Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616000508471
Ethics application status
Approved
Date submitted
29/06/2015
Date registered
20/04/2016
Date last updated
16/07/2021
Date data sharing statement initially provided
16/07/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
A school-based health education package for prevention of soil-transmitted helminth infections in the Philippines
Scientific title
Filipino schoolchildren cartoon-based health education package versus a control for the prevention of soil-transmitted helminth infections
Secondary ID [1] 287000 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Soil-transmitted helminths: Trichuris, Ascaris, Hookworm 295466 0
Condition category
Condition code
Public Health 295719 295719 0 0
Epidemiology
Public Health 295720 295720 0 0
Health promotion/education
Infection 295721 295721 0 0
Studies of infection and infectious agents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention will be a video-based health education package comprised of: 1) health education cartoon: narrative 12 min cartoon video; content: story about a boy who gets infected with Soil-transmitted Helminths (STH) because of unhygienic behaviour. Key messages: a) symptoms of the disease. b) where and how can children get infected. c) how can disease be prevented. 2) A take-home pamphlet with key messages; 3) Classroom discussions; and 4) Drawing and essay competitions for key message reinforcement.

The cartoon will be shown twice (immediately following each other) in June/July 2016 followed by distribution of the pamphlet and classroom discussions (for 10-15 mins post the viewing by the research team assisted by the child's regular teacher); and then shown twice (immediately following each other) in August/September 2016 followed by classroom discussions (for 10-15 mins post the viewing by the research team assisted by the child's regular teacher) and the drawing and essay competitions. This will take place in the intervention schools.

Albendazole chemotherapy will be administered following the baseline survey in July 2016 in all study schools. Albendazole will also be administered to those found positive at the two follow-up surveys in Feb 2017 and Feb 2018 respectively. The Albendazole regimen will follow standard World Health Organization (WHO) guidelines (a single oral dose of 400mg). This will done in concert with the National de-worming program in the Philippines

Intervetnion and drug delivery will be directly observed and record kept for monitoring purposes
Intervention code [1] 292210 0
Prevention
Intervention code [2] 292211 0
Treatment: Drugs
Intervention code [3] 294525 0
Behaviour
Comparator / control treatment
Albendazole treatment at baseline and of positives at follow-up: same as for intervention group.
Control group
Active

Outcomes
Primary outcome [1] 295429 0
Soil-transmitted helminth infection rate will be assessed by follow-up
parasitological stool tests using Kato-Katz thick smear to count the
parasite eggs per species. Molecular diagnostics will also be undertaken.
Timepoint [1] 295429 0
Soil-transmitted helminth infection rates will be assessed at baseline (June/July 2016) and then at each follow-up (Feb/March 2017 and Feb/March 2018).
Primary outcome [2] 295430 0
Child's knowledge on infection risk of soil-transmitted helminth will be assessed with baseline and follow-up questionnaires. These questionnaires were designed specifically for the study, although they were an adaptation (to the Filippino context) of what we have used in previous trials in China
Timepoint [2] 295430 0
Knowledge will be assessed at baseline (July/August 2015) and at follow-up (Feb/March 2016 and Feb/March 2017).
Secondary outcome [1] 315571 0
Measures of STH associated morbidity (anaemia). This will be measured by Haemoglobin levels (blood via finger prick and Hb machine) at baseline and follow-up.
Timepoint [1] 315571 0
Morbidity measures will be assessed at baseline (June/July 2016) and at follow-up (Feb/March 2017 and Feb/March 2018).
Secondary outcome [2] 323014 0
Measures of STH associated morbidity (stunted growth). This will be measured by height and weight (stadiometer and calibrated digital scales) at baseline and follow-up.
Timepoint [2] 323014 0
Assessed at baseline (June/July 2016) and at follow-up (Feb/March 2017 and Feb/March 2018).
Secondary outcome [3] 323015 0
Measures of STH associated morbidity (academic performance). This will be measured by school attendance and academic grades (obtained from school records); at baseline and follow-up.
Timepoint [3] 323015 0
Assessed at baseline (June/July 2016) and at follow-up (Feb/March 2017 and Feb/March 2018).

Eligibility
Key inclusion criteria
Grade 4 pupil of study school
Pupil at school for duration of study
Informed consent obtained
Age 9-11 years
Minimum age
9 Years
Maximum age
11 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
No informed consent
Outside of specified age range
Pupil will not be present for duration of study

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)
All 4th grade students in the selected study schools, from whom's
informed consent was received, will be enrolled for the study. Allocation is not concealed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple Randomisation: Random number generation will be used in MS Excel to randomise schools into control or intervention groups
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
We estimated a design effect of 1.1 based on our previous study. Sample size calculations were then undertaken for an individually randomized trial and multiplied by the design effect. Assuming an STH incidence of 18% (typical of communities with 50% prevalence) and an intervention efficacy of 33%; the study will have 80% power with a
sample size of 20 intervention clusters (40 in total) and 44 students per cluster at the end of the trial following a predicted annual 10% loss to follow-up (total N = 1760).

