An Effectiveness Trial of the PrEP for WINGS Study

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

Interventions

BEHAVIORAL

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.

BEHAVIORAL

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.

Sponsors & Collaborators

• National Institutes of Health (NIH)

  collaborator NIH

• National Institute on Alcohol Abuse and Alcoholism (NIAAA)

  collaborator NIH

• Columbia University

  lead OTHER

Principal Investigators

• Anindita Dasgupta, MPH, PhD · Columbia University

• Louisa Gilbert, MSW, PhD · Columbia University

• Rachel Groth, MSW, MPH · Columbia University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

FEMALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2026-03-28

Primary Completion

2027-06-30

Completion

2027-06-30

Countries

• United States

Study Locations