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Trial registered on ANZCTR
Registration number
ACTRN12624001176550
Ethics application status
Approved
Date submitted
12/09/2024
Date registered
25/09/2024
Date last updated
13/10/2024
Date data sharing statement initially provided
25/09/2024
Type of registration
Prospectively registered
Titles & IDs
Public title
Evaluation of a Japanese encephalitis vaccine decision aid in adults travelling overseas to at-risk areas
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Scientific title
Randomised Controlled Trial of a web-based Japanese encephalitis vaccine decision aid on decisional conflict in adults travelling overseas to at-risk areas
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Secondary ID [1]
312657
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None
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Japanese encephalitis
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Vaccine decision-making
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Condition category
Condition code
Public Health
331207
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0
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Health promotion/education
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Infection
331208
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0
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Other infectious diseases
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Intervention being studied:
The intervention is an online Japanese Encephalitis Vaccine Decision Aid (JEVADA), developed according to the International Patient Decision Aids Standards (IPDAS) and created using a comprehensive co-design and user-testing process (described below). JEVADA takes users through a self-guided, step-by-step process, divided into three key sections, along with additional resources such as a Frequently Asked Questions (FAQ) page. It provides detailed information on Japanese encephalitis, including its geographic distribution, transmission methods, clinical features, severity, and associated risks. Preventive measures, including mosquito bite avoidance strategies and a comparison of the available vaccines in Australia, are also covered. JEVADA encourages participants to reflect on their personal circumstances, values, and beliefs to help guide their vaccination decision, while prompting them to consult with a healthcare provider to discuss their options. The tool includes visual aids and interactive elements to support decision-making, such as a side-by-side risk-benefit analysis and a values clarification exercise. JEVADA is designed as an educational resource, and emphasises the importance of consulting a trusted healthcare provider before making a vaccination decision. A downloadable short-form PDF version of the decision aid, offering a condensed version of the content (without interactive features), is also available.
Mode of delivery:
Online.
Procedures:
Participants assigned to the intervention arm will receive a link to JEVADA and will be asked to review the materials.
Timing:
The intervention will be delivered in a single session, during which participants will also complete pre- and post-intervention surveys. The estimated time to review JEVADA is approximately 15 minutes.
Location:
Participants can access JEVADA from any location of their choice.
Strategies to monitor adherence:
Participants will complete self-reported questions regarding the extent of their review, including time spent and whether they reviewed the entire content or only specific sections. Additionally, we will track the time elapsed between the completion of pre- and post-intervention surveys. Website analytics will also be used to capture the timing, frequency, and duration of visits to the decision aid website during the intervention period.
JEVADA co-design and user testing process:
The co-design process involved Australian consumers and healthcare providers. Three rounds of Zoom workshops, each lasting two hours, were held over five months. The first two rounds focused on decisional needs and design requirements, with separate sessions for consumers and providers. Participants reviewed example components and gave feedback. In the final round, both groups were brought together to evaluate a prototype of the decision aid, commenting on its language, layout, and presentation. Feedback was collected verbally, via chat, and through an online whiteboard. Those who missed the final session provided feedback by email.
User testing involved semi-structured Zoom interviews with a new group of consumers and providers. A "think aloud" method was used to explore their interactions with the prototype. Additional feedback was collected through a follow-up survey. Content experts in vaccination, vector-borne diseases, encephalitis, and travel medicine also reviewed the decision aid and provided feedback via an online survey.
A steering group of experts in immunisation, travel medicine, vaccine communication, social science, and a consumer representative oversaw the process. They worked with a graphic designer to create iterative PDF prototypes informed by co-design and user testing, which were later adapted into a web-based format by a developer.
