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Trial registered on ANZCTR


Registration number
ACTRN12614000680662
Ethics application status
Approved
Date submitted
16/06/2014
Date registered
27/06/2014
Date last updated
27/06/2014
Type of registration
Retrospectively registered

Titles & IDs
Public title
Integration of deworming with a water, sanitation and hygiene program for the prevention of intestinal parasites in Timor-Leste
Scientific title
A cluster randomised controlled trial comparing the impact of a water, sanitation and hygiene (WASH) intervention integrated with albendazole distribution versus albendazole distribution alone, on reinfection with intestinal parasites in rural communities in Timor-Leste
Secondary ID [1] 284809 0
Nil
Universal Trial Number (UTN)
Nil
Trial acronym
WASH for WORMS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Soil transmitted helminths – Trichuris trichiura, Ascaris lumbricoides, hookworms (Necator americanus and Ancylostoma duodenale) 292186 0
Intestinal protozoa (Giardia duodenalis, Entamoeba histolytica, Strongyloides sp., Cryptosporidium sp.) 292187 0
Anaemia 292188 0
Stunting 292189 0
Wasting 292190 0
Condition category
Condition code
Public Health 292526 292526 0 0
Epidemiology
Infection 292527 292527 0 0
Studies of infection and infectious agents

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, which will be supported by WaterAid, Australia (WA). The sanitation component is based on the Community Led Total Sanitation approach with WA giving technical support to the construction of latrines. Furthermore, WA staff will lead the construction of piped water from springs/streams to storage tanks/tapstands in villages; and local partner NGOs will promote hand washing with soap. The hygiene intervention will be based on 2-3 visits to each village shortly after the triggering takes place, to promote hand washing with soap using several methods including a hygiene promotion film, establishing a children group and developing a hygiene promotion drama, and a female group. Monitoring visits will happen monthly until the completion of the water intervention and every 6 months for 2 years after the water infrastructure is completed.
All communities (control and intervention arm) will receive mass chemotherapy with one oral tablet of albendazole 400mg every six months for 2 years, starting when 80% of the households have sanitation. Albendazole intake will be directly observed by the field workers delivering the pills who will be working under the supervision of a registered nurse.
Questionnaires including questions on access to water, sanitation and hygiene practices will be used to monitor the progression of the implementation of the integration; and will be part of field work at each 6 monthly visit.
Intervention code [1] 289598 0
Prevention
Intervention code [2] 289645 0
Treatment: Drugs
Comparator / control treatment
Control communities will receive mass chemotherapy with one oral tablet of albendazole 400mg every six months for 2 years.
Albendazole intake will be directly observed by the field workers delivering the pills who will be working under the supervision of a registered nurse.
Control group
Active

