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NCT Number: NCT05657106

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

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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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Harm reduction kiosk

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).

Primary outcomes

  1. Change in syringe coverage for injections

    Time frame: 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

  2. Change in harm reduction program supplied syringe coverage for injections

    Time frame: 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)

  3. Change in SSP / KyOSK-provided syringe coverage for injections

    Time frame: 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 outcomes

  1. Change in frequency of receptive syringe sharing among participants who inject drugs

    Time frame: 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)

  2. Change in frequency of distributive syringe sharing among participants who inject drugs

    Time frame: 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)

  3. Change in number of people with whom person shared syringes and injection equipment

    Time frame: 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)

  4. Change in frequency of syringe reuse among participants who inject drugs

    Time frame: 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)

  5. Change in frequency of safe syringe disposal among participants who inject drugs

    Time frame: Measured at baseline and then every 6 months up to 5 years

    Self-reported recent (past 30-day) disposal of syringes in a sharps container or syringe exchange program (binary)

  6. Change in frequency of condom-less anal and/or vaginal sex

    Time frame: 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)

  7. Change in frequency of overdose

    Time frame: Measured at baseline and then every 6 months up to 5 years

    Self-reported number of times overdosed in the past 6 months (continuous).

  8. Change in use of naloxone during overdose events by participants who witnessed an overdose

    Time frame: Measured at baseline and then every 6 months up to 5 years

    Self-reported number of times overdosed in the past 6 months (continuous)

  9. Change in number of days carrying naloxone

    Time frame: Measured at baseline and then every 6 months up to 5 years

    Self-reported recent (past 30-day) frequency of carrying naloxone (continuous)

  10. Change in number of times contacting or visiting a pharmacy to obtain naloxone

    Time frame: 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)

  11. Change in number of days on medications for opioid use disorder (MOUD) among participants who use opioids to get high

    Time frame: Measured at baseline and then every 6 months up to 5 years

    Self-reported recent (past 30-day) frequency of being on MOUD (continuous)

  12. Change in frequency of use of harm reduction services among participants who inject drugs

    Time frame: 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)

  13. Change in frequency of use of fentanyl test strips among participants who use drugs

    Time frame: 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)

  14. Change in frequency of engagement in overdose protective behaviors among participants who use drugs

    Time frame: 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

Sponsors and collaborators

Lead sponsor

April M Young

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
Dec 20, 2022
Registry last updated
Jul 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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