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Trial registered on ANZCTR


Registration number
ACTRN12619000309189
Ethics application status
Approved
Date submitted
25/02/2019
Date registered
28/02/2019
Date last updated
14/05/2019
Date data sharing statement initially provided
28/02/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Comparing the impact of school-based and community-based deworming for controlling intestinal worm infections in school-aged children in Vietnam
Scientific title
School versus community-based albendazole deworming for control of soil transmitted helminths in school-age children in Vietnam – a cluster randomised controlled trial
Secondary ID [1] 297518 0
NHMRC: APP1139561
Universal Trial Number (UTN)
U1111-1220-0338
Trial acronym
CoDe-STH (COmmunity DEworming against STH)
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Soil-transmitted helminth infection 311723 0
Condition category
Condition code
Public Health 310345 310345 0 0
Epidemiology
Infection 310346 310346 0 0
Other infectious diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
In the intervention arm of the study, the drug albendazole will be given as a single dose of 400mg, to all students attending each study primary school (grades 1-5). This will be done once every six months for one year (3 doses in total). The drugs will be delivered by study researchers, at the primary school, and tablets taken under direct observation. In addition, in the 2-3 hamlets that send the most children to the primary school, single-dose albendazole 400mg will be delivered to all community members living in those hamlets. Children under 2 years of age will receive half a dose (200mg) as per World Health Organization (WHO) guidelines. Children under 1 year of age and pregnant women in the first trimester will be excluded from treatment as per WHO guidelines. The drugs will be delivered by the research team by going house-to-house in participating hamlets. All tablets will be taken under direct observation.
Intervention code [1] 313756 0
Treatment: Drugs
Comparator / control treatment
In the control arm, single-dose albendazole 400mg will be given only to students attending each study primary school (grades 1-5). This will be done once every six months for one year (3 doses in total). The drugs will be delivered by study researchers, at the primary school, and tablets taken under direct observation.
Control group
Active

Outcomes
Primary outcome [1] 319221 0
Prevalence of hookworm infection (unspeciated) in school-aged children, diagnosed on stool samples using quantitative PCR (qPCR)
Timepoint [1] 319221 0
12 months after study baseline
Secondary outcome [1] 367352 0
Prevalence of Necator americanus infection in school-aged children, diagnosed on stool samples using quantitative PCR (qPCR)
Timepoint [1] 367352 0
12 months after study baseline
Secondary outcome [2] 367353 0
Prevalence of Ancylostoma duodenale infection in school-aged children, diagnosed on stool samples using quantitative PCR (qPCR)
Timepoint [2] 367353 0
12 months after study baseline
Secondary outcome [3] 367354 0
Prevalence of Ancylostoma ceylanicum infection in school-aged children, diagnosed on stool samples using quantitative PCR (qPCR)
Timepoint [3] 367354 0
12 months after study baseline
Secondary outcome [4] 367355 0
Prevalence of Ascaris spp. infection in school-aged children, diagnosed on stool samples using quantitative PCR (qPCR)
Timepoint [4] 367355 0
12 months after study baseline
Secondary outcome [5] 367358 0
Prevalence of Trichuris spp. infection in school-aged children, diagnosed on stool samples using quantitative PCR (qPCR)
Timepoint [5] 367358 0
12 months after study baseline
Secondary outcome [6] 367359 0
Intensity of infection with each STH species in school-aged children, diagnosed on stool samples using quantitative PCR (qPCR)
Timepoint [6] 367359 0
12 months after study baseline

Eligibility
Key inclusion criteria
Children attending study primary schools, in grades 1-4
Minimum age
5 Years
Maximum age
12 Years
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Children attending study primary schools in grade 5

Study design
Purpose of the study
Treatment
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)
Simple block randomisation, stratified by district, using a computer-generated random number
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Cluster-randomised controlled trial (randomisation occurs at school level, not individual level)
Phase
Phase 4
Type of endpoint(s)
Efficacy
Statistical methods / analysis
The sample size calculation was performed as follows:
We used the generalized linear model described in our recent meta-analysis of STH reinfection after deworming, that predicts the impact of mass vs targeted treatment on prevalence reduction in school-aged children, adjusted for baseline prevalence, number of doses and follow-up time (Clarke et al, Lancet 2017, https://doi.org/10.1016/S0140-6736(16)32123-7). For hookworm, assuming a baseline prevalence of 20% (based on our preliminary surveys conducted in Dak Lak in December 2018), the model predicts a prevalence reduction of 85% after mass community-wide deworming vs 56% in the targeted approach, after 2 rounds of deworming and 6 months follow-up. Assuming an average cluster size of 120 and an intra-cluster correlation of 0.12, with a power of 80% and a=0.05, the required sample size is 32 elementary schools in each arm. The ICC was estimated based on the WASH for WORMS trial in Timor-Leste (Nery et al, Am J Trop Med Hyg 2019, https://doi.org/10.4269/ajtmh.18-0705).

For statistical analysis of study results, each of the trial outcomes will be compared between control and intervention arms. Generalized linear mixed models will be used to account for within and between cluster variability. If there is a need to adjust for confounding or differences in the baseline characteristics of the intervention and control groups, variables measured in the study questionnaires will be incorporated as covariates, allowing an adjusted effect estimate to be calculated for the intervention. For prevalence, Bernoulli logistic regression models will be developed with the infection status of the individual as the outcome, and for infection intensity, linear regression models will be developed. For all models, age and sex will entered as covariates, and school as a random effect. Adjustment for baseline prevalence will involve entering baseline prevalence as fixed effect. The intervention will be entered as a binary fixed effect to estimate differences in prevalence and intensity, and a relative risk of infection, comparing the two arms at each follow-up survey. All analyses will be conducted using Stata software, and a 5% level of significance will be used.

