Evaluating a Digital Toolkit for IPV

A Stepped-Wedge Randomized Controlled Trial Evaluating a Digital Toolkit for IPV

The study evaluates a web-based digital toolkit designed to screen for intimate partner violence (IPV), post-traumatic stress disorder (PTSD), and related mental health concerns within opioid treatment programs. Providers use the toolkit during routine care with patients receiving treatment for opioid use disorder. The study examines how the toolkit is implemented into clinic workflows and whether its use improves detection, referral, and patient outcomes.

Study Overview

• Status: Not yet recruiting
• Conditions: Opioid Use Disorder
• Intervention / Treatment: Other: Digital Toolkit

• Study Type: Interventional
• Enrollment (Estimated): 792
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ariel Worley, MPH; Phone Number: (843) 792-8208; Email: worleyar@musc.edu

Participation Criteria

Eligibility Criteria

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

Description

Inclusion criteria for all participants:

• Age 18 and older
• Able to understand and sign a consent form in English

Inclusion criteria for OTPs:

• Current experience working in one of the three opioid treatment clinics serving as a recruitment site for this study
• Health care professional training (e.g., social worker, counselor, physician, psychologist, nurse practitioner)

Exclusion criteria for OTPs:

- None

Inclusion criteria for patients with OUD:

• Report opioids as their primary substance of use for which they are seeking treatment
• Receive treatment at one of the three opioid treatment clinics serving as a recruitment site for this study

Exclusion criteria for patients with OUD:

• An acute medical problem requiring inpatient treatment (e.g., detoxification)
• Incarceration at the time of the study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Treatment as Usual; Treatment as usual consists of screening and care practices as usual, as provided by the clinic setting
Experimental: Digital Toolkit; Digital toolkit used for screening and providing referral/treatment planning information for intimate partner violence and mental health conditions	Other: Digital Toolkit; The digital toolkit intervention consists of validated tools to screen patients for intimate partner violence and mental health conditions and evidence-based suggestions for personalized treatment plans and/or referrals; Other Names: Intimate Partner Violence and Opioid Toolkit; IPVOT

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of patients who receive screening	Proportion of patients seen who receive intimate partner violence and mental health screening	From enrollment until the end of study participation at (up to) 35 months
Proportion of patients screened positive for intimate partner violence	Proportion of patients screened who screen positive for intimate partner violence	From enrollment until the end of study participation at (up to) 35 months
Proportion of intimate partner violence-positive patients who receive recommended or referred services	Proportion of patients screened positive for intimate partner violence who received recommended or referred services for intimate partner violence	From enrollment until the end of study participation at (up to) 35 months
Proportion of patients retained on MOUD following intimate partner violence and mental health screening	Proportion of patients retained in MOUD services for at least 18 months following intimate partner violence and mental health screening	From enrollment until the end of study participation at (up to) 35 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of providers completing intimate partner violence and mental health screening	Proportion of providers completing intimate partner violence and mental health screening with at least 70% of eligible patients	From enrollment until the end of study participation at (up to) 35 months
Proportion of providers providing resources and referrals for patients who screened positive for intimate partner violence	Proportion of providers who provided resources and/or referrals for patients who screened positive for intimate partner violence	From enrollment until the end of study participation at (up to) 35 months
Proportion of providers who had patients accept referrals and/or attempted to attend recommended psychosocial services	Proportion of providers for whom at least 60% of patients accepted referrals and/or attempted to attend recommended psychosocial services	From enrollment until the end of study participation at (up to) 35 months

Collaborators and Investigators

• Sponsor: Medical University of South Carolina
• Collaborators: National Institute on Drug Abuse (NIDA)
• Investigators: Principal Investigator: Amber M Jarnecke, PhD, Medical University of South Carolina; Principal Investigator: Tanya C Saraiya, PhD, Medical University of South Carolina

Study record dates

Study Major Dates

• Study Start (Estimated): December 1, 2026
• Primary Completion (Estimated): August 1, 2030
• Study Completion (Estimated): August 1, 2030

Study Registration Dates

• First Submitted: May 12, 2026
• First Submitted That Met QC Criteria: May 14, 2026
• First Posted (Actual): May 20, 2026

Study Record Updates

• Last Update Posted (Actual): May 20, 2026
• Last Update Submitted That Met QC Criteria: May 14, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: PTSD; mental health; opioid use disorder; posttraumatic stress disorder; intimate partner violence
• Additional Relevant MeSH Terms: Trauma and Stressor Related Disorders; Narcotic-Related Disorders; Mental Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Stress Disorders, Traumatic; Behavior; Personal Satisfaction; Opioid-Related Disorders; Stress Disorders, Post-Traumatic; Psychological Well-Being
• Other Study ID Numbers: Pro00151072; 1R61DA061371 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Demographic, survey, and clinical data will be acquired. The raw interview, survey, and clinical data will be stored within a secure computing environment. All direct identifiers will be removed and maintained in a secure file. All other scientific data (coded interview data, scale composites, recodes) will be both preserved and shared via ICPSR. Documentation to be made available will include a study protocol, reference to study publication of primary outcomes, data sets, case report forms, a data dictionary, and study-specific notes. Variables in the data dictionary will include a description, variable name, variable label, and standard codes for missing values.
• IPD Sharing Time Frame: The first batch of data will be deposited 6 months after enrollment of the first participants and data will be deposited every 6 months thereafter until study completion. The research community will have access to the full data set approximately 18 months following the end of the randomized clinical trial or after the primary paper has been accepted for publication, whichever happens first.
• IPD Sharing Access Criteria: Data will be findable for the research community through ICPSR. For all publications, an ICPSR study will be created and assigned a digital object identifier (DOI). The DOI will be referenced in the publication to allow the research community to access the data used.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ANALYTIC_CODE; CSR

Drug and device information, study documents

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