NCT07764458

Brief Summary

Hospital-Based Violence Intervention Programs (HVIPs) affiliated with U.S. trauma centers often focus on individual behavior modification to reduce re-victimization. There is a lack of reproducible evidence that has demonstrated effectiveness, given the exclusion of addressing social and economic risks, often the root cause of violent injury and preventable homicide. This study tests a novel Medical-Legal Partnership that offers legal support to address social and economic risks, reduce perceived stress, and reduce firearm injury, while collaborating with the CFVP Coordinating Center for broad trauma center distribution and public health impact.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
12mo left

Started May 2026

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 Progress22%
May 2026Jul 2027

Study Start

First participant enrolled

May 11, 2026

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

August 4, 2026

Completed
10 days until next milestone

First Posted

Study publicly available on registry

August 14, 2026

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2027

Last Updated

August 14, 2026

Status Verified

August 1, 2026

Enrollment Period

1.2 years

First QC Date

August 4, 2026

Last Update Submit

August 11, 2026

Conditions

Firearm InjuryInjury TraumaticEconomic Problems

Outcome Measures

Primary Outcomes (1)

  • Perceived Stress

    The Perceived Stress Scale-10 (PSS-10) is a 10-item psychological questionnaire used to measure how unpredictable, uncontrollable, and overloaded a person feels over the last month. Scores range from 0 to 40, with higher numbers meaning higher stress.

    Baseline, 3 months, 6 months, 12 months

Secondary Outcomes (2)

  • Firearm victimization and aggression

    Baseline, 3 months, 6 months, 12 months

  • Legal needs self-efficacy

    Baseline, 3 months, 6 months, 12 months

Other Outcomes (2)

  • Health-related quality of life

    Baseline, 3 months, 6 months, 12 months

  • Post-Traumatic Stress Disorder (PTSD) Symptoms

    Baseline, 3 months, 6 months, 12 months

Study Arms (2)

HVIP-MLP

EXPERIMENTAL

This arm includes patients receiving usual care and also support from Recovery Legal Care (HVIP+MLP).

Other: Recovery Legal Care

HVIP

ACTIVE COMPARATOR

This arm includes patients receiving usual care (HVIP only).

Other: HVIP Standard of Care

Interventions

Recovery Legal CareOTHER

These patients will receive support from our HVIP standard of care (Violence Recovery Program) plus our Medical Legal Partnership (Recovery Legal Care) for additional legal support to address health-harming legal needs and public benefits.

HVIP-MLP
HVIP Standard of CareOTHER

These patients will receive HVIP standard of care (Violence Recovery Program Support).

HVIP

Eligibility Criteria

Age14 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Treatment for an interpersonal violent injury at the University of Chicago Trauma Center (e.g., gunshot, stab wound, assault)
  • Ages 14+ years
  • Able to provide informed consent (18 years and older) or assent (14-17 years)

You may not qualify if:

  • Unable to provide informed consent due to mental status or severe mental illness
  • Prior receipt of legal services at UCMC within the past year
  • Currently imprisoned or incarcerated
  • Residing at a non-Illinois address
  • Non-English speakers

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Chicago Medical Center

Chicago, Illinois, 60637, United States

RECRUITING

Related Publications (1)

  • Tung EL, Pillai R, Sen-Gupta N, Nigro A, Cosey-Gay F, Stolbach BC, Rogers SO, Zakrison TL. Income Support Needs and Bedside Legal Assistance for Patients Recovering From Violent Injuries. JAMA Netw Open. 2025 Oct 1;8(10):e2538044. doi: 10.1001/jamanetworkopen.2025.38044.

    PMID: 41100080RESULT

MeSH Terms

Conditions

Wounds and Injuries

Central Study Contacts

Tanya L Zakrison, MD, MPH

CONTACT

786-266-2228tzakrison@bsd.uchicago.edu

Elizabeth L Tung, MD, MS

CONTACT

773-702-6840etung2@bsd.uchicago.edu

Study Design

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

Study Record Dates

First Submitted

August 4, 2026

First Posted

August 14, 2026

Study Start

May 11, 2026

Primary Completion (Estimated)

July 31, 2027

Study Completion (Estimated)

July 31, 2027

Last Updated

August 14, 2026

Record last verified: 2026-08

Data Sharing

IPD Sharing
Will share

Data from this project will be shared with the Community Firearm Violence Prevention (CFVP) Network at the University of Michigan as part of a data sharing agreement stipulated under the UG3/UH3 award funding this research.

Shared Documents
STUDY PROTOCOL, SAP, CSR
Time Frame
IPD and supporting information will be available at the conclusion of data collection (7/31/2027) and will last for 5 years (7/31/2032).
Access Criteria
Data will be shared with trained and credentialed analysts from the CFVP team. They will be able to access de-identified survey data through an encrypted portal.

Locations

US(1)