Gun Shot WoundMS-VIPNCT06736730
Mississippi Violence Injury Prevention (VIP) Program
A study testing Hospital-Linked Violence Intervention Program, Mobile Community Event Support and Unrestricted Cash Assistance in people with Gun Shot Wound, run by University of Mississippi Medical Center at 1 site in United States.
Trial summary
This clinical trial is designed to evaluate the effectiveness of three interventions aimed at preventing violence and supporting those affected by it. Over next three years, the impact of these interventions on key areas will be measured, including the incidence of firearm injuries, the recovery of victims, the… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gun Shot Wound
- What is being tested?
- Hospital-Linked Violence Intervention Program, Mobile Community Event Support and Unrestricted Cash Assistance
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2025to 30 Jun 2028
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 years or older
- Firearm injury within the last 24 hours prior to their arrival at the University of Mississippi Medical Center
- Residency/home address within one of the designated clusters.
- Be approached by the research team within 72 hours of arrival.
- Ability to understand the clinical trial, sign the consent form, and commit to follow-ups.
- Ability and willingness to engage in all aspects of the intervention arm (must agree to Operation Good, Survey Participation, and Unrestricted Cash Assistance, these interventions/evaluations cannot be separated)
Who cannot join
- Self-inflicted gunshot wounds
- Less than 18 years of age
- Patients who are incarcerated or in-custody
- Patients who are unable to understand the clinical trial or sign consent (whether from intoxication, injury, or other cause)
- Patients unable to commit to follow-up or be contacted through routine means
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
University of Mississippi Medical Center
Jackson, Mississippi, 39216
Alyscia Severance, M.D, 601-815-1292 ext. 51292, aseverance@umc.edu
Leila Seidfaraji, MPH, 601-984-6237 ext. 46237, lseidfaraji@umc.edu
About this study
Official title: A Proposal to Establish the Mississippi Violence Injury Prevention (VIP) Program
This clinical trial is designed to evaluate the effectiveness of three interventions aimed at preventing violence and supporting those affected by it. Over next three years, the impact of these interventions on key areas will be measured, including the incidence of firearm injuries, the recovery of victims, the occurrence of retaliation and re-injury, and health economics. The interventions are developed based on data collected from a comprehensive needs assessment, community summit, retrospective medical chart reviews, and focus group sessions. The defined interventions are as follows:
Intervention A - Integration of an existing community-based intervention program with Hospital services intervention B - Unrestricted Cash Assistance Intervention C - Mobile Community Support Services
Additionally, the investigators will implement a detailed violence-focused survey for firearm survivors at the time of study enrollment. Follow-up is planned at 3,6 and 12 months. The results of this trial (including analyses of firearm injury rates, recovery outcomes, retaliation/re-injury occurrences, and economic data) will be shared with the affected communities and stakeholders to promote ongoing improvement and support.
Read the detailed description
To achieve the goals of this trial, the investigators will activate community-focused interventions developed during the first phase of the study to help enroll participants in the study using a stepped wedge cluster design based on their dwelling addresses.
The investigators will formalize the 9 clusters using geographic and demographic data specific to Jackson, Mississippi. Patients presenting in the ER with gunshot injuries will be randomized based on their dwelling address, which will be matched to their corresponding cluster's randomization assignments for the interventions of VIP (Operation Good), Cash Assistance, and Mobile Community Support Services. Any patient with a gunshot injury, regardless of their dwelling address, will be eligible for consent to participate in the longitudinal follow-up of the study. Those not in a currently active clusters at the time of injury will serve as controls for the survey results. Study investigators plan to enroll up to 15 active patients per cluster per year for this follow-up, and community events will be aligned with the same cluster random assignments used for patient interventions.
- Conditions
- Gun Shot Wound
- Being tested
- Hospital-Linked Violence Intervention Program, Mobile Community Event Support, Unrestricted Cash Assistance
- Keywords
- Violence prevention, Community-based interventions, Health economics of violence, Clinical trial on violence prevention, Firearm injury prevention, Retaliation and reinjury
- Medical subject headings
- Wounds, Gunshot, Reinjuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hospital-Linked Violence Intervention ProgramBehavioural
Activation of Operation Good, our community partner with a history of direct violence interruption in the streets and longitudinal health and wellness services to firearm injured patient (i.e. linking and aiding those who have suffered from violent injury to mental healthcare, job services, educational services)
Mobile Community Event SupportBehavioural
A menu of services provided to the community in an activated cluster where funding will be provided to assist that community in holding events that support overall health and wellness (community clean-up, legal advisory services, pop-up clinic for blood pressure checks).
