Menu
Not yet recruiting NCT07600307

Evaluating a Digital Toolkit for IPV

No phase Interventional Opioid Use Disorder

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Digital Toolkit.
Who it may be relevant to
Registry conditions: Opioid Use Disorder. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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

  • 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

Primary outcome measures

  • Proportion of patients who receive screening [Time frame: From enrollment until the end of study participation at (up to) 35 months]
  • 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 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 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]
Secondary outcome measures (3)
  • 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 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 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]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Sequential
Masking
Open label
Primary purpose
Screening

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07600307 · Pro00151072 · 1R61DA061371

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