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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05844020
Other study ID # 22-05-1198
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date April 17, 2023
Est. completion date August 2027

Study information

Verified date October 2023
Source Meharry Medical College
Contact Maureen Sanderson, PhD
Phone 615-321-2977
Email msanderson@mmc.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.


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].


Recruitment information / eligibility

Status Recruiting
Enrollment 250
Est. completion date August 2027
Est. primary completion date March 2027
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 79 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Educational materials
Trauma-informed intimate partner violence screening, brief interventions, and referrals to treatment by providers

Locations

Country Name City State
United States Meharry Medical College Nashville Tennessee

Sponsors (2)

Lead Sponsor Collaborator
Meharry Medical College Matthew Walker Comprehensive Health Center

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of patients who received appropriate intimate partner violence screening and trauma/mental health services referral 12 months
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