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Compensation: Varies

Number of Visits: 6

752 Participants Needed

Harm Reduction Kiosk for Substance Use-Related Health Risks

Overseen ByApril M Young, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: April M Young

Disqualifiers: Violent crime, Stalking, Inpatient facility, others

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

Trial Summary

What is the purpose of this trial?

This trial will test a new harm reduction kiosk called KyOSK in rural Appalachia to help people who use drugs stay safer. The kiosk provides clean needles and other supplies to reduce the risk of HIV, hepatitis C, and overdoses. The study aims to determine if this new approach is more effective and cost-efficient.

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 data supports the effectiveness of the harm reduction kiosk treatment?

Research shows that harm reduction strategies, like needle exchanges and safe injection sites, are effective in reducing the negative effects of drug use. These strategies provide additional tools for people who may not be ready to stop using drugs completely, suggesting that harm reduction kiosks could also be beneficial.¹ ² ³ ⁴ ⁵

Is the harm reduction kiosk generally safe for humans?

Harm reduction strategies, including needle exchanges and safe injection sites, have been widely studied and are generally considered safe, with no harmful effects reported in numerous studies. These interventions are designed to reduce the negative consequences of substance use without requiring complete abstinence.² ³ ⁶ ⁷ ⁸

How is the harm reduction kiosk treatment different from other treatments for substance use-related health risks?

The harm reduction kiosk is unique because it provides a low-barrier, community-based approach to reducing the risks associated with substance use without requiring abstinence. Unlike traditional treatments that often focus on complete cessation, this approach offers practical tools and resources to minimize harm, making it accessible to individuals who may not be ready or able to stop using substances entirely.² ⁴ ⁶ ⁸ ⁹

Research Team

April M Young, PhD

Principal Investigator

University of Kentucky

Eligibility Criteria

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

I am 18 years old or older.

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

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Timeline

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

Treatment Details

Interventions

Harm reduction kiosk

Trial OverviewThe 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.

Participant Groups

2Treatment groups

Experimental Treatment

Active Control

Group I: Syringe Service Program Plus a Harm Reduction Kiosk InterventionExperimental Treatment1 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 ProgramActive Control1 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.

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Who Is Running the Clinical Trial?

April M Young

Lead Sponsor

Trials

Recruited

990+

National Institute on Drug Abuse (NIDA)

Collaborator

Trials

2,658

Recruited

3,409,000+

Findings from Research

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]

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]

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]