Statistical analyses
A hierarchical generalised linear model with school as a random effect will be used for formal analyses of infection and knowledge, and carried out using SAS software (SAS Institute, Cary, NC). Models will be fitted using Generalised Estimating Equations (GEE) and a log-binomial distribution used to estimate relative risks and therefore intervention efficacy against infection. Analyses of changes in knowledge and
behaviour scores will use a log-normal distribution, and a timeintervention interaction to estimate differential change over time. Potential confounders such as age and sex will be incorporated. Spearman correlation coefficients will be used to estimate correlations among behaviour, knowledge, and incidence.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
6/06/2016
Actual
11/06/2016
Date of last participant enrolment
Anticipated
Actual
21/07/2016
Date of last data collection
Anticipated
Actual
14/07/2017
Sample size
Target
1760
Accrual to date
Final
3832
Recruitment outside Australia
Country [1] 7006 0
Philippines
State/province [1] 7006 0
Laguna

Funding & Sponsors
Funding source category [1] 291555 0
Government body
Name [1] 291555 0
National Health and Medical Research Council
Country [1] 291555 0
Australia
Funding source category [2] 291556 0
Charities/Societies/Foundations
Name [2] 291556 0
United Bank of Switzerland (UBS) Optimus Foundation
Country [2] 291556 0
Switzerland
Primary sponsor type
Individual
Name
Darren Gray
Address
The Australian National University, Research School of Population Health, Canberra, ACT, 2601, Australia
Country
Australia
Secondary sponsor category [1] 290232 0
Individual
Name [1] 290232 0
Donald McManus
Address [1] 290232 0
Molecular Parasitology Laboratory QIMR Berghofer Medical Research Institute, 300 Herston Road, Brisbane, QLD 4006, Australia
Country [1] 290232 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293097 0
QIMR Berghofer Medical Research Institute Human Ethics Committee
Ethics committee address [1] 293097 0
Ethics committee country [1] 293097 0
Australia
Date submitted for ethics approval [1] 293097 0
Approval date [1] 293097 0
16/04/2013
Ethics approval number [1] 293097 0
P1271
Ethics committee name [2] 293098 0
University of Queensland Medical Research Ethics Committee
Ethics committee address [2] 293098 0
Ethics committee country [2] 293098 0
Australia
Date submitted for ethics approval [2] 293098 0
Approval date [2] 293098 0
13/05/2013
Ethics approval number [2] 293098 0
2103000116
Ethics committee name [3] 293099 0
Australian National University Human Ethics Committee
Ethics committee address [3] 293099 0
Ethics committee country [3] 293099 0
Australia
Date submitted for ethics approval [3] 293099 0
Approval date [3] 293099 0
30/10/2014
Ethics approval number [3] 293099 0
2014/356

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

Contacts
Principal investigator
Name 58454 0
A/Prof Darren Gray
Address 58454 0
The Australian National University, Research School of Population Health, Canberra, ACT, 2601
Country 58454 0
Australia
Phone 58454 0
+61 2 6125 8595
Fax 58454 0
Email 58454 0
[email protected]
Contact person for public queries
Name 58455 0
Darren Gray
Address 58455 0
The Australian National University, Research School of Population Health, Canberra, ACT, 2601
Country 58455 0
Australia
Phone 58455 0
+61 2 6125 8595
Fax 58455 0
Email 58455 0
[email protected]
Contact person for scientific queries
Name 58456 0
Darren Gray
Address 58456 0
The Australian National University, Research School of Population Health, Canberra, ACT, 2601
Country 58456 0
Australia
Phone 58456 0
+61 2 6125 8595
Fax 58456 0
Email 58456 0
[email protected]

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


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
SourceTitleYear of PublicationDOI
EmbaseSoil-transmitted helminth infections and nutritional indices among Filipino schoolchildren.2021https://dx.doi.org/10.1371/journal.pntd.0010008
EmbaseCost analysis for "The Magic Glasses Philippines" health education package to prevent intestinal worm infections among Filipino schoolchildren.2023https://dx.doi.org/10.1016/j.lanwpc.2022.100597
N.B. These documents automatically identified may not have been verified by the study sponsor.