An Effectiveness Trial of the PrEP for WINGS Study

NCT06853314 | Withdrawn DMC

• 2 other identifiers: AAAU73121R01AA030462
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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 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.

Conditions

HIV Infections; Alcohol Use Disorder; Violence, Gender-Based

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Number of completed PrEP provider meetings (PrEP Initiation)

  Meeting with a PrEP provider to start PrEP once will meet the threshold for PrEP initiation.

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

Secondary Outcomes (2)

• Revised Conflict Tactic Scale Score

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

• AUDIT Score

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

Study Arms (2)

PrEP for WINGS (intervention arm)

EXPERIMENTAL

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.

Behavioral: PrEP for WINGS

PrEP alone (control arm)

ACTIVE COMPARATOR

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. 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.

Behavioral: PrEP Decision Aid

Interventions

PrEP for WINGS BEHAVIORAL

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 for WINGS (intervention arm)

PrEP Decision Aid BEHAVIORAL

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.

PrEP alone (control arm)

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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)

Sponsors & Collaborators

• Columbia University: lead
• National Institutes of Health (NIH): collaborator
• National Institute on Alcohol Abuse and Alcoholism (NIAAA): collaborator

MeSH Terms

Conditions

HIV Infections; Alcoholism

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Study Officials

• Anindita Dasgupta, MPH, PhD

  Columbia University

  PRINCIPAL INVESTIGATOR

• Louisa Gilbert, MSW, PhD

  Columbia University

  PRINCIPAL INVESTIGATOR

• Rachel Groth, MSW, MPH

  Columbia University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: February 25, 2025
• First Posted: February 28, 2025
• Study Start: April 1, 2025
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: May 20, 2025

Record last verified: 2025-05