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

Dawn A. Goddard-Eckrich

Status: Invitation-only

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

Treatments: Behavioral: Pre-Pilot WINGS++++

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT07665502

1R61DA061375-01A1 (U.S. NIH Grant/Contract)

AAAV9733

Details and patient eligibility

About

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

Full 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.

Enrollment: 7 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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.

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.

Trial design

Primary purpose: Screening

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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7 participants in 1 patient group

Pre-Pilot WINGS+++ Intervention

Experimental group

Description:

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.

Treatment:

Behavioral: Pre-Pilot WINGS++++