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Trial registered on ANZCTR


Registration number
ACTRN12617001048370
Ethics application status
Approved
Date submitted
8/06/2017
Date registered
18/07/2017
Date last updated
29/01/2019
Date data sharing statement initially provided
29/01/2019
Date results information initially provided
29/01/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
A randomized controlled trial to evaluate the impact of combining hygiene education with deworming.
Scientific title
A randomized controlled trial to evaluate if combining school-based hygiene education with mass drug administration (MDA) of deworming medication decreases the reinfection rate of soil-transmitted helminths (STH) in school-age children.
Secondary ID [1] 292159 0
Nil known
Universal Trial Number (UTN)
U1111-1197-5299
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Soil-transmitted helminthiasis 303600 0
Condition category
Condition code
Infection 303010 303010 0 0
Other infectious diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The core goal of the study is to assess if adding a hygiene education package, designed to be implemented at scale, to deworming campaigns can improve the success of deworming by reducing the reinfection rate in children. Accordingly, there are two components to the intervention: (i) a hygiene education package; and (ii) distribution of deworming tablets via mass drug administration of deworming medication at schools.

Brief name of Intervention: Integrated hygiene education and deworming MDA.

A single hygiene education package comprising two components will be evaluated in combination with deworming MDAs:
1) A short cartoon (‘Magic Glasses’) originally evaluated by Bieri and colleagues [Bieri F.A., et al (2013) Health education package to prevent worm infections in Chinese schoolchildren. NEJM (368): 1603-1612]. This cartoon, approximately 14 minutes in duration, explains to children: (a) how STH infections are transmitted (e.g. poor sanitation practices such as defecating in fields rather than using latrines; poor hygiene practices such as not washing hands after defecating or not washing food before eating); (b) the health consequences of STH infections (e.g. abdominal pain, diarrhoea, fatigue, lack of concentration at school); and (c) how children can minimize their risk of being infected by STH by improving their hygiene and sanitation habits.
2) A pamphlet, based on the Magic Glasses cartoon. This pamphlet shows screenshots from the cartoon, aiming to reinforce the key messages from the cartoon about how children can change their hygiene and sanitation habits to minimize their risk of STH infection.

The intervention will comprise teachers showing the Magic Glasses cartoon to their students twice during the academic year. The first delivery of the hygiene education package will be the week prior to a government-implemented deworming MDA; the second delivery of the intervention will be approximately 6 months later:

1) During the first delivery of the intervention, teachers will show the Magic Glasses cartoon to their students twice during a single class period, in combination with teachers distributing pamphlets to the children to take home. This first delivery will take place as part of a broader deworming program -- government-implemented school-based deworming MDAs will take place annually in the province of Phu Tho, targeting all primary schools (children aged 6-11 years old). School-based deworming MDAs in Phu Tho (and throughout Vietnam) are conducted by local health workers visiting schools and distributing a single tablet (either albendazole [400 milligrams] or mebendazole [500 milligrams]) to each child present on the day. A mop-up day is conducted three to four days later to deworm children who were not able to receive a tablet on the first day due to absence, illness, etc. The intervention to be tested in this study will leverage the government-implemented, province-wide, school-based deworming MDA in Phu Tho which will take place in November, 2017.

2) The second delivery of the intervention will also entail teachers showing the Magic Glasses cartoon (twice) in a single class period; however, for the second delivery, there will be no pamphlets distributed, nor deworming MDA conducted.

Depending on school infrastructure, the Magic Glasses cartoon could be shown either on a one classroom/grade at a time basis or some other combination of classrooms – schools will be free to devise their own mechanism of how to deliver the intervention, with the only stipulation that they ensure the cartoon is displayed on a clearly visible screen (some schools will utilize computers and projectors, while others will utilize a television (TV) and video compact disc (VCD) player; the cartoon will be provided to schools on a VCD). Adherence of the schools to showing the video will be assessed through a simple form filled-in by teachers. This form will report if the video was or was not shown at each of the two expected delivery times. Fidelity to a specific teaching regime will not be assessed: this is an effectiveness study designed to evaluate whether the integrated intervention can be implemented at scale in the particular context under consideration, not under rigid experimental conditions.

