University of Kentucky
Lexington, Kentucky, 40506, United States
NCT Number: NCT05657106
This study will test the effectiveness, implementation outcomes, and cost effectiveness of a locally-tailored, health kiosk to reduce overdose, hepatitis C, and HIV risk behavior and improve linkage to care in rural Appalachia. The proposed project will take place in two counties in Appalachian Kentucky, an epicenter for the intertwined national crises of overdoses, hepatitis C, and injection-related infections.
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 health kiosk on HIV, HCV, and overdose risk in rural Appalachia, and a mixed methods evaluation of implementation outcomes. The trial will compare the standard health department program (staffed, brick-and-mortar) to an enhanced model involving a health kiosk + standard health department program. 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, 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, local agencies, 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 its existing health department model with a Kentucky Outreach Service Kiosk (KyOSK).
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-month) frequency of engaging in substance use treatment services (binary)
Time frame: Measured at baseline and then every 6 months up to 5 years
Self-reported recent (past 6 month) number of injection-site abscesses among those who inject drugs (continuous)
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 participant used naloxone to reverse someone's overdose 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 being on MOUD (continuous)
Time frame: Measured at 18-month follow-up and thereafter
Self-reported recent (past 6 months) frequency of providing naloxone to others (binary)
Time frame: Measured at baseline and then every 6 months up to 5 years
Self-reported recent (past 6 month) hospitalization for an injection-site infection among those who inject drugs (binary)
Time frame: Measured at 18-month follow-up and thereafter
Self-reported recent (past 6 month) frequency of providing wound care supplies to other (binary)
Time frame: Measured at baseline and then every 6 months up to 5 years
Composite measure of recent (past 6 month) self-reported social capital (receipt and provision of support), physical capital (housing, transportation, food security, technology, and health care access), and human capital (quality of life, experience of shame) (continuous)
April M Young
Other
Kentucky Outreach Service Kiosk (KyOSK): Addressing Health Needs and Improving Service Linkage in Rural Appalachia Through Health 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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