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Harm Reduction Kiosk for Substance Use-Related Health Risks

N/A

Recruiting

Led By April M Young, PhD

Research Sponsored by April M Young

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up measured at baseline and then every 6 months up to 5 years

Awards & highlights

Study Summary

This trial tests a community-tailored kiosk to reduce HIV, hepatitis C, and overdose risk in Appalachian Kentucky, an area at the center of the injection drug use, overdoses, and hepatitis C crises.

Who is the study for?

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.Check my eligibility

What is being tested?

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.See study design

What are the potential side effects?

Since this trial involves using a service (harm reduction kiosk) rather than a medical intervention like medication or surgery, traditional side effects are not applicable.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ measured at baseline and then every 6 months up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~measured at baseline and then every 6 months up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and measured at baseline and then every 6 months up to 5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in SSP / KyOSK-provided syringe coverage for injections

Change in harm reduction program supplied syringe coverage for injections

Change in syringe coverage for injections

Secondary outcome measures

Change in frequency of condom-less anal and/or vaginal sex

Change in frequency of distributive syringe sharing among participants who inject drugs

Change in frequency of engagement in overdose protective behaviors among participants who use drugs

+11 more

Trial Design

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.

Do I qualify?Apply below to find out

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Who is running the clinical trial?

April M YoungLead Sponsor

1 Previous Clinical Trials

234 Total Patients Enrolled

National Institute on Drug Abuse (NIDA)NIH

2,469 Previous Clinical Trials

2,618,659 Total Patients Enrolled

April M Young, PhDPrincipal InvestigatorUniversity of Kentucky

Media Library

Harm reduction kiosk Clinical Trial Eligibility Overview. Trial Name: NCT05657106 — N/A

Opiate Substitution Therapy Research Study Groups: Syringe Service Program Plus a Harm Reduction Kiosk Intervention, Syringe Service Program

Opiate Substitution Therapy Clinical Trial 2023: Harm reduction kiosk Highlights & Side Effects. Trial Name: NCT05657106 — N/A

Harm reduction kiosk 2023 Treatment Timeline for Medical Study. Trial Name: NCT05657106 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the current number of individuals being trialed with this intervention?

"Affirmative, the trial is still in progress according to clinicaltrials.gov. It was first posted on March 6th 2023 and revised most recently on March 7th of the same year. A total of 700 participants are required from one primary site for this research project."

Answered by AI

Are any additional participants being accepted for this trial?

"By referencing clinicaltrials.gov, it is evident that this trial has initiated its recruitment phase; the listing was created on March 6th 2023 and most recently updated one day later."

Answered by AI

To what purpose is this clinical trial geared?

"This clinical trial, whose results will be evaluated over a five-year span from baseline, aims to assess the alteration in syringe coverage for injectable drugs. Secondary objectives include examination of changes in overdose frequency (measured as self-reported incidents within six months), modification in MOUD usage (defined by self-reported days taking medications for opioid use disorder), and alterations with regards to linkage to treatment among those who test HCV positive that have never received therapy before (binary)."

Answered by AI