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Active, not recruitingNCT05657106Updated Aug 18, 2026

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

An interventional study of Health kiosk in Opioid-Related Disorders, Hepatitis C (HCV) and Human Immunodeficiency Virus (HIV), sponsored by April M Young. Active, not recruiting at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-08-18.

Sponsored by April M Young · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
752
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
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Study summary

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.

Read the 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.

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Conditions studied

  • Opioid-Related Disorders
  • Hepatitis C (HCV)
  • Human Immunodeficiency Virus (HIV)
  • Drug Overdose
  • Substance Abuse
  • Intravenous Drug Usage
  • Opiate Substitution Treatment
  • Sexually Transmitted Diseases
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In context

Opioid-Related Disorders

1,411 studies on the registry are indexed under Opioid-Related Disorders; 290 are open to participants now.

This study's enrollment of 752 is above the median of 63 across 1,123 interventional studies indexed under Opioid-Related Disorders.

Browse Opioid-Related Disorders studies →

Lead sponsor

April M Young is the lead sponsor of 2 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
752 participants (actual)

Study arms

  • 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

  • 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.

Interventions

  • BehavioralHealth kiosk

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

06

What researchers measure

Primary outcomes

  1. Change in number of days carrying naloxone

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

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

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

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

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

  3. Change in number of injection-related abscesses

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

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

Secondary outcomes

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

    Self-reported recent (past 30-day) frequency of anal or vaginal sex without a condom (continuous; number and proportion of all sex events)

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

  2. Change in frequency of overdose

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

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

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

    Self-reported number of times participant used naloxone to reverse someone's overdose in the past 6 months (continuous)

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

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

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

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

  5. Change in frequency of helping others access naloxone

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

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

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

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

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

  7. Change in frequency of helping others access wound care

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

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

  8. Change in recovery capital

    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)

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

07

Study locations

1 site
  • University of Kentucky
    Lexington, Kentucky 40506, United States
08

References and documents

Publications

  • Young AM, Jahangir T, Westneat S, Cheatom C, Fallin-Bennett A, Fanucchi LC, Freeman PR, Havens JR, Knudsen HK, McCollister KE, Stitzer S, Stone J, Vickerman P, Livingston MD. Preferences for harm reduction vending machine design among rural people who use drugs. Drug Alcohol Depend Rep. 2025 Oct 31;17:100391. doi: 10.1016/j.dadr.2025.100391. eCollection 2025 Dec. PubMed 41322680 ↗
  • Young AM, Havens JR, Cooper HLF, Fallin-Bennett A, Fanucchi L, Freeman PR, Knudsen H, Livingston MD, McCollister KE, Stone J, Vickerman P, Freeman E, Jahangir T, Larimore E, White CR, Cheatom C, Community Staff K, Design Team K. Kentucky Outreach Service Kiosk (KyOSK) Study protocol: a community-level, controlled quasi-experimental, type 1 hybrid effectiveness study to assess implementation, effectiveness and cost-effectiveness of a community-tailored harm reduction kiosk on HIV, HCV and overdose risk in rural Appalachia. BMJ Open. 2024 Mar 1;14(3):e083983. doi: 10.1136/bmjopen-2024-083983. PubMed 38431295 ↗

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 18, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05657106
Lead sponsor
April M Young
Collaborators
National Institute on Drug Abuse (NIDA)
Responsible party
April M Young (Professor, University of Kentucky) — Sponsor-investigator
First posted
Dec 20, 2022
Start date
Mar 6, 2023
Primary completion
May 31, 2027 (estimated)
Completion
Dec 31, 2027 (estimated)
Last update
Aug 18, 2026

Study contacts

April M Young, PhD
principal investigator · University of Kentucky

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.

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