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

Opioid-Related Disorders Clinical Trial

Official title:

Kentucky Outreach Service Kiosk (KyOSK): Reducing HIV, HCV, and Overdose Risk in Rural Appalachia Through Harm Reduction Kiosks

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05657106
• Other study ID #: KyOSK
• Secondary ID: 1R01DA055872
• Status: Recruiting
• Phase: N/A
• Start date: March 6, 2023
• Est. completion date: July 2027

Study information

• Verified date: January 2024
• Source: University of Kentucky
• Contact: Carol R White, MPH
• Phone: 8593518277
• Email: crwhit3[@]uky.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 750
• Est. completion date: July 2027
• Est. primary completion date: July 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

Behavioral:
• Harm reduction kiosk
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).

Locations

Country	Name	City	State
United States	University of Kentucky	Lexington	Kentucky

Sponsors (2)

Lead Sponsor	Collaborator
April M Young	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	Change in frequency of receptive syringe sharing among participants who inject drugs	Self-reported recent (past 30-day) frequency of using a syringe that had been previously used by someone else (continuous; number and proportion)	Measured at baseline and then every 6 months up to 5 years
Secondary	Change in frequency of distributive syringe sharing among participants who inject drugs	Self-reported recent (past 30-day) frequency of providing a used syringe to someone else (continuous)	Measured at baseline and then every 6 months up to 5 years
Secondary	Change in number of people with whom person shared syringes and injection equipment	Self-reported number of people participant shared syringes and other injection equipment with in the past 30 days (continuous)	Measured at baseline and then every 6 months up to 5 years
Secondary	Change in frequency of syringe reuse among participants who inject drugs	Self-reported recent (past 30-day) number of times re-using syringes (continuous)	Measured at baseline and then every 6 months up to 5 years
Secondary	Change in frequency of safe syringe disposal among participants who inject drugs	Self-reported recent (past 30-day) disposal of syringes in a sharps container or syringe exchange program (binary)	Measured at baseline and then every 6 months up to 5 years
Secondary	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)	Measured at baseline and then every 6 months up to 5 years
Secondary	Change in frequency of overdose	Self-reported number of times overdosed in the past 6 months (continuous).	Measured at baseline and then every 6 months up to 5 years
Secondary	Change in use of naloxone during overdose events by participants who witnessed an overdose	Self-reported number of times overdosed in the past 6 months (continuous)	Measured at baseline and then every 6 months up to 5 years
Secondary	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
Secondary	Change in number of times contacting or visiting a pharmacy to obtain naloxone	Self-reported recent (past 6 months) frequency of naloxone seeking at a pharmacy (continuous)	Measured at baseline and then every 6 months up to 5 years
Secondary	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)	Measured at baseline and then every 6 months up to 5 years
Secondary	Change in frequency of use of harm reduction services among participants who inject drugs	Self-reported recent (past 30-day) frequency of providing a used syringe to someone else (continuous, number and proportion of syringes)	Measured at baseline and then every 6 months up to 5 years
Secondary	Change in frequency of use of fentanyl test strips among participants who use drugs	Self-reported recent (past 30-day) frequency of using a fentanyl test strips (binary)	Measured at baseline and then every 6 months up to 5 years
Secondary	Change in frequency of engagement in overdose protective behaviors among participants who use drugs	Self-reported recent (past 30-day) frequency of engaging in overdose protective behaviors	Measured at baseline and then every 6 months up to 5 years