Firearm InjuryHVIP-MLPNCT07764458
Recovery Legal Care Trial
A study testing Recovery Legal Care in people with Firearm Injury and Injury Traumatic, run by University of Chicago at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 14 years and older
- Conditions the study is for
- Firearm Injury, Injury Traumatic, Economic Problems
- What is being tested?
- Recovery Legal Care
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 11 May 2026to 31 Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Chicago Medical Center
Chicago, Illinois, 60637
About this study
Official title: Health Impact of the "Recovery Legal Care" Medical-Legal Partnership
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.
- Conditions
- Firearm Injury, Injury Traumatic, Economic Problems
- Being tested
- Recovery Legal Care, HVIP Standard of Care
- Medical subject headings
- Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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 Standard of CareOther
These patients will receive HVIP standard of care (Violence Recovery Program Support).
| Study group | Role | What they receive |
|---|---|---|
| HVIP-MLP | Experimental | This arm includes patients receiving usual care and also support from Recovery Legal Care (HVIP+MLP). Receives: Other: Recovery Legal Care |
| HVIP | Active comparator | This arm includes patients receiving usual care (HVIP only). Receives: Other: HVIP Standard of Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, 3 months, 6 months, 12 months
Secondary outcomes (2)
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.
Measured: Baseline, 3 months, 6 months, 12 months
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.
Measured: Baseline, 3 months, 6 months, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2026
- Study start11 May 2026
- Primary completion31 Jul 2027 (estimated)
- Study completion31 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Firearm InjuryStudies of the same condition, open and under way.
- More trials run by University of ChicagoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Chicago
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07764458
- Sponsor's protocol ID
- IRB25-1731
- Other IDs
- 5UH3HD111325-03
- Acronym
- HVIP-MLP
- Status last verified
- Oct 2026
- First submitted
- 4 Aug 2026
- Last updated
- 28 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
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
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Health Impact of the "Recovery Legal Care" Medical-Legal Partnership
- ClinicalTrials.gov ID
- NCT07764458
- Acronym / sponsor ID
- HVIP-MLP / IRB25-1731
- Conditions
- Firearm Injury, Injury Traumatic, Economic Problems
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University of ChicagoUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- 11 May 2026 (actual)
- Primary completion
- 31 Jul 2027 (estimated)
- Study completion
- 31 Jul 2027 (estimated)
- First posted
- 14 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HVIP-MLP | Experimental | Other: Recovery Legal CareThis arm includes patients receiving usual care and also support from Recovery Legal Care (HVIP+MLP). |
| HVIP | Active comparator | Other: HVIP Standard of CareThis arm includes patients receiving usual care (HVIP only). |
Who may qualify
- Ages
- 14 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Recovery Legal CareThese 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 | HVIP-MLP |
| HVIP Standard of CareThese patients will receive HVIP standard of care (Violence Recovery Program Support). | Other | HVIP |
Primary outcome
Perceived Stress
Time frame: Baseline, 3 months, 6 months, 12 months
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.
2 secondary outcomes
Firearm victimization and aggression
Time frame: Baseline, 3 months, 6 months, 12 months
Legal needs self-efficacy
Time frame: Baseline, 3 months, 6 months, 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2026.
- Results publication: PubMed 41100080Tung 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.
- Individual participant dataSharing planned: 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.
Related trials for Firearm Injury
Active, not recruiting
Recovery Legal Care Pilot
Firearm Injury, Economic Problems
Recruiting
Launching the Houston Hospital-Based Violence Intervention Program (Houston-HVIP): Developing and Evaluating a Hospital-Based Intervention to Reduce Recurrent Violence
Firearm Injury
Enrolling by invitation
Pediatric Trauma Centers RE-AIM at Gun Safety
Firearm Injury, Safety Issues
Not yet recruiting
Enhancing an Existing Prevention Strategy to Reduce Intentional Firearm Injuries Among High-risk Youth (Phase 1)
Prevention
Enrolling by invitation
Rise up! A Youth-Informed Video Program For Young Children To Stay Safe From Community Violence
Firearm Injury
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Recovery Legal Care in people with Firearm Injury and Injury Traumatic, run by University of Chicago at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tanya L Zakrison, MD, MPH (786-266-2228, tzakrison@bsd.uchicago.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Perceived Stress (time frame: Baseline, 3 months, 6 months, 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07764458, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2026.