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Kentucky Outreach Service Kiosk (KyOSK): Reducing HIV, HCV, and Overdose Risk

Primary Purpose

Opioid-Related Disorders, Hepatitis C (HCV), Human Immunodeficiency Virus (HIV)

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Harm reduction kiosk
Sponsored by
April M Young
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Opioid-Related Disorders

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Individuals are eligible if they are: age 18 or older, live in the intervention or comparison county, and have engaged in injection or non-injection illicit drug use to get high in the past 6 months (excluding marijuana, alcohol, and tobacco). Exclusion Criteria: Individuals are not eligible if they are: less than age 18 or older, do not live in the intervention or comparison county, and have not engaged in injection or non-injection illicit drug use to get high in the past 6 months (excluding marijuana, alcohol, and tobacco).

Sites / Locations

  • University of KentuckyRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Syringe Service Program Plus a Harm Reduction Kiosk Intervention

Syringe Service Program

Arm Description

The intervention to be implemented in the intervention county involves enhancing its existing SSP model with a KyOSK. The intervention county SSP operates identically to the comparison county. As in the comparison county, a card reader will be installed in the intervention county SSP at the beginning of the study to provide objective data on visits and supply access. The KyOSK will resemble a vending machine. The KyOSK will include harm reduction, wound care, hygiene, and other supplies; offer overdose education and other content; a sharps container with a device to obtain data on syringe disposal; and an innovative call-back feature for care navigation by recovery coaches. While the KyOSK is operating, the intervention county will operate its traditional SSP 40 hours/week.

The comparison county SSP operates in the local health department and provides syringes, cookers/cottons, naloxone, wound care kits, condoms and lubricant, snacks, drinks, and sharps containers. A peer support specialist is present for consultation with clients upon request during SSP hours. The SSP will expand it hours from 3 hours/week to 40 hours/week at the same time the intervention county receives its KyOSK, to be comparable. SSP clients who enroll in the study will receive a swipe card linked to their SSP client identification. Card readers will be installed in the SSP for clients to swipe upon entry. Staff will provide clients with the same menu of supplies as those in the KyOSK and the same supply/time interval limits will be imposed. SSP clients will receive a resource guide.

Outcomes

Primary Outcome Measures

Change in syringe coverage for injections
Self-reported number of injections in the past 30 days where a clean syringe was used divided by the total number of injections in the past 30 days
Change in harm reduction program supplied syringe coverage for injections
Number of syringes obtained at the SSP and/or KyOSK in the past 30 days (obtained from card swipe/supply dispensing data)
Change in SSP / KyOSK-provided syringe coverage for injections
Self-reported number of injections in the past 30 days where a clean syringe from the [KyOSK/SSP] was used divided by the total number of injections in the past 30 days

Secondary Outcome Measures

Change in receptive syringe sharing
Self-reported recent (past 30-day) frequency of using a syringe that had been previously used by someone else (continuous; number and proportion)
Change in distributive syringe sharing
Self-reported recent (past 30-day) frequency of providing a used syringe to someone else (continuous)
Change in number of people with whom person shared syringes and injection equipment
Self-reported number of people participant shared syringes and other injection equipment with in the past 30 days (continuous)
Change in syringe reuse
Self-reported recent (past 30-day) number of times re-using syringes (continuous)
Change in safe syringe disposal
Self-reported recent (past 30-day) disposal of syringes in a sharps container or syringe exchange program (binary)
Change in frequency of condom- less sex
Self-reported recent (past 30-day) frequency of anal or vaginal sex without a condom (continuous; number and proportion of all sex events)
Change in frequency of overdose
Self-reported number of times overdosed in the past 6 months (continuous).
Change in use of naloxone during overdose events by participants who witnessed an overdose
Self-reported number of times overdosed in the past 6 months (continuous)
Change in number of days carrying naloxone
Self-reported recent (past 30-day) frequency of carrying naloxone (continuous)
Change in number of times contacting or visiting a pharmacy to obtain naloxone
Self-reported recent (past 6 months) frequency of naloxone seeking at a pharmacy (continuous)
Change in number of days on medications for opioid use disorder (MOUD) among participants who use opioids to get high
Self-reported recent (past 30-day) frequency of being on MOUD (continuous)
Change in linkage to treatment among those who test HCV positive
Self-reported recent (past 6 month) frequency of receiving treatment among those who test positive and have never received treatment (binary)
Change in use of harm reduction services among participants who inject drugs
Self-reported recent (past 30-day) frequency of providing a used syringe to someone else (continuous, number and proportion of syringes)
Change in use of fentanyl test strips among participants who use drugs
Self-reported recent (past 30-day) frequency of using a fentanyl test strips (binary)
Change in overdose protective behaviors among participants who use drugs
Self-reported recent (past 30-day) frequency of engaging in overdose protective behaviors

