Recruiting

WINGS & PrEP

Sponsor:

Columbia University

Code:

NCT06853314

Conditions

HIV Infections

Alcohol Use Disorder

Violence, Gender-Based

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Accepted

Interventions

PrEP for WINGS

PrEP Decision Aid

Study Details

Brief 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.

Conditions

HIV Infections

Alcohol Use Disorder

Violence, Gender-Based

Study ID

NCT06853314

Start date

Apr 9, 2026

Status verified date

Jun, 2026

Completion date

Jun 1, 2027

Anticipated

Primary completion date

Jun 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Accepted

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)

Study Design

Enrollment

307 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: PrEP for WINGS (intervention arm)

Participants randomized to the PrEP for WINGS intervention arm will receive three sessions on a self-paced intervention delivered via a mobile health platform. Session 1 will focus on HIV risk reduction and deliver the PrEP Decision Aid. Sessions 2-3 will involve sessions focused on IPV and alcohol SBIRT sessions with peer navigation that will be completed within a 30 day period (3 sessions total). PrEP for WINGS mHealth sessions may be delivered using smart phones or using tablets available at study data collection sites. Intervention participants will also receive three peer navigation sessions from Community Health Advocates who will help participants trouble shoot any barriers to linking to care, and meeting goals set during the intervention sessions.

active comparator: PrEP alone (control arm)

Participants randomized to the control arm of the study will receive a single session on HIV risk reduction and 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.

Interventions

PrEP for WINGS

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.

PrEP Decision Aid

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.

Primary outcome measure

  • Number of completed PrEP provider meetings (PrEP Initiation) [ Time Frame: From enrollment (baseline) to the end of 12-month follow up ]

Central Contacts and Locations

Central contacts

Anindita Dasgupta, MPH, PhD

646-808-4861ad3341@cumc.columbia.edu

Louisa Gilbert, MSW, PhD

lg123@columbia.edu

Locations

The Columbia Community Partnership for Health

Recruiting

New York, New York, United States, 10033

Contacts

Dora Ventura

646-697-2274irvinginst_community@cumc.columbia.edu

Principal Investigator:

Anindita Dasgupta, MPH, PhD

More Information

Sponsor

Columbia University

Last update posted

Jun 22, 2026

Last verified

Jun, 2026

Keywords

  • Intimate partner violence
  • Hazardous alcohol use
  • HIV infection
  • PrEP

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Columbia University on 2026-06-22.