Clinical trial NCT05463341: Evaluating an Intervention to Prevent Overdoses in Rural and Urban Counties
Official title: Evaluating an Intervention to Prevent Overdoses in Rural and Urban Counties
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Opiate Overdose
Fentanyl Overdose
Harm Reduction
Lead sponsor: Nationwide Children's Hospital
Sponsor class: OTHER
First posted: 2022-07-19
Enrollment: 2400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.")

Exclusion Criteria:

- None (must meet inclusion criteria)

Primary outcomes:
measure: Determine the perceived barriers and facilitating factors associated with incorporating FTS education and distribution in existing OEND programs in rural and urban counties.
timeFrame: Quarter 2 of Year 1
measure: Determine the perceived barriers and facilitating factors associated with incorporating FTS education and distribution in existing OEND programs in rural and urban counties.
timeFrame: Quarter 3 of Year 5
measure: Determine the perceived barriers and facilitating factors associated with incorporating FTS education and distribution in existing OEND programs in rural and urban counties.
timeFrame: Quarter 2 of Year 5
measure: Determine the perceived barriers and facilitating factors associated with incorporating FTS education and distribution in existing OEND programs in rural and urban counties.
timeFrame: 6-month follow-up
measure: 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.
timeFrame: 6-month follow-up
measure: 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").
timeFrame: Quarter 3 of Year 5
Secondary outcomes:
Other outcomes:
Locations:
city: Columbus
country: United States
facility: Nationwide Children's Hospital
state: Ohio
Study officials:
affiliation: Nationwide Children's Hospital, Center for Injury Research & Policy
name: Nichole Michaels, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Nationwide Children's Hospital, Center for Injury Research & Policy
name: Gary Smith, MD, DRPH
role: PRINCIPAL_INVESTIGATOR
References: