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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01DA055872 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Syringe Service Program Plus a Harm Reduction Kiosk Intervention | Experimental | The intervention to be implemented in the intervention county involves enhancing its existing SSP model with a KyOSK. The intervention county SSP operates identically to the comparison county. As in the comparison county, a card reader will be installed in the intervention county SSP at the beginning of the study to provide objective data on visits and supply access. The KyOSK will resemble a vending machine. The KyOSK will include harm reduction, wound care, hygiene, and other supplies; offer overdose education and other content; a sharps container with a device to obtain data on syringe disposal; and an innovative call-back feature for care navigation by recovery coaches. While the KyOSK is operating, the intervention county will operate its traditional SSP 40 hours/week. |
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| Syringe Service Program | No Intervention | The comparison county SSP operates in the local health department and provides syringes, cookers/cottons, naloxone, wound care kits, condoms and lubricant, snacks, drinks, and sharps containers. A peer support specialist is present for consultation with clients upon request during SSP hours. The SSP will expand it hours from 3 hours/week to 40 hours/week at the same time the intervention county receives its KyOSK, to be comparable. SSP clients who enroll in the study will receive a swipe card linked to their SSP client identification. Card readers will be installed in the SSP for clients to swipe upon entry. Staff will provide clients with the same menu of supplies as those in the KyOSK and the same supply/time interval limits will be imposed. SSP clients will receive a resource guide. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Harm reduction kiosk | Behavioral | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Change in frequency of distributive syringe sharing among participants who inject drugs |
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Inclusion Criteria:
Individuals are eligible if they are:
Exclusion Criteria:
Individuals are not eligible if they meet any of the exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| April M Young, PhD | University of Kentucky | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Kentucky | Lexington | Kentucky | 40506 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41322680 | Derived | Young AM, Jahangir T, Westneat S, Cheatom C, Fallin-Bennett A, Fanucchi LC, Freeman PR, Havens JR, Knudsen HK, McCollister KE, Stitzer S, Stone J, Vickerman P, Livingston MD. Preferences for harm reduction vending machine design among rural people who use drugs. Drug Alcohol Depend Rep. 2025 Oct 31;17:100391. doi: 10.1016/j.dadr.2025.100391. eCollection 2025 Dec. | |
| 38431295 | Derived | Young AM, Havens JR, Cooper HLF, Fallin-Bennett A, Fanucchi L, Freeman PR, Knudsen H, Livingston MD, McCollister KE, Stone J, Vickerman P, Freeman E, Jahangir T, Larimore E, White CR, Cheatom C, Community Staff K, Design Team K. Kentucky Outreach Service Kiosk (KyOSK) Study protocol: a community-level, controlled quasi-experimental, type 1 hybrid effectiveness study to assess implementation, effectiveness and cost-effectiveness of a community-tailored harm reduction kiosk on HIV, HCV and overdose risk in rural Appalachia. BMJ Open. 2024 Mar 1;14(3):e083983. doi: 10.1136/bmjopen-2024-083983. |
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Type 1 hybrid effectiveness study involving a community-level, controlled quasi-experimental trial and a mixed methods evaluation of implementation outcomes.
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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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| ID | Term |
|---|---|
| D009293 | Opioid-Related Disorders |
| D006526 | Hepatitis C |
| D000163 | Acquired Immunodeficiency Syndrome |
| D062787 | Drug Overdose |
| D019966 | Substance-Related Disorders |
| D012749 | Sexually Transmitted Diseases |
| ID | Term |
|---|---|
| D000079524 | Narcotic-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D006525 | Hepatitis, Viral, Human |
| D014777 | Virus Diseases |
| D018178 | Flaviviridae Infections |
| D012327 | RNA Virus Infections |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D015658 | HIV Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012897 | Slow Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
| D063487 | Prescription Drug Misuse |
| D000076064 | Drug Misuse |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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