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Trial registered on ANZCTR


Registration number
ACTRN12615001012561
Ethics application status
Approved
Date submitted
4/09/2015
Date registered
28/09/2015
Date last updated
11/04/2017
Type of registration
Retrospectively registered

Titles & IDs
Public title
Should integrated deworming and water, sanitation and hygiene (WASH) programs for soil-transmitted helminth (STH) control be delivered in schools or the community? A pilot study
Scientific title
A pilot study comparing the impact of school- and community-based integrated water, sanitation and hygiene (WASH) and deworming programmes on soil-transmitted helminth infections in school-aged children in Timor-Leste
Secondary ID [1] 287231 0
OPP1119041 (Grant number from Bill and Melinda Gates Foundation)
Universal Trial Number (UTN)
U1111-1172-9719
Trial acronym
(S)WASH-D for Worms pilot
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Soil-transmitted helminth infection - Trichuris trichiura, Ascaris lumbricoides, hookworms (Necator americanus and Ancylostoma duodenale) 295831 0
Stunting 295837 0
Wasting 295838 0
Anaemia 295839 0
Intestinal protozoa (Giardia duodenalis, Entamoeba histolytica, Strongyloides spp., Cryptosporidium spp.) 296125 0
Condition category
Condition code
Infection 296091 296091 0 0
Other infectious diseases
Public Health 296092 296092 0 0
Epidemiology
Oral and Gastrointestinal 296443 296443 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention to be evaluated in this proposal will involve provision of access to improved water and sanitation and improving related hygiene practices, implemented at both a community level and a primary school level. This intervention will be implemented by non-governmental organisation Plan International in Timor-Leste. The sanitation component will involve construction of school latrines by contractors working with Plan International, as well a Community Led Total Sanitation approach. Access to an improved water supply will also be provided, and local partner NGOs will provide house-by-house education on hygiene practices, in particular hand-washing with soap at critical times. Hygiene education including posters relating to handwashing with soap will be provided to schools, and handwashing stations with soap will be constructed as part of the school latrines.

Furthermore, communities in the intervention arm of the pilot study will receive mass chemotherapy (distributed to all members of the community) with one oral tablet of albendazole 400mg, which will be administered once 80% of the households have sanitation (as defined by the presence of a household latrine) and the school latrines have been completed. Albendazole intake will be directly observed by the field workers delivering the tablets, who will be working under the supervision of a registered nurse.

The intervention period will continue until the school latrine construction is finished, household latrine construction is complete, hygiene promotion has been conducted in all households and mass chemotherapy has been delivered. This is estimated to take between 2-4 months.
Intervention code [1] 292519 0
Prevention
Intervention code [2] 292520 0
Treatment: Drugs
Intervention code [3] 292815 0
Behaviour
Comparator / control treatment
Communities in the control group will be provided with access to improved water and sanitation and hygiene promotion implemented only at primary school level. This will be implemented by non-governmental organisation Cruz Vermelha Timor-Leste (CVTL), and will involve construction of school latrines, access to an improved water supply and promotion of hand washing with soap and related hygiene behaviours. This intervention will be similar to that in the intervention arm (although conducted by a different NGO) but will only be delivered to primary school children.

Furthermore, communities in the control arm of the pilot study will receive chemotherapy (distributed to school-aged children only) with one oral tablet of albendazole 400mg, which will be administered once the school latrines have been completed. Albendazole intake will be directly observed by the field workers delivering the tablets, who will be working under the supervision of a registered nurse.
Control group
Active

