University of Kentucky
Lexington, Kentucky, 40506, United States
NCT Number: NCT05657106
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.
This study is active but is not currently recruiting participants.
Notify Me18 year and older
All sexes
Interventional
Not applicable
Lexington, Kentucky, 40506, United States
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Individuals are eligible if they are:
Exclusion criteria
Individuals are not eligible if they meet any of the exclusion criteria:
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).
Time frame: Measured at baseline and then every 6 months up to 5 years
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
Time frame: Measured at baseline and then every 6 months up to 5 years
Number of syringes obtained at the SSP and/or KyOSK in the past 30 days (obtained from card swipe/supply dispensing data)
Time frame: Measured at baseline and then every 6 months up to 5 years
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
Time frame: Measured at baseline and then every 6 months up to 5 years
Self-reported recent (past 30-day) frequency of using a syringe that had been previously used by someone else (continuous; number and proportion)
Time frame: Measured at baseline and then every 6 months up to 5 years
Self-reported recent (past 30-day) frequency of providing a used syringe to someone else (continuous)
Time frame: Measured at baseline and then every 6 months up to 5 years
Self-reported number of people participant shared syringes and other injection equipment with in the past 30 days (continuous)
Time frame: Measured at baseline and then every 6 months up to 5 years
Self-reported recent (past 30-day) number of times re-using syringes (continuous)
Time frame: Measured at baseline and then every 6 months up to 5 years
Self-reported recent (past 30-day) disposal of syringes in a sharps container or syringe exchange program (binary)
Time frame: Measured at baseline and then every 6 months up to 5 years
Self-reported recent (past 30-day) frequency of anal or vaginal sex without a condom (continuous; number and proportion of all sex events)
Time frame: Measured at baseline and then every 6 months up to 5 years
Self-reported number of times overdosed in the past 6 months (continuous).
Time frame: Measured at baseline and then every 6 months up to 5 years
Self-reported number of times overdosed in the past 6 months (continuous)
Time frame: Measured at baseline and then every 6 months up to 5 years
Self-reported recent (past 30-day) frequency of carrying naloxone (continuous)
Time frame: Measured at baseline and then every 6 months up to 5 years
Self-reported recent (past 6 months) frequency of naloxone seeking at a pharmacy (continuous)
Time frame: Measured at baseline and then every 6 months up to 5 years
Self-reported recent (past 30-day) frequency of being on MOUD (continuous)
Time frame: Measured at baseline and then every 6 months up to 5 years
Self-reported recent (past 30-day) frequency of providing a used syringe to someone else (continuous, number and proportion of syringes)
Time frame: Measured at baseline and then every 6 months up to 5 years
Self-reported recent (past 30-day) frequency of using a fentanyl test strips (binary)
Time frame: Measured at baseline and then every 6 months up to 5 years
Self-reported recent (past 30-day) frequency of engaging in overdose protective behaviors
April M Young
Other
Kentucky Outreach Service Kiosk (KyOSK): Reducing HIV, HCV, and Overdose Risk in Rural Appalachia Through Harm Reduction Kiosks
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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