Opioid-Related Disorders Clinical Trial
Official title:
Kentucky Outreach Service Kiosk (KyOSK): Reducing HIV, HCV, and Overdose Risk in Rural Appalachia Through Harm Reduction Kiosks
Verified date | May 2024 |
Source | University of Kentucky |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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. |
Country | Name | City | State |
---|---|---|---|
United States | University of Kentucky | Lexington | Kentucky |
Lead Sponsor | Collaborator |
---|---|
April M Young | National Institute on Drug Abuse (NIDA) |
United States,
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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