The integrated intervention will target all primary school classes (grade 1-5; age 6-11 years old).
Intervention code [1] 298308 0
Prevention
Intervention code [2] 298577 0
Treatment: Other
Comparator / control treatment
The control group will be children who receive deworming medication as part of the province-wide, government-implemented school-based deworming MDA. These children will receive a single tablet of albendazole (400 milligram) or mebendazole (500 milligrams) administered by local health workers.
Control group
Active

Outcomes
Primary outcome [1] 302383 0
STH infection, as assessed by Kato-Katz thick smear analysis of stool samples
Timepoint [1] 302383 0
Baseline, and 11 months after intervention commencement
Secondary outcome [1] 335797 0
Change in knowledge of STH infections, as assessed by a questionnaire specifically designed around the information conveyed in the Magic Glasses cartoon pertinent to STH infections.
Timepoint [1] 335797 0
Baseline, and 11 months after intervention commencement
Secondary outcome [2] 336802 0
Change in hygiene and sanitation practices as assessed by a questionnaire specifically designed around the key hygiene and sanitation messages conveyed in the Magic Glasses cartoon pertinent to the transmission of STH.
Timepoint [2] 336802 0
Baseline, and 11 months after intervention commencement

Eligibility
Key inclusion criteria
The target population of this intervention is primary school children (grade 1 to 5; age 6-11 years old) receiving deworming treatment as part of an annual province-wide school-based deworming MDA in Phu Tho. All children from participating schools will receive the intervention designated to their cohort, but the study will be based on studying children from grade 4 (age 9-10 years old). At each participating school, all children from grade 4 will be recruited to a longitudinal cohort.
Minimum age
6 Years
Maximum age
11 Years
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
All children from participating schools will receive the intervention designated to their cohort, but the study will be based on studying children from grade 4 (age 9-10 years old). Children younger than this will be excluded as they are considered unlikely to provide reliable responses to questionnaires; children older than this be excluded as they will not be available for follow-up in the next school year.

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint(s)
Statistical methods / analysis
Sample size calculations are conservative and were performed according to Donner and Klar (Donner A and Klar N., Design and Analysis of Cluster Randomization Trials in Health Research. Arnold, London 2000) with an incidence of 30%, a control program effectiveness of 33%, a design effect of 1.5, and a multiplication factor of 3 to account for mebendazole’s efficacy against Trichuris triciura. The study will have 80% power with a sample size of 50 intervention clusters (schools are the clusters; 100 clusters in total, including control clusters) and 54 students per cluster at the end of the trial following a predicted annual 10% loss to follow-up. As such 60 students per cluster will be recruited for a total sample size of N=6000.

A hierarchical generalized 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 Generalized Estimating Equations (GEE) and a log-binomial distribution used to estimate relative risks and therefore control program effectiveness against infection. Analyses of changes in knowledge and behavior 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 behavior, knowledge, and incidence.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 8959 0
Viet Nam
State/province [1] 8959 0
Phu Tho

Funding & Sponsors
Funding source category [1] 296693 0
Charities/Societies/Foundations
Name [1] 296693 0
Dubai Cares
Address [1] 296693 0
Al Riyadh Street, Dubai Healthcare City, Building 16, level 4, Dubai,
Country [1] 296693 0
United Arab Emirates
Primary sponsor type
Individual
Name
Ms. Duong Hong Loan
Address
East Meets West Foundation,
No.2, lane 10, Dang Thai Mai, Tay Ho, Hanoi.
Country
Viet Nam
Secondary sponsor category [1] 295653 0
Individual
Name [1] 295653 0
Dr. Paul Monaghan
Address [1] 295653 0
Evidence Action,
Care of: No.2, lane 10, Dang Thai Mai, Tay Ho, Hanoi,
Country [1] 295653 0
Viet Nam
Other collaborator category [1] 279599 0
Individual
Name [1] 279599 0
Dr. Darren Gray
Address [1] 279599 0
Department of Global Health, Australian National University, Canberra ACT 2601
Country [1] 279599 0
Australia
Other collaborator category [2] 279600 0
Individual
Name [2] 279600 0
Professor Don McManus
Address [2] 279600 0
QIMR Berghofer Medical Research Institute, 300 Herston Road, Herston, Queensland 4006
Country [2] 279600 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 297921 0
Research Ethics Committee of Thai Binh University of Medicine and Pharmacy
Ethics committee address [1] 297921 0
Thai Binh University of Medicine and Pharmacy, 373 Ly Bon, Ky Ba, Thai Binh,
Ethics committee country [1] 297921 0
Viet Nam
Date submitted for ethics approval [1] 297921 0
02/06/2017
Approval date [1] 297921 0
08/06/2017
Ethics approval number [1] 297921 0
6/2017
Ethics committee name [2] 297923 0
Australian National University Human Research Ethics Committee
Ethics committee address [2] 297923 0
Australian National University, Committee, Canberra ACT 2601
Ethics committee country [2] 297923 0
Australia
Date submitted for ethics approval [2] 297923 0
05/07/2017
Approval date [2] 297923 0
19/09/2017
Ethics approval number [2] 297923 0
Ethics committee name [3] 297924 0
QIMR Berghofer Medical Research Institute Human Research Ethics Committee
Ethics committee address [3] 297924 0
QIMR Berghofer Medical Research Institute, 300 Herston Road, Herston, Queensland 4006
Ethics committee country [3] 297924 0
Australia
Date submitted for ethics approval [3] 297924 0
15/06/2017
Approval date [3] 297924 0
19/06/2017
Ethics approval number [3] 297924 0