Recruitment
Recruitment status
Not yet recruiting
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] 21308 0
Viet Nam
State/province [1] 21308 0
Dak Lak province

Funding & Sponsors
Funding source category [1] 302077 0
Government body
Name [1] 302077 0
National Health and Medical Research Council, Australia
Address [1] 302077 0
16 Marcus Clarke St, Canberra ACT 2601
Country [1] 302077 0
Australia
Primary sponsor type
University
Name
University of New South Wales
Address
High St, Kensington NSW 2052
Country
Australia
Secondary sponsor category [1] 301894 0
None
Name [1] 301894 0
Address [1] 301894 0
Country [1] 301894 0
Other collaborator category [1] 280569 0
University
Name [1] 280569 0
Tay Nguyen University
Address [1] 280569 0
567 Le Duan, Ea Tam, Thanh pho Buon Ma Thuot, Dak Lak 630000, Vietnam
Country [1] 280569 0
Viet Nam

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 302757 0
Human Research Ethics Committee, University of New South Wales
Ethics committee address [1] 302757 0
High St, Kensington NSW 2052
Ethics committee country [1] 302757 0
Australia
Date submitted for ethics approval [1] 302757 0
04/03/2019
Approval date [1] 302757 0
07/05/2019
Ethics approval number [1] 302757 0
HC190136
Ethics committee name [2] 302758 0
Human Research Ethics Committee, Tay Nguyen University
Ethics committee address [2] 302758 0
567 Le Duan, Ea Tam, Thanh pho Buon Ma Thuot, Dak Lak 630000, Vietnam
Ethics committee country [2] 302758 0
Viet Nam
Date submitted for ethics approval [2] 302758 0
04/03/2019
Approval date [2] 302758 0
18/03/2019
Ethics approval number [2] 302758 0
1804 QD DHTN TCCB

Summary
Brief summary
This research project aims to determine if school-aged children are less likely to be reinfected with intestinal worms after deworming medication is delivered all community members, compared to when it is delivered only to school-aged children.

Intestinal worms (referred to as soil-transmitted helminths or STH) infect nearly 1.5 billion individuals worldwide and can cause chronic health problems, especially in children. To treat intestinal worms in endemic countries, large-scale distribution of deworming medication occurs once or twice a year, usually targeted to school-aged children and delivered at school. Re-infection with intestinal worms is common in areas without adequate sanitation and hygiene, because infections are spread through soil contaminated with human faeces.

We hypothesize that by expanding the delivery of deworming medications to all members of the community, there will be less contamination of soil with worm eggs and larvae, and children will therefore be less likely to be reinfected.

To test this hypothesis, we will conduct a research study in Dak Lak province in Vietnam. The study will take place in 64 primary schools. These schools will be randomly allocated to either the “intervention” or “control” arm. In the intervention arm, deworming medication will be delivered both to all children at the primary school, and to all community members (except children under 1 year of age and pregnant women in the first trimester), in 2-3 communities that send children to the primary school. In the control arm, deworming medication will be delivered only to children at the primary school, which is the usual practice in Vietnam. Deworming medications will be delivered every 6 months for one year. Intestinal worm infections in school-aged children will be measured prior to each round of deworming to compare the impact of the two deworming approaches.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 91294 0
A/Prof Susana Vaz Nery
Address 91294 0
The Kirby Institute
University of New South Wales
Sydney NSW 2052
Country 91294 0
Australia
Phone 91294 0
+61 2 9385 0867
Fax 91294 0
Email 91294 0
snery@kirby.unsw.edu.au
Contact person for public queries
Name 91295 0
A/Prof Susana Vaz Nery
Address 91295 0
The Kirby Institute
University of New South Wales
Sydney NSW 2052
Country 91295 0
Australia
Phone 91295 0
+61 2 9385 0867
Fax 91295 0
Email 91295 0
snery@kirby.unsw.edu.au
Contact person for scientific queries
Name 91296 0
A/Prof Susana Vaz Nery
Address 91296 0
The Kirby Institute
University of New South Wales
Sydney NSW 2052
Country 91296 0
Australia
Phone 91296 0
+61 2 9385 0867
Fax 91296 0
Email 91296 0
snery@kirby.unsw.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Deidentified data regarding intestinal worm infections at each study time point
When will data be available (start and end dates)?
Data will be made available when the study results are published. This is estimated to be in late 2020. Data will be available indefinitely.
Available to whom?
Anyone who wishes to access it
Available for what types of analyses?
For IPD meta-analyses
How or where can data be obtained?
Data will be placed in an online data repository
What supporting documents are/will be available?
Study protocol
Informed consent form
Ethical approval
How or where can supporting documents be obtained?
Type [1] 1448 0
Study protocol
Citation [1] 1448 0
Link [1] 1448 0
Email [1] 1448 0
Other [1] 1448 0
See attached document
Type [2] 1449 0
Informed consent form
Citation [2] 1449 0
Link [2] 1449 0
Email [2] 1449 0
Other [2] 1449 0
See attached document
Type [3] 1450 0
Ethical approval
Citation [3] 1450 0
Link [3] 1450 0
Email [3] 1450 0
Other [3] 1450 0
See attached documents
Type [4] 2081 0
Ethical approval
Citation [4] 2081 0
Link [4] 2081 0
Email [4] 2081 0
Other [4] 2081 0
Summary results
No Results