Firearm InjuryHVIP-MLPNCT06618794
Recovery Legal Care Pilot
A study testing Recovery Legal Care in people with Firearm Injury and Economic Problems, run by University of Chicago at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 14 years and older
- Conditions the study is for
- Firearm Injury, Economic Problems, Injury Traumatic
- What is being tested?
- Recovery Legal Care
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 202 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Feb 2025to 30 Jun 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)
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Chicago Medical Center
Chicago, Illinois, 60637
About this study
Official title: Recovery Legal Care Pilot (Cohort 1)
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.
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 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.
- Conditions
- Firearm Injury, Economic Problems, Injury Traumatic
- Being tested
- Recovery Legal Care, HVIP Standard of Care
- Keywords
- Firearm injury, Community violence, Medical-Legal Partnership, Structural violence, Civil law attorneys, Health-Harming Legal Needs, Hospital-Based Violence Intervention Program
- 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
Also called Civil Law Attorney Support, Public Benefits Attorney Support, Legal Aid Chicago Support
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
Also called HVIP - Violence Recovery Program
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; Other: HVIP Standard of 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.
Stress
The Patient-Reported Outcomes Measurement Information System (PROMIS) scale measures self-reported psychological stress.
Measured: Baseline, 3 months, 6 months, 12 months, 18 months
Secondary outcomes (2)
Firearm victimization and aggression
The adapted Conflict Tactics Scale 2 (CTS2) measures behaviors related to firearm victimization and aggression over the past 3 months.
Measured: Baseline, 3 months, 6 months, 12 months, 18 months
Legal needs self-efficacy
The adapted Bandura Self-Efficacy Scale measures belief in one's ability to have legal needs addressed.
Measured: Baseline, 3 months, 6 months, 12 months, 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2024
- Study start10 Feb 2025
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Jun 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 202 participants (actual)
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), U.S. Department of Justice, National Institute on Minority Health and Health Disparities (NIMHD)
- Responsible party
- Sponsor
- Investigators
- TANYA L ZAKRISON, MD, MPH, Principal investigator, University of ChicagoELIZABETH L TUNG, MD, MS, Principal investigator, University of Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06618794
- Sponsor's protocol ID
- IRB24-0491
- Other IDs
- 4UH3HD111325-02, P50MD017349
- Acronym
- HVIP-MLP
- Status last verified
- Oct 2026
- First submitted
- 6 Mar 2024
- Last updated
- 27 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 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Recovery Legal Care Pilot (Cohort 1)
- ClinicalTrials.gov ID
- NCT06618794
- Acronym / sponsor ID
- HVIP-MLP / IRB24-0491
- Conditions
- Firearm Injury, Economic Problems, Injury Traumatic
- Keywords
- Firearm injury, Community violence, Medical-Legal Partnership, Structural violence, Civil law attorneys, Health-Harming Legal Needs, Hospital-Based Violence Intervention Program
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 202 participants (actual)
- Lead sponsor
- University of ChicagoUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), U.S. Department of Justice, National Institute on Minority Health and Health Disparities (NIMHD)
- Study start
- 10 Feb 2025 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 1 Oct 2024 (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 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.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HVIP-MLP | Experimental | Other: Recovery Legal Care, Other: HVIP Standard of 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 (5 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)
- 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.
Key exclusion criteria (8 listed)
- 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
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 CareAlso: Civil Law Attorney Support, Public Benefits Attorney Support, Legal Aid Chicago SupportThese 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 CareAlso: HVIP - Violence Recovery ProgramThese patients will receive HVIP standard of care (Violence Recovery Program Support) | Other | HVIP, HVIP-MLP |
Primary outcome
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.
2 secondary outcomes
Firearm victimization and aggression
Time frame: Baseline, 3 months, 6 months, 12 months, 18 months
Legal needs self-efficacy
Time frame: Baseline, 3 months, 6 months, 12 months, 18 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 27 Oct 2026.
- Background: 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.
- Program/intervention websiteLink provided by the sponsor.
- 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.
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Rise up! A Youth-Informed Video Program For Young Children To Stay Safe From Community Violence
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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. This study is not recruiting at the moment.
TANYA L ZAKRISON, MD, MPH principal investigator
University of Chicago
ELIZABETH L TUNG, MD, MS principal investigator
University of Chicago
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 Economic Problems, 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 5 inclusion and 8 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: under way, not looking for participants, as of the sponsor's last update on 27 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Stress (time frame: Baseline, 3 months, 6 months, 12 months, 18 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 NCT06618794, 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 27 Oct 2026; AzTrials last refreshed its copy on 6 Nov 2026.