Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619000534189
Ethics application status
Approved
Date submitted
1/04/2019
Date registered
3/04/2019
Date last updated
3/04/2019
Date data sharing statement initially provided
3/04/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
S-Check App Trial: To determine the feasibility and efficacy of the S-Check App as a self-administered harm reduction and early intervention tool for those who use methamphetamine.
Scientific title
Feasibility and efficacy of the S-Check App: A harm reduction and early intervention smartphone application for methamphetamine use
Secondary ID [1] 297829 0
Nil Known
Universal Trial Number (UTN)
Trial acronym
S-Check App Trial
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Methamphetamine Use Disorder 312198 0
Condition category
Condition code
Mental Health 310743 310743 0 0
Addiction

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The S-Check App has been developed as a self-administered smartphone based harm reduction and early intervention application for those who use methamphetamine. The S-Check App will be provide the user with information to manage their methamphetamine use and support services available, should they need to seek help. One group will be randomize to have immediate access to the App for 28 days while the one group will be randomize to have delayed access to the App 28 days later. Both groups will be asked to complete a surveys at the start and 28 days to assess whether there has been any behavioral change in their methamphetamine use.
Frequency and use of the features of the App will be at the discretion of the participant for the 28 days that they will have access to the App. The App has several sections, such as physical health, social health and psychological well being. The participant will be able to enter information into these sections and the App will be able to provide advice based on the associated risk of the information supplied. The App also has a diary section, where the participant can write and upload videos, audio and pictures to seek track of their progression. They will be awarded achievement badges upon completion of each section of the App. Internal metrics will capture which sections of the App are used, the frequency and the duration of App use. This information together with the surveys will assist the study team in determining the efficacy and feasibility of the App as a harm reduction and early intervention tool.
Intervention code [1] 314066 0
Behaviour
Intervention code [2] 314103 0
Treatment: Other
Comparator / control treatment
The delayed group will not have access to the S-Check App for 28 days.
Control group
Active

Outcomes
Primary outcome [1] 319592 0
To see whether the S-Check App can motivate behavioural change amongst people who use methamphetamine. Participants in both arms will be asked to complete the Readiness to Change, General Help-Seeking and Actual Help Seeking Surveys. Those who have immediate access to the App will complete the surveys at the start of the trial and 28 days following usage of the App. Those who have been randomised to having delayed access will complete the survey at the start of the trial and then again at 28 days before having access. The data from both groups will be reviewed to assess whether the App motivated change in behaviour.
Timepoint [1] 319592 0
28 days
Secondary outcome [1] 368885 0
To assess App usability. Participants will be invited to participate in a telephone interview to provide feedback on the use of the App. Internal App metrics will also be collected to determine the frequency and use of the features of the App,
Timepoint [1] 368885 0
Days 28 and 56.
Secondary outcome [2] 368886 0
To assess App usage. Internal App metrics will also be collected to determine the frequency and use of the features of the App,
Timepoint [2] 368886 0
Days 28 and 56.
Secondary outcome [3] 368888 0
To assess App engagement by treatment naive people. Internal App metrics will also be collected to determine the frequency and use of the features of the App,
Timepoint [3] 368888 0
Days 28 and 56.
Secondary outcome [4] 368890 0
To assess predictors of engagement (by age, gender, sexual orientation, duration and frequency of methamphetamine use, previous or current treatment participation). Questions regarding age, gender, sexual orientation, duration and frequency of methamphetamine use, previous or current treatment participation and frequency of methamphetamine use have been included as part of the trial. The information obtained will assess predictors of engagement.
Timepoint [4] 368890 0
Days 28 and 56.
Secondary outcome [5] 368892 0
To understand participant experiences in using the App and factors affecting engagement and impact. Participants will be invited to participate in a telephone interview to provide feedback on the use of the App. Internal App metrics will also be collected to determine the factors affecting engagement and impact of the App,
Timepoint [5] 368892 0
Days 28 and 56.

Eligibility
Key inclusion criteria
• Be aged over 18 years old
• Currently residing in Australia
• Report use of methamphetamine at least once within the previous month
• Have access to an individualised smartphone for the duration of the study (56 days)
• Be willing and able to provide informed consent (via the S-Check App)
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
There are no exclusion criteria.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Wait controlled. Participants are either randomized to have immediate access to the S-Check App (case group) or wait 28 days before having access to the S-Check App (Control).
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
510 participants will be recruited in the delayed access group and 510 participants in the immediate access group. Overall, 1020 participants will be recruited altogether. The study is designed to detect a medium effect size (e.g. d=0.5, 20) with a power of 0.8 and alpha set at 0.05. To allow for attrition, 1020 participants will be recruited, with an estimated drop-out rate of 50% at Day 28.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
6/05/2019
Actual
Date of last participant enrolment
Anticipated
1/01/2020
Actual
Date of last data collection
Anticipated
30/04/2020
Actual
Sample size
Target
1020
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC
Recruitment hospital [1] 13526 0
St Vincent's Hospital (Darlinghurst) - Darlinghurst
Recruitment postcode(s) [1] 26146 0
2010 - Darlinghurst

Funding & Sponsors
Funding source category [1] 302351 0
Government body
Name [1] 302351 0
NSW Health
Country [1] 302351 0
Australia
Primary sponsor type
Hospital
Name
St Vincent's Hospital Sydney Ltd
Address
St Vincent's Hospital Sydney
390 Victoria St
DARLINGHURST NSW 2010
Country
Australia
Secondary sponsor category [1] 302263 0
None
Name [1] 302263 0
Address [1] 302263 0
Country [1] 302263 0
Other collaborator category [1] 280625 0
University
Name [1] 280625 0
University of New South Wales Sydney
Address [1] 280625 0
UNSW Sydney NSW 2052 Australia
Country [1] 280625 0
Australia
Other collaborator category [2] 280626 0
University
Name [2] 280626 0
University of Newcastle
Address [2] 280626 0
University Dr, Callaghan NSW 2308
Country [2] 280626 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 303025 0
St Vincent's Hospital Human Research Ethics Committee
Ethics committee address [1] 303025 0
Ethics committee country [1] 303025 0
Australia
Date submitted for ethics approval [1] 303025 0
30/07/2018
Approval date [1] 303025 0
20/09/2018
Ethics approval number [1] 303025 0
HREC/18/SVH/196

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

Contacts
Principal investigator
Name 92210 0
A/Prof Nadine Ezard
Address 92210 0
Drug and Alcohol Service
St Vincent's Hospital Sydney
390 Victoria St
DARLINGHURST NSW 2010
Country 92210 0
Australia
Phone 92210 0
+61 2 8382 1012
Fax 92210 0
Email 92210 0
[email protected]
Contact person for public queries
Name 92211 0
Quoc Nguyen
Address 92211 0
National Centre for Clinical Research on Emerging Drugs (NCCRED)
National Centre for Drug and Alcohol Research (NDARC)
University of NSW Sydney
22-32 King St, RANDWICK NSW 2031
Country 92211 0
Australia
Phone 92211 0
+61 2 9385 0151
Fax 92211 0
Email 92211 0
[email protected]
Contact person for scientific queries
Name 92212 0
Quoc Nguyen
Address 92212 0
National Centre for Clinical Research on Emerging Drugs (NCCRED)
National Centre for Drug and Alcohol Research (NDARC)
University of NSW Sydney
22-32 King St, RANDWICK NSW 2031
Country 92212 0
Australia
Phone 92212 0
+61 2 9385 0151
Fax 92212 0
Email 92212 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?




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.