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Take-home fentanyl test strips among people who use heroin

Feasibility, consumer acceptability and behavioural outcomes associated with take-home fentanyl test strips among people who use heroin

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12620000872932
Enrollment
78
Registered
2020-09-01
Start date
2020-07-17
Completion date
2021-05-05
Last updated
2025-09-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

The primary aim of this project is to examine the feasibility, consumer acceptability and behavioural outcomes associated with take-home fentanyl test strips (FTS), providing an evidence base for implementation and expansion across services in Australia. People who use heroin (n=80) will be trained in how to use FTS to test their heroin (or other illicit substances) for the presence of fentanyl, and how to interpret the results, Upon completion of the training, participants will complete a short baseline survey, and be given ten strips to take home and use as they wish. Participants will be followed-up four weeks later to assess uptake and consumer acceptability of the strips, as well as associated behavioural changes.

Interventions

Participants will be given ten fentanyl test strips to take home, and provided with training on how to use them and how to interpret the results. The fentanyl test strips being distributed to participants are commercially available (FYL-18S7-5) and were purchased directly from BTNX in the United States. The test strip is a lateral flow chromatographic immunoassay for the qualitative detection of Fentanyl/Norfentanyl in liquid and powder substances at the cut-off concentration of 20 ng/mL. It is

Participants will be given ten fentanyl test strips to take home, and provided with training on how to use them and how to interpret the results. The fentanyl test strips being distributed to participants are commercially available (FYL-18S7-5) and were purchased directly from BTNX in the United States. The test strip is a lateral flow chromatographic immunoassay for the qualitative detection of Fentanyl/Norfentanyl in liquid and powder substances at the cut-off concentration of 20 ng/mL. It is specific for fentanyl screening with no significant cross reactivity to other opiates, such as morphine and heroin, and has been shown to have high sensitivity (96-100%) and specificity (90% and 98%) for detecting fentanyl in illicit substances. The test strip operates in a similar manner to a pregnancy test strips, and can be used to test either urine or the substance itself (off-label). In this study, the strips will be used to test illicit substances. This is done by adding a small sample of the substance (i.e., a grain or two) to ~10 drops of sterile water, or adding water to an empty bag with residue in it, and mixing well. The blue end of the strip in then dipped into this solution for 15 seconds, with the results appearing within two minutes. A single line means that fentanyl has been detected (positive), two lines means that fentanyl has not been detected (negative), and no lines or no control line means that the result is invalid and the test should be repeated with a new strip. To mitigate the risk of a false negative, participants will be informed that fentanyl or fentanyl analogues may still be present in a sample despite a negative test strip result. Upon completion of the training (which comprises watching two short videos, each about 2-3 minutes long), participants will receive 10 fentanyl test strips for personal use, as well as written and visual materials how to use and interpret the test strips (developed specifically for this study). Participants are not provided with any instructions on when to use the strips, as the purpose of the project is to determine if and how often people would use these strips if they were freely available. They will, however, be instructed to take a photo of each strip that they use and send the photo via text message OR to bring any used strips to their four week follow-up survey (note: this is to verify that they have used the strip/s, not the results). All participants will also receive a naloxone kit, as well as general overdose information (the latter of which has been designed specifically for this study). At KRC, training on how to use and interpret the test strips will be provided by internal site staff (research co-ordinator and registered nurse), while at Rankin Court it will be provided by external research staff. The naloxone kit will be distributed by authorised, trained staff at each site, and will mitigate the risk of overdose (i.e. naloxone is a short-acting medicine that can be administered either via intramuscular injection or intranasal spray and can temporarily reverse an overdose caused by opioid drugs). Participants who have received naloxone training within the past two years (to be verified via the naloxone training database at each of the sites) will not be required to receive further training on how to administer naloxone. However, participants who have not previously received naloxone training, or whose most recent training session was >2 years ago, will be required to participate in a short training session prior to being administered naloxone. This will be delivered by site staff (this is already part of the core duties of each site, and includes a short oral presentation + demonstration) and will add an additional 5 minutes to the baseline visit. Four weeks after receiving the fentanyl test strips, participants will be contacted via their preferred method of contact (text, call, email) to schedule in a follow-up survey. The survey will take approximately 20-30 minutes to complete and will be conducted at a location convenient to the participant (e.g. café).

Sponsors

University of New South Wales (UNSW)
Lead SponsorUniversity

Study design

Allocation
Non-randomised trial
Primary purpose
Educational / counselling / training

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

1) At least 18 years of age 2) Have used heroin in the past 6 months (self-report) 3) Consent to participate in naloxone training program or engagement in naloxone training in the previous two years 4) consent to provide phone-number and other contact details, to enable follow-up

Exclusion criteria

Nil.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026