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
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
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
Single group
Pre-Pilot WINGS++++
BehavioralPre-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.
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.
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.
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.
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.
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.
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Dawn A. Goddard-Eckrich
Lead sponsor
Columbia University
Sponsor institution
National Institute on Drug Abuse (NIDA)
Collaborator
City University of New York
Collaborator
University of Pennsylvania
Collaborator
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