Unrestricted Cash AssistanceBehavioural
A participant in an activated cluster after firearm injury will receive two disbursements of 500$. One at the time of initial hospital evaluation and a second disbursement ~1 month later to offset the financial burden associated with firearm injury on the individual.
| Study group | Role | What they receive |
|---|---|---|
| Active Arm | Experimental | Intervention: It includes three key components:
1. Unrestricted Cash Assistance provided to individuals to support their immediate needs,
2. Mobile Community Support Services that offer on-site assistance and resources, and
3. Activation of Operation Good with coordination between hospital and community services to ensure seamless support for individuals affected by violence, promoting recovery and reducing the risk of re-injury or retaliation. Receives: Behavioral: Hospital-Linked Violence Intervention Program; Behavioral: Mobile Community Event Support; Behavioral: Unrestricted Cash Assistance |
| In-Active Arm | No intervention | This group will receive no intervention beyond the standard care provided in the hospital setting. No additional services, cash assistance, or community-based support will be offered. This arm will serve as a comparison group to evaluate the effectiveness of the intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of death and gunshot injuries
The data will be collected from hospital and JPD records. Excluding self-inflicted such as suicide or adjudicated to be accidental/unintentional.
Measured: Three years starting upon implementation of the intervention protocol
Secondary outcomes (1)
Incidence of PTSD, Score of perceived stress and social cohesion
Individual level longitudinal measure and includes "incidence of PTSD, score of perceived stress and social cohesion" collected by individual level surveys.
Measured: Three years starting upon implementation of the intervention protocol
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2024
- Study start1 Mar 2025 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion30 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Gun Shot WoundStudies of the same condition, open and under way.
- 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
- Sequential
- Model description
- Jackson, MS will be divided into 9 clusters (with defined geographic boundaries and know population totals) and those clusters will undergo randomization for activation. 3 clusters will be activated each year for three years and those living in the activated clusters will receive the interventions upon activation. Results from participants living in active clusters will be compared to those not in active clusters until at the end of the three years study period all clusters will be activated.
- Masking
- None (open label)
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Mississippi Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute on Minority Health and Health Disparities (NIMHD)
- Responsible party
- Sponsor
- Investigators
- Lei Zhang, PHD, Principal investigator, Associate Dean For Research And Scholarship
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06736730
- Sponsor's protocol ID
- UMMC-IRB-2024-347
- Other IDs
- 4UH3MD018298-02
- Acronym
- MS-VIP
- Status last verified
- Jan 2025
- First submitted
- 30 Oct 2024
- Last updated
- 16 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Formica MK. An Eye on Disparities, Health Equity, and Racism-The Case of Firearm Injuries in Urban Youth in the United States and Globally. Pediatr Clin North Am. 2021 Apr;68(2):389-399. doi: 10.1016/j.pcl.2020.12.009. Epub 2021 Jan 26.
PubMed 33678293Girling AJ, Hemming K. Statistical efficiency and optimal design for stepped cluster studies under linear mixed effects models. Stat Med. 2016 Jun 15;35(13):2149-66. doi: 10.1002/sim.6850. Epub 2016 Jan 7.
PubMed 26748662Hooper R, Teerenstra S, de Hoop E, Eldridge S. Sample size calculation for stepped wedge and other longitudinal cluster randomised trials. Stat Med. 2016 Nov 20;35(26):4718-4728. doi: 10.1002/sim.7028. Epub 2016 Jun 28.
PubMed 27350420Morris MC, Rao U, Garber J. Cortisol responses to psychosocial stress predict depression trajectories: social-evaluative threat and prior depressive episodes as moderators. J Affect Disord. 2012 Dec 20;143(1-3):223-30. doi: 10.1016/j.jad.2012.05.059. Epub 2012 Aug 1.
PubMed 22858210Zun LS, Downey L, Rosen J. The effectiveness of an ED-based violence prevention program. Am J Emerg Med. 2006 Jan;24(1):8-13. doi: 10.1016/j.ajem.2005.05.009.
