Trial Review

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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] 301757 0
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)
 318216 0
Condition category
Condition code
Public Health 316226 316226 0 0
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] 318052 0
Behaviour
Intervention code [2] 318239 0
Prevention
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 324413 0
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] 324413 0
Four weeks after the training and baseline survey has been completed
Primary outcome [2] 324414 0
How many strips each participant uses

This will be assessed via a survey which has been developed specifically for this project, and will rely on self-reported data.
Timepoint [2] 324414 0
Four weeks after the training and baseline survey has been completed
Primary outcome [3] 324415 0
Results of the strips (i.e. positive, negative, invalid, don’t know)

This will be assessed via a survey which has been developed specifically for this project, and will rely on self-reported data.
Timepoint [3] 324415 0
Four weeks after the training and baseline survey has been completed
Secondary outcome [1] 384573 0
Behavioural changes associated with take-home fentanyl test strips (i.e., self-reported behaviours following any positive, negative and/or invalid results).

This will be assessed via a survey which has been developed specifically for this project, and will rely on self-reported data.
Timepoint [1] 384573 0
Four weeks after the training and baseline survey has been completed
Secondary outcome [2] 384574 0
Inform features of a take-home fentanyl test strip distribution program that reflect consumer needs and wants (e.g., feedback on the strips and training provided) - composite variable.

This will be assessed via a survey which has been developed specifically for this project, and will rely on self-reported data.
Timepoint [2] 384574 0
Four weeks after the training and baseline survey has been completed
Secondary outcome [3] 384575 0
Support for other drug-checking mechanisms (e.g., would participants like to be able to test their substances for the presence of substances other than fentanyl).

This will be assessed via a survey which has been developed specifically for this project, and will rely on self-reported data.
Timepoint [3] 384575 0
Four weeks after the training and baseline survey has been completed
Secondary outcome [4] 385336 0
Future use of the strips (i.e. would they use again/recommend to peers) - primary outcome

This will be assessed via a survey which has been developed specifically for this project, and will rely on self-reported data.
Timepoint [4] 385336 0
Four weeks after the training and baseline survey has been completed

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Nil.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
17/07/2020
Date of last participant enrolment
Anticipated
31/12/2020
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
80
Accrual to date
13
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 306188 0
Other Collaborative groups
Name [1] 306188 0
National Centre for Clinical Research on Emerging Drugs Seed Funding Grant
Country [1] 306188 0
Australia
Funding source category [2] 306189 0
Government body
Name [2] 306189 0
Department of Health/Drug and Alcohol Program
Country [2] 306189 0
Australia
Primary sponsor type
University
Name
University of New South Wales (UNSW)
Address
Grants Management Office UNSW Australia Kensington NSW 2052
Country
Australia
Secondary sponsor category [1] 306879 0
None
Name [1] 306879 0
Address [1] 306879 0
Country [1] 306879 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 306400 0
South Eastern Sydney Local Health District HREC
Ethics committee address [1] 306400 0
G71 East Wing Edmund Blacket Building,
Prince of Wales Hospital,
Randwick NSW 2031
Ethics committee country [1] 306400 0
Australia
Date submitted for ethics approval [1] 306400 0
Approval date [1] 306400 0
14/05/2020
Ethics approval number [1] 306400 0
2019/ETH13776

Summary
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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 103754 0
Dr Rachel Sutherland
Address 103754 0
National Drug and Alcohol Research Centre
22 – 32 King Street
Randwick NSW 2031
Country 103754 0
Australia
Phone 103754 0
+61 416779889
Fax 103754 0
Email 103754 0
rachels@unsw.edu.au
Contact person for public queries
Name 103755 0
Dr Rachel Sutherland
Address 103755 0
National Drug and Alcohol Research Centre
22 – 32 King Street
Randwick NSW 2031
Country 103755 0
Australia
Phone 103755 0
+61 416779889
Fax 103755 0
Email 103755 0
rachels@unsw.edu.au
Contact person for scientific queries
Name 103756 0
Dr Rachel Sutherland
Address 103756 0
National Drug and Alcohol Research Centre
22 – 32 King Street
Randwick NSW 2031
Country 103756 0
Australia
Phone 103756 0
+61 416779889
Fax 103756 0
Email 103756 0
rachels@unsw.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
8481Study protocol  rachels@unsw.edu.au
8482Informed consent form  rachels@unsw.edu.au
8483Ethical approval  rachels@unsw.edu.au



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.