Full Information

First Posted
November 3, 2022
Last Updated
October 5, 2023
Sponsor
April M Young
Collaborators
National Institute on Drug Abuse (NIDA)
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1. Study Identification

Unique Protocol Identification Number
NCT05657106
Brief Title
Kentucky Outreach Service Kiosk (KyOSK): Reducing HIV, HCV, and Overdose Risk
Official Title
Kentucky Outreach Service Kiosk (KyOSK): Reducing HIV, HCV, and Overdose Risk in Rural Appalachia Through Harm Reduction Kiosks
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 6, 2023 (Actual)
Primary Completion Date
July 2026 (Anticipated)
Study Completion Date
July 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
April M Young
Collaborators
National Institute on Drug Abuse (NIDA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This study will test the effectiveness, implementation outcomes, and cost effectiveness of a community-tailored, harm reduction kiosk in reducing HIV, hepatitis C, and overdose risk behavior in rural Appalachia. The proposed project will take place in two counties in Appalachian Kentucky, an epicenter for the intertwined national crises of injection drug use, overdoses, and hepatitis C.
Detailed Description
This is a Type 1 hybrid effectiveness study involving a community-level, controlled quasi-experimental trial to assess the impact of a community-tailored harm reduction kiosk on HIV, HCV, and overdose risk in rural Appalachia, and a mixed methods evaluation of implementation outcomes. The trial will compare the standard local syringe service program (SSP) design (brick-and-mortar, staffed by department of health staff) to an enhanced model involving a harm reduction kiosk + standard SSP. The kiosk, referred to as the KyOSK (Kentucky Outreach Service Kiosk) will be tailored through a community-engaged adaptation process. For evaluation of the KyOSK's impact on HCV and overdose risk behavior, the investigators will enroll 700 People Who Use Drugs (PWUD) in the intervention (n=400) and comparison (n=300) counties, collectively referred to as the kiosk trial cohort. The kiosk trial cohort will be recruited from three sources: existing cohorts of PWUD, SSPs, and peer-referral. Throughout the trial and following the implementation outcome framework (IOF) measurement model by Proctor et al., acceptability, appropriateness, fidelity, cost, penetration, and sustainability will be assessed using a combination of validated scales, qualitative interviews, checklists, invoices, and program data. Following the trial, the investigators will use data collected from the kiosk cohort and implementation outcome assessment (primarily cost and reach) in a dynamic, deterministic model of HCV transmission and overdose to examine the impact and cost-effectiveness of the KyOSK model.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Opioid-Related Disorders, Hepatitis C (HCV), Human Immunodeficiency Virus (HIV), Drug Overdose, Substance Abuse, Intravenous Drug Usage, Opiate Substitution Treatment, Sexually Transmitted Diseases