PubMed 16338502Bauer DJ, Preacher KJ, Gil KM. Conceptualizing and testing random indirect effects and moderated mediation in multilevel models: new procedures and recommendations. Psychol Methods. 2006 Jun;11(2):142-63. doi: 10.1037/1082-989X.11.2.142.
PubMed 16784335
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Proposal to Establish the Mississippi Violence Injury Prevention (VIP) Program
- ClinicalTrials.gov ID
- NCT06736730
- Acronym / sponsor ID
- MS-VIP / UMMC-IRB-2024-347
- Conditions
- Gun Shot Wound
- Keywords
- Violence prevention, Community-based interventions, Health economics of violence, Clinical trial on violence prevention, Firearm injury prevention, Retaliation and reinjury
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- University of Mississippi Medical CenterUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute on Minority Health and Health Disparities (NIMHD)
- Study start
- 1 Mar 2025 (estimated)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 30 Jun 2028 (estimated)
- First posted
- 17 Dec 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.
This clinical trial is designed to evaluate the effectiveness of three interventions aimed at preventing violence and supporting those affected by it. Over next three years, the impact of these interventions on key areas will be measured, including the incidence of firearm injuries, the recovery of victims, the occurrence of retaliation and re-injury, and health economics. The interventions are developed based on data collected from a comprehensive needs assessment, community summit, retrospective medical chart reviews, and focus group sessions. The defined interventions are as follows:
Intervention A - Integration of an existing community-based intervention program with Hospital services intervention B - Unrestricted Cash Assistance Intervention C - Mobile Community Support Services
Additionally, the investigators will implement a detailed violence-focused survey for firearm survivors at the time of study enrollment. Follow-up is planned at 3,6 and 12 months. The results of this trial (including analyses of firearm injury rates, recovery outcomes, retaliation/re-injury occurrences, and economic data) will be shared with the affected communities and stakeholders to promote ongoing improvement and support.
Detailed description
To achieve the goals of this trial, the investigators will activate community-focused interventions developed during the first phase of the study to help enroll participants in the study using a stepped wedge cluster design based on their dwelling addresses.
The investigators will formalize the 9 clusters using geographic and demographic data specific to Jackson, Mississippi. Patients presenting in the ER with gunshot injuries will be randomized based on their dwelling address, which will be matched to their corresponding cluster's randomization assignments for the interventions of VIP (Operation Good), Cash Assistance, and Mobile Community Support Services. Any patient with a gunshot injury, regardless of their dwelling address, will be eligible for consent to participate in the longitudinal follow-up of the study. Those not in a currently active clusters at the time of injury will serve as controls for the survey results. Study investigators plan to enroll up to 15 active patients per cluster per year for this follow-up, and community events will be aligned with the same cluster random assignments used for patient interventions.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Jackson, MS will be divided into 9 clusters (with defined geographic boundaries and know population totals) and those clusters will undergo randomization for activation. 3 clusters will be activated each year for three years and those living in the activated clusters will receive the interventions upon activation. Results from participants living in active clusters will be compared to those not in active clusters until at the end of the three years study period all clusters will be activated.
| Arm | Type | Receives |
|---|---|---|
| Active Arm | Experimental | Behavioral: Hospital-Linked Violence Intervention Program, Behavioral: Mobile Community Event Support, Behavioral: Unrestricted Cash AssistanceIntervention: It includes three key components: 1. Unrestricted Cash Assistance provided to individuals to support their immediate needs, 2. Mobile Community Support Services that offer on-site assistance and resources, and 3. Activation of Operation Good with coordination between hospital and community services to ensure seamless support for individuals affected by violence, promoting recovery and reducing the risk of re-injury or retaliation. |
| In-Active Arm | No intervention | –This group will receive no intervention beyond the standard care provided in the hospital setting. No additional services, cash assistance, or community-based support will be offered. This arm will serve as a comparison group to evaluate the effectiveness of the intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age 18 years or older
- Firearm injury within the last 24 hours prior to their arrival at the University of Mississippi Medical Center
- Residency/home address within one of the designated clusters.
- Be approached by the research team within 72 hours of arrival.
