Clinical trial NCT05657106: Kentucky Outreach Service Kiosk (KyOSK): Reducing HIV, HCV, and Overdose Risk
Official title: Kentucky Outreach Service Kiosk (KyOSK): Reducing HIV, HCV, and Overdose Risk in Rural Appalachia Through Harm Reduction Kiosks
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Opioid-Related Disorders
Hepatitis C (HCV)
Human Immunodeficiency Virus (HIV)
Drug Overdose
Substance Abuse
Intravenous Drug Usage
Opiate Substitution Treatment
Sexually Transmitted Diseases
Lead sponsor: University of Kentucky
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2022-12-20
Enrollment: 752
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Type 1 hybrid effectiveness study involving a community-level, controlled quasi-experimental trial and a mixed methods evaluation of implementation outcomes.
Primary purpose: PREVENTION

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.

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 harm reduction kiosk on HIV, HCV, and overdose risk in rural Appalachia, and a mixed methods evaluation of implementation outcomes. The trial will compare the standard local syringe service program (SSP) design (brick-and-mortar, staffed by department of health staff) to an enhanced model involving a harm reduction kiosk + standard SSP. 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's impact on HCV and overdose risk behavior, 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, SSPs, 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in syringe coverage for injections
timeFrame: Measured at baseline and then every 6 months up to 5 years
measure: Change in harm reduction program supplied syringe coverage for injections
timeFrame: Measured at baseline and then every 6 months up to 5 years
measure: Change in SSP / KyOSK-provided syringe coverage for injections
timeFrame: Measured at baseline and then every 6 months up to 5 years
Secondary outcomes:
measure: Change in frequency of receptive syringe sharing among participants who inject drugs
timeFrame: Measured at baseline and then every 6 months up to 5 years
measure: Change in frequency of distributive syringe sharing among participants who inject drugs
timeFrame: Measured at baseline and then every 6 months up to 5 years
measure: Change in number of people with whom person shared syringes and injection equipment
timeFrame: Measured at baseline and then every 6 months up to 5 years
measure: Change in frequency of syringe reuse among participants who inject drugs
timeFrame: Measured at baseline and then every 6 months up to 5 years
measure: Change in frequency of safe syringe disposal among participants who inject drugs
timeFrame: Measured at baseline and then every 6 months up to 5 years
measure: Change in frequency of condom-less anal and/or vaginal sex
timeFrame: Measured at baseline and then every 6 months up to 5 years
measure: Change in frequency of overdose
timeFrame: Measured at baseline and then every 6 months up to 5 years
measure: Change in use of naloxone during overdose events by participants who witnessed an overdose
timeFrame: Measured at baseline and then every 6 months up to 5 years
measure: Change in number of days carrying naloxone
timeFrame: Measured at baseline and then every 6 months up to 5 years
measure: Change in number of times contacting or visiting a pharmacy to obtain naloxone
timeFrame: Measured at baseline and then every 6 months up to 5 years
measure: Change in number of days on medications for opioid use disorder (MOUD) among participants who use opioids to get high
timeFrame: Measured at baseline and then every 6 months up to 5 years
measure: Change in frequency of use of harm reduction services among participants who inject drugs
timeFrame: Measured at baseline and then every 6 months up to 5 years
measure: Change in frequency of use of fentanyl test strips among participants who use drugs
timeFrame: Measured at baseline and then every 6 months up to 5 years
measure: Change in frequency of engagement in overdose protective behaviors among participants who use drugs
timeFrame: Measured at baseline and then every 6 months up to 5 years
Other outcomes:
Locations:
city: Lexington
country: United States
facility: University of Kentucky
state: Kentucky
Study officials:
affiliation: University of Kentucky
name: April M Young, PhD
role: PRINCIPAL_INVESTIGATOR
References: