WithdrawnNot Applicable

An Effectiveness Trial of the PrEP for WINGS Study

Stopped: Loss of funding

0Started 2025-04

Plain-language 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 measured by urine assay of Tenofovir (TDF) and longer-term adherence by self-report/medical records over the 12-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.

Who can participate

Age range18 Years

SexFEMALE

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Identify as a cis-gender woman * Aged 18 or older * Test negative for HIV using a rapid OraSure oral test at screening * Are currently on probation, parole or an ATI programs as verified by CSP records * Score positive for risk of hazardous drinking or alcohol dependence on AUDIT with a cut off score of 6 or higher; or indicated they drank 4 or more drinks on one occasion in the past 30 days * Report ever experiencing any intimate partner violence (HARK score of ≤1) * Report not taking PrEP in the past 90 days * Report having had condomless vaginal or anal sex in the past 90 days; and report an outside HIV risk in the past year (i.e. sex with more than one partner, shared injected equipment, tested positive for a bacterial STI, had sex with a man with HIV and not virally suppressed). 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)

What they're measuring

Number of completed PrEP provider meetings (PrEP Initiation)

Timeframe: From enrollment (baseline) to the end of 12-month follow up

Trial details

NCT IDNCT06853314

SponsorColumbia University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-06-01