- Ability to understand the clinical trial, sign the consent form, and commit to follow-ups.
Key exclusion criteria (5 listed)
- Self-inflicted gunshot wounds
- Less than 18 years of age
- Patients who are incarcerated or in-custody
- Patients who are unable to understand the clinical trial or sign consent (whether from intoxication, injury, or other cause)
- Patients unable to commit to follow-up or be contacted through routine means
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 |
|---|---|---|
| Hospital-Linked Violence Intervention ProgramActivation of Operation Good, our community partner with a history of direct violence interruption in the streets and longitudinal health and wellness services to firearm injured patient (i.e. linking and aiding those who have suffered from violent injury to mental healthcare, job services, educational services) | Behavioural | Active Arm |
| Mobile Community Event SupportA menu of services provided to the community in an activated cluster where funding will be provided to assist that community in holding events that support overall health and wellness (community clean-up, legal advisory services, pop-up clinic for blood pressure checks). | Behavioural | Active Arm |
| Unrestricted Cash AssistanceA participant in an activated cluster after firearm injury will receive two disbursements of 500$. One at the time of initial hospital evaluation and a second disbursement ~1 month later to offset the financial burden associated with firearm injury on the individual. | Behavioural | Active Arm |
Primary outcome
Incidence of death and gunshot injuries
Time frame: Three years starting upon implementation of the intervention protocol
The data will be collected from hospital and JPD records. Excluding self-inflicted such as suicide or adjudicated to be accidental/unintentional.
1 secondary outcome
Incidence of PTSD, Score of perceived stress and social cohesion
Time frame: Three years starting upon implementation of the intervention protocol
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 16 Jan 2025.
- Background: PubMed 33678293Formica MK. An Eye on Disparities, Health Equity, and Racism-The Case of Firearm Injuries in Urban Youth in the United States and Globally. Pediatr Clin North Am. 2021 Apr;68(2):389-399. doi: 10.1016/j.pcl.2020.12.009. Epub 2021 Jan 26.
- Background: PubMed 26748662Girling AJ, Hemming K. Statistical efficiency and optimal design for stepped cluster studies under linear mixed effects models. Stat Med. 2016 Jun 15;35(13):2149-66. doi: 10.1002/sim.6850. Epub 2016 Jan 7.
- Background: PubMed 27350420Hooper R, Teerenstra S, de Hoop E, Eldridge S. Sample size calculation for stepped wedge and other longitudinal cluster randomised trials. Stat Med. 2016 Nov 20;35(26):4718-4728. doi: 10.1002/sim.7028. Epub 2016 Jun 28.
- Background: PubMed 22858210Morris MC, Rao U, Garber J. Cortisol responses to psychosocial stress predict depression trajectories: social-evaluative threat and prior depressive episodes as moderators. J Affect Disord. 2012 Dec 20;143(1-3):223-30. doi: 10.1016/j.jad.2012.05.059. Epub 2012 Aug 1.
- Background: PubMed 16338502Zun LS, Downey L, Rosen J. The effectiveness of an ED-based violence prevention program. Am J Emerg Med. 2006 Jan;24(1):8-13. doi: 10.1016/j.ajem.2005.05.009.
- Background: PubMed 16784335Bauer DJ, Preacher KJ, Gil KM. Conceptualizing and testing random indirect effects and moderated mediation in multilevel models: new procedures and recommendations. Psychol Methods. 2006 Jun;11(2):142-63. doi: 10.1037/1082-989X.11.2.142.
- Mississippi Violence Injury Prevention Program Overview,Link provided by the sponsor.
- Individual participant dataSharing planned: No
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.
Lei Zhang, PHD principal investigator
Associate Dean For Research And Scholarship
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hospital-Linked Violence Intervention Program, Mobile Community Event Support and Unrestricted Cash Assistance in people with Gun Shot Wound, run by University of Mississippi Medical Center 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 6 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: opening soon, as of the sponsor's last update on 16 Jan 2025. 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 Lei Zhang, PHD (601-984-6234, lzhang2@umc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of death and gunshot injuries (time frame: Three years starting upon implementation of the intervention protocol). 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 NCT06736730, which also lists 6 linked publications.
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 16 Jan 2025; AzTrials last refreshed its copy on 31 Oct 2026.