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RecruitingNCT07764458HVIP-MLPUpdated Aug 14, 2026

Recovery Legal Care Randomized Trial

An interventional study of Recovery Legal Care and HVIP Standard of Care in Firearm Injury, Injury Traumatic and Economic Problems, sponsored by University of Chicago. Recruiting at 1 site in United States. Open to participants aged 14 Years and older. Per ClinicalTrials.gov, last updated 2026-08-14.

Sponsored by University of Chicago · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
200
Allocation
Randomized
Ages
14 Years and older
Sex
All
01

Study 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.

Read the 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 no evidence to date that has demonstrated effectiveness in this approach for HVIPs, despite proliferation across the country. A criticism of this approach to violence prevention is the difficulty for community-based violence prevention specialists from HVIP programs to address the broader social and economic risk factors that lead to violence through individual behavior modification. Medical-Legal Partnerships (MLPs) have been 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. The MLP approach has yet to be done for trauma patients and has not been incorporated into any HVIP approach thus far. In the study's biphasic proposal, the UG3 aims are to clearly identify the types of health-harming legal needs of patients and families affected by firearm violence and examine the population-level differences in types of legal needs by sociodemographic and geographic factors. The investigators then aim to develop the HVIP-MLP model for implementation at an urban, Level I Trauma Center on the South Side of Chicago. The UH3 aims are to examine implementation outcomes (acceptability and feasibility) of this novel MLP compared to standard of care with HVIP; and examine health outcomes via a clinical trial measuring primary health outcome (perceived stress) and secondary outcomes (improvements in legal need self-efficacy, PTSD symptoms, and firearm aggression and victimization). Close coordination with the CFVP Coordinating Center will be essential for data handling, measurement, analytics support and consultation with future public/stakeholder engagement and dissemination to demonstrate public health impact. 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.

02

Conditions studied

  • Firearm Injury
  • Injury Traumatic
  • Economic Problems

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03

Who can participate

Ages eligible
14 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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)

Exclusion criteria

Exclusion Criteria:

  • 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
04

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
200 participants (estimated)

Study arms

  • Experimental
    HVIP-MLP

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

    Other: Recovery Legal Care

  • Active comparator
    HVIP

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

    Other: HVIP Standard of Care

Interventions

  • OtherRecovery 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.

  • OtherHVIP Standard of Care

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

05

What researchers measure

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.

    Time frame: Baseline, 3 months, 6 months, 12 months

Secondary outcomes

  1. Firearm victimization and aggression

    The adapted Conflict Tactics Scale 2 (CTS2) measures behaviors related to firearm victimization and aggression. The adapted version includes 3 items on non-partner victimization and 3 items on non-partner aggression, each rated on a 7-point frequency scale (never to 20+ times). Each domain generates a score from 0 to 18 with a higher score indicating higher victimization or aggression.

    Time frame: Baseline, 3 months, 6 months, 12 months

  2. Legal needs self-efficacy

    Adapted Bandura Self-Efficacy Scale measures belief in one's ability to have legal needs addressed and is scored on a scale from 0 to 100, with a higher score indicating higher self-efficacy.

    Time frame: Baseline, 3 months, 6 months, 12 months

Other outcomes

  1. Health-related quality of life

    The SF-12 (12-Item Short-Form Health Survey) is a brief, 12-question patient-reported tool used to measure physical and mental health-related quality of life. Derived from the longer SF-36 survey, it takes about two minutes to complete and evaluates eight core health domains. The SF-12 survey yields two primary summary scores-the Physical Component Summary (PCS-12) and the Mental Component Summary (MCS-12). Both scores use norm-based calculations scaled to a general population average (mean) of 50 and a standard deviation of 10, with higher scores indicating higher quality of life.

    Time frame: Baseline, 3 months, 6 months, 12 months

  2. Post-Traumatic Stress Disorder (PTSD) Symptoms

    The PCL-5 (Posttraumatic Stress Disorder Checklist for DSM-5) is a 20-question self-test that tracks post-traumatic stress disorder (PTSD) symptoms. You rate each question from 0 to 4. Add all numbers for a total score between 0 and 80, with higher scores indicating more severe PTSD symptoms.

    Time frame: Baseline, 3 months, 6 months, 12 months

06

Study locations

1 of 1 sites recruiting
  • University of Chicago Medical Center
    Chicago, Illinois 60637, United States
    Recruiting
07

References and documents

Publications

  • 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. PubMed 41100080 ↗

Individual participant data

Plan to share: Yes — 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.

Supporting information: Study protocol, Sap, Csr

08

Registry details

Key details

Study ID
NCT07764458
Lead sponsor
University of Chicago
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Responsible party
Sponsor
First posted
Aug 14, 2026
Start date
May 11, 2026
Primary completion
Jul 31, 2027 (estimated)
Completion
Jul 31, 2027 (estimated)
Last update
Aug 14, 2026

Study contacts

Tanya L Zakrison, MD, MPH
Contact
tzakrison@bsd.uchicago.edu
786-266-2228
Elizabeth L Tung, MD, MS
Contact
etung2@bsd.uchicago.edu
773-702-6840

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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