NCT05657106

Brief Summary

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
752

participants targeted

Target at P75+ for not_applicable

Timeline
15mo left

Started Mar 2023

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress72%
Mar 2023Jul 2027

First Submitted

Initial submission to the registry

November 3, 2022

Completed
2 months until next milestone

First Posted

Study publicly available on registry

December 20, 2022

Completed
3 months until next milestone

Study Start

First participant enrolled

March 6, 2023

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2026

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2027

Last Updated

May 6, 2026

Status Verified

May 1, 2026

Enrollment Period

3.4 years

First QC Date

November 3, 2022

Last Update Submit

May 4, 2026

Conditions

Outcome Measures

Primary Outcomes (3)

  • Change in syringe coverage for injections

    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

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

  • Change in harm reduction program supplied syringe coverage for injections

    Number of syringes obtained at the SSP and/or KyOSK in the past 30 days (obtained from card swipe/supply dispensing data)

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

  • Change in SSP / KyOSK-provided syringe coverage for injections

    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

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

Secondary Outcomes (14)

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

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

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

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

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

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

  • Change in frequency of syringe reuse among participants who inject drugs

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

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

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

  • +9 more secondary outcomes

Study Arms (2)

Syringe Service Program Plus a Harm Reduction Kiosk Intervention

EXPERIMENTAL

The intervention to be implemented in the intervention county involves enhancing its existing SSP model with a KyOSK. The intervention county SSP operates identically to the comparison county. As in the comparison county, a card reader will be installed in the intervention county SSP at the beginning of the study to provide objective data on visits and supply access. The KyOSK will resemble a vending machine. The KyOSK will include harm reduction, wound care, hygiene, and other supplies; offer overdose education and other content; a sharps container with a device to obtain data on syringe disposal; and an innovative call-back feature for care navigation by recovery coaches. While the KyOSK is operating, the intervention county will operate its traditional SSP 40 hours/week.

Behavioral: Harm reduction kiosk

Syringe Service Program

NO INTERVENTION

The comparison county SSP operates in the local health department and provides syringes, cookers/cottons, naloxone, wound care kits, condoms and lubricant, snacks, drinks, and sharps containers. A peer support specialist is present for consultation with clients upon request during SSP hours. The SSP will expand it hours from 3 hours/week to 40 hours/week at the same time the intervention county receives its KyOSK, to be comparable. SSP clients who enroll in the study will receive a swipe card linked to their SSP client identification. Card readers will be installed in the SSP for clients to swipe upon entry. Staff will provide clients with the same menu of supplies as those in the KyOSK and the same supply/time interval limits will be imposed. SSP clients will receive a resource guide.

Interventions

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).

Syringe Service Program Plus a Harm Reduction Kiosk Intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

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.

  • 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.

MeSH Terms

Conditions

Opioid-Related DisordersHepatitis CAcquired Immunodeficiency SyndromeDrug OverdoseSubstance-Related DisordersSexually Transmitted Diseases

Condition Hierarchy (Ancestors)

Narcotic-Related DisordersChemically-Induced DisordersMental DisordersBlood-Borne InfectionsCommunicable DiseasesInfectionsHepatitis, Viral, HumanVirus DiseasesFlaviviridae InfectionsRNA Virus InfectionsHepatitisLiver DiseasesDigestive System DiseasesHIV InfectionsSexually Transmitted Diseases, ViralLentivirus InfectionsRetroviridae InfectionsSlow Virus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesPrescription Drug MisuseDrug MisuseDisease AttributesPathologic ProcessesPathological 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
Model Details: Type 1 hybrid effectiveness study involving a community-level, controlled quasi-experimental trial and a mixed methods evaluation of implementation outcomes.
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

November 3, 2022

First Posted

December 20, 2022

Study Start

March 6, 2023

Primary Completion (Estimated)

July 31, 2026

Study Completion (Estimated)

July 31, 2027

Last Updated

May 6, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will not share

Locations