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Active, not recruiting

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 locally-tailored, health kiosk to reduce overdose, hepatitis C, and HIV risk behavior and improve linkage to care in rural Appalachia. The proposed project will take place in two counties in Appalachian Kentucky, an epicenter for the intertwined national crises of overdoses, hepatitis C, and injection-related infections.

Active, not recruiting

This study is active but is not currently recruiting participants.

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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 health kiosk on HIV, HCV, and overdose risk in rural Appalachia, and a mixed methods evaluation of implementation outcomes. The trial will compare the standard health department program (staffed, brick-and-mortar) to an enhanced model involving a health kiosk + standard health department program. 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, 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, local agencies, 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

Health kiosk

Behavioral

The intervention involves enhancing its existing health department model with a Kentucky Outreach Service Kiosk (KyOSK).

Primary outcomes

  1. 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)

  2. Change in frequency of use of substance use treatment, detoxification, and/or peer-support services

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

    Self-reported recent (past 6-month) frequency of engaging in substance use treatment services (binary)

  3. Change in number of injection-related abscesses

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

    Self-reported recent (past 6 month) number of injection-site abscesses among those who inject drugs (continuous)

Secondary outcomes

  1. 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)

  2. 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).

  3. 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 participant used naloxone to reverse someone's overdose in the past 6 months (continuous)

  4. 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)

  5. Change in frequency of helping others access naloxone

    Time frame: Measured at 18-month follow-up and thereafter

    Self-reported recent (past 6 months) frequency of providing naloxone to others (binary)

  6. Change in frequency of hospitalization for an injection-related infection

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

    Self-reported recent (past 6 month) hospitalization for an injection-site infection among those who inject drugs (binary)

  7. Change in frequency of helping others access wound care

    Time frame: Measured at 18-month follow-up and thereafter

    Self-reported recent (past 6 month) frequency of providing wound care supplies to other (binary)

  8. Change in recovery capital

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

    Composite measure of recent (past 6 month) self-reported social capital (receipt and provision of support), physical capital (housing, transportation, food security, technology, and health care access), and human capital (quality of life, experience of shame) (continuous)

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): Addressing Health Needs and Improving Service Linkage in Rural Appalachia Through Health Kiosks

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
Dec 20, 2022
Registry last updated
Aug 18, 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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