Community-based Education, Navigation, and Support Intervention for Military Veterans
NCT05343169 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 300
Last updated 2025-07-01
Summary
Military veterans in the U.S. represent one of the populations most disproportionately impacted by the current opioid crisis. Veterans who use opioids and are not connected to the VA healthcare system have high rates of homelessness and experience higher prevalence of comorbid substance use disorder and mental health diagnoses than their "service-connected" counterparts. Due to these vulnerabilities and the observed barriers to testing and treatment among veterans-especially substance- and mental health-related stigma, drug naiveté, and limited support networks-veterans who use opioids represent a critical target for interventions designed to mitigate overdose and HIV/HCV risk behaviors. For socially isolated veterans and veterans with limited access to healthcare, programs that work outside of formal healthcare institutions and agencies are desperately needed. This application proposes to achieve the following Aims: 1) Evaluate the effectiveness of a peer-delivered, community-based education, navigation and support (CENS) intervention to reduce opioid-related risk behaviors; 2) Examine factors that mediate (e.g., knowledge, self-efficacy, self-stigma) and moderate (e.g., mental health, pain/OUD severity, age) intervention effectiveness; and 3) Explore intervention participants' and peer outreach staff perspectives on implementation as well as barriers to and facilitators of intervention effectiveness. The proposed intervention will be delivered by veteran peer outreach workers. The study will recruit 300 veterans with opioid use disorder to participate in a randomized controlled trial. The CENS intervention will engage 150 participants in ongoing educational sessions, healthcare and treatment navigation, and social support (involving both one-on-one and group social integration protocols) designed to improve self-efficacy, reduce self-stigma, increase service and healthcare utilization, and bolster knowledge. This study stands to contribute a timely, culturally-tailored innovation to overdose and HIV/HCV prevention-as-usual that, informed by the theory of triadic influence, directly confronts the social, intrapersonal, and structural-level barriers to opioid-related risk reduction among veterans. Study findings will be of great interest to community-based and civic healthcare organizations that provide overdose and HIV/HCV risk reduction outreach, as well as to agencies committed to improving healthcare engagement among veterans.
Conditions
- Overdose
- Opioid Use Disorder
- HIV Infections
Interventions
- BEHAVIORAL
-
Overdose Education and Naloxone Distribution
Education on OD risk behaviors and methods for responding to an OD, including naloxone use. Duration and dose: Single 20-minute training at time of enrollment, provided to all participants in both arms
- BEHAVIORAL
-
Advanced Education in Safer Substance Use, Treatment, and Self-Care
Education about misinformation about OAT, self-care, SEP services, HIV/HCV treatment Duration/dose: 9 mos., monthly \~2 hr. group sessions + ongoing access to video archive of recorded trainings.
- BEHAVIORAL
-
Social Service and Health Navigation
Help navigate access and barriers to healthcare, motivation and health goals Duration/dose: 9 mos., monthly face-to-face sessions to set goals and schedule appts, phone calls between sessions \> 1x/wk.
- BEHAVIORAL
-
Peer Social Support
Support with social (re)integration, isolation, relationship building Duration/dose: 9 mos., monthly face-to-face events and phone calls/texts between sessions \> 1x/wk.
Sponsors & Collaborators
-
New York University
lead OTHER
Principal Investigators
-
Alexander S Bennett, PhD · New York University
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2022-10-21
- Primary Completion
- 2026-06-01
- Completion
- 2026-07-31
Countries
- United States
Study Locations
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