Journal Article

Evaluating fentanyl test strips as a harm reduction strategy in rural and urban counties: study protocol for a randomized controlled trial

Grella, Christine, Smith, Gary A., Freisthler, Bridget, Short Mejia, Ashley, Michaels, Nichole L., Fernandez, Soledad A.

2024

Overview

Background Opioid-related fatalities are a leading cause of death in Ohio and nationally, with an increasing number of overdoses attributable to fentanyl. Rapid fentanyl test strips can identify fentanyl and some fentanyl analogs in urine samples and are increasingly being used to check illicit drugs for fentanyl before they are used. Fentanyl test strips are a promising harm reduction strategy; however, little is known about the real-world acceptability and impact of fentanyl test strip use. This study investigates fentanyl test strip distribution and education as a harm reduction strategy to prevent overdoses among people who use drugs. Methods The research team will recruit 2400 individuals ≥ 18 years with self-reported use of illicit drugs or drugs purchased on the street within the past 6 months. Recruitment will occur at opioid overdose education and naloxone distribution programs in 16 urban and 12 rural Ohio counties. Participating sites will be randomized at the county level to the intervention or non-intervention study arm. A brief fentanyl test strip educational intervention and fentanyl test strips will be provided to participants recruited from sites in the intervention arm. These participants will be eligible to receive additional fentanyl test strips for 2 years post-enrollment. Participants recruited from sites in the non-intervention arm will not receive fentanyl test strip education or fentanyl test strips. All participants will be followed for 2 years post-enrollment using biweekly, quarterly, and 6-month surveys. Primary outcomes include (1) identification of perceived barriers and facilitating factors associated with incorporating fentanyl test strip education and distribution into opioid overdose education and naloxone distribution programs; (2) differences in knowledge and self-efficacy regarding how to test drugs for fentanyl and strategies for reducing overdose risk between the intervention and non-intervention groups; and (3) differences in non-fatal and fatal overdose rates between the intervention and non-intervention groups. Discussion Findings from this cluster randomized controlled trial will contribute valuable information about the feasibility, acceptability, and impact of integrating fentanyl test strip drug checking in rural and urban communities in Ohio and help guide future overdose prevention interventions. Trial registration ClinicalTrials.gov NCT05463341. Registered on July 19, 2022. https://clinicaltrials.gov/study/NCT05463341

• Publisher: BioMed Central,BioMed Central Ltd,Springer Nature B.V,BMC
• Subject: Analgesics, Opioid - adverse effects / Analgesics, Opioid - urine / Biomedicine / Central nervous system depressants / Consent / Curricula / Drug delivery systems / Drug overdose / Drug Overdose - prevention & control / Drug Overdose - urine / Drug testing / Drug use / Drugs / Education / Fatalities / Fentanyl / Fentanyl - adverse effects / Fentanyl - urine / Fentanyl test strips / Harm Reduction / Health Sciences / Humans / Hypotheses / Illegal drugs / Illicit Drugs - urine / Intervention / Medicine / Medicine & Public Health / Multicenter Studies as Topic / Naloxone - administration & dosage / Narcotic Antagonists / Narcotics / Non-pharmacological intervention / Ohio / Opiate Overdose - epidemiology / Opiate Overdose - prevention & control / Opioid-Related Disorders - diagnosis / Opioid-Related Disorders - prevention & control / Opioid-Related Disorders - urine / Overdose / Prevention / Public health / Randomized controlled trial / Randomized Controlled Trials as Topic / Reagent Strips / Self-efficacy / Statistics for Life Sciences / Study Protocol / Substance abuse / Substance Abuse Detection - methods / Urban Health Services