NCT06263647

Brief Summary

A prior violent injury is one of the strongest predictors of future violent injury, highlighting the importance of effective hospital-based interventions to prevent reinjury. This project will establish and evaluate the Houston Hospital-Based Violence Intervention Program (Houston-HVIP). Using a randomized controlled trial, the study will assess the effectiveness of Houston-HVIP in reducing violent reinjury and improving behavioral, mental, and physical health outcomes over a 12-month follow-up period among those enrolled in the study in ages 16-35 years of age.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
274

participants targeted

Target at P75+ for not_applicable

Timeline
25mo left

Started Sep 2025

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress24%
Sep 2025May 2028

First Submitted

Initial submission to the registry

February 8, 2024

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 16, 2024

Completed
1.6 years until next milestone

Study Start

First participant enrolled

September 16, 2025

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2028

Expected
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2028

Last Updated

January 21, 2026

Status Verified

May 1, 2025

Enrollment Period

2.4 years

First QC Date

February 8, 2024

Last Update Submit

January 19, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Change in repeat violent victimization as assessed by the number of participants who return to the hospital system for for an intentional firearm injury

    Baseline , 3 months, 6 months, 9 months and 12 months

Secondary Outcomes (5)

  • Change in repeat non-firearm violent victimization as assessed by the number of participants who return to the hospital system for an intentional non-firearm injury

    Baseline , 3 months, 6 months, 9 months and 12 months

  • Change in attitudes towards firearm violence as assessed by Firearm Violences Attitudes (Sheley; Shapiro) questionnaire

    Baseline , 3 months, 6 months, 9 months and 12 months

  • Change in post-traumatic stress as assessed by the post-Traumatic Stress Disorder Checklist Version 5(PCL-5)

    Baseline , 3 months, 6 months, 9 months and 12 months

  • Change in aggression as assessed by the Copeland-Linder questionnaire.

    Baseline , 3 months, 6 months, 9 months and 12 months

  • Change in general health as assessed by the 12-item Short Form Health Survey (SF-12)

    Baseline , 3 months, 6 months, 9 months and 12 months

Study Arms (2)

Houston-HVIP treatment group

EXPERIMENTAL
Behavioral: Houston-HVIP treatment

Standard of Care group

ACTIVE COMPARATOR
Behavioral: Standard of Care

Interventions

Participants will be assigned a case manager to provide a brief assessment of , psychological and social needs and a risk assessment and create individualized discharge planning. Participants will be referred to tailored social service programs based on the needs, including assessments of social determinants of health, educational and financial needs, and subsequent referral for programs such as job training, educational support, housing assistance, or financial assistance programs for identified needs. Participants identified at risk for violence perpetration via a risk assessment screener will be referred to the violence interrupter services. Long-term opportunities for engagement with the trauma survivors' network within Memorial Hermann Hospital will be available and encouraged.Participants will receive a structured curriculum that will include regular check-in with an assigned case manager over 6 months to promote successful community-based program integration and completion.

Houston-HVIP treatment group

Participants will be assigned a case manager to meet with the injured patients to briefly assess (a) psychological and social needs and (b) a risk assessment and create individualized discharge planning. Resources for the patient to connect with social service programs will be provided by the case manager. Long-term opportunities for engagement with the trauma survivors' network within Memorial Hermann Hospital will be available and encouraged. Follow-up contacts and services from an assigned case manager over two weeks following discharge from the hospital to ensure that the patient has contacted the community-level violence outreach organizations.

Standard of Care group

Eligibility Criteria

Age16 Years - 35 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • presented for a gunshot injury stemming from community violence at Memorial Hermann Hospital
  • English or Spanish-speaking
  • provide informed voluntary consent to participate in the study
  • live in Harris County at time of enrollment

You may not qualify if:

  • presenting for a firearm injury arising from a self-inflicted gunshot or unintentional gun violence
  • actively detained by criminal justice systems at time of enrollment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

RECRUITING

MeSH Terms

Interventions

Standard of Care

Intervention Hierarchy (Ancestors)

Quality Indicators, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and Evaluation

Study Officials

  • Sandra McKay, MD

    The University of Texas Health Science Center, Houston

    PRINCIPAL INVESTIGATOR
  • Alexander Testa, PhD

    The University of Texas Health Science Center, Houston

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
Participants will be partially blinded in that they will know some information about the intervention but will not be exposed to the details of the intervention or the intervention manual.
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

February 8, 2024

First Posted

February 16, 2024

Study Start

September 16, 2025

Primary Completion (Estimated)

February 1, 2028

Study Completion (Estimated)

May 31, 2028

Last Updated

January 21, 2026

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share

Locations