Evaluating an Intervention to Prevent Overdoses in Rural and Urban Counties

NCT ID: NCT05463341

Last Updated: 2025-01-28

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 2400 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-09-09
• Study Completion Date: 2026-01-31

Brief Summary

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

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 Project DAWN sites in rural and urban communities in Ohio and help us achieve our long-term goal of reducing overdose deaths.

Study Design: Project DAWN 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

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

• 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.

Incentives: Participants will be compensated for their time with a gift cards for completing the baseline survey, the survey at 6-months, and each biweekly survey.

Recruitment and Retention: Having a close partnership with Project DAWN sites will help us recruit and retain study participants. In addition to key informant interviews in year one and questionnaires in year five, the research team will survey coordinators quarterly to collect data on Project DAWN site and coordinator experiences, identify concerns, and take corrective actions. The investigators will also maintain regular communication with Project DAWN site coordinators 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. Project DAWN 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.

Conditions

Opiate Overdose; Fentanyl Overdose; Harm Reduction

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Fentanyl Test Strips

Intervention Type: BEHAVIORAL

A brief fentanyl test strip (FTS) education intervention will be given to participants at Project DAWN 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.

Non-Intervention Arm

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 5.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Fentanyl Test Strips

A brief fentanyl test strip (FTS) education intervention will be given to participants at Project DAWN 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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Age 18 years or older
• Visitor to a Project DAWN site in Ohio that does not currently distribute FTS and has agreed to participate in the study
• Self-reported use of illicit drugs or prescription drugs purchased on the street within 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.")

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Nationwide Children's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Nichole Michaels

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Nichole Michaels, PhD

Role: PRINCIPAL_INVESTIGATOR

Nationwide Children's Hospital, Center for Injury Research & Policy

Gary Smith, MD, DRPH

Role: PRINCIPAL_INVESTIGATOR

Nationwide Children's Hospital, Center for Injury Research & Policy

Locations

Nationwide Children's Hospital

Columbus, Ohio, United States

Countries

United States

References

Short Mejia A, Smith GA, Fernandez SA, Freisthler B, Grella C, Michaels NL. Evaluating fentanyl test strips as a harm reduction strategy in rural and urban counties: study protocol for a randomized controlled trial. Trials. 2024 Sep 4;25(1):587. doi: 10.1186/s13063-024-08440-y.

Reference Type: DERIVED

PMID: 39232778 (View on PubMed)

Other Identifiers

NCH

Identifier Type: -

Identifier Source: org_study_id