Kentucky Outreach Service Kiosk (KyOSK): Reducing HIV, HCV, and Overdose Risk
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Syringe Service Program Plus a Harm Reduction Kiosk Intervention 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
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).
|
| No Intervention: Syringe Service Program 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. |
Outcome Measures
Primary Outcome Measures
- Change in syringe coverage for injections [Measured at baseline and then every 6 months up to 5 years]
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 [Measured at baseline and then every 6 months up to 5 years]
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 [Measured at baseline and then every 6 months up to 5 years]
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 [Measured at baseline and then every 6 months up to 5 years]
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 [Measured at baseline and then every 6 months up to 5 years]
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 [Measured at baseline and then every 6 months up to 5 years]
Self-reported number of people participant shared syringes and other injection equipment with in the past 30 days (continuous)
- Change in syringe reuse [Measured at baseline and then every 6 months up to 5 years]
Self-reported recent (past 30-day) number of times re-using syringes (continuous)
- Change in safe syringe disposal [Measured at baseline and then every 6 months up to 5 years]
Self-reported recent (past 30-day) number of times re-using syringes (continuous)
- Change in frequency of condom- less sex [Measured at baseline and then every 6 months up to 5 years]
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 [Measured at baseline and then every 6 months up to 5 years]
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 [Measured at baseline and then every 6 months up to 5 years]
Self-reported number of times overdosed in the past 6 months (continuous)
- Change in number of days carrying naloxone [Measured at baseline and then every 6 months up to 5 years]
Self-reported recent (past 30-day) frequency of carrying naloxone (continuous)
- Change in number of times contacting or visiting a pharmacy to obtain naloxone [Measured at baseline and then every 6 months up to 5 years]
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 [Measured at baseline and then every 6 months up to 5 years]
Self-reported recent (past 30-day) frequency of being on MOUD (continuous)
- Change in linkage to treatment among those who test HCV positive [Measured at baseline and then every 6 months up to 5 years]
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 [Measured at baseline and then every 6 months up to 5 years]
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 [Measured at baseline and then every 6 months up to 5 years]
Self-reported recent (past 30-day) frequency of using a fentanyl test strips (binary)
- Change in overdose protective behaviors among participants who use drugs [Measured at baseline and then every 6 months up to 5 years]
Self-reported recent (past 30-day) frequency of engaging in overdose protective behaviors
Eligibility Criteria
Criteria
Inclusion Criteria:
Individuals are eligible if they are:
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age 18 or older,
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live in the intervention or comparison county, and
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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:
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less than age 18 or older,
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do not live in the intervention or comparison county, and
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have not engaged in injection or non-injection illicit drug use to get high in the past 6 months (excluding marijuana, alcohol, and tobacco).
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- April M Young
- National Institute on Drug Abuse (NIDA)
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- KyOSK
- 1R01DA055872