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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

752 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-03-06

Study Completion Date

2027-07-31

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.

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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 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

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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

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Type 1 hybrid effectiveness study involving a community-level, controlled quasi-experimental trial and a mixed methods evaluation of implementation outcomes.

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Harm reduction kiosk

Intervention Type BEHAVIORAL

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).

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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).

Intervention Type BEHAVIORAL

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

* 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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes