Mississippi Violence Injury Prevention (VIP) Program (MS-VIP)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Gun Shot Wound
• Intervention / Treatment: Behavioral: Hospital-Linked Violence Intervention Program; Behavioral: Mobile Community Event Support; Behavioral: Unrestricted Cash Assistance

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 Type: Interventional
• Enrollment (Estimated): 500
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Lei Zhang, PHD; Phone Number: 601-984-6234; Email: lzhang2@umc.edu
• Study Contact Backup: Name: Masoumeh Karimi, PHD; Phone Number: 601-984-6230; Email: mkarimi@umc.ed

Study Locations

• United States
  • Mississippi
    • Jackson, Mississippi, United States, 39216
      • University of Mississippi Medical Center
      • Contact: Lei Zhang, PHD
      • Contact: Matthew E. Kutcher, MD
      • Contact: Alyscia Severance, M.D; Phone Number: 51292 601-815-1292; Email: aseverance@umc.edu
      • Contact: Leila Seidfaraji, MPH; Phone Number: 46237 601-984-6237; Email: lseidfaraji@umc.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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)

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Active Arm; Intervention: It includes three key components: Unrestricted Cash Assistance provided to individuals to support their immediate needs,; Mobile Community Support Services that offer on-site assistance and resources, and; 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.	Behavioral: Hospital-Linked Violence Intervention Program; 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); Behavioral: Mobile Community Event Support; 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).; Behavioral: Unrestricted Cash Assistance; 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.
No Intervention: In-Active Arm; 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 the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Three years starting upon implementation of the intervention protocol

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Three years starting upon implementation of the intervention protocol

Collaborators and Investigators

• Sponsor: University of Mississippi Medical Center
• Collaborators: National Institute on Minority Health and Health Disparities (NIMHD); National Institutes of Health (NIH)
• Investigators: Principal Investigator: Lei Zhang, PHD, Associate Dean For Research And Scholarship

Publications and helpful links

General Publications

• Girling 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.
• Bauer 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.
• Hooper 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.
• 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.
• Morris 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.
• Zun 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.

Helpful Links

• Mississippi Violence Injury Prevention Program Overview,

Study record dates

Study Major Dates

• Study Start (Estimated): March 1, 2025
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): June 30, 2028

Study Registration Dates

• First Submitted: October 30, 2024
• First Submitted That Met QC Criteria: December 13, 2024
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 13, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Keywords: Violence prevention; Community-based interventions; Health economics of violence; Clinical trial on violence prevention; Firearm injury prevention; Retaliation and reinjury
• Additional Relevant MeSH Terms: Wounds and Injuries; Wounds, Penetrating; Wounds, Gunshot
• Other Study ID Numbers: UMMC-IRB-2024-347; 4UH3MD018298-02 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No