Evaluation of a Novel Intervention to Prevent Polysubstance Overdoses Involving Illicit Stimulants

The purpose of the study is to investigate the feasibility, acceptability, and associated benefits and harms of integrating FTS education and distribution into select courts in rural and urban communities in Ohio.

Study Overview

• Status: Recruiting
• Conditions: Harm Reduction; Opiate Overdose; Fentanyl Overdose
• Intervention / Treatment: Behavioral: Fentanyl Test Strips

Detailed Description

Purpose: 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 (FTS) test for the presence of some types of fentanyl in urine samples and are increasingly being used to check illicit drugs for fentanyl before they are used. FTS use is a promising harm reduction strategy and research shows when people who use drugs (PWUD) receive a positive result, they are more likely to perform overdose risk reduction behaviors. However, access to FTS is limited, and there are barriers to the adoption of this intervention in some communities. This study will investigate FTS distribution and education as a harm reduction strategy to prevent overdoses among PWUD. Study findings will contribute valuable information about the feasibility and acceptability of integrating FTS drug checking into court sites in rural and urban communities in Ohio and help study personnel achieve the long-term goal of reducing overdose deaths.

Study Design: Court sites that volunteer to participate in the study will be randomly assigned to either the intervention or non-intervention arm of the study.

Clients in the intervention arm of the study will receive:

• One-on-one education on the purpose, benefits, and limitations of FTS testing
• A brief 20-minute fentanyl test strip educational intervention, including a 2-3-minute video and hands-on demonstrations on how to use FTS
• A supply of FTS upon enrollment and throughout the 2-year follow up period
• Opioid overdose education and a naloxone kit upon enrollment and re-supply of naloxone as needed throughout the 2-year follow up period

Clients in the non-intervention arm of the study will receive:

• Opioid overdose education and a naloxone kit upon enrollment and re-supply of naloxone as needed throughout the 2-year follow up period
• FTS education and a supply of FTS will be offered to participants in the non-intervention arm in the last year of the study

Consent: Written documentation of informed consent will be obtained from all participants.

Recruitment and Retention: Having a close partnership with the Supreme Court of Ohio will help study staff recruit and retain study participants. In addition to key informant interviews in year one and questionnaires in year three, the research team will survey court managers quarterly to collect data on the court's satisfaction with the program and identify any areas of concern. The investigators will also maintain regular communication with court personnel when the study staff are onsite.

The research team will handle all enrollment of study clients, delivery of the FTS intervention, and follow up with study participants. Court sites will be asked to provide a small space for the research team to enroll participants and provide the FTS intervention (if applicable). The sites will also be asked to refer potentially eligible individuals to the research team at times when they are on-site.

• Study Type: Interventional
• Enrollment (Estimated): 1750
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ashley Short Mejia, MSW; Phone Number: 614-355-6686; Email: Ashley.ShortMejia@nationwidechildrens.org
• Study Contact Backup: Name: Nichole Michaels, PhD; Phone Number: 614-355-5870; Email: nichole.michaels@nationwidechildrens.org

Study Locations

• United States
  • Ohio
    • Columbus, Ohio, United States, 43207
      • Recruiting
      • Nationwide Children's Hospital
      • Contact: Nichole Michaels, PhD; Phone Number: 614-355-5870; Email: nichole.michaels@nationwidechildrens.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Age 18 years or older
• Not incarcerated at time of study enrollment
• Currently enrolled in one of the following Ohio drug courts: Criminal drug court, Veterans' court, Mental health court, Human trafficking court, Family treatment court, O.V.I. court or on probation with a participating court
• Self-reported use of illicit stimulants in the past 6 months
• Has a phone number or email address to allow for follow-up contact
• Understands English (Based on the 2012-2016 American Community Survey, only 2.4% of Ohioans 5 years and older speak English less than "very well.")

Exclusion Criteria:

