Opioid Use DisorderNCT07600307
Evaluating a Digital Toolkit for IPV
A study testing Digital Toolkit in people with Opioid Use Disorder, run by Medical University of South Carolina.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Opioid Use Disorder
- What is being tested?
- Digital Toolkit
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 792 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2026to Aug 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
- 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
Who cannot join
- None
- An acute medical problem requiring inpatient treatment (e.g., detoxification)
- Incarceration at the time of the study
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
- Conditions
- Opioid Use Disorder
- Being tested
- Digital Toolkit
- Keywords
- opioid use disorder, intimate partner violence, mental health, PTSD, posttraumatic stress disorder
- Medical subject headings
- Opioid-Related Disorders, Psychological Well-Being, Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Digital ToolkitOther
Also called Intimate Partner Violence and Opioid Toolkit, IPVOT
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: Digital Toolkit |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients who receive screening
Proportion of patients seen who receive intimate partner violence and mental health screening
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Proportion of providers completing intimate partner violence and mental health screening with at least 70% of eligible patients
Measured: 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
Measured: 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
Measured: From enrollment until the end of study participation at (up to) 35 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2026
- Study start1 Dec 2026 (estimated)
- Primary completionAug 2030 (estimated)
- Study completionAug 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Opioid Use DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Sequential
- 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.
- Masking
- None (open label)
- Enrolment
- 792 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of South Carolina
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
- Investigators
- Amber M Jarnecke, PhD, Principal investigator, Medical University of South CarolinaTanya C Saraiya, PhD, Principal investigator, Medical University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07600307
- Sponsor's protocol ID
- Pro00151072
- Other IDs
- 1R61DA061371
- Status last verified
- May 2026
- First submitted
- 12 May 2026
- Last updated
- 20 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Stepped-Wedge Randomized Controlled Trial Evaluating a Digital Toolkit for IPV
- ClinicalTrials.gov ID
- NCT07600307
- Acronym / sponsor ID
- Pro00151072
- Conditions
- Opioid Use Disorder
- Keywords
- opioid use disorder, intimate partner violence, mental health, PTSD, posttraumatic stress disorder
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 792 participants (estimated)
- Lead sponsor
- Medical University of South CarolinaUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 1 Dec 2026 (estimated)
- Primary completion
- Aug 2030 (estimated)
- Study completion
- Aug 2030 (estimated)
- First posted
- 20 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| 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 | Other: Digital ToolkitDigital toolkit used for screening and providing referral/treatment planning information for intimate partner violence and mental health conditions |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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)
- Report opioids as their primary substance of use for which they are seeking treatment
Key exclusion criteria (3 listed)
- None
- An acute medical problem requiring inpatient treatment (e.g., detoxification)
- Incarceration at the time of the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Digital ToolkitAlso: Intimate Partner Violence and Opioid Toolkit, IPVOTThe 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 | Digital Toolkit |
Primary outcome
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
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
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
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
3 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2026.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Amber M Jarnecke, PhD principal investigator
Medical University of South Carolina
Tanya C Saraiya, PhD principal investigator
Medical University of South Carolina
Questions about this trial
What is this clinical trial studying?
A study testing Digital Toolkit in people with Opioid Use Disorder, run by Medical University of South Carolina.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 20 May 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ariel Worley, MPH ((843) 792-8208, worleyar@musc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients who receive screening (time frame: From enrollment until the end of study participation at (up to) 35 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2026.