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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT05657106
Other study ID # KyOSK
Secondary ID 1R01DA055872
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date March 6, 2023
Est. completion date July 31, 2027

Study information

Verified date May 2024
Source University of Kentucky
Contact n/a
Is FDA regulated No
Health authority
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 Active, not recruiting
Enrollment 752
Est. completion date July 31, 2027
Est. primary completion date July 31, 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.

Study Design


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
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