Mississippi Violence Injury Prevention (VIP) Program

NCT06736730 | Not Yet Recruiting DMC

• 2 other identifiers: UMMC-IRB-2024-3474UH3MD018298-02
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 1

Brief 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 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.

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Incidence of PTSD, Score of perceived stress and social cohesion

  Three years starting upon implementation of the intervention protocol

Study Arms (2)

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.

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.

Interventions

Hospital-Linked Violence Intervention Program BEHAVIORAL

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)

Active Arm

Mobile Community Event Support BEHAVIORAL

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).

Active Arm

Unrestricted Cash Assistance BEHAVIORAL

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.

Active Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Mississippi Medical Center: lead
• National Institutes of Health (NIH): collaborator
• National Institute on Minority Health and Health Disparities (NIMHD): collaborator

Study Sites (1)

University of Mississippi Medical Center

Jackson, Mississippi, 39216, United States

Location

Related Publications (6)

• 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.

  PMID: 33678293 BACKGROUND

• 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.

  PMID: 26748662 BACKGROUND

• 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.

  PMID: 27350420 BACKGROUND

• 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.

  PMID: 22858210 BACKGROUND

• 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.

  PMID: 16338502 BACKGROUND

• 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.

  PMID: 16784335 BACKGROUND

Related Links

• Mississippi Violence Injury Prevention Program Overview,

MeSH Terms

Conditions

Wounds, Gunshot; Reinjuries

Condition Hierarchy (Ancestors)

Wounds, Penetrating; Wounds and Injuries

Study Officials

• Lei Zhang, PHD

  Associate Dean For Research And Scholarship

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lei Zhang, PHD

CONTACT

601-984-6234; lzhang2@umc.edu

Masoumeh Karimi, PHD

CONTACT

601-984-6230; mkarimi@umc.ed

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: October 30, 2024
• First Posted: December 17, 2024
• Study Start: March 1, 2025
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): June 30, 2028
• Last Updated: January 16, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)