Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613001089729
Ethics application status
Approved
Date submitted
2/09/2013
Date registered
30/09/2013
Date last updated
30/09/2013
Type of registration
Prospectively registered

Titles & IDs
Public title
A school-based health education package for prevention of soil-transmitted helminth infections in China
Scientific title
Chinese schoolchildren cartoon-based health education package versus a health education poster for the prevention of soil-transmitted helminth infections
Secondary ID [1] 283027 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 289859 0
Condition category
Condition code
Public Health 290218 290218 0 0
Epidemiology
Public Health 290219 290219 0 0
Health promotion/education
Infection 290359 290359 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 12min 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 in October 2013 followed by distribution of the pamphlet and classroom discussions; and then shown twice in February/March 2014 followed by classroom discussions and the drawing and essay competitions. This will take place in the intervention schools.

Two rounds of Albendazole chemotherapy will be administered following the baseline survey in October 2013 in all study schools. Albendazole will also be administered to those found positive at the two follow-up surveys in June 2014 and June 2015 respectively.

The Albendazole regimen will follow standard World Health Organization (WHO) guidelines (a single oral dose of 400mg).
Intervention code [1] 287748 0
Prevention
Intervention code [2] 287749 0
Treatment: Drugs
Comparator / control treatment
Traditional health education material: textbook-based general hygiene education and wall-posters in schools. Frequency of textbook based teaching: twice per semester, school-year 3-6, total of one year intervention. Wall-poster: permanent during intervention.

Albendazole treatment at baseline and of positives at follow-up: same as for intervention group
Control group
Active

Outcomes
Primary outcome [1] 290240 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] 290240 0
Soil-transmitted helminth infection rates will be assessed at baseline (October 2013) and then at each follow-up (June 2014 and June 2015).
Primary outcome [2] 290242 0
Child's knowledge on infection risk of soil-transmitted helminth will be assessed with baseline and follow-up questionnaires.
Timepoint [2] 290242 0
Knowledge will be assessed at baseline (October 2013) and at follow-up (June 2014 and June 2015).
Secondary outcome [1] 304189 0
Change in infection risk behaviour will be assessed with standardised behaviour observations by the investigatory team at baseline and at follow-up.
Timepoint [1] 304189 0
Behaviour will be assessed at baseline (October 2013) and at follow-up (June 2014 and June 2015).
Secondary outcome [2] 304190 0
Measures of STH associated morbidity (anaemia, stunted growth, academic performance). These will be measured by Haemoglobin levels, height and weight, school attendance and academic grades; at baseline and follow-up.
Timepoint [2] 304190 0
Morbidity measures will be assessed at baseline (October 2013) and at follow-up (June 2014 and June 2015).

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 time-intervention 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
Not yet recruiting
Date of first participant enrolment
Anticipated
21/10/2013
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
2000
Accrual to date
Final
Recruitment outside Australia
Country [1] 5299 0
China
State/province [1] 5299 0
Yunnan

Funding & Sponsors
Funding source category [1] 287790 0
Government body
Name [1] 287790 0
National Health and Medical Research Council
Country [1] 287790 0
Australia
Funding source category [2] 287791 0
Charities/Societies/Foundations
Name [2] 287791 0
United Bank of Switzerland (UBS) Optimus Foundation
Country [2] 287791 0
Switzerland
Primary sponsor type
Individual
Name
Darren Gray
Address
University of Queensland, School of Population Health, Herston Road, Brisbane, QLD 4006, Australia
Country
Australia
Secondary sponsor category [1] 286520 0
Individual
Name [1] 286520 0
Donald McManus
Address [1] 286520 0
Molecular Parasitology Laboratory QIMR Berghofer Medical Research Institute, 300 Herston Road, Brisbane, QLD 4006, Australia
Country [1] 286520 0
Australia
Secondary sponsor category [2] 286522 0
Individual
Name [2] 286522 0
Franziska Bieri
Address [2] 286522 0
University of Queensland, School of Population Health, Herston Road, Brisbane, QLD 4006, Australia
Country [2] 286522 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289740 0
QIMR Berghofer Medical Research Institute Human Ethics Committee
Ethics committee address [1] 289740 0
Ethics committee country [1] 289740 0
Australia
Date submitted for ethics approval [1] 289740 0
Approval date [1] 289740 0
16/04/2013
Ethics approval number [1] 289740 0
P1271
Ethics committee name [2] 289741 0
University of Queensland Medical Research Ethics Committee
Ethics committee address [2] 289741 0
Ethics committee country [2] 289741 0
Australia
Date submitted for ethics approval [2] 289741 0
Approval date [2] 289741 0
13/05/2013
Ethics approval number [2] 289741 0
2103000116

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

Contacts
Principal investigator
Name 42186 0
Dr Darren Gray
Address 42186 0
University of Queensland, School of Population Health, Herston Rd, Herston, Brisbane, QLD 4006
Country 42186 0
Australia
Phone 42186 0
+61 7 33464651
Fax 42186 0
Email 42186 0
[email protected]
Contact person for public queries
Name 42187 0
Franziska Bieri
Address 42187 0
University of Queensland, School of Population Health, Herston Rd, Herston, Brisbane, QLD 4006
Country 42187 0
Australia
Phone 42187 0
+61 424455618
Fax 42187 0
Email 42187 0
[email protected]
Contact person for scientific queries
Name 42188 0
Franziska Bieri
Address 42188 0
University of Queensland, School of Population Health, Herston Rd, Herston, Brisbane, QLD 4006
Country 42188 0
Australia
Phone 42188 0
+61 424455618
Fax 42188 0
Email 42188 0
[email protected]

No information has been provided regarding IPD availability


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
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