Harm Reduction Kiosk for Substance Use-Related Health Risks

Overseen By April M Young, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: April M Young

Disqualifiers: Violent crime, Stalking, Inpatient facility, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 6

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new harm reduction kiosk designed to lower the risks of HIV, hepatitis C, and overdoses in rural Appalachia. The kiosk functions like a vending machine, providing supplies for safe drug use, wound care, and hygiene, along with educational content and support from recovery coaches. It targets individuals in two counties in Kentucky who have used injection or non-injection drugs (excluding marijuana, alcohol, and tobacco) to get high in the last six months. Participants will either use the enhanced kiosk system or continue with an existing syringe service program (SSP) to determine which is more effective. The study is open to residents of the specified counties who meet the drug use criteria. As an unphased trial, this study offers a unique opportunity to contribute to innovative harm reduction strategies in the community.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that this harm reduction kiosk is safe for use in reducing substance use-related health risks?

Research has shown that harm reduction kiosks, like the one tested in this trial, have distributed thousands of kits to reduce drug-related harm. These kiosks provide supplies such as clean syringes, wound care packages, and condoms. Studies suggest that these kiosks are popular in communities, offering a safe and easy way to access important health supplies.

Although specific data on the safety of these kiosks is lacking, their widespread use for similar purposes suggests general safety. People have used them without major safety issues being reported, making them a promising option for reducing risks related to drug use, such as overdose or infection. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Harm Reduction Kiosk because it offers a fresh approach to addressing substance use-related health risks. Unlike traditional methods, which often rely on person-to-person interactions and limited hours, the kiosk functions like a vending machine, providing 24/7 access to essential supplies such as syringes, wound care kits, and educational materials. This innovative system also includes a call-back feature for personalized care navigation, allowing users to connect with recovery coaches. By enhancing accessibility and privacy, this kiosk could significantly improve harm reduction efforts and support individuals in their recovery journey.

What evidence suggests that the harm reduction kiosk is effective for reducing substance use-related health risks?

Research has shown that harm reduction kiosks, like the KyOSK, can help reduce drug-related problems in rural areas. In this trial, one arm will implement the Syringe Service Program Plus a Harm Reduction Kiosk Intervention, offering essential supplies such as clean syringes, naloxone (a drug that can reverse overdoses), and wound care kits. Studies suggest that these kiosks improve access to these supplies, which can lower the risk of HIV and hepatitis C. Evidence also indicates that these kiosks encourage safer habits among people who use drugs. Early findings suggest that this approach may reduce overdose risks by providing crucial education and resources. ^{1 3 6 7 8}

Who Is on the Research Team?

April M Young, PhD

Principal Investigator

University of Kentucky

Are You a Good Fit for This Trial?

This trial is for adults over 18 living in specific Kentucky counties who've used drugs (other than marijuana, alcohol, and tobacco) to get high via injection or other methods in the past 6 months. It's not open to those under 18 or outside these areas.

Inclusion Criteria

Living in the intervention or comparison county

Engaged in injection or non-injection illicit drug use to get high in the past 6 months (excluding marijuana, alcohol, and tobacco)

Exclusion Criteria

I am under 18 years old.

Current charges of violent crime or stalking

Conviction in the past 10 years of a violent crime (i.e., murder, manslaughter, rape, robbery, and /or aggravated assault) or stalking

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention Implementation

Implementation of the KyOSK in the intervention county, enhancing the existing SSP model with a harm reduction kiosk

5 years

Continuous access to KyOSK and SSP

Evaluation and Monitoring

Evaluation of the KyOSK's impact on HCV and overdose risk behavior, including assessments of acceptability, appropriateness, fidelity, cost, penetration, and sustainability

5 years

Measured at baseline and then every 6 months

Follow-up

Participants are monitored for safety and effectiveness after the main intervention period

6 months

What Are the Treatments Tested in This Trial?

Interventions

• Harm reduction kiosk

Trial Overview The study is examining if a harm reduction kiosk can lower risks of HIV, hepatitis C, and drug overdoses among drug users in rural Appalachia. The effectiveness and cost will be evaluated by comparing two counties.

How Is the Trial Designed?

Group I: Syringe Service Program Plus a Harm Reduction Kiosk Intervention Experimental Treatment 1 Intervention

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.

Group II: Syringe Service Program Active Control 1 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.