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Intervention code [1]
329156
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Prevention
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Intervention code [2]
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Behaviour
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Comparator / control treatment
Comparator being studied:
Participants randomised to the comparator arm will be provided a link to an online health information page on Japanese encephalitis (JE), hosted by Healthdirect Australia. Healthdirect Australia is a national virtual public health information service, which collaborates with federal, state, and territory governments to offer a wide range of evidence-based health resources. The JE webpage covers key information on the disease, including geographic distribution, modes of transmission, symptoms, severity, and preventive measures such as mosquito bite avoidance and vaccines available in Australia. The content is presented in a single, continuous page, organised into sub-sections for ease of navigation. The page also includes tools for symptom checking and locating local health services, alongside accessibility features such as text enlargement, page-masking, and text-to-speech options. Users can download the information as a PDF, and additional resources and support links are provided.
Mode of delivery:
Online.
Procedures:
Participants in the comparator arm will receive a link to the Healthdirect page and will be asked to review the content.
Timing:
The comparator will be accessed in a single session, during which participants will also complete pre- and post-intervention surveys. Reviewing the Healthdirect page is expected to take approximately 11 minutes.
Location:
Participants can access the Healthdirect JE webpage from any location of their choice.
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Control group
Active
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Outcomes
Primary outcome [1]
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Decisional Conflict
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Assessment method [1]
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The Decisional Conflict Scale (DCS) will be used to assess participants' decisional conflict. The DCS is a widely recognised and validated tool in decision-making research, particularly for evaluating the impact of patient decision aids. We will use the traditional 16-item version, which has been extensively tested and psychometrically validated. This version measures five key dimensions of decision-making and is the most commonly used format in the literature. Each of the 16 statements is rated on a 5-point Likert scale.
The primary outcome will be the change in decisional conflict, as measured by the DCS, from pre- to post-intervention. The outcome will be assessed by comparing the difference in DCS scores (post- vs. pre-intervention) between the intervention group (who receive the decision aid) and the control group (who receive standard information).
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Timepoint [1]
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Decisional conflict will be measured at two timepoints: immediately before and immediately after participants engage with the intervention or control.
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Secondary outcome [1]
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Intention to vaccinate
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Assessment method [1]
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Intention to vaccinate is defined as planning to receive JE vaccination before travel. It will be measured based on responses to the question; “Do you plan to get a JE vaccine before your upcoming trip?". This question is derived from the WHO’s Behavioural and Social Drivers of Vaccination survey. Responses will be categorised into four groups: 1) those who do not intend to get vaccinated, 2) those who are unsure, 3) those who intend to get vaccinated, and 4) those who are already vaccinated. The outcome will be the change in participants' intention to get vaccinated before their trip, comparing pre- and post-intervention responses between the intervention and control groups.
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Timepoint [1]
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Intention to vaccinate will be measured at two timepoints: immediately before and immediately after participants engage with the intervention or control.
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Secondary outcome [2]
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Knowledge of Japanese encephalitis (JE)
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Assessment method [2]
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Knowledge of JE will be assessed at the individual level by comparing participants’ responses to 9 knowledge statements about JE in the pre- and post-intervention surveys. Participants will be asked to indicate whether they believe each statement true, false or if they are not sure. Responses will be categorised as correct (where participants correctly identify a true statement as true or a false statement as false), incorrect (where participants incorrectly identify a true statement as false or a false statement as true), or “not sure” responses. The secondary outcome will be the change in the proportion of correct responses from pre- to post-intervention, with the difference in knowledge gains compared between the intervention and control groups.
Knowledge questions have been developed specifically for this study, based on the content presented in the decision aid and knowledge considered important in the literature. The statements have been reviewed and refined with input from both clinicians and consumers to ensure accuracy and relevance.
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Timepoint [2]
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Knowledge will be measured at two timepoints: immediately before and immediately after participants engage with the intervention or control.
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Secondary outcome [3]
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JE vaccine uptake
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Assessment method [3]
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For participants who consent to the follow-up survey, uptake of JE vaccine will be assessed through self-reported responses to the question, " Did you receive a vaccine for Japanese encephalitis before your trip?".
