Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624001263583
Ethics application status
Approved
Date submitted
4/09/2024
Date registered
16/10/2024
Date last updated
16/10/2024
Date data sharing statement initially provided
16/10/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
S-Check 2.0: a smartphone application to address methamphetamine use in adults
Scientific title
The S-Check 2.0 cohort study: evaluating usage of a smartphone application to address methamphetamine use in adults
Secondary ID [1] 312865 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Methamphetamine use problems 335002 0
Addiction 335003 0
Psychological distress 335104 0
Condition category
Condition code
Mental Health 331518 331518 0 0
Addiction

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The S-Check 2.0 smartphone app is based on the service model of the St Vincent's Hospital Sydney Stimulant Treatment Program. The app i) engages methamphetamine users who are not seeking traditional modes of treatment, and ii) develops app users’ knowledge of methamphetamine and the risks and harms associated with methamphetamine use. S-Check 2.0 content includes (1) initial self-assessment (i.e. self-reported responses to a series of brief validated measures) of social health and lifestyle, physical health, sexual health and psychological wellbeing, (2) feedback on self-assessment results (i.e. tailored feedback text summarising results), along with links to readily available support resources and information on methamphetamine, (3) daily tracking functionality for app users to track their methamphetamine use and its associated risks over time. Participants are able to access S-Check 2.0 as frequently as they wish over the course of the study; usage data (e.g. log-in data) will be collected to assess adherence. S-Check 2.0 will be available for 24 months in total (October 2024 to October 2026); participants will be recruited over the course of this 24-month period, with recruitment closing one month prior (i.e. September 2026) to S-Check 2.0 becoming unavailable to allow one month of data collection for the final participants.
Intervention code [1] 329405 0
Treatment: Other
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 339263 0
App usage
Timepoint [1] 339263 0
Daily app usage collected over the 24-month study period
Secondary outcome [1] 439292 0
Professional help-seeking
Timepoint [1] 439292 0
At baseline, then every 28 days over the 24-month study period
Secondary outcome [2] 439293 0
Days of methamphetamine use
Timepoint [2] 439293 0
At baseline, then every 28 days over the 24-month study period

Eligibility
Key inclusion criteria
18 years of age and older
Currently residing in Australia
Report methamphetamine use at least once within the previous month
Have access to an individualised smartphone for the duration of the study
Able to provide informed consent
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
No exclusion criteria

Study design
Purpose of the study
Treatment
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
Not yet recruiting
Date of first participant enrolment
Anticipated
21/10/2024
Actual
Date of last participant enrolment
Anticipated
23/09/2026
Actual
Date of last data collection
Anticipated
21/10/2026
Actual
Sample size
Target
250
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 317310 0
Government body
Name [1] 317310 0
Australian Government Department of Health and Aged Care
Country [1] 317310 0
Australia
Primary sponsor type
Hospital
Name
St Vincent's Hospital Sydney
Address
Country
Australia
Secondary sponsor category [1] 319590 0
None
Name [1] 319590 0
Address [1] 319590 0
Country [1] 319590 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 316041 0
St Vincent’s Hospital Human Research Ethics Committee
Ethics committee address [1] 316041 0
Ethics committee country [1] 316041 0
Australia
Date submitted for ethics approval [1] 316041 0
19/06/2024
Approval date [1] 316041 0
09/08/2024
Ethics approval number [1] 316041 0
2024/ETH01154

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 136590 0
Dr Krista Siefried
Address 136590 0
St Vincent’s Hospital Sydney Alcohol and Drug Service 390 Victoria Street Darlinghurst NSW 2010
Country 136590 0
Australia
Phone 136590 0
+61 410360102
Fax 136590 0
Email 136590 0
[email protected]
Contact person for public queries
Name 136591 0
Kathryn Fletcher
Address 136591 0
Centre for Clinical Research on Emerging Drugs, University of New South Wales, 22-32 King Street, Randwick NSW 2031
Country 136591 0
Australia
Phone 136591 0
+61 2 9385 0333
Fax 136591 0
Email 136591 0
[email protected]
Contact person for scientific queries
Name 136592 0
Dr Krista Siefried
Address 136592 0
St Vincent’s Hospital Sydney Alcohol and Drug Service 390 Victoria Street Darlinghurst NSW 2010
Country 136592 0
Australia
Phone 136592 0
+61 2 9385 0333
Fax 136592 0
Email 136592 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
All participants will be anonymous. Only group data will be used in any analysis or publications.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
24155Ethical approval    388383-(Uploaded-02-09-2024-13-29-23)-2024_ETH01154_ Application HREA - Approved.pdf
24156Informed consent form    388383-(Uploaded-02-09-2024-13-33-36)-S-Check 2.0_PISCF V3.0 9 August 2024.pdf



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.