NCT05657106

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

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

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 752 (actual)
• Sponsor: April M Young · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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 750 People Who Use Drugs (PWUD) in the intervention (n=425) and comparison (n=325) 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.

Conditions

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

Interventions

Type	Name	Description
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).

Timeline

• Start date: 2023-03-06
• Primary completion: 2026-07-31
• Completion: 2027-07-31
• First posted: 2022-12-20
• Last updated: 2025-05-23

Locations

1 site across 1 country: United States