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Type 1 hybrid effectiveness study involving a community-level, controlled quasi-experimental trial and a mixed methods evaluation of implementation outcomes.
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
700 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Syringe Service Program Plus a Harm Reduction Kiosk Intervention
Arm Type
Experimental
Arm Description
The intervention to be implemented in the intervention county involves enhancing its existing SSP model with a KyOSK. The intervention county SSP operates identically to the comparison county. As in the comparison county, a card reader will be installed in the intervention county SSP at the beginning of the study to provide objective data on visits and supply access. The KyOSK will resemble a vending machine. The KyOSK will include harm reduction, wound care, hygiene, and other supplies; offer overdose education and other content; a sharps container with a device to obtain data on syringe disposal; and an innovative call-back feature for care navigation by recovery coaches. While the KyOSK is operating, the intervention county will operate its traditional SSP 40 hours/week.
Arm Title
Syringe Service Program
Arm Type
No Intervention
Arm Description
The comparison county SSP operates in the local health department and provides syringes, cookers/cottons, naloxone, wound care kits, condoms and lubricant, snacks, drinks, and sharps containers. A peer support specialist is present for consultation with clients upon request during SSP hours. The SSP will expand it hours from 3 hours/week to 40 hours/week at the same time the intervention county receives its KyOSK, to be comparable. SSP clients who enroll in the study will receive a swipe card linked to their SSP client identification. Card readers will be installed in the SSP for clients to swipe upon entry. Staff will provide clients with the same menu of supplies as those in the KyOSK and the same supply/time interval limits will be imposed. SSP clients will receive a resource guide.
Intervention Type
Behavioral
Intervention Name(s)
Harm reduction kiosk
Intervention Description
The intervention involves enhancing an existing staffed harm reduction program (syringe service program) located in a local health department with a Kentucky Outreach Service Kiosk (KyOSK).
Primary Outcome Measure Information:
Title
Change in syringe coverage for injections
Description
Self-reported number of injections in the past 30 days where a clean syringe was used divided by the total number of injections in the past 30 days
Time Frame
Measured at baseline and then every 6 months up to 5 years
Title
Change in harm reduction program supplied syringe coverage for injections
Description
Number of syringes obtained at the SSP and/or KyOSK in the past 30 days (obtained from card swipe/supply dispensing data)
Time Frame
Measured at baseline and then every 6 months up to 5 years
Title
Change in SSP / KyOSK-provided syringe coverage for injections
Description
Self-reported number of injections in the past 30 days where a clean syringe from the [KyOSK/SSP] was used divided by the total number of injections in the past 30 days
Time Frame
Measured at baseline and then every 6 months up to 5 years
Secondary Outcome Measure Information:
Title
Change in receptive syringe sharing
Description
Self-reported recent (past 30-day) frequency of using a syringe that had been previously used by someone else (continuous; number and proportion)
Time Frame
Measured at baseline and then every 6 months up to 5 years
Title
Change in distributive syringe sharing
Description
Self-reported recent (past 30-day) frequency of providing a used syringe to someone else (continuous)
Time Frame
Measured at baseline and then every 6 months up to 5 years
Title
Change in number of people with whom person shared syringes and injection equipment
Description
Self-reported number of people participant shared syringes and other injection equipment with in the past 30 days (continuous)
Time Frame
Measured at baseline and then every 6 months up to 5 years
Title
Change in syringe reuse
Description
Self-reported recent (past 30-day) number of times re-using syringes (continuous)
Time Frame
Measured at baseline and then every 6 months up to 5 years
Title
Change in safe syringe disposal
Description
Self-reported recent (past 30-day) disposal of syringes in a sharps container or syringe exchange program (binary)
Time Frame
Measured at baseline and then every 6 months up to 5 years
Title
Change in frequency of condom- less sex
Description
Self-reported recent (past 30-day) frequency of anal or vaginal sex without a condom (continuous; number and proportion of all sex events)
Time Frame
Measured at baseline and then every 6 months up to 5 years
Title
Change in frequency of overdose
Description
Self-reported number of times overdosed in the past 6 months (continuous).
Time Frame
Measured at baseline and then every 6 months up to 5 years
Title
Change in use of naloxone during overdose events by participants who witnessed an overdose
Description
Self-reported number of times overdosed in the past 6 months (continuous)
Time Frame
Measured at baseline and then every 6 months up to 5 years
Title
Change in number of days carrying naloxone
Description
Self-reported recent (past 30-day) frequency of carrying naloxone (continuous)
Time Frame
Measured at baseline and then every 6 months up to 5 years
Title
Change in number of times contacting or visiting a pharmacy to obtain naloxone
Description
Self-reported recent (past 6 months) frequency of naloxone seeking at a pharmacy (continuous)
Time Frame
Measured at baseline and then every 6 months up to 5 years
Title
Change in number of days on medications for opioid use disorder (MOUD) among participants who use opioids to get high
Description
Self-reported recent (past 30-day) frequency of being on MOUD (continuous)
Time Frame
Measured at baseline and then every 6 months up to 5 years
Title
Change in linkage to treatment among those who test HCV positive
Description
Self-reported recent (past 6 month) frequency of receiving treatment among those who test positive and have never received treatment (binary)
Time Frame
Measured at baseline and then every 6 months up to 5 years
Title
Change in use of harm reduction services among participants who inject drugs
Description
Self-reported recent (past 30-day) frequency of providing a used syringe to someone else (continuous, number and proportion of syringes)
Time Frame
Measured at baseline and then every 6 months up to 5 years
Title
Change in use of fentanyl test strips among participants who use drugs
Description
Self-reported recent (past 30-day) frequency of using a fentanyl test strips (binary)
Time Frame
Measured at baseline and then every 6 months up to 5 years
Title
Change in overdose protective behaviors among participants who use drugs
Description
Self-reported recent (past 30-day) frequency of engaging in overdose protective behaviors
Time Frame
Measured at baseline and then every 6 months up to 5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Individuals are eligible if they are: age 18 or older, live in the intervention or comparison county, and have engaged in injection or non-injection illicit drug use to get high in the past 6 months (excluding marijuana, alcohol, and tobacco). Exclusion Criteria: Individuals are not eligible if they are: less than age 18 or older, do not live in the intervention or comparison county, and have not engaged in injection or non-injection illicit drug use to get high in the past 6 months (excluding marijuana, alcohol, and tobacco).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Carol R White, MPH
Phone
8593518277
Email
crwhit3@uky.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
April M Young, PhD
Organizational Affiliation
University of Kentucky
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Kentucky
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40506
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Carol R White, MPH
Phone
859-351-8277
Email
crwhit3@uky.edu
First Name & Middle Initial & Last Name & Degree
April M Young, PhD

12. IPD Sharing Statement

Plan to Share IPD
No

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Kentucky Outreach Service Kiosk (KyOSK): Reducing HIV, HCV, and Overdose Risk

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