HIV Infections Clinical Trial
— CENSOfficial title:
Evaluation of a Community-based Education, Navigation, and Support (CENS) Intervention to Reduce Opioid-related Harms Among Military Veterans
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.
Status | Recruiting |
Enrollment | 300 |
Est. completion date | June 30, 2026 |
Est. primary completion date | June 30, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Veteran status - Adult (18+) age - Current nonmedical use of opioids - Current clinical (DSM-5) opioid use disorder of any level of severity Exclusion Criteria: - Unable to speak English - Unable to provide informed consent. |
Country | Name | City | State |
---|---|---|---|
United States | New York University | New York | New York |
Lead Sponsor | Collaborator |
---|---|
New York University |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in Opioid Overdose Risk Behaviors Scale | Change in Overdose Risk Behavior Scale score, from baseline to 9 months. Min Score= 0 Max Score = 660 Higher scores indicate more engagement in overdose risk behaviors | 9 months follow-up assesment | |
Primary | Change in HIV/HCV Risk Behaviors | Change in HIV/HCV risk behaviors as measured by the National HIV Behavioral Surveillance System questions about unsafe sexual and injection risk, from baseline to 9 month follow up. | 9 months follow-up assessment | |
Secondary | Health service utilization | Utilization of services as measured by number of visits in past 3 months, e.g. VHA hospitals, syringe exchange, healthcare providers. Measured by the investigator-developed questionnaire. | 9 months follow-up assessment | |
Secondary | Drug Treatment | Utilization of drug treatment in the past 3-months Yes/No Response | 9 months follow-up assessment | |
Secondary | HIV/HCV Testing | Past 3-month number of antibody tests for HIV and HCV | 9 months follow-up assessment |
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