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 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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
752
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).
University of Kentucky
Lexington, Kentucky, United States
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
Time frame: 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)
Time frame: 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
Time frame: Measured at baseline and then every 6 months up to 5 years
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)
Time frame: Measured at baseline and then every 6 months up to 5 years
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)
Time frame: 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
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
Change in frequency of syringe reuse among participants who inject drugs
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
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)
Time frame: Measured at baseline and then every 6 months up to 5 years
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)
Time frame: Measured at baseline and then every 6 months up to 5 years
Change in frequency of overdose
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
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)
Time frame: Measured at baseline and then every 6 months up to 5 years
Change in number of days carrying naloxone
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
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)
Time frame: Measured at baseline and then every 6 months up to 5 years
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)
Time frame: Measured at baseline and then every 6 months up to 5 years
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)
Time frame: Measured at baseline and then every 6 months up to 5 years
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)
Time frame: Measured at baseline and then every 6 months up to 5 years
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
Time frame: Measured at baseline and then every 6 months up to 5 years
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