Evaluating an Intervention to Prevent Overdoses in Rural and Urban Counties

NCT05463341 | Active Not Recruiting

• 1 other identifier: NCH
• Study Type: interventional
• Target: 2,400
• Locations: 1 country
• Sites: 1

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.

Conditions

Opiate Overdose; Fentanyl Overdose; Harm Reduction

Outcome Measures

Primary Outcomes (6)

• Determine the perceived barriers and facilitating factors associated with incorporating FTS education and distribution in existing OEND programs in rural and urban counties.

  Key informant interviews with all site personnel and peer recovery mentors. Quantitative Data/Process Measures: * \# interested Project DAWN sites * \# Project DAWN sites enrolled * \# potential participants who request to enroll * \# participants successfully enrolled * \# people who receive FTS education and testing materials at baseline * \# replacement FTS requested/distributed * total # FTS 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

• Determine the perceived barriers and facilitating factors associated with incorporating FTS education and distribution in existing OEND programs in rural and urban counties.

  Follow up with intervention arm site personnel to gauge satisfaction with the program and identify any concerns. Quantitative Data/Process Measures: * \# interested Project DAWN sites * \# Project DAWN sites enrolled * \# potential participants who request to enroll * \# participants successfully enrolled * \# people who receive FTS education and testing materials at baseline * \# replacement FTS requested/distributed * total # FTS 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 5

• Determine the perceived barriers and facilitating factors associated with incorporating FTS education and distribution in existing OEND programs in rural and urban counties.

  Interview intervention arm site personnel to identify barriers and facilitating factors related to offering FTS education and distribution at OEND sites. Quantitative Data/Process Measures: * \# interested Project DAWN sites * \# Project DAWN sites enrolled * \# potential participants who request to enroll * \# participants successfully enrolled * \# people who receive FTS education and testing materials at baseline * \# replacement FTS requested/distributed * total # FTS 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 5

• Determine the perceived barriers and facilitating factors associated with incorporating FTS education and distribution in existing OEND programs in rural and urban counties.

  Interview intervention arm sites about the acceptability of the program. Quantitative Data/Process Measures: * \# interested Project DAWN sites * \# Project DAWN sites enrolled * \# potential participants who request to enroll * \# participants successfully enrolled * \# people who receive FTS education and testing materials at baseline * \# replacement FTS requested/distributed * total # FTS 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

• Test the hypothesis that PWUD who receive FTS education and testing materials as part of an OEND program will have improved knowledge and self-efficacy regarding how to test drugs for fentanyl and strategies for lowering their risk of an opioid overdose.

  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 (Appendix). Participants will be compensated for their time with gift cards for completing the questionnaires.

  6-month follow-up

• Test the hypothesis that individuals who receive FTS education and testing materials as part of an OEND program will have a lower opioid overdose rate than individuals who receive OEND only ("usual practice").

  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. Participating Project DAWN sites will be asked to advise the study team if they become aware of any fatal overdoses among clients who are enrolled in the study.

  Quarter 3 of Year 5

Study Arms (2)

Intervention Arm

EXPERIMENTAL

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.

Behavioral: Fentanyl Test Strips

Non-Intervention Arm

NO INTERVENTION

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.

Interventions

Fentanyl Test Strips 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.

Intervention Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.")

Sponsors & Collaborators

• Nationwide Children's Hospital: lead

Study Sites (1)

Nationwide Children's Hospital

Columbus, Ohio, 43205, United States

Location

Related Publications (1)

• 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.

  PMID: 39232778 DERIVED

MeSH Terms

Conditions

Opiate Overdose; Harm Reduction

Condition Hierarchy (Ancestors)

Drug Overdose; Prescription Drug Misuse; Drug Misuse; Substance-Related Disorders; Chemically-Induced Disorders; Opioid-Related Disorders; Narcotic-Related Disorders; Mental Disorders; Behavior

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 1, 2022
• First Posted: July 19, 2022
• Study Start: September 9, 2022
• Primary Completion: April 29, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: May 28, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share
• 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
• Access Criteria: De-identified information will be shared with collaborators or for educational purposes only.

Locations

US (1)