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Evaluating a Digital Toolkit for IPV

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

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07600307
Enrollment
792
Registered
2026-05-20
Start date
2026-12-01
Completion date
2030-08-01
Last updated
2026-05-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Opioid Use Disorder

Keywords

opioid use disorder, intimate partner violence, mental health, PTSD, posttraumatic stress disorder

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.

Interventions

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

Sponsors

Medical University of South Carolina
Lead SponsorOTHER
National Institute on Drug Abuse (NIDA)
CollaboratorNIH

Study design

Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
SCREENING
Masking
NONE

Intervention model description

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.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Proportion of patients who receive screeningFrom enrollment until the end of study participation at (up to) 35 monthsProportion of patients seen who receive intimate partner violence and mental health screening
Proportion of patients screened positive for intimate partner violenceFrom enrollment until the end of study participation at (up to) 35 monthsProportion of patients screened who screen positive for intimate partner violence
Proportion of intimate partner violence-positive patients who receive recommended or referred servicesFrom enrollment until the end of study participation at (up to) 35 monthsProportion of patients screened positive for intimate partner violence who received recommended or referred services for intimate partner violence
Proportion of patients retained on MOUD following intimate partner violence and mental health screeningFrom enrollment until the end of study participation at (up to) 35 monthsProportion of patients retained in MOUD services for at least 18 months following intimate partner violence and mental health screening

Secondary

MeasureTime frameDescription
Proportion of providers completing intimate partner violence and mental health screeningFrom enrollment until the end of study participation at (up to) 35 monthsProportion of providers completing intimate partner violence and mental health screening with at least 70% of eligible patients
Proportion of providers providing resources and referrals for patients who screened positive for intimate partner violenceFrom enrollment until the end of study participation at (up to) 35 monthsProportion of providers who provided resources and/or referrals for patients who screened positive for intimate partner violence
Proportion of providers who had patients accept referrals and/or attempted to attend recommended psychosocial servicesFrom enrollment until the end of study participation at (up to) 35 monthsProportion of providers for whom at least 60% of patients accepted referrals and/or attempted to attend recommended psychosocial services

Contacts

CONTACTAriel Worley, MPH
worleyar@musc.edu(843) 792-8208
PRINCIPAL_INVESTIGATORAmber M Jarnecke, PhD

Medical University of South Carolina

PRINCIPAL_INVESTIGATORTanya C Saraiya, PhD

Medical University of South Carolina

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 21, 2026