NCT05844020

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
250

participants targeted

Target at P75+ for not_applicable

Timeline
16mo left

Started Apr 2023

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress70%
Apr 2023Aug 2027

First Submitted

Initial submission to the registry

March 14, 2023

Completed
1 month until next milestone

Study Start

First participant enrolled

April 17, 2023

Completed
19 days until next milestone

First Posted

Study publicly available on registry

May 6, 2023

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2027

Expected
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2027

Last Updated

May 13, 2025

Status Verified

May 1, 2025

Enrollment Period

4 years

First QC Date

March 14, 2023

Last Update Submit

May 7, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Number of patients who received appropriate intimate partner violence screening and trauma/mental health services referral

    12 months

Study Arms (2)

TVIC Intervention

EXPERIMENTAL
Behavioral: Educational materials

Usual Care

NO INTERVENTION

Interventions

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

TVIC Intervention

Eligibility Criteria

Age18 Years - 79 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Not Black female intimate partner violence survivor of Meharry or Matthew Walker Comprehensive Health Center
  • Those without English or Spanish language fluency

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Meharry Medical College

Nashville, Tennessee, 37208, United States

RECRUITING

Central Study Contacts

Maureen Sanderson, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 14, 2023

First Posted

May 6, 2023

Study Start

April 17, 2023

Primary Completion (Estimated)

March 31, 2027

Study Completion (Estimated)

August 31, 2027

Last Updated

May 13, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share

Locations