Who Is Running the Clinical Trial?

April M Young

Lead Sponsor

Trials

2

Recruited

990+

National Institute on Drug Abuse (NIDA)

Collaborator

Trials

2,658

Recruited

3,409,000+

Published Research Related to This Trial

The ORION tool, an innovative e-health psychoeducational software, was developed to inform opioid-dependent individuals about overdose risks and identified seven key risk factors related to their behaviors.

While the ORION tool did not significantly change self-efficacy scores in participants, it effectively identified those at higher risk, suggesting that it could be a valuable component of a broader intervention strategy when combined with other support methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Engagement in the Overdose RIsk InfOrmatioN (ORION) e-Health Tool for Opioid Overdose Prevention and Self-Efficacy: A Preliminary Study. Carrà, G., Crocamo, C., Humphris, G., et al.[2022]

The ORION project developed an e-health tool designed to educate drug users about overdose risks, emphasizing the importance of evidence-based interventions to improve risk perception and self-efficacy among users.

Initial testing of the ORION tool showed promise in helping users understand their risk factors for overdose, paving the way for further evaluation in clinical settings across Europe to assess its effectiveness and generalizability.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Decision support in addiction: The development of an e-health tool to assess and prevent risk of fatal overdose. The ORION Project. Baldacchino, A., Crocamo, C., Humphris, G., et al.[2022]

A qualitative study involving interviews with 20 staff and providers at 3 harm reduction and medical care sites in New York identified 8 key themes for integrating harm reduction into patient care, emphasizing a collaborative and stigma-free environment.

The findings suggest that adopting harm reduction strategies, such as low-threshold care and robust referral networks, can help medical providers effectively engage patients with substance use disorders and improve their overall care experience.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Integrating Harm Reduction into Medical Care: Lessons from Three Models. Chang, JE., Lindenfeld, Z., Hagan, H.[2023]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10910671/

Kentucky Outreach Service Kiosk (KyOSK) Study protocol Innovative harm reduction service models, such as vending machines or kiosks, can expand access to services that reduce drug-related harms.

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38431295/

Kentucky Outreach Service Kiosk (KyOSK) Study protocol The KyOSK study assesses a harm reduction kiosk's effectiveness in reducing HIV, HCV, and overdose risk in rural Appalachia, comparing it to ...

3. scholars.uky.edu scholars.uky.edu/en/projects/kentucky-outreach-service-kiosk-kyosk-reducing-hiv-hcv-and-overdo/

Kentucky Outreach Service Kiosk (KyOSK): Reducing HIV ... KyOSK is a harm reduction kiosk in rural Appalachia, providing injection equipment, naloxone, and other supplies to reduce HIV, HCV, and overdose risks.

4. centerwatch.com centerwatch.com/clinical-trials/listings/NCT05657106/kentucky-outreach-service-kiosk-kyosk-reducing-hiv-hcv-and-overdose-risk

Kentucky Outreach Service Kiosk (KyOSK): Reducing HIV ... This study will test the effectiveness, implementation outcomes, and cost effectiveness of a community-tailored, harm reduction kiosk in ...

5. inhsu.org inhsu.org/wp-content/uploads/2024/02/INHSU_2023_-_Vending_Machines-138-315-Young-April.pdf

Willingness to Use Harm Reduction Vending Machine ... These data were used to guide design of an ongoing, hybrid effectiveness trial of a harm reduction kiosk in rural Kentucky. This trial is engaging a Kiosk ...

6. cph.uky.edu cph.uky.edu/sites/default/files/2024-08/6_poster.pdf

Community Input In Harm Reduction Kiosk Design Implementing a harm reduction vending machine or "kiosk" might provide community members with a more low-threshold way to access items that could reduce their ...

7. harmreductionjournal.biomedcentral.com harmreductionjournal.biomedcentral.com/articles/10.1186/s12954-025-01222-y

a qualitative study with people who use drugs and service staff ... We report on guidance from people who use drugs (PWUD) and health department staff on how to adapt HRVMs to suit local needs in rural Appalachian Kentucky.

8. iris.ssw.umaryland.edu iris.ssw.umaryland.edu/harm-reduction-kiosk

Harm Reduction Kiosk Proof of Concept Over 3,000 safe smoking kits were given out, helping individuals manage harm reduction while using substances. A total of 10,000+ male and female condoms were ...