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

August 14, 2026 updated by: April M Young

Kentucky Outreach Service Kiosk (KyOSK): Addressing Health Needs and Improving Service Linkage in Rural Appalachia Through Health Kiosks

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed 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 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.

Study Type

Interventional

Enrollment (Actual)

752

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Kentucky
      • Lexington, Kentucky, United States, 40506
        • University Of Kentucky

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Health Department Program Plus a Health Kiosk Intervention
The intervention involves enhancing the health department's existing staffed model of service delivery with a KyOSK. The intervention county's staffed program operates identically to the comparison county. Both counties' staffed programs and the kiosk will use an identically structured unique ID to provide objective data on service engagement. The KyOSK will resemble a vending machine but with a touchscreen, audiovisual interface. The KyOSK will include naloxone, wound care kits, and supplies for basic needs (e.g., hygiene items, food, water, emergency blankets); offer overdose education materials; and an innovative call-back feature for care navigation by recovery coaches. While the KyOSK is operating, the county will continue to operate its traditional program.
Behavioral: Health kiosk
The intervention involves enhancing its existing health department model with a Kentucky Outreach Service Kiosk (KyOSK).
No Intervention: Staffed Health Department Program
A staffed program located in the local department of health (DOH) and staffed by DOH personnel currently operates in the comparison county. The program provides supplies (e.g., naloxone, wound care kits, snacks, drinks, resource guides). A peer support specialist from a nearby recovery facility is present for consultation with clients (by request of client) during operating hours. New clients to the program "register" by providing information for establishment of a client ID and answer a brief survey of demographic and behavioral questions used by all state programs. Program clients will also receive a resource guide covering the same categories as those covered in the call-back feature of the KyOSK.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
Measured at baseline and then every 6 months up to 5 years
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)
Measured at baseline and then every 6 months up to 5 years
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)
Measured at baseline and then every 6 months up to 5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
Measured at baseline and then every 6 months up to 5 years
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)
Measured at baseline and then every 6 months up to 5 years
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)
Measured at baseline and then every 6 months up to 5 years
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)
Measured at baseline and then every 6 months up to 5 years
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)
Measured at 18-month follow-up and thereafter
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)
Measured at baseline and then every 6 months up to 5 years
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)
Measured at 18-month follow-up and thereafter
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)
Measured at baseline and then every 6 months up to 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

April M Young

Collaborators

National Institute on Drug Abuse (NIDA)

Investigators

  • Principal Investigator: April M Young, PhD, University Of Kentucky

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 6, 2023

Primary Completion (Estimated)

May 31, 2027

Study Completion (Estimated)

December 31, 2027

Study Registration Dates

First Submitted

November 3, 2022

First Submitted That Met QC Criteria

December 9, 2022

First Posted (Actual)

December 20, 2022

Study Record Updates

Last Update Posted (Actual)

August 18, 2026

Last Update Submitted That Met QC Criteria

August 14, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

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

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe