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

Last updated: May 19, 2025
Sponsor: April M Young
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Hiv/aids

Substance Abuse

Hiv (Pediatric)

Treatment

Harm reduction kiosk

Clinical Study ID

NCT05657106
KyOSK
1R01DA055872
  • Ages > 18
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

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

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 thepast 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 inan inpatient facility.

Study Design

Total Participants: 752
Treatment Group(s): 1
Primary Treatment: Harm reduction kiosk
Phase:
Study Start date:
March 06, 2023
Estimated Completion Date:
July 31, 2027

Study 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.

Connect with a study center

  • University of Kentucky

    Lexington, Kentucky 40506
    United States

    Site Not Available

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