Outcomes
Primary outcome [1] 292386 0
Reduction in prevalence of infection with A. lumbricoides. Infection status will be assessed by real time PCR on a stool sample obtained at each visit.
Timepoint [1] 292386 0
Each six-monthly follow-up (Follow-up (FU) 1=6 months after 1st alb distribution), FU2, FU3, FU4=2yrs after 1st albendazole (ALB) distribution).
Primary outcome [2] 292387 0
Reduction in prevalence of infection with T. trichiura.
Infection status will be assessed by real time PCR on a stool sample obtained at each visit.
Timepoint [2] 292387 0
Each six-monthly follow-up (FU1=6 months after 1st alb distribution), FU2, FU3, FU4=2yrs after 1st ALB distribution).
Primary outcome [3] 292388 0
Reduction in prevalence of infection with hookworms (undifferentiated)
Infection status will be assessed by real time PCR on a stool sample obtained at each visit.
Timepoint [3] 292388 0
Each six-monthly follow-up (FU1=6 months after 1st alb distribution), FU2, FU3, FU4=2yrs after 1st ALB distribution).
Secondary outcome [1] 308849 0
Reduction in prevalence of G. duodenalis.
Infection status will be assessed by real time PCR on a stool sample obtained at each visit.
Timepoint [1] 308849 0
At each six-monthly follow-up (FU1=6 months after 1st alb distribution), FU2, FU3, FU4=2yrs after 1st ALB distribution).
Secondary outcome [2] 308850 0
Reduction in prevalence of E. histolytica.
Infection status will be assessed by real time PCR on a stool sample obtained at each visit.
Timepoint [2] 308850 0
At each six-monthly follow-up (FU1=6 months after 1st alb distribution), FU2, FU3, FU4=2yrs after 1st ALB distribution).
Secondary outcome [3] 308851 0
Changes in the ratio of numbers of people infected with the hookworms A. duodenalis, N. Americanus and A. ceylanicum.
Species differentiation will be done by real time PCR on a stool sample obtained at each visit
Timepoint [3] 308851 0
At each six-monthly follow-up (FU1=6 months after 1st alb distribution), FU2, FU3, FU4=2yrs after 1st ALB distribution).
Secondary outcome [4] 308852 0
Changes in mean haemoglobin concentration (measured with a portable analyser).
Timepoint [4] 308852 0
At baseline and at the annual follow-ups (FU2=1 year after 1st ALB distribution and FU4=2 years after 1st ALB distribution)
Secondary outcome [5] 308853 0
Changes in height-for-age z-scores
Timepoint [5] 308853 0
At baseline and at the annual follow-ups (FU2=1 year after 1st ALB distribution and FU4=2 years after 1st ALB distribution)
Secondary outcome [6] 308854 0
Changes in weight-for-age z-score
Timepoint [6] 308854 0
At baseline and at the annual follow-ups (FU2=1 year after 1st ALB distribution and FU4=2 years after 1st ALB distribution)
Secondary outcome [7] 308855 0
Changes in height-for-weight z-scores.
Timepoint [7] 308855 0
At baseline and at the annual follow-ups (FU2=1 year after 1st ALB distribution and FU4=2 years after 1st ALB distribution)
Secondary outcome [8] 308856 0
Reductions in the mean intensity of infection (calculated as the average number of eggs per gram of faeces) of A. lumbricoides. Intensity of infection assessed by real-time quantitative PCR.
Timepoint [8] 308856 0
At each six-monthly follow-up (FU1=6 months after 1st alb distribution), FU2, FU3, FU4=2yrs after 1st ALB distribution).
Secondary outcome [9] 308857 0
Reductions in the mean intensity of infection (calculated as the average number of eggs per gram of faeces) of T. trichiura . Intensity of infection assessed by real-time quantitative PCR
Timepoint [9] 308857 0
At each six-monthly follow-up (FU1=6 months after 1st alb distribution), FU2, FU3, FU4=2yrs after 1st ALB distribution).
Secondary outcome [10] 308858 0
Reductions in the mean intensity of infection (calculated as the average number of eggs per gram of faeces) of hookworms (undifferentiated) . Intensity of infection assessed by real-time quantitative PCR
Timepoint [10] 308858 0
At each six-monthly follow-up (FU1=6 months after 1st alb distribution), FU2, FU3, FU4=2yrs after 1st ALB distribution).

Eligibility
Key inclusion criteria
Resident of each selected community
Informed consent obtained
Over 1 year of age
Not in the 1st trimester of pregnancy
Minimum age
1 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Not a resident of the community
No informed consent
Outside of the specified age range
Pregnant in the 1st trimester

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 members of the randomly selected communities, from whom informed consent was obtained will be enrolled in the study provided they are older than one year of age and not pregnant in the 1st trimester. Allocation is not concealed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
This is a cluster randomised trial. Cluster units will be small rural villages in Manufahi district, Timor-Leste. Random number generation will be used in MS excel to randomise villages/communities 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
Sample size calculations were for the primary outcome Using A. lumbricoides as an example, given an assumed baseline prevalence of 60% and a reduction in prevalence at the 6-month follow-up of 25% in the control group (albendazole chemotherapy only), we estimate a control-group prevalence of 45%. Using data from a recent national helminth survey in the Philippines (Leonardo et al., unpublished), we estimate an intracluster correlation coefficient for prevalence of A. lumbricoides of 0.19. We have assumed a fixed population size in each village; 150 people, of whom 120 participate with a subsequent 10% loss to follow-up. To determine whether the community-based hygiene and sanitation programme results in a 50% reduction of the follow-up prevalence compared to the control group (i.e., to 22.5%), with a power of 80% and a=0.05, we would need to include 12 villages in each of the intervention and control arms. Similar results were obtained for the other STH. Thus, we will enrol 2,880 people, located in 24 villages, randomised 1:1 between the intervention and control arms.
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
Active, not recruiting
Date of first participant enrolment
Anticipated
28/05/2012
Actual
28/05/2012
Date of last participant enrolment
Anticipated
18/10/2013
Actual
18/10/2013
Date of last data collection
Anticipated
Actual
Sample size
Target
2880
Accrual to date
Final
Recruitment outside Australia
Country [1] 6151 0
Timor-Leste
State/province [1] 6151 0
Manufahi

