Recovery Legal Care Clinical Trial (HVIP-MLP)

June 4, 2026 updated by: University of Chicago
Hospital-Based Violence Intervention Programs (HVIPs) affiliated with trauma centers in the US often focus on individual behavior modification for reduction in re-victimization. There is a lack of reproducible evidence that has demonstrated effectiveness, given the exclusion of addressing inequities in the Social and Structural Determinants of Health (SSDOH), often the root causes of violent injury and preventable homicide. The study investigators created a Medical Legal Partnership (MLP) to partner with an existing HVIP. This novel program offers beside legal assistance to address the SSDOH. The purpose of this study is to evaluate the effectiveness of the HVIP-MLP program in improving perceived stress, violence-related outcomes, legal needs, health-related quality of life, and PTSD symptoms.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

National trauma center verification relies on a commitment to injury prevention efforts, including prevention of community-level violence. Hospital-Based Violence Recovery Programs (HVIPs) have expanded across the country as extensions of level I and II trauma centers to address trauma recidivism with individual behavioral modification during the "teachable moment." There is little evidence that has demonstrated consistent effectiveness of this approach. One possible reason is the difficulty for community-based violence prevention specialists from HVIP programs to address the larger inequities in the Structural and Social Determinants of Health (SSDOH) that lead to violence through. Medical-Legal Partnership is one approach that has demonstrated evidence and success in improving health outcomes and reducing health-harming legal needs of patients, by connecting legal experts to medical experts for holistic care. This has yet to be done for trauma patients and has, to our knowledge, not been incorporated into any HVIP approach thus far. This clinical trial will evaluate the effectiveness of the HVIP-MLP model to address legal needs rooted in the SSDOH and improve perceived stress. As secondary objectives, it will also evaluate whether the HVIP-MLP model can improve violence-related outcomes, health-related quality of life, and PTSD symptoms among study participants. This novel HVIP-MLP approach has the potential to broadly impact the HVIP model to include an MLP component to all trauma centers for verification to support patients, families and providers alike in this important public health work.

Study Type

Interventional

Enrollment (Estimated)

500

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

Study Contact Backup

Study Locations

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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)

Inclusion of women and minorities: This research proposal includes women and ethnic minorities. Patient participants will be primarily non-Hispanic Black or Hispanic race and ethnicity. The study expects participants to be proportional to the population-wide estimates for the South Side community. The majority will be low-income with variable functional health literacy. These characteristics are representative of the target population and describe the population most likely to benefit from the proposed study. Youth stakeholder participants will be multi-ethnic and racially diverse.

Inclusion of children: This study will include children ages 14-17 years old, based on Illinois state labor laws for child employment, as well as the ages of youth who are primarily treated for penetrating injury at the UCMC trauma center. This age is also a pragmatic cutoff for children providing meaningful input on community and healthcare solutions to violence.

Exclusion Criteria:

  • Diagnosis of severe mental illness (e.g., psychotic disorder, schizophrenia, suicidality)
  • Treated for a non-interpersonal violent injury type (e.g., car accident)
  • Treated for self-inflicted or accidental injuries
  • Unable to provide informed consent due to mental status
  • Prior receipt of legal services at UCMC within the past year
  • Currently imprisoned or incarcerated
  • Residing at a non-Illinois address
  • Non-English speakers

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: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: HVIP-MLP
This arm includes patients receiving usual care and also support from Recovery Legal Care (HVIP+MLP)
Other: Recovery Legal Care
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.
Other Names:
  • Civil Law Attorney Support
  • Public Benefits Attorney Support
  • Legal Aid Chicago Support
Other: HVIP Standard of Care
These patients will receive HVIP standard of care (Violence Recovery Program Support)
Other Names:
  • HVIP - Violence Recovery Program
Active Comparator: HVIP
This arm includes patients receiving usual care (HVIP only).
Other: HVIP Standard of Care
These patients will receive HVIP standard of care (Violence Recovery Program Support)
Other Names:
  • HVIP - Violence Recovery Program

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Stress
Time Frame: Baseline, 3 months, 6 months, 12 months, 18 months
The Patient-Reported Outcomes Measurement Information System (PROMIS) scale measures self-reported psychological stress.
Baseline, 3 months, 6 months, 12 months, 18 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Firearm victimization and aggression
Time Frame: Baseline, 3 months, 6 months, 12 months, 18 months
The adapted Conflict Tactics Scale 2 (CTS2) measures behaviors related to firearm victimization and aggression over the past 3 months.
Baseline, 3 months, 6 months, 12 months, 18 months
Legal needs self-efficacy
Time Frame: Baseline, 3 months, 6 months, 12 months, 18 months
The adapted Bandura Self-Efficacy Scale measures belief in one's ability to have legal needs addressed.
Baseline, 3 months, 6 months, 12 months, 18 months
Health-related quality of life
Time Frame: Baseline, 3 months, 6 months, 12 months, 18 months
The SF-12 Health Survey measures both physical and mental health domains of health-related quality of life.
Baseline, 3 months, 6 months, 12 months, 18 months
Post-Traumatic Stress Disorder (PTSD) Symptoms
Time Frame: Baseline, 3 months, 6 months, 12 months, 18 months
The PCL-5 measures symptoms of PTSD.
Baseline, 3 months, 6 months, 12 months, 18 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Chicago

Collaborators

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
National Institute on Minority Health and Health Disparities (NIMHD)
U.S. Department of Justice

Investigators

  • Principal Investigator: TANYA L ZAKRISON, MD, MPH, University of Chicago
  • Principal Investigator: ELIZABETH L TUNG, MD, MS, University of Chicago

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

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)

February 10, 2025

Primary Completion (Estimated)

August 31, 2027

Study Completion (Estimated)

August 31, 2027

Study Registration Dates

First Submitted

March 6, 2024

First Submitted That Met QC Criteria

September 26, 2024

First Posted (Actual)

October 1, 2024

Study Record Updates

Last Update Posted (Actual)

June 8, 2026

Last Update Submitted That Met QC Criteria

June 4, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB25-1731
  • P50MD017349 (U.S. NIH Grant/Contract)
  • 4UH3HD111325-02 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

IPD Sharing Time Frame

IPD and supporting information will be available at the conclusion of data collection (11/1/2027) and will last for 5 years (10/31/2032).

IPD Sharing 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.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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