Outcomes
Primary outcome [1] 295768 0
Cumulative incidence of of infection with A. lumbricoides, T. trichiura, N. americanus and Ancylostoma spp. (undifferentiated) in school aged children - to be assessed by both microscopy and PCR examination of stool
Timepoint [1] 295768 0
At baseline and at follow-up six months after the distribution of albendazole
Secondary outcome [1] 316469 0
Proportion of eligible children for whom informed consent is gained - using school records to determine number of eligible children
Timepoint [1] 316469 0
At baseline and at follow-up six months after the distribution of albendazole
Secondary outcome [2] 316470 0
Proportion of eligible children for whom stool samples are provided - using school records to determine number of eligible children
Timepoint [2] 316470 0
At baseline and at follow-up six months after the distribution of albendazole
Secondary outcome [3] 316471 0
Proportion of eligible children who complete questionnaires - using school records to determine number of eligible children
Timepoint [3] 316471 0
At baseline and at follow-up six months after the distribution of albendazole
Secondary outcome [4] 316472 0
Proportion of eligible children who undergo measurement of height, weight and haemoglobin - using school records to determine number of eligible children
Timepoint [4] 316472 0
At baseline and at follow-up six months after the distribution of albendazole
Secondary outcome [5] 317297 0
Prevalence of S. stercoralis, G. duodenalis, E. histolytica, and Cryptosporidium spp. (composite outcome) - assessed using laboratory analysis (PCR) of stool samples
Timepoint [5] 317297 0
At baseline and at follow-up six months after the distribution of albendazole
Secondary outcome [6] 317298 0
Mean haemoglobin concentration - measured using serum assay on a Hb201 (Hemocue) analyser device
Timepoint [6] 317298 0
At baseline and at follow-up six months after the distribution of albendazole
Secondary outcome [7] 317301 0
Anthropometric index weight-for-height Z-score (to identify wasting)
Timepoint [7] 317301 0
At baseline and at follow-up six months after the distribution of albendazole
Secondary outcome [8] 317302 0
Anthropometric index weight-for-age Z-score (to identify underweight)
Timepoint [8] 317302 0
At baseline and at follow-up six months after the distribution of albendazole
Secondary outcome [9] 317303 0
Anthropometric index height-for-age Z-score (to identify stunting)
Timepoint [9] 317303 0
At baseline and at follow-up six months after the distribution of albendazole
Secondary outcome [10] 317304 0
Mean intensity of infection (average number of eggs per gram of faeces)
Timepoint [10] 317304 0
Six months following distribution of albendazole

Eligibility
Key inclusion criteria
Inclusion criteria for enrollment in the study:
- Child enrolled in and attending the primary school
- Informed consent obtained from parent/caregiver

Selection of communities for inclusion in the study:
- Communities were selected for inclusion in this pilot study in consultation with each partner NGO (Plan International and Cruz Vermelha Timor-Leste (CVTL))
- For the intervention clusters, Plan International identified three villages in which they were planning both a school- and community-based WASH programme.
- For the control clusters, the research team and CVTL identified three schools suitable for a school-based WASH programme, located in a nearby district to the intervention communities.
Minimum age
1 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Exclusion criteria for enrollment in the study:
- Not attending the primary school
- Informed consent not obtained

Exclusion criteria for receiving albendazole (including students enrolled in the study AND other members of communities in the intervention clusters):
- Women in the first trimester of pregnancy
- Children under the age of 1 year

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
All children who are enrolled in and attending the primary school in each of the six communities participating in this pilot study will be eligible for inclusion in the study. Consent will be sought from parents/caregivers at a meeting which will be held at the school. Allocation is not concealed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
This pilot project is not randomised. This is because the WASH intervention for each arm of the study is being performed by a different NGO, and communities participating in the study are those in which those NGOs are working.
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
Descriptive statistics will be used to determine the proportion of eligible participants who gave informed consent, provided stool samples, completed questionnaires and underwent measurement of height and weight.

Primary and secondary outcomes will be calculated and compared across both arms of the trial using mixed effects multivariate regression models that account for clustering of participants in villages.

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] 7082 0
Timor-Leste
State/province [1] 7082 0
Aileu and Manufahi Districts

