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Trial registered on ANZCTR

Registration number

ACTRN12620000872932

Ethics application status

Approved

Date submitted

13/07/2020

Date registered

1/09/2020

Date last updated

1/09/2020

Date data sharing statement initially provided

1/09/2020

Type of registration

Retrospectively registered

Titles & IDs

Public title

Take-home fentanyl test strips among people who use heroin

Scientific title

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

Secondary ID [1]

CT-2020-CTN-00619-1 (FYLAUS001)

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Adulterated substances (i.e. testing illicit substances for the presence of fentanyl)

Condition category

Condition code

Public Health

Health promotion/education

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

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).

Intervention code [1]

Behaviour

Intervention code [2]

Prevention

Comparator / control treatment

No control group

Control group

Uncontrolled

Outcomes

Primary outcome [1]

Number/percentage of participants who use the fentanyl test strips,

This will be assessed via a survey which has been developed specifically for this project, and will rely on self-reported data.

Timepoint [1]