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Timepoint [3]
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3-6 months post-intervention
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Eligibility
Key inclusion criteria
Currently living in Australia
Able to read and understand English
Intention to travel to a country (outside of Australia) where JE is a risk within the next 6-months
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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Key exclusion criteria
Given that the survey will be conducted in English and recruitment will be online, participation will be limited to individuals who are reasonably fluent in written English and have access to the Internet.
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Study design
Purpose of the study
Prevention
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
We will use REDCap’s automated randomisation module for participant assignment. A statistician, independent of the central research team, will create and upload the randomisation tables. The randomisation tables will be concealed from the primary investigators and used by REDCap for real-time allocation.
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by a statistician
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
Efficacy
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Statistical methods / analysis
Data will be analysed using the statistical analysis software package STATA v18. Baseline characteristics of participants will be tabulated by randomisation groups. Continuous variables will be summarised using means (standard deviations), while categorical variables will be summarised by frequencies (percentages). Graphical visualisations will be conducted where appropriate.
Linear regression will be used to estimate the effect of intervention (vs control) on change in DCS scores (post- vs. pre-intervention) with pre-intervention DCS scores adjusted for in the model, i.e. an analysis of covariance (ANCOVA) structure. Statistical significance will be declared if a two-sided p-value is <0.05.
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Recruitment
Recruitment status
Not yet recruiting
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Date of first participant enrolment
Anticipated
21/10/2024
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Actual
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Date of last participant enrolment
Anticipated
25/11/2024
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Actual
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Date of last data collection
Anticipated
21/04/2025
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Actual
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Sample size
Target
500
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC
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Funding & Sponsors
Funding source category [1]
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University
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Name [1]
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Monash University Early Career Research Excellence Program
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Address [1]
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Country [1]
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Australia
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Funding source category [2]
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Government body
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Name [2]
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National Health and Medical Research Council Emerging Leadership Fellowship
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Address [2]
317130
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Country [2]
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Australia
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Primary sponsor type
University
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Name
Monash University
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Address
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Country
Australia
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Secondary sponsor category [1]
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None
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Name [1]
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Address [1]
319394
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Country [1]
319394
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
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Monash University Human Research Ethics Committee
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Ethics committee address [1]
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MUHREC@monash.edu
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Ethics committee country [1]
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Australia
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Date submitted for ethics approval [1]
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04/10/2024
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Approval date [1]
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08/10/2024
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Ethics approval number [1]
315821
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44547
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Summary
Brief summary
This study is part of the TRAvel VAccine Decision Aids for Decision-making (TRAVAID) Project, which is establishing a platform for the development of a suite of evidence-based travel vaccine decision aids for travel medicine. In this randomised controlled trial, we will measure the impact of a Japanese Encephalitis Vaccine Decision Aid (JEVADA) compared with standard practice (an online fact sheet) on vaccine decision-making for Japanese encephalitis in a representative cohort of Australian travellers. We hypothesise that JEVADA will reduce uncertainty about JE vaccination and help users make decisions that align with their personal values. This should lead to an increase in both the intention to get vaccinated and actual vaccine uptake before travel.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Dr Sarah McGuinness
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Address
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School of Public Health and Preventive Medicine, Monash University, 553 St Kilda Road Melbourne VIC 3004
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Country
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Australia
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Phone
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+61 3 9903 0118
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Fax
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Email
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[email protected]
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Contact person for public queries
Name
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Owen Eades
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Address
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School of Public Health and Preventive Medicine, Monash University, 553 St Kilda Road Melbourne VIC 3004
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Country
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Australia
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Phone
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+61 403418173
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Name
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Sarah McGuinness
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Address
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School of Public Health and Preventive Medicine, Monash University, 553 St Kilda Road Melbourne VIC 3004
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Country
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Australia
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Phone
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+61 3 9903 0118
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Fax
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Email
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
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What supporting documents are/will be available?
No Supporting Document Provided
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.
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