Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000271606
Ethics application status
Approved
Date submitted
7/02/2023
Date registered
13/03/2023
Date last updated
3/08/2024
Date data sharing statement initially provided
13/03/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
A Cluster Randomised Controlled Trial to investigate the acceptability and impact of an educational cartoon package targeting knowledge of Opisthorchis viverrini and soil-transmitted helminths among schoolchildren in the Lower Mekong Basin
Scientific title
A Cluster Randomised Controlled Trial to investigate the acceptability and impact of an educational cartoon package targeting knowledge of Opisthorchis viverrini and soil-transmitted helminths among schoolchildren in the Lower Mekong Basin
Secondary ID [1] 308880 0
none
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Soil-transmitted helminth infection 328873 0
Opisthorchiasis 328874 0
Condition category
Condition code
Public Health 325867 325867 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention will consist of two "Magic Glasses" cartoons: “Magic Glasses Lower Mekong” (MGLM) targeting soil-transmitted helminths (STH), and “Magic Glasses Opisthorchiasis” (MGO), targeting Opisthorchis viverrini (OV). “Magic Glasses” is an educational cartoon that targets water, sanitation and hygiene (WASH) practices and has been tested in previous studies.
MGLM will be adapted from existing Magic Glasses cartoons. The storyline used in previous cartoons (two child protagonists exploring the village and identifying ways that STH is spread, and then how to prevent this) will be retained. To ensure the key messages (e.g., transmission – consumption of contaminated fruit/veg, or uncovered feet when outdoors); treatment – anti-parasitic oral tablets, and prevention of STH – proper WASH practices eg washing hands after going to the toilet/before eating, washing or cooking fruit and vegetables before eating) of existing cartoons are relevant to the LMB, literature reviews conducted by research staff exploring knowledge, attitudes, practices (KAP) and risk factors associated with STH in the LMB region. As necessary, the script will be adapted to address behaviours or risk factors specific to the LMB.
MGO will employ a similar storyline to the existing Magic Glasses cartoons, but will contain different key messages, based on the transmission, treatment and prevention of OV. The key messages of MGO (transmission – consumption of raw/undercooked fish; treatment –anti-parasitic oral tablet and prevention – cooking fish before consumption) will be informed by literature reviews conducted by research staff that explored knowledge, attitudes, practices (KAP) and risk factors associated with OV in the LMB region.
Research staff will also review popular cartoons in Southeast Asia to inform the cartoon style. Current photos of the local environment, schools, and health clinic settings in the LMB will also be used to ensure that the cartoon depictions are appropriate/accurate.
Once completed, MGLM and MGO will each run for approx. 10-15 minutes.
At baseline, informed consent will be sought from parents and teachers to participate in the trial, and assent from prospective students. Once consent/assent is obtained, all consenting participants in Years 3-5 at control and intervention schools will complete two questionnaires to ascertain baseline knowledge of STH and OV. The STH questionnaire will include questions on demographic information and students’ knowledge of STH, including general knowledge, transmission, symptoms and treatment; attitudes and health education, and behaviour. The OV questionnaire will follow the same format to assess students’ knowledge of OV.

In intervention schools, once baseline is completed, MGLM will be shown to all participating students in the classroom. The cartoon will be shown once, followed by the distribution of a discussion guide with questions on the key messages of the cartoon. The cartoon will then be shown again, and students will be asked to pay attention and answer the questions, in preparation for a classroom discussion following the second showing. Fieldworkers will monitor the showing to ensure students are paying attention to the cartoons. After the cartoon is played again, students will receive a comic developed using content and key messages taken directly from the cartoon. A classroom discussion will then be held to go over the health messages of the cartoon. Once the classroom discussion is complete, students will be asked to complete a questionnaire on acceptability. Once the acceptability questionnaire is completed, students will be asked to participate in a homework drawing competition where they will draw risk behaviours for STH infection. The best drawing will receive a prize.
Six to eight weeks after the first presentation of MGLM, the cartoon will be shown twice and classroom discussion will be held again to the school audience again to reinforce the health messages of the cartoon (approx. 15-20 minutes; MGLM delivery 2). Once the cartoon and discussion is finished, students will be asked to participate in a homework essay competition where they will write how people can get infection, and how to prevent it. The best essay will win a prize.