Summary
Brief summary
School-based MDA campaigns, whereby anti-helminthic medication is administered to school-age children, are a model proven to cost-effectively control intestinal worm infections. However, deworming MDAs do not prevent reinfection and need to be repeated regularly, with frequency of treatment dependent upon prevalence levels.

The Government of Vietnam has determined to provide annual treatment in the intervention area, and in order to determine how to reduce reinfection rates of STH, the research partners are interested in evaluating the integration of a school-based health education package with the deworming MDA. There is a general assumption that greater knowledge of health and sanitation issues amongst children will lead to greater and longer-term reductions in reinfection compared to deworming alone, but there is a lack of rigorous studies to confirm this. In order to address the lack of evidence, we will conduct a cluster randomized controlled trial (RCT) to evaluate the impact of such an integrated approach.

A consortium from the Australian National University, QIMR Berghofer Medical Research Institute and University of Queensland has previously demonstrated that students exposed to a hygiene education package featuring an educational video (“Magic Glasses”) in line with receiving deworming medication, supplemented with class-based supporting activities throughout the school year, suffered roughly half the worm infections of those receiving deworming medication alone (Bieri F.A., et al (2013) Health education package to prevent worm infections in Chinese schoolchildren. NEJM (368): 1603-1612). Due to the striking effects of this intervention on reinfection rates, combined with the potential for scale, we are interested to rigorously evaluate if a similar impact with a scaled-down version of this intervention can be achieved in Vietnam. The purpose of the experiment is to conduct an effectiveness study of the integrated intervention, not an efficacy study; the experiment will evaluate whether the integrated intervention can be implemented at scale in the particular context under consideration, not under rigid experimental conditions.

It is anticipated that this large-scale RCT will provide evidence about whether the hygiene education package is successful and cost-effective at reducing reinfection among school-age children when combined with school-based deworming. The results of this research will be used to inform the design of a nationwide deworming program in Vietnam.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 75466 0
Ms Duong Hong Loan
Address 75466 0
East Meets West Foundation
No.2, lane 10, Dang Thai Mai, Tay Ho, Hanoi,
Country 75466 0
Viet Nam
Phone 75466 0
+84-4-38347790
Fax 75466 0
Email 75466 0
loan.duong@eastmeetswest.org
Contact person for public queries
Name 75467 0
Ms Duong Hong Loan
Address 75467 0
East Meets West Foundation
No.2, lane 10, Dang Thai Mai, Tay Ho, Hanoi,
Country 75467 0
Viet Nam
Phone 75467 0
+84-4-38347790
Fax 75467 0
Email 75467 0
loan.duong@eastmeetswest.org
Contact person for scientific queries
Name 75468 0
Dr Paul Monaghan
Address 75468 0
Evidence Action
Care of: East Meets West, No.2, lane 10, Dang Thai Mai, Tay Ho, Hanoi,
Country 75468 0
Viet Nam
Phone 75468 0
+84-1-693026404
Fax 75468 0
Email 75468 0
paul.monaghan@evidenceaction.org

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?
Summary results
Have study results been published in a peer-reviewed journal?
No
Other publications
Have study results been made publicly available in another format?
No
Results – basic reporting
Results – plain English summary