Funding & Sponsors
Funding source category [1] 291801 0
Charities/Societies/Foundations
Name [1] 291801 0
Bill and Melinda Gates Foundation - Grand Challenges Explorations
Address [1] 291801 0
500 Fifth Avenue North
Seattle, WA 98109
United States of America
Country [1] 291801 0
United States of America
Primary sponsor type
Individual
Name
Susana Vaz Nery
Address
ANU College of Medicine, Biology and Environment
The Australian National University
Building 62 Mills Road
Canberra ACT 0200
Country
Australia
Secondary sponsor category [1] 290460 0
Individual
Name [1] 290460 0
Darren Gray
Address [1] 290460 0
ANU College of Medicine, Biology and Environment
The Australian National University
Building 62 Mills Road
Canberra ACT 0200
Country [1] 290460 0
Australia
Secondary sponsor category [2] 290461 0
Individual
Name [2] 290461 0
Archie Clements
Address [2] 290461 0
ANU College of Medicine, Biology and Environment
The Australian National University
Building 62 Mills Road
Canberra ACT 0200
Country [2] 290461 0
Australia
Other collaborator category [1] 278614 0
Individual
Name [1] 278614 0
Rebecca J Traub, BSc BVMS (Hons) PhD
Address [1] 278614 0
Faculty of Veterinary Science
University of Melbourne
Parkville VIC 3052
Country [1] 278614 0
Australia
Other collaborator category [2] 278615 0
Individual
Name [2] 278615 0
James McCarthy
Address [2] 278615 0
QIMR Berghofer Medical Research Institute
University of Queensland
Dept. of Infectious Diseases,
Royal Brisbane and Womens Hospital
Herston Rd Herston
QLD 4029
Country [2] 278615 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293318 0
The Australian National University Human Research Ethics Committee
Ethics committee address [1] 293318 0
The Australian National University
Acton ACT 2601
Ethics committee country [1] 293318 0
Australia
Date submitted for ethics approval [1] 293318 0
20/03/2015
Approval date [1] 293318 0
08/05/2015
Ethics approval number [1] 293318 0
2015/111
Ethics committee name [2] 293319 0
Cabinet for Ethics and Quality Control - Ministry of Health Timor-Leste
Ethics committee address [2] 293319 0
Instituto National Saude
Comoro
Dili
Ethics committee country [2] 293319 0
Timor-Leste
Date submitted for ethics approval [2] 293319 0
13/02/2015
Approval date [2] 293319 0
13/04/2015
Ethics approval number [2] 293319 0
MS-INS/GDE-Peskija/II/2015/196

Summary
Brief summary
The current WHO strategy for control of soil-transmitted helminths (STH) is school-based targeted drug treatment focusing on school-age children. Deworming programmes with anthelminthic drugs are highly effective in reducing morbidity but rapid reinfection occurs if there is no reduction in environmental contamination with parasite infective stages. Therefore, provision of water, sanitation and hygiene (WASH) programs is of critical importance in the sustainable control of STHs. In fact, WASH programs have been shown to reduce worm infection, both when implemented at schools and in entire communities. On the other hand, recent modeling has raised questions about WHO guidelines, demonstrating limited impact from school-based delivery of interventions on community health and, importantly, STH transmission. This is contrary to the currently accepted idea that adults benefit from school-based deworming as a result of its impact on the overall intensity of transmission within the population. Therefore, when thinking of the long-term control of STH, it will be necessary to optimise strategies for deworming and WASH programs, with respect to school versus community-based delivery of interventions.

This pilot study aims to establish the feasibility of conducting a large cluster-randomised trial investigating the differential impact of school- versus community-based integrated WASH and deworming programmes. The pilot study also aims to establish "proof of principle" that a community-based intervention will be more effective than a school-based intervention at reducing STH infections in school-aged children.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 59366 0
Dr Susana Vaz Nery
Address 59366 0
Research School of Population Health
The Australian National University
Building 62 Mills Road
Canberra ACT 0200
Country 59366 0
Australia
Phone 59366 0
+61 2 6125 0155
Fax 59366 0
Email 59366 0
susana.nery@anu.edu.au
Contact person for public queries
Name 59367 0
Dr Susana Vaz Nery
Address 59367 0
Research School of Population Health
The Australian National University
Building 62 Mills Road
Canberra ACT 0200
Country 59367 0
Australia
Phone 59367 0
+61 2 6125 0155
Fax 59367 0
Email 59367 0
susana.nery@anu.edu.au
Contact person for scientific queries
Name 59368 0
Dr Susana Vaz Nery
Address 59368 0
Research School of Population Health
The Australian National University
Building 62 Mills Road
Canberra ACT 0200
Country 59368 0
Australia
Phone 59368 0
+61 2 6125 0155
Fax 59368 0
Email 59368 0
susana.nery@anu.edu.au

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