Intimate Partner ViolenceNCT05844020
Perceptions of Trauma and Violence Informed Care
A study testing Educational materials in people with Intimate Partner Violence, run by Meharry Medical College at 1 site in United States.
Trial summary
The purpose of this study is to adapt, implement and evaluate a trauma and violence informed care intervention designed for Black women in middle Tennessee. Read more about this study
- Who is it for?
- Ages 18 to 79 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Intimate Partner Violence
- What is being tested?
- Educational materials
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Apr 2023to 31 Aug 2027
- 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 to 79 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Meharry or Matthew Walker Comprehensive Health Center female patients
- Self-identify as Black
- Self-identify as intimate partner violence survivors
- English or Spanish language fluency
Who cannot join
- Not Black female intimate partner violence survivor of Meharry or Matthew Walker Comprehensive Health Center
- Those without English or Spanish language fluency
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Meharry Medical College
Nashville, Tennessee, 37208
Maureen Sanderson, PhD, 6153212977, msanderson@mmc.edu
About this study
Official title: Assessment of Survivor and Provider Perceptions of Trauma and Violence Informed Care Among Black Women
The purpose of this study is to adapt, implement and evaluate a trauma and violence informed care intervention designed for Black women in middle Tennessee.
Read the detailed description
The primary goal is the adaptation, implementation and evaluation of a trauma and violence informed care (TVIC) intervention designed for Black women in middle Tennessee. In this 5-year RCMI project, the investigators propose 3 aims. Aim 1) Engage a stakeholder committee of patients, providers, and experts (COPE) to adapt a TVIC intervention for Black women and their healthcare providers at Meharry. [Years 1-2]. Aim 2) Implement and prospectively evaluate the adapted TVIC intervention at the healthcare provider-level, measuring changes in Meharry healthcare provider's self-efficacy for TVIC implementation and alignment with TIC knowledge, attitudes, and practices. [Years 2-3] Aim 3) Implement the adapted TVIC intervention at the patient-level to provide trauma-informed IPV screening, brief interventions, and referrals to treatment (SBIRT), and rigorously evaluate this TVIC intervention's impact on the primary outcome of patient-perceived usefulness of intervention and reported linkage to IPV services, and the secondary outcome of changes at the clinic-level relative to climate and culture, through a non-randomized pragmatic trial design. [Year 4-5].
- Conditions
- Intimate Partner Violence
- Being tested
- Educational materials
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Educational materialsBehavioural
Trauma-informed intimate partner violence screening, brief interventions, and referrals to treatment by providers
| Study group | Role | What they receive |
|---|---|---|
| TVIC Intervention | Experimental | Not described Receives: Behavioral: Educational materials |
| Usual Care | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients who received appropriate intimate partner violence screening and trauma/mental health services referral
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2023
- Study start17 Apr 2023
- Primary completion31 Mar 2027 (estimated)
- Study completion31 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intimate Partner ViolenceStudies 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
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Meharry Medical College
- Sponsor type
- University, hospital or other
- Collaborators
- Matthew Walker Comprehensive Health Center
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05844020
- Sponsor's protocol ID
- 22-05-1198
- Status last verified
- May 2025
- First submitted
- 14 Mar 2023
- Last updated
- 13 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Survivor and Provider Perceptions of Trauma and Violence Informed Care Among Black Women
- ClinicalTrials.gov ID
- NCT05844020
- Acronym / sponsor ID
- 22-05-1198
- Conditions
- Intimate Partner Violence
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Meharry Medical CollegeUniversity, hospital or other
- Collaborators
- Matthew Walker Comprehensive Health Center
- Study start
- 17 Apr 2023 (actual)
- Primary completion
- 31 Mar 2027 (estimated)
- Study completion
- 31 Aug 2027 (estimated)
- First posted
- 6 May 2023 (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 purpose of this study is to adapt, implement and evaluate a trauma and violence informed care intervention designed for Black women in middle Tennessee.
Detailed description
The primary goal is the adaptation, implementation and evaluation of a trauma and violence informed care (TVIC) intervention designed for Black women in middle Tennessee. In this 5-year RCMI project, the investigators propose 3 aims. Aim 1) Engage a stakeholder committee of patients, providers, and experts (COPE) to adapt a TVIC intervention for Black women and their healthcare providers at Meharry. [Years 1-2]. Aim 2) Implement and prospectively evaluate the adapted TVIC intervention at the healthcare provider-level, measuring changes in Meharry healthcare provider's self-efficacy for TVIC implementation and alignment with TIC knowledge, attitudes, and practices. [Years 2-3] Aim 3) Implement the adapted TVIC intervention at the patient-level to provide trauma-informed IPV screening, brief interventions, and referrals to treatment (SBIRT), and rigorously evaluate this TVIC intervention's impact on the primary outcome of patient-perceived usefulness of intervention and reported linkage to IPV services, and the secondary outcome of changes at the clinic-level relative to climate and culture, through a non-randomized pragmatic trial design. [Year 4-5].
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TVIC Intervention | Experimental | Behavioral: Educational materials |
| Usual Care | No intervention | – |
Who may qualify
- Ages
- 18 to 79 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Meharry or Matthew Walker Comprehensive Health Center female patients
- Self-identify as Black
- Self-identify as intimate partner violence survivors
- English or Spanish language fluency
Key exclusion criteria (2 listed)
- Not Black female intimate partner violence survivor of Meharry or Matthew Walker Comprehensive Health Center
- Those without English or Spanish language fluency
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 |
|---|---|---|
| Educational materialsTrauma-informed intimate partner violence screening, brief interventions, and referrals to treatment by providers | Behavioural | TVIC Intervention |
Primary outcome
Number of patients who received appropriate intimate partner violence screening and trauma/mental health services referral
Time frame: 12 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 13 May 2025.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Educational materials in people with Intimate Partner Violence, run by Meharry Medical College at 1 site in United States.
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 4 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 13 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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 Maureen Sanderson, PhD (615-321-2977, msanderson@mmc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients who received appropriate intimate partner violence screening and trauma/mental health services referral (time frame: 12 months). 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 13 May 2025.