- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05844020
Perceptions of Trauma and Violence Informed Care
May 7, 2025 updated by: Meharry Medical College
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Estimated)
250
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Maureen Sanderson, PhD
- Phone Number: 615-321-2977
- Email: msanderson@mmc.edu
Study Locations
-
-
Tennessee
-
Nashville, Tennessee, United States, 37208
- Recruiting
- Meharry Medical College
-
Contact:
- Maureen Sanderson, PhD
- Phone Number: 6153212977
- Email: msanderson@mmc.edu
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- Not Black female intimate partner violence survivor of Meharry or Matthew Walker Comprehensive Health Center
- Those without English or Spanish language fluency
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Usual Care
|
|
|
Experimental: TVIC Intervention
|
Trauma-informed intimate partner violence screening, brief interventions, and referrals to treatment by providers
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Number of patients who received appropriate intimate partner violence screening and trauma/mental health services referral
Time Frame: 12 months
|
12 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 17, 2023
Primary Completion (Estimated)
March 31, 2027
Study Completion (Estimated)
August 31, 2027
Study Registration Dates
First Submitted
March 14, 2023
First Submitted That Met QC Criteria
May 3, 2023
First Posted (Actual)
May 6, 2023
Study Record Updates
Last Update Posted (Actual)
May 13, 2025
Last Update Submitted That Met QC Criteria
May 7, 2025
Last Verified
May 1, 2025
More Information
Terms related to this study
Other Study ID Numbers
- 22-05-1198
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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