Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
Healthy Volunteers
NCT07356492

Expanding Veteran Sponsorship Initiative+ to Support High-Risk Transitioning Servicemembers and Veterans: A Precision Medicine Approach

Led by VA Office of Research and Development ยท Updated on 2026-01-21

2700

Participants Needed

1

Research Sites

91 weeks

Total Duration

On this page

Sponsors

V

VA Office of Research and Development

Lead Sponsor

V

VISN 2 Mental Illness Research, Education, and Clinical Center

Collaborating Sponsor

AI-Summary

What this Trial Is About

Background Young Veterans in the U.S. face a heightened risk of suicide, particularly during the first year after leaving military service-a period often referred to as the "deadly gap." Suicide rates among Veterans aged 18 to 34 have nearly doubled since 2001, and research shows that reintegration challenges during this transition are closely linked to increased suicide risk. The Veteran Sponsorship Initiative (VSI) was developed to address this critical period by connecting Transitioning Servicemembers and Veterans (TSMVs) with trained, VA-certified peer sponsors. These sponsors help TSMVs navigate civilian life and access VA care. Early evaluations show that TSMVs matched with sponsors are more likely to report lower levels of reintegration difficulties, higher levels of social support, engage in VA services and report lower rates of depression and suicide risk. This project enhances VSI by integrating predictive analytics-developed in partnership with Harvard Medical School and the DoW STARRS-LS team-to identify high-risk TSMVs before they leave the military. Those identified receive not only a sponsor but also targeted VA mental and health care services. This hybrid effectiveness-implementation study will evaluate the impact of this enhanced model (VSI+) on mental health outcomes and VA engagement among 2,700 high-risk TSMVs. Method/Design The purpose of this PEI proposal is to evaluate VSI expansion into VSI+ with enrollment occurring on four US Army installations (FY2026-2027). The study employs a pragmatic cluster-randomized trial with embedded mixed-method implementation evaluation to compare three arms: 1. Transition as Usual (TAU) 2. VSI Base= peer sponsorship and community support 3. VSI+= VSI Base plus VA stepped care services The evaluation is guided by the RE-AIM framework to assess: * Reach (enrollment rates) * Effectiveness (reintegration difficulties, depression, anxiety, suicidal ideation/behavior, and VA utilization outcomes) * Adoption (site and staff uptake) * Implementation (fidelity and feasibility) * Maintenance (sustainability) Study Aims 1. Effectiveness: Evaluate the impact of VSI Base and VSI+ on reintegration difficulties, depression, anxiety, suicidal ideation/behavior, and VA utilization outcomes. 2. Implementation: Assess the feasibility and fidelity of implementing VSI Base and VSI+ across multiple sites using a bundled strategy. 3. Economic Impact: Estimate the budget impact of VSI Base and VSI+ on healthcare costs, including inpatient, emergency, and outpatient care.

CONDITIONS

Official Title

Expanding Veteran Sponsorship Initiative+ to Support High-Risk Transitioning Servicemembers and Veterans: A Precision Medicine Approach

Who Can Participate

Age: 18Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • TSMVs must be 18-years of age or older
  • Enroll prior to military discharge
  • Be planning to transition from one of the target military installations included in the evaluation during an active enrollment window
Not Eligible

You will not qualify if you...

  • The participant's Army STARRS score identifies the TSMV as low risk or acute high risk for suicide

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

James J. Peters VA Medical Center, Bronx, NY

The Bronx, New York, United States, 10468-3904

Actively Recruiting

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Research Team

J

Joseph C Geraci, PhD

CONTACT

D

David E Goodrich, EdD MS MA

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

3

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Expanding Veteran Sponsorship Initiative+ to Support High-Risk Transitioning Servicemembers and Veterans: A Precision Medicine Approach | DecenTrialz