Vending Machine Naloxone Distribution for Your Community (VENDY)

Phase 4

Not yet recruiting

• Conditions: Harm Reduction; Naloxone; Opioid Overdose
• Interventions: Behavioral: VENDY

• Registration Number: NCT06429436
• Lead Sponsor: University of Colorado, Denver

Brief Summary

Vending machines are an innovative strategy shown to increase access to naloxone, a medication used to reverse opioid overdose. The aim of this proposal is to study the reach of a community-initiated, stakeholder engaged adaptation of naloxone distribution, VEnding machine Naloxone Distribution for Your community (VENDY) program.

Detailed Description

This pilot assessment of the VENDY program will take place in 3 communities. Each community will have a machine (vending or kiosks) in which naloxone will be distributed for free to community members. Our preliminary work identified the locations desired by community members who use illegal drugs for machine placement. The pilot test test will include evaluation of the reach (naloxone distribution), adoption (% of sites and staff implementing), and implementation (fidelity to restocking and maintenance protocol) of VENDY in each community.

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Status Verified: 2024-05
• Study First Submitted: 2024-05-10
• Study First Submitted QC: 2024-05-20
• Last Update Submitted: 2024-05-20
• Study First Posted: 2024-05-28
• Last Update Posted: 2024-05-28
• Study Start: 2024-06-01
• Primary Completion: 2025-06-01
• Study Completion: 2026-01-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 1489

Inclusion Criteria

• Any person in the community who desires to obtain naloxone will be able to use the machines

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Exclusion Criteria

• Inability to enter a code on a vending machine or open a kiosk.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
VENDY	VENDY	Each participating site will install at least 1 machine (vending or kiosks) in the respective community for naloxone distribution.

Primary Outcome Measures

Name	Time	Method
Reach	the 6 months pre VENDY implementation and the 6 months post VENDY implementation	Reach will be assessed using monthly counts of naloxone distribution in the 6 months before and after VENDY implementation. Naloxone counts will include distribution from all sources within the organization and captured through pharmacy fills from the electronic health record and distribution tracking logs. Naloxone machine distribution will be added to the total monthly count in the post implementation phase and obtained using the vending machine electronic software (reporting date and time of distribution) or (for kiosks) the staff monthly refill tracking log capturing quantity of naloxone kits required to fill the machine (captured at least monthly).

Secondary Outcome Measures

Name	Time	Method
Adoption	At the end of program development (program development is the first phase in which each site is developing VENDY over a 6-18 month period of time)	Adoption is the percentage of sites placing a naloxone vending machine in the respective community that is made available for community members to obtain naloxone.
Fatal Opioid Overdose Events-Effectiveness	pre-implementation in the year prior to a live VENDY program and post implementation in the year following live VENDY program	The count of fatal opioid overdose events for each respective county in which the participating organization and vending machine reside in the year before and year after VENDY implementation. Overdose will be captured from publicly available data from death records reported by the Colorado Department of Public Health and Environment. To address temporality we will include fatal opioid overdose deaths in a comparison community matching community features (urban/rural status, community population, and opioid death rate).
Fidelity-Implementation	the 6 months following VENDY implementation	Fidelity is the percentage of time staff refill and maintain the machine per protocol as measured by the vending machine software and machine activity tracking log.
Maintenance	the 6 months following the initial implementation phase (6 months)	Number of months each organization implementing VENDY continues to make naloxone available in the machines for the 6 months following the initial implementation phase (6 months).