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

NCT05657106 | Active Not Recruiting DMC

• 2 other identifiers: KyOSK1R01DA055872
• Study Type: interventional
• Target: 752
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Outcome Measures

Primary Outcomes (3)

• Change in number of days carrying naloxone

  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

  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

  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 Outcomes (8)

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

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

• Change in frequency of overdose

  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

  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

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

• Change in frequency of helping others access naloxone

  Measured at 18-month follow-up and thereafter

Study Arms (2)

Health Department Program Plus a Health Kiosk Intervention

EXPERIMENTAL

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

Staffed Health Department Program

NO INTERVENTION

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

Health kiosk BEHAVIORAL

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

Health Department Program Plus a Health Kiosk Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• April M Young: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

University of Kentucky

Lexington, Kentucky, 40506, United States

Location

Related Publications (2)

• 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.

  PMID: 41322680 DERIVED

• 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.

  PMID: 38431295 DERIVED

MeSH Terms

Conditions

Opioid-Related Disorders; Hepatitis C; Acquired Immunodeficiency Syndrome; Drug Overdose; Substance-Related Disorders; Sexually Transmitted Diseases

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis; Liver Diseases; Digestive System Diseases; HIV Infections; Sexually Transmitted Diseases, Viral; Lentivirus Infections; Retroviridae Infections; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Prescription Drug Misuse; Drug Misuse; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• April M Young, PhD

  University of Kentucky

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Model Details: Type 1 hybrid effectiveness study involving a community-level, controlled quasi-experimental trial and a mixed methods evaluation of implementation outcomes.

Study Record Dates

• First Submitted: November 3, 2022
• First Posted: December 20, 2022
• Study Start: March 6, 2023
• Primary Completion (Estimated): May 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: August 18, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)