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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Kentucky Outreach Service Kiosk (KyOSK): Reducing HIV, HCV, and Overdose Risk in Rural Appalachia Through Harm Reduction Kiosks

Conditions
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Opioid-Related Disorders, Hepatitis C (HCV), Human Immunodeficiency Virus (HIV), Drug Overdose, Substance Abuse, Intravenous Drug Usage, Opiate Substitution Treatment, Sexually Transmitted Diseases

Intervention / Treatment
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* Behavioral: Harm reduction kiosk


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional 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)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Syringe Service Program Plus a Harm Reduction Kiosk Intervention<br>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. | Behavioral: Harm reduction kiosk<br>* 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).<br>|
| No Intervention: Syringe Service Program<br>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. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Measured at baseline and then every 6 months up to 5 years | 
| 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) | Measured at baseline and then every 6 months up to 5 years | 
| 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 | Measured at baseline and then every 6 months up to 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | Measured at baseline and then every 6 months up to 5 years | 
| Change in distributive syringe sharing | Self-reported recent (past 30-day) frequency of providing a used syringe to someone else (continuous) | Measured at baseline and then every 6 months up to 5 years | 
| 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) | Measured at baseline and then every 6 months up to 5 years | 
| Change in syringe reuse | Self-reported recent (past 30-day) number of times re-using syringes (continuous) | Measured at baseline and then every 6 months up to 5 years | 
| Change in safe syringe disposal | Self-reported recent (past 30-day) disposal of syringes in a sharps container or syringe exchange program (binary) | Measured at baseline and then every 6 months up to 5 years | 
| 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) | Measured at baseline and then every 6 months up to 5 years | 
| Change in frequency of overdose | Self-reported number of times overdosed in the past 6 months (continuous). | Measured at baseline and then every 6 months up to 5 years | 
| 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) | Measured at baseline and then every 6 months up to 5 years | 
| Change in number of days carrying naloxone | Self-reported recent (past 30-day) frequency of carrying naloxone (continuous) | Measured at baseline and then every 6 months up to 5 years | 
| 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) | Measured at baseline and then every 6 months up to 5 years | 
| 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) | Measured at baseline and then every 6 months up to 5 years | 
| 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) | Measured at baseline and then every 6 months up to 5 years | 
| 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) | Measured at baseline and then every 6 months up to 5 years | 
| 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) | Measured at baseline and then every 6 months up to 5 years | 
| Change in overdose protective behaviors among participants who use drugs | Self-reported recent (past 30-day) frequency of engaging in overdose protective behaviors | Measured at baseline and then every 6 months up to 5 years |