NCT07600307

Brief Summary

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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
792

participants targeted

Target at P75+ for not_applicable

Timeline
45mo left

Started Dec 2026

Longer than P75 for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 12, 2026

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 20, 2026

Completed
7 months until next milestone

Study Start

First participant enrolled

December 1, 2026

Expected
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2030

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2030

Last Updated

May 20, 2026

Status Verified

May 1, 2026

Enrollment Period

3.7 years

First QC Date

May 12, 2026

Last Update Submit

May 14, 2026

Conditions

Opioid Use Disorder

Keywords

opioid use disorderintimate partner violencemental healthPTSDposttraumatic stress disorder

Outcome Measures

Primary Outcomes (4)

  • 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 Outcomes (3)

  • Proportion of providers completing intimate partner violence and mental health screening

    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

    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

    From enrollment until the end of study participation at (up to) 35 months

Study Arms (2)

Treatment as Usual

NO INTERVENTION

Treatment as usual consists of screening and care practices as usual, as provided by the clinic setting

Digital Toolkit

EXPERIMENTAL

Digital toolkit used for screening and providing referral/treatment planning information for intimate partner violence and mental health conditions

Other: Digital Toolkit

Interventions

Digital ToolkitOTHER

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

Also known as: Intimate Partner Violence and Opioid Toolkit, IPVOT
Digital Toolkit

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • \- None
  • 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
  • An acute medical problem requiring inpatient treatment (e.g., detoxification)
  • Incarceration at the time of the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Opioid-Related DisordersPsychological Well-BeingStress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Narcotic-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental DisordersPersonal SatisfactionBehaviorStress Disorders, TraumaticTrauma and Stressor Related Disorders

Study Officials

  • Amber M Jarnecke, PhD

    Medical University of South Carolina

    PRINCIPAL INVESTIGATOR

  • Tanya C Saraiya, PhD

    Medical University of South Carolina

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ariel Worley, MPH

CONTACT

(843) 792-8208worleyar@musc.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SCREENING
Intervention Model
SEQUENTIAL
Model Details: This study uses a stepped-wedge cluster randomized trial design. Opioid treatment program sites are randomized to transition from treatment as usual to the digital screening toolkit at staggered time intervals until all sites have implemented the intervention.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 12, 2026

First Posted

May 20, 2026

Study Start (Estimated)

December 1, 2026

Primary Completion (Estimated)

August 1, 2030

Study Completion (Estimated)

August 1, 2030

Last Updated

May 20, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
STUDY PROTOCOL, SAP, CSR, ANALYTIC CODE
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.
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.