Funding & Sponsors
Funding source category [1] 289422 0
Government body
Name [1] 289422 0
National Health and Medical Research Council (NHMRC)
Country [1] 289422 0
Australia
Funding source category [2] 289423 0
Charities/Societies/Foundations
Name [2] 289423 0
WaterAid Australia
Country [2] 289423 0
Australia
Primary sponsor type
Individual
Name
Archie Clements
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] 288105 0
Individual
Name [1] 288105 0
James McCarthy
Address [1] 288105 0
QIMR Berghofer Medical Research Institute
University of Queensland
Dept. of Infectious Diseases,
Royal Brisbane and Womens Hospital
Herston Rd Herston
QLD 4029 Australia
Country [1] 288105 0
Australia
Secondary sponsor category [2] 288106 0
Individual
Name [2] 288106 0
Rebecca J Traub, BSc BVMS (Hons) PhD
Address [2] 288106 0
Faculty of Veterinary Science
University of Melbourne
Parkville VIC 3052
Country [2] 288106 0
Australia
Secondary sponsor category [3] 288107 0
Individual
Name [3] 288107 0
Darren Gray
Address [3] 288107 0
ANU College of Medicine, Biology and Environment
The Australian National University
Building 62 Mills Road
Canberra ACT 0200
Country [3] 288107 0
Australia
Secondary sponsor category [4] 288108 0
Individual
Name [4] 288108 0
Jim Black
Address [4] 288108 0
Nossal Institute for Global Health
Melbourne School of Population and Global Health
Level 4, Alan Gilbert Building
161 Barry St, Carlton, VIC, 3010
Australia
Country [4] 288108 0
Australia
Secondary sponsor category [5] 288109 0
Individual
Name [5] 288109 0
Ross Andrews
Address [5] 288109 0
Menzies School of Health Research
PO Box 41096
Casuarina NT 081
Country [5] 288109 0
Australia
Secondary sponsor category [6] 288110 0
Individual
Name [6] 288110 0
Susana Nery
Address [6] 288110 0
School of Population Health, University of Queensland
Level 4, Public Health Building;
Herston Road; Herston 4006; Queensland; Australia
Country [6] 288110 0
Australia
Other collaborator category [1] 278001 0
Individual
Name [1] 278001 0
Martha Morrow
Address [1] 278001 0
Nossal Institute for Global Health
Level 4, Alan Gilbert Building
Corner of Barry and Grattan Streets (161 Barry St)
The University of Melbourne
Carlton, Victoria, 3010
Country [1] 278001 0
Australia
Other collaborator category [2] 278002 0
Individual
Name [2] 278002 0
Andrey Vallely
Address [2] 278002 0
University of New South Wales
The CFI Building
Corner Boundary and West Streets
Darlinghurst NSW 2010
Country [2] 278002 0
Australia
Other collaborator category [3] 278003 0
Individual
Name [3] 278003 0
Gail Williams
Address [3] 278003 0
School of Population Health, University of Queensland
Level 4, Public Health Building;
Herston Road; Herston 4006; Queensland; Australia
Country [3] 278003 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291180 0
The University of Queensland – Medical Research Ethics Committee (MREC)
Ethics committee address [1] 291180 0
Ethics committee country [1] 291180 0
Australia
Date submitted for ethics approval [1] 291180 0
Approval date [1] 291180 0
13/07/2011
Ethics approval number [1] 291180 0
2011000734
Ethics committee name [2] 291181 0
Gabinete Pesquisa e Desenvolvimento Saude, Ministerio da Saude, Timor-Leste
Ethics committee address [2] 291181 0
Ethics committee country [2] 291181 0
Timor-Leste
Date submitted for ethics approval [2] 291181 0
Approval date [2] 291181 0
09/08/2011
Ethics approval number [2] 291181 0
MS-CHRD/VIII/2011/51

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

Contacts
Principal investigator
Name 49218 0
Prof Archie Clements
Address 49218 0
Research School of Population Health
ANU College of Medicine, Biology and Environment
The Australian National University
Building 62 Mills Road
Canberra ACT 0200
Country 49218 0
Australia
Phone 49218 0
+61 2 6125 4578
Fax 49218 0
+61 2 6125 5608
Email 49218 0
Director.RSPH@anu.edu.au
Contact person for public queries
Name 49219 0
Susana Nery
Address 49219 0
School of Population Health, University of Queensland
Level 4, Public Health Building;
288 Herston Road; Herston 4006; Queensland
Country 49219 0
Australia
Phone 49219 0
+670 7700 5990
Fax 49219 0
Email 49219 0
s.nery@uq.edu.au
Contact person for scientific queries
Name 49220 0
Susana Nery
Address 49220 0
School of Population Health, University of Queensland
Level 4, Public Health Building;
288 Herston Road; Herston 4006; Queensland
Country 49220 0
Australia
Phone 49220 0
+670 7700 5990
Fax 49220 0
Email 49220 0
s.nery@uq.edu.au

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
SourceTitleYear of PublicationDOI
EmbaseA cluster-randomised controlled trial integrating a community-based water, sanitation and hygiene programme, with mass distribution of albendazole to reduce intestinal parasites in Timor-Leste: The WASH for WORMS research protocol.2015https://dx.doi.org/10.1136/bmjopen-2015-009293
EmbaseApplication of a Multiplex Quantitative PCR to Assess Prