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

April M Young

Status: Active, not recruiting

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

Treatments: Behavioral: Harm reduction kiosk

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05657106

KyOSK

1R01DA055872 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 752 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts 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 meet any of the exclusion criteria:

• being under the age of 18,
• not living in the intervention or comparison county,
• having not engaged in injection or non-injection illicit drug use to get high in the past 6 months (excluding marijuana, alcohol, and tobacco),
• not being able to speak or understand English,
• conviction in the past 10 years of a violent crime (i.e., murder, manslaughter, rape, robbery, and /or aggravated assault) or stalking,
• current charges of violent crime or stalking, or
• having plans to move out of the study counties in the next 6 months, or residing in an inpatient facility.

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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752 participants in 2 patient groups

Syringe Service Program Plus a Harm Reduction Kiosk Intervention

Experimental group

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.

Treatment:

Behavioral: Harm reduction kiosk

Syringe Service Program

No Intervention group

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.