- None (must meet inclusion criteria)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention Arm; Each participant in the intervention arm will receive one-on-one education on the purpose, benefits, and limitations of fentanyl test strip (FTS) testing and undergo a brief 20-minute FTS educational intervention (including a 2-3-minute video and hands-on demonstrations on how to use FTS). They will also receive a supply of 10 FTS upon enrollment and continued supply upon request throughout the 2-year follow up period. Each participant will also receive Opioid overdose education and a naloxone kit upon enrollment and re-supply of naloxone as needed throughout the 2-year follow up period.	Behavioral: Fentanyl Test Strips; A brief fentanyl test strip (FTS) education intervention will be given to participants at court sites in the intervention arm after enrollment and collecting baseline data. It will be offered one-on-one with participants and will include the purpose, benefits, and limitations of FTS testing, and information on how to use FTS, interpret the results, what to do if the FTS is positive, and how to use FTS for different drug delivery methods. Participants will practice and demonstrate use of the FTS, and the short video on how to interpret the FTS will include an on-camera statement on the importance of testing for fentanyl. The video will be accessible to participants after study enrollment. Participants will be advised of the possibility of both false positive/negative results, and that the drugs may be mixed with other substances not detectable with FTS. Participants will be encouraged to practice other harm reduction strategies.
No Intervention: Non-Intervention Arm; Each participant will receive Opioid overdose education and a naloxone kit upon enrollment and re-supply of naloxone as needed throughout the 2-year follow up period. Fentanyl test strip (FTS) education and a supply of FTS will be offered to participants in the non-intervention arm of the study during the final quarter of year 3.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Key informant interviews	Key informant interviews will be conducted with court personnel and peer recovery mentors who are affiliated with the court sites to discuss and obtain feedback on the intervention design and research protocols. Key informants will be asked to provide feedback on participant recruitment strategies, discuss potential barriers to the program's success, and describe any concerns with the implementation plan. Quantitative Data/Process Measures: # interested court sites; # Court sites enrolled; # potential participants who request to enroll; # participants successfully enrolled; # people who receive FTSED and OEND at baseline; # replacement FTS and Naloxone kits requested/distributed; total # FTS and Naloxone kits distributed; proportion of participants in the intervention arm who complete the biweekly surveys; proportion of participants who complete the 6-month follow-up questionnaire	Quarter 2 of Year 1
Follow-up questionnaire	A follow-up questionnaire will occur with intervention arm site personnel to gauge satisfaction with the program and identify any concerns. Quantitative Data/Process Measures: # interested court sites; # Court sites enrolled; # potential participants who request to enroll; # participants successfully enrolled; # people who receive FTSED and OEND at baseline; # replacement FTS and Naloxone kits requested/distributed; total # FTS and Naloxone kits distributed; proportion of participants in the intervention arm who complete the biweekly surveys; proportion of participants who complete the 6-month follow-up questionnaire	Quarter 3 of Year 3
Interview	Intervention arm site personnel will be interviewed to identify barriers and facilitating factors related to offering FTS education and distribution at OEND sites. Quantitative Data/Process Measures: # interested court sites; # Court sites enrolled; # potential participants who request to enroll; # participants successfully enrolled; # people who receive FTSED and OEND at baseline; # replacement FTS and Naloxone kits requested/distributed; total # FTS and Naloxone kits distributed; proportion of participants in the intervention arm who complete the biweekly surveys; proportion of participants who complete the 6-month follow-up questionnaire	Quarter 2 of Year 3
Interview	Intervention arm sites will be interviewed about the acceptability of the program. Quantitative Data/Process Measures: # interested court sites; # Court sites enrolled; # potential participants who request to enroll; # participants successfully enrolled; # people who receive FTSED and OEND at baseline; # replacement FTS and Naloxone kits requested/distributed; total # FTS and Naloxone kits distributed; proportion of participants in the intervention arm who complete the biweekly surveys; proportion of participants who complete the 6-month follow-up questionnaire	6-month follow-up
Questionnaire	All participants (in both the intervention and non-intervention arms) will complete a questionnaire at enrollment (for the intervention group, prior to the intervention) and again at 6 months. Both questionnaires (baseline and 6 months) will include the same questions about the participant's knowledge of and self-efficacy in reducing their risk of an opioid overdose by using FTS.	6-month follow-up
Questionnaire	Participants in the intervention arm will be contacted biweekly for 2 years and asked if they had an overdose in the past 2 weeks and, if so, what drug they were using at the time. Intervention arm participants will be asked to notify the study team when they receive a positive FTS result. Participants in the non-intervention arm will be contacted biweekly up to a maximum of 2 years after enrollment to ask if they had an overdose in the past 2 weeks and, if so, what drug they were using at the time. Fatal overdoses among participants in the intervention and non-intervention arms of the study will be identified by reviewing death certificates issued by the Ohio Department of Health quarterly starting in Year 2.	Quarter 3 of Year 3

Collaborators and Investigators

• Sponsor: Nationwide Children's Hospital
• Investigators: Principal Investigator: Nichole Michaels, PhD, Nationwide Children's Hospital, Center for Injury Research & Policy; Principal Investigator: Gary Smith, MD, DRPH, Nationwide Children's Hospital, Center for Injury Research & Policy

Study record dates

Study Major Dates

• Study Start (Actual): November 10, 2022
• Primary Completion (Estimated): September 1, 2025
• Study Completion (Estimated): September 1, 2025

Study Registration Dates

• First Submitted: July 25, 2022
• First Submitted That Met QC Criteria: August 5, 2022
• First Posted (Actual): August 9, 2022

Study Record Updates

• Last Update Posted (Actual): April 16, 2024
• Last Update Submitted That Met QC Criteria: April 12, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders; Narcotic-Related Disorders; Opioid-Related Disorders; Prescription Drug Misuse; Drug Misuse; Drug Overdose; Opiate Overdose; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Analgesics, Opioid; Narcotics; Adjuvants, Anesthesia; Fentanyl
• Other Study ID Numbers: Nationwide Children's Hospital

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: De-identified information on the number of overdoses reported to research staff by study participants and what drug the participant thought they were using at the time will be shared with the Ohio Department of Health's Violence and Injury Prevention Section. Personal stories of potential overdoses averted by use of FTS will be shared in a de-identified form in future trainings.
• IPD Sharing Time Frame: Number of overdoses will be shared with ODH throughout the study; Personal stories of potential overdoses will be shared with no end-date
• IPD Sharing Access Criteria: De-identified information will be shared with collaborators or for educational purposes only.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No