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Clinical Trials/NCT06429436
NCT06429436Active, not recruitingPhase 4

Vending Machine Naloxone Distribution for Your Community (VENDY): Increasing Reach and Implementation of Naloxone Distribution

University of Colorado, Denver6 sites in 1 country4,000 target enrollmentStarted: June 1, 2024Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Phase 4
Status
Active, not recruiting
Enrollment
4,000
Locations
6
Primary Endpoint
Reach

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Health Services Research
Masking
None

Masking Description

There will be no masking.

Eligibility Criteria

Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

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

Exclusion Criteria

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

Arms & Interventions

VENDY

Experimental

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

Intervention: VENDY (Behavioral)

Outcomes

Primary Outcomes

Reach

Time Frame: 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 Outcomes

  • 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))
  • 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)
  • Fidelity-Implementation(the 6 months following VENDY implementation)
  • Maintenance(the 6 months following the initial implementation phase (6 months))

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (6)

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