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NCT Number: NCT07600307

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.

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Key information

Conditions

Opioid Use Disorder Behavior Chemically-Induced Disorders Mental Disorders Narcotic-Related Disorders Opioid-Related Disorders Personal Satisfaction Psychological Well-Being Stress Disorders, Post-Traumatic Stress Disorders, Traumatic Substance-Related Disorders Trauma and Stressor Related Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Digital Toolkit

Other

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

Primary outcomes

  1. Proportion of patients who receive screening

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

    Proportion of patients seen who receive intimate partner violence and mental health screening

  2. Proportion of patients screened positive for intimate partner violence

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

    Proportion of patients screened who screen positive for intimate partner violence

  3. Proportion of intimate partner violence-positive patients who receive recommended or referred services

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

    Proportion of patients screened positive for intimate partner violence who received recommended or referred services for intimate partner violence

  4. Proportion of patients retained on MOUD following intimate partner violence and mental health screening

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

    Proportion of patients retained in MOUD services for at least 18 months following intimate partner violence and mental health screening

Secondary outcomes

  1. Proportion of providers completing intimate partner violence and mental health screening

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

    Proportion of providers completing intimate partner violence and mental health screening with at least 70% of eligible patients

  2. Proportion of providers providing resources and referrals for patients who screened positive for intimate partner violence

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

    Proportion of providers who provided resources and/or referrals for patients who screened positive for intimate partner violence

  3. Proportion of providers who had patients accept referrals and/or attempted to attend recommended psychosocial services

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

    Proportion of providers for whom at least 60% of patients accepted referrals and/or attempted to attend recommended psychosocial services

Study contacts

Contact information is provided by the study sponsor or research team.

Ariel Worley, MPH

CONTACT

[email protected]

(843) 792-8208

Sponsors and collaborators

Lead sponsor

Medical University of South Carolina

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2030
Study completion
2030
First posted
May 20, 2026
Registry last updated
May 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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