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

University of Mississippi

Status: Not yet enrolling

Conditions: Gun Shot Wound

Treatments: Behavioral: Hospital-Linked Violence Intervention Program; Behavioral: Mobile Community Event Support; Behavioral: Unrestricted Cash Assistance

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06736730

4UH3MD018298-02 (U.S. NIH Grant/Contract)

UMMC-IRB-2024-347

Details and patient eligibility

About

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.

Full 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.

Enrollment: 500 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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500 participants in 2 patient groups

Active Arm

Experimental group

Description:

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.

Treatment:

Behavioral: Unrestricted Cash Assistance

Behavioral: Mobile Community Event Support

Behavioral: Hospital-Linked Violence Intervention Program

In-Active Arm

No Intervention group

Description:

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.