Clinical trial NCT06429436: Vending Machine Naloxone Distribution for Your Community (VENDY)
Official title: Vending Machine Naloxone Distribution for Your Community (VENDY): Increasing Reach and Implementation of Naloxone Distribution
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Harm Reduction
Naloxone
Opioid Overdose
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
Collaborators: name: Southern Colorado Harm Reduction Association
name: Denver Health and Hospital Authority
name: Summit County Public Health Department
First posted: 2024-05-28
Enrollment: 1489
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: We will be using an interrupted time series design to evaluate naloxone distribution before and after vending machine implementation in each community.
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Reach
timeFrame: the 6 months pre VENDY implementation and the 6 months post VENDY implementation
Secondary outcomes:
measure: Adoption
timeFrame: 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)
measure: Fatal Opioid Overdose Events-Effectiveness
timeFrame: pre-implementation in the year prior to a live VENDY program and post implementation in the year following live VENDY program
measure: Fidelity-Implementation
timeFrame: the 6 months following VENDY implementation
measure: Maintenance
timeFrame: the 6 months following the initial implementation phase (6 months)
Other outcomes:
Locations:
city: Denver
country: United States
facility: Denver Health
state: Colorado
city: Frisco
country: United States
facility: Summit County Public Health Department
state: Colorado
city: Pueblo
country: United States
facility: Southern Colorado Harm Reduction Association
state: Colorado
Study officials:
affiliation: University of Colorado, Denver
name: Nicole Wagner, PhD
role: PRINCIPAL_INVESTIGATOR
References: