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NCT Number: NCT06736730

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Mississippi Medical Center

Jackson, Mississippi, 39216, United States

Location contact

Alyscia Severance, M.D

CONTACT

[email protected]

601-815-1292 ext. 51292

Lei Zhang, PHD

CONTACT

Leila Seidfaraji, MPH

CONTACT

[email protected]

601-984-6237 ext. 46237

Matthew E. Kutcher, MD

CONTACT

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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)

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).

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Incidence of PTSD, Score of perceived stress and social cohesion

    Time frame: Three years starting upon implementation of the intervention protocol

    Individual level longitudinal measure and includes "incidence of PTSD, score of perceived stress and social cohesion" collected by individual level surveys.

Study contacts

Contact information is provided by the study sponsor or research team.

Lei Zhang, PHD

CONTACT

[email protected]

601-984-6234

Masoumeh Karimi, PHD

CONTACT

[email protected]

601-984-6230

Sponsors and collaborators

Lead sponsor

University of Mississippi Medical Center

Other

Collaborators

  • National Institute on Minority Health and Health Disparities (NIMHD)
  • National Institutes of Health (NIH)

Registry information

Official study title

A Proposal to Establish the Mississippi Violence Injury Prevention (VIP) Program

Acronym: MS-VIP

Important dates

Study start
2025
Primary completion
2027
Study completion
2028
First posted
Dec 17, 2024
Registry last updated
Jan 16, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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