NCT07356492 Expanding Veteran Sponsorship Initiative+ to Support High-Risk Transitioning Servicemembers and Veterans: A Precision Medicine Approach
| NCT ID | NCT07356492 |
| Status | Recruiting |
| Phase | — |
| Sponsor | VA Office of Research and Development |
| Condition | Reintegration Difficulties |
| Study Type | INTERVENTIONAL |
| Enrollment | 2,700 participants |
| Start Date | 2026-01-01 |
| Primary Completion | 2027-09-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 2,700 participants in total. It began in 2026-01-01 with a primary completion date of 2027-09-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: * 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 Exclusion Criteria: * The participants Army STARRS score cannot identify the TSMV as low risk nor as acute high risk for suicide
Contact & Investigator
Joseph C Geraci, PhD
PRINCIPAL INVESTIGATOR
James J. Peters Veterans Affairs Medical Center
Frequently Asked Questions
Who can join the NCT07356492 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Reintegration Difficulties. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07356492 currently recruiting?
Yes, NCT07356492 is actively recruiting participants. Contact the research team at Joseph.Geraci@va.gov for enrollment information.
Where is the NCT07356492 trial being conducted?
This trial is being conducted at The Bronx, United States.
Who is sponsoring the NCT07356492 clinical trial?
NCT07356492 is sponsored by VA Office of Research and Development. The principal investigator is Joseph C Geraci, PhD at James J. Peters Veterans Affairs Medical Center. The trial plans to enroll 2,700 participants.