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NCT05343169 · ClinicalTrials.gov registry record · NA
Community-based Education, Navigation, and Support Intervention for Military Veterans
A NA study of HIV Infections and Opioid Use Disorder, sponsored by New York University.
- Recruiting
- Registry status
- NA
- Development phase
- 300
- Enrollment target
- 1
- Study location
NCT05343169: Recruiting NA study of HIV Infections and Opioid Use Disorder, sponsored by New York University.
NCT05343169 is a NA study of HIV Infections and Opioid Use Disorder that is actively recruiting participants, run by New York University. The registered enrollment target is 300 participants, below the 445-participant average among 542 other HIV Infections trials with a reported enrollment target (33% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05343169, a NA study of HIV Infections and Opioid Use Disorder, is actively recruiting participants, sponsored by New York University.
- RECRUITING
- Registry status
- NA
- Development phase
- 300 participants
- Enrollment target
- 1
- Study location
Study 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-tai
Primary Outcome
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
Conditions Studied
Interventions
- BEHAVIORAL Overdose Education and Naloxone Distribution
- BEHAVIORAL Advanced Education in Safer Substance Use, Treatment, and Self-Care
- BEHAVIORAL Social Service and Health Navigation
- BEHAVIORAL Peer Social Support
Study Locations (1)
New York
- New York University - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 300 participants |
| Start Date | 2022-10-21 |
| Est. Completion | 2026-07-31 |
| Phase | NA |
What NCT05343169 shows while recruiting
NCT05343169 is an interventional study that assigns participants to a tested intervention. The registered 300 participants enrollment target is mid-sized for trials with a published cap, below the 445-participant average among 542 other HIV Infections trials with a reported enrollment target (33% lower).
The record links to 3 conditions, with HIV Infections appearing as the primary indexed condition, and to 4 interventions - of which Overdose Education and Naloxone Distribution is the first listed.
NCT05343169 reports a single indexed study location in New York.
Frequently Asked Questions
What is clinical trial NCT05343169 about?
NCT05343169 is a clinical study titled "Community-based Education, Navigation, and Support Intervention for 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...
What is the current status of trial NCT05343169?
This trial is currently recruiting. It is a NA study. The enrollment target is 300 participants. The study started on 2022-10-21. Estimated completion is 2026-07-31.
What conditions does trial NCT05343169 study?
This clinical trial studies the following conditions: HIV Infections, Opioid Use Disorder, Overdose.
What interventions are being tested in trial NCT05343169?
The interventions under investigation include: Overdose Education and Naloxone Distribution (BEHAVIORAL), Advanced Education in Safer Substance Use, Treatment, and Self-Care (BEHAVIORAL), Social Service and Health Navigation (BEHAVIORAL), Peer Social Support (BEHAVIORAL).
Who is sponsoring clinical trial NCT05343169?
This trial is sponsored by New York University, which has 83 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05343169 being conducted?
This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05343169's enrollment target sits among peer trials
300 115th of 542 higher than 417 of 542 other HIV Infections trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other HIV Infections trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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