Delivery of MGO and the associated acceptability assessment will commence on the same or following day (depending on school size) that the OV baseline questionnaire is completed (MGO delivery 1), and follow the same procedure delivery as used for MGLM.
Intervention code [1] 325325 0
Prevention
Intervention code [2] 325326 0
Behaviour
Comparator / control treatment
No treatment/intervention given. Control participants will receive health education in-line with the standard education procedures in each country.
Control group
Active

Outcomes
Primary outcome [1] 333697 0
STH and OV knowledge, attitudes and practices (KAP). KAP will be measured by a questionnaire that was developed by the research team and utilised in four previous RCTs assessing STH. We will pilot the questionnaire in each country to ensure applicability.
Timepoint [1] 333697 0
Approx. nine months after intervention commencement.
Secondary outcome [1] 417986 0
Acceptability of intervention. Acceptability will be measured by (1) questionnaire that was developed by the research team adapted from the Theoretical Framework of Acceptability, (2) key-informant interviews with teachers and parents, and (3) focus group discussions with schoolchildren
Timepoint [1] 417986 0
Immediately following intervention delivery and approx. nine months after intervention commencement.

Eligibility
Key inclusion criteria
Enrollment in the study schools for at least 1 year; enrolled in Grades 3-6 at intervention commencement.
Minimum age
8 Years
Maximum age
12 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
none

Study design
Purpose of the study
Prevention
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)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Sample size was calculated to retain 80% power, assuming baseline knowledge of 30 percentage points (as reported in the original Magic Glasses study by Bieri et al. 2013) and a design effect of 2 to account for cluster sampling. Accounting for 10% attrition, it was estimated that a total of 227 participants would be needed to detect a difference of 5 percentage points in knowledge between intervention and control groups. As such, we will enroll a total of 228 schoolchildren in Grades 3-5 (114 intervention, 114 control) in each country.

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
1/06/2023
Actual
4/09/2023
Date of last participant enrolment
Anticipated
1/09/2023
Actual
2/02/2024
Date of last data collection
Anticipated
30/11/2024
Actual
Sample size
Target
684
Accrual to date
Final
718
Recruitment outside Australia
Country [1] 25241 0
Cambodia
State/province [1] 25241 0
Preah Vihear province
Country [2] 25242 0
Thailand
State/province [2] 25242 0
Khon Kaen province
Country [3] 25243 0
Lao People's Democratic Republic
State/province [3] 25243 0
Savannakhet province

Funding & Sponsors
Funding source category [1] 313096 0
Government body
Name [1] 313096 0
National Health and Medical Research Council
Country [1] 313096 0
Australia
Primary sponsor type
Individual
Name
Professor Darren Gray
Address
National Centre of Epidemiology and Population Health
Balmain Cottage
24 Balmain Crescent
Australian National University
Acton
ACT 2601
Country
Australia
Secondary sponsor category [1] 314788 0
None
Name [1] 314788 0
Address [1] 314788 0
Country [1] 314788 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 312341 0
Australian National University Human Research Ethics Committee
Ethics committee address [1] 312341 0
Ethics committee country [1] 312341 0
Australia
Date submitted for ethics approval [1] 312341 0
31/03/2023
Approval date [1] 312341 0
17/08/2022
Ethics approval number [1] 312341 0

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

Contacts
Principal investigator
Name 124318 0
Prof Darren Gray
Address 124318 0
QIMR Berghofer Medical Research Institute
300 Herston Road, Herston QLD 4006
Locked Bag 2000 Royal Brisbane Hospital, QLD 4029
Country 124318 0
Australia
Phone 124318 0
+61 0733620247
Fax 124318 0
Email 124318 0
[email protected]
Contact person for public queries
Name 124319 0
Darren Gray
Address 124319 0
QIMR Berghofer Medical Research Institute
300 Herston Road, Herston QLD 4006
Locked Bag 2000 Royal Brisbane Hospital, QLD 4029
Country 124319 0
Australia
Phone 124319 0
+61 0733620247
Fax 124319 0
Email 124319 0
[email protected]
Contact person for scientific queries
Name 124320 0
Darren Gray
Address 124320 0
QIMR Berghofer Medical Research Institute
300 Herston Road, Herston QLD 4006
Locked Bag 2000 Royal Brisbane Hospital, QLD 4029
Country 124320 0
Australia
Phone 124320 0
+61 0733620247
Fax 124320 0
Email 124320 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


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
18524Study protocol    385315-(Uploaded-07-03-2023-13-14-20)-Study-related document.docx
18525Informed consent form    385315-(Uploaded-07-03-2023-13-15-17)-Study-related document.docx
18527Informed consent form    385315-(Uploaded-07-03-2023-13-16-02)-Study-related document.docx



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.