Drug Overdose, Hepatitis C (HCV), Human Immunodeficiency Virus (HIV), Intravenous Drug Usage, Opiate Substitution Treatment, Opioid-Related Disorders, Sexually Transmitted Diseases, Substance Abuse
Conditions
Brief summary
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.
Detailed description
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.
Interventions
BEHAVIORALHealth kiosk
The intervention involves enhancing its existing health department model with a Kentucky Outreach Service Kiosk (KyOSK).
Sponsors
April M Young
National Institute on Drug Abuse (NIDA)
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
Type 1 hybrid effectiveness study involving a community-level, controlled quasi-experimental trial and a mixed methods evaluation of implementation outcomes.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in number of days carrying naloxone | Measured at baseline and then every 6 months up to 5 years | Self-reported recent (past 30-day) frequency of carrying naloxone (continuous) |
| Change in frequency of use of substance use treatment, detoxification, and/or peer-support services | 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) |
| Change in number of injection-related abscesses | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in frequency of condom-less anal and/or vaginal sex | 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) |
| Change in frequency of overdose | Measured at baseline and then every 6 months up to 5 years | Self-reported number of times overdosed in the past 6 months (continuous). |
| Change in use of naloxone during overdose events by participants who witnessed an overdose | 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) |
| Change in number of days on medications for opioid use disorder (MOUD) among participants who use opioids to get high | Measured at baseline and then every 6 months up to 5 years | Self-reported recent (past 30-day) frequency of being on MOUD (continuous) |
| Change in frequency of helping others access naloxone | Measured at 18-month follow-up and thereafter | Self-reported recent (past 6 months) frequency of providing naloxone to others (binary) |
| Change in frequency of hospitalization for an injection-related infection | 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) |
| Change in frequency of helping others access wound care | Measured at 18-month follow-up and thereafter | Self-reported recent (past 6 month) frequency of providing wound care supplies to other (binary) |
| Change in recovery capital | 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) |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORApril M Young, PhD
University of Kentucky
Outcome results
None listed