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

Pre-Pilot WINGS +++ An Effectiveness Trial of Syndemic Mhealth Intervention to Increase MOUD Uptake Among Women Impacted by Intimate Partner Violence and PTSD

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:

1. Does WINGS+++ lower non-prescription opioid and other drug use in women?
2. Does WINGS+++ help connect women to treatment for substance use, intimate partner violence, and post-traumatic stress disorder (PTSD)?

Researchers will compare WINGS+++ to standard care to see if WINGS+++ works better to lower drug use and link women to helpful services.

WINGS+++ is a 3-session program on a mobile device that:

• 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

Study Overview

• Status: Not yet recruiting
• Conditions: Substance-Related Disorders; Stress Disorders, Post-Traumatic; Opioid-Related Disorders; Domestic Violence; Intimate Partner Violence (IPV); Post Traumatic Stress Disorder PTSD; Medication for Opioid Use Disorder (MOUD)
• Intervention / Treatment: Behavioral: Pre-Pilot WINGS++++

Detailed Description

The goal of this pre-pilot for the clinical trial is to develop a mobile health (mHealth) program called WINGS+++ that 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.

WINGS+++ is delivered across 3 sessions on a mobile device and combines three components into a single program: a tool that screens for physical, sexual, and emotional abuse and provides brief support and safety planning; a tool that identifies trauma-related (PTSD) symptoms and offers brief education and coping strategies; and a tool that screens for substance use concerns and helps connect women to appropriate treatment. The program also includes peer navigators, trained individuals with lived experience of substance use, intimate partner violence, or both who help connect participants to services based on their screening results and preferences.

This pre-pilot is a single-arm study in which all participants receive WINGS+++. The main goals are to assess whether the program and study procedures are feasible, acceptable to participants, and safe. Feasibility will be measured through factors such as recruitment, retention, session completion, and successful connection to referred services. Acceptability will be assessed through participant feedback, including interviews about their experience. Safety will be monitored by tracking any adverse events. Findings will be used to refine the program before later phases of the study.

• Study Type: Interventional
• Enrollment (Estimated): 7
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Dawn A Goddard-Eckrich, EdD; Phone Number: 3-6601 212-853-6601; Email: dg2121@columbia.edu
• Study Contact Backup: Name: Cathy Pak, MPH; Phone Number: 3-6601 212-853-6601; Email: chp2102@columbia.edu

Study Locations

• United States
  • New York
    • New York, New York, United States, 10027
      • Columbia University School of Social Work
      • Contact: Cathy Pak, MPH; Phone Number: 212-851-5660; Email: chp2102@columbia.edu
    • Newburgh, New York, United States, 12550
      • Cornerstone
      • Contact: Donna Muller; Phone Number: 845-533-2047; Email: dricard@cornerstonefh.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Identify as a woman (cis-gender 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Pre-Pilot WINGS+++ Intervention; 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++++; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants Who Complete All 3 WINGS+++ Sessions - Pre-Pilot Phase	Feasibility of intervention delivery will be assessed as the percentage of participants who complete all 3 WINGS+++ sessions. Higher percentages indicate greater feasibility.	30 days per participant
Number of Participants Who Complete the Post-Intervention Focus Group - Pre-Pilot Phase	Participant feedback to refine the intervention will be gathered through a post-intervention focus group workshop. Reported as the number of participants who complete the focus group.	1 month post intervention
Number of Key Stakeholders Who Complete the Survey and Interview - Group Pre-Pilot Phase	Key stakeholder input to inform pre-pilot refinement and pilot phase design will be gathered using the WINGS+++ Coalition and Key Stakeholder Survey (adapted from the HEALing Communities Study Community Coalition and Key Stakeholder Survey) and a qualitative interview. Reported as the number of stakeholders who complete both the survey and interview.	12 months
Mean Stakeholder Rating of WINGS+++ Acceptability and Feasibility Pre-Pilot	Key stakeholder and coalition input to inform pilot phase design will be assessed using the WINGS+++ Coalition and Key Stakeholder Survey, adapted from the HEALing Communities Study Community Coalition and Key Stakeholder Survey. Stakeholders rate items on 5-point Likert scales (e.g., 1 = Strongly Disagree to 5 = Strongly Agree; 1 = Very Dissatisfied to 5 = Very Satisfied), with mean scores ranging from 1 to 5. Higher scores indicate greater readiness, satisfaction, and support for implementing WINGS+++. Findings will be used to refine the intervention and study protocols for the subsequent pilot phase.	12 months

Collaborators and Investigators

• Sponsor: Dawn A. Goddard-Eckrich
• Collaborators: National Institute on Drug Abuse (NIDA); University of Pennsylvania; City University of New York
• Investigators: Study Chair: Louisa Gilbert, PhD, Columbia University; Study Chair: Nabila El-Bassel, PhD, Columbia University; Principal Investigator: Dawn A Goddard-Eckrich, EdD, Columbia University

Study record dates

Study Major Dates

• Study Start (Estimated): June 15, 2026
• Primary Completion (Estimated): July 30, 2027
• Study Completion (Estimated): August 31, 2027

Study Registration Dates

• First Submitted: May 14, 2026
• First Submitted That Met QC Criteria: June 18, 2026
• First Posted (Actual): June 24, 2026

Study Record Updates

• Last Update Posted (Actual): June 24, 2026
• Last Update Submitted That Met QC Criteria: June 18, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Trauma and Stressor Related Disorders; Narcotic-Related Disorders; Mental Disorders; Chemically-Induced Disorders; Stress Disorders, Traumatic; Opioid-Related Disorders; Substance-Related Disorders; Stress Disorders, Post-Traumatic; Combat Disorders
• Other Study ID Numbers: AAAV9733; 1R61DA061375-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No