Rapid Self-Testing to Prevent Fentanyl Overdose Among Young People Who Use Drugs

Study Overview
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Brief Summary
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The research team will enroll 100 young adults who use cocaine, heroin, inject drugs, or purchase prescription medications on the illicit market in a pilot study to be known as the Rhode Island Young Adult Prescription and Illicit Drug Study (RAPIDS). Participants will be trained to use a take-home home rapid drug test to test for the presence or absence of fentanyl in their drug supply. Half of the enrolled participants will be asked to test their urine for presence or absence of fentanyl, and the other half will be asked to test their drug residue for presence or absence of fentanyl. All participants will receive up to 15 take-home rapid drug tests for fentanyl. A follow-up survey will examine and compare utilization of the tests between the two groups. The study will be guided by the information-motivation-behavioral skills (IMB) model of engagement in health behaviors. The IMB model hypothesizes that if a person possesses the information, motivation, and behavioral skills to act, there is an increased likelihood that she/he will fulfill and maintain the desired behaviors (behaviors that will reduce accidental overdose).

Detailed Description
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The research team will administer a brief survey to ascertain behavioral, psychosocial, and clinical factors that may be related to non-prescription fentanyl (NPF) exposure among young people who use illicit drugs. The researchers will also characterize knowledge of and perceptions towards drugs contaminated with NPF, as well as the potential diversion of prescription fentanyl formulations (e.g., transdermal patches). After the interviewer-administered survey has been completed, participants will provide urine samples to determine recent exposure to NPF and other illicit drugs. The research team will assess the acceptability and feasibility of take home rapid drug tests to test for fentanyl exposure among 100 participants from the target population. After the enrollment and baseline survey, participants will be provided with rapid drug tests that detect the presence or absence of fentanyl in their drug supply. Half the participants will be asked to test their urine to see if they have been exposed to a fentanyl-contaminated drug. The other half will be asked to test the residue of the drug that they intend to use. Study participants will then be asked to return in 2 weeks for a brief follow-up survey that will assess whether they used the self-tests, whether the technology was acceptable and easy to use, and whether and how a positive test result altered their drug-using and overdose prevention behaviors.

Official Title
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Rapid Self-Testing to Prevent Fentanyl Overdose Among Young People Who Use Drugs

Conditions
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Accidental Overdose of Opiate

Intervention / Treatment
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* Behavioral: Take home rapid drug test


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria 18-35 years of age resident of Rhode Island able to complete interviews in English self-reported heroin, cocaine, injection drug use, or counterfeit prescription pill use in the past 30 days Exclusion Criteria -participants who exclusively misuse medications obtained from a physician or diversion from someone else's prescription

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Participants will be assigned to either ARM1 or ARM2 depending on when they enrolled in the study.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm 1<br>50 participants will receive a kit containing 10 Rapid Response fentanyl test strips. We will ask participants to use the take-home rapid drug test to test their urine for presence or absence of fentanyl. | Behavioral: Take home rapid drug test<br>* The Rapid Response fentanyl test strips will be offered as take-home rapid drug tests to all participants to assess the willingness to use take-home rapid drug tests and the feasibility of using such an intervention at home. Arm 1 will be offered one method of using the take-home rapid drug test (urine testing). Arm 2 will be offered a second method of using the take-home rapid drug test (testing drug residue).<br>* Other names: Rapid Response fentanyl test strips;|
| Experimental: Arm 2<br>50 participants will receive a kit containing 10 Rapid Response fentanyl test strips. We will ask the participants to use the take-home rapid drug test to test the residue of their drug (ie. instruct them to test bags, cookers, spoons, etc.) for the presence or absence of fentanyl. | Behavioral: Take home rapid drug test<br>* The Rapid Response fentanyl test strips will be offered as take-home rapid drug tests to all participants to assess the willingness to use take-home rapid drug tests and the feasibility of using such an intervention at home. Arm 1 will be offered one method of using the take-home rapid drug test (urine testing). Arm 2 will be offered a second method of using the take-home rapid drug test (testing drug residue).<br>* Other names: Rapid Response fentanyl test strips;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Willingness to use the take-home rapid drug test | Self-reported measure of willingness to use take-home rapid drug tests (compare Arm1 and Arm2), measured by response to Likert-scale survey question (Strongly Agree--Strongly Disagree). | At 2 week follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Current overdose prevention behaviors | Self-reported steps taken to avoid accidental overdose, measured by a check all that apply survey question (what they do to avoid an accidental overdose). | At baseline enrollment | 
| Number of take-home rapid drug tests conducted | Self-reported number of take home rapid drug tests used by participant (Arm1 vs Arm2). | At 2 week follow-up | 
| Change in overdose prevention behaviors | Self-reported actions taken in response to the take home rapid drug test results, measured by a check all that apply survey question (what they did after they found out the drugs were laced with fentanyl). | At 2 week follow-up | 
| Recent non-prescription fentanyl exposure | Self-reported from personal experience (belief that they had ever been exposed to fentanyl), measured by Likert-Scale survey question (Strongly Agree--Strongly Disagree). | At baseline enrollment | 
| Recent non-prescription fentanyl exposure | Self-reported measure from take home rapid drug test results (any positive result). | At 2 week follow-up. | 
| Prevalence of take home drug tests reporting the presence of fentanyl exposure | Self-reported measure of the number of times they received a positive rapid drug test result. | At 2 week follow-up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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overdose prevention, opioid overdose, risk behavior, harm reduction