment: 307
Sponsor: Columbia University
Location: The Columbia Community Partnership for Health New York New York
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 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)
Source: ClinicalTrials.gov (NCT06853314). StuddyBuddy aggregates publicly available trial information.