Pre-Pilot (R61) WINGS+++: mHealth to Improve MOUD Uptake in Women Experiencing Intimate Partner Violence and PTSD

NCT07665502 | Enrolling By Invitation DMC

• 2 other identifiers: AAAV97331R61DA061375-01A1
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 2

Brief Summary

The goal of this pre-pilot for the clinical trial is to develop a mobile health (mHealth) program called WINGS+++ can help women with opioid use disorder or other substance use disorders who have experienced intimate partner violence. The pre-pilot study will take place in Orange County, New York with n=7 women. . The main questions it aims to answer are:

• Screens for intimate partner violence, PTSD, and substance use
• Offers brief support and referrals based on each woman's needs and preferences
• Connects women to a peer navigator who helps link them to services Participants will:
• Take part in only the WINGS+++ program for the pre-pilot
• Answer survey questions about drug use, intimate partner violence, and PTSD symptoms
• Provide biological samples (such as urine or hair) to check for drug use
• Share information about the services they have used

Conditions

Opioid-Related Disorders; Substance-Related Disorders; Intimate Partner Violence (IPV); Stress Disorders, Post-Traumatic; Domestic Violence; Post Traumatic Stress Disorder PTSD; Medication for Opioid Use Disorder (MOUD)

Outcome Measures

Primary Outcomes (1)

• Mean Score on the WINGS+++ Satisfaction Scale - Pre-Pilot Phase

  Acceptability will be measured using a study-specific 12-item satisfaction scale administered after the intervention. Each item is rated on a 4-point Likert scale from 1 (very unsatisfied) to 4 (very satisfied). A mean score is calculated across the 12 items, ranging from 1 to 4. Higher scores indicate greater acceptability.

  1 month post-intervention

Other Outcomes (4)

• Percentage of Participants Who Complete All 3 WINGS+++ Sessions - Pre-Pilot Phase

  30 days per participant

• Number of Participants Who Complete the Post-Intervention Focus Group - Pre-Pilot Phase

  1 month post intervention

• Number of Key Stakeholders Who Complete the Survey and Interview - Group Pre-Pilot Phase

  1 months

Study Arms (1)

Pre-Pilot WINGS+++ Intervention

EXPERIMENTAL

Participants will receive the WINGS+++ 3-session mHealth intervention with peer navigation delivered over a 30-day period. Session 1 focuses on OUD/SUD screening, brief intervention, and referral to treatment (SBIRT) and includes a 40-minute mHealth tool plus a 20-minute peer navigator check-in. Session 2 focuses on IPV SBIRT and includes a 60-minute mHealth tool plus 20 minutes of peer navigation. Session 3 focuses on PTSD SBIRT and closing activities and includes a 60-minute mHealth tool plus 20 minutes of peer navigation. WINGS+++ mHealth sessions may be delivered using tablets at study sites or participant smartphones. Participants will also receive peer navigation from Community Health Advocates with lived experience of substance use disorder and/or intimate partner violence.

Behavioral: Pre-Pilot WINGS++++

Interventions

Pre-Pilot WINGS++++ BEHAVIORAL

Pre-Pilot WINGS+++ Intervention (3 sessions) After completing the baseline survey, they will participate in the three-session WINGS+++ program using a tablet, computer, or smartphone. The sessions include educational videos, interactive exercises, safety planning tools, and activities designed to address intimate partner violence, trauma symptoms, and substance use. Work with a Community Health Advocate (Peer Navigator) who will help set goals and connect you to services such as MOUD treatment, harm reduction services, mental health services, and intimate partner violence services.

Pre-Pilot WINGS+++ Intervention

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Identify as a woman (cisgender or transgender)
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Identify as a woman (cisgender or transgender)
• Aged 18 or older
• Report use of non-prescribed opioids in the past 30 days
• Score positive for risk of opioid use disorder or other substance use disorder on the Drug Abuse Screening Test (DAST) with a cut-off score of 6 or higher
• Report experiencing any severe psychological abuse or any physical or sexual abuse by a female or male intimate partner in the past year.

You may not qualify if:

• Evidence of significant psychiatric or cognitive impairment that would limit effective participation, as confirmed during informed consent;
• Inability to speak and understand English sufficiently to participate in assessments or intervention sessions.

Sponsors & Collaborators

• University of Pennsylvania: collaborator
• Dawn A. Goddard-Eckrich: lead
• National Institute on Drug Abuse (NIDA): collaborator
• City University of New York: collaborator

Study Sites (2)

Columbia University School of Social Work

New York, New York, 10027, United States

Location

Cornerstone

Newburgh, New York, 12550, United States

Location

MeSH Terms

Conditions

Opioid-Related Disorders; Substance-Related Disorders; Stress Disorders, Post-Traumatic; Combat Disorders

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Stress Disorders, Traumatic; Trauma and Stressor Related Disorders

Study Officials

• Louisa Gilbert, PhD

  Columbia University

  STUDY CHAIR

• Nabila El-Bassel, PhD

  Columbia University

  STUDY CHAIR

• Dawn A Goddard-Eckrich, EdD

  Columbia University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Director

Model Details: The R61 pre-pilot phase is a single-arm pilot trial evaluating the feasibility, acceptability, and safety of WINGS+++ and assessing pre- to post-intervention changes in primary and secondary outcomes. 7 women with opioid use disorder or other substance use disorder who have experienced intimate partner violence in the past year will be enrolled from two harm reduction programs in Orange County, New York. All participants receive WINGS+++, a 3-session mHealth intervention integrating an IPV screening, brief intervention, and referral (SBIRT) tool, a novel PTSD SBIRT tool, and an OUD/SUD SBIRT with a service linkage platform (NYMatters), delivered alongside peer navigation. Assessments occur at baseline and 1-months post-intervention. Findings will inform refinement of WINGS+++ and the implementation infrastructure for the R61 pilot phase and the subsequent R33 effectiveness trial.

Study Record Dates

• First Submitted: May 14, 2026
• First Posted: June 24, 2026
• Study Start: April 21, 2026
• Primary Completion (Estimated): August 27, 2027
• Study Completion (Estimated): August 31, 2027
• Last Updated: July 28, 2026

Record last verified: 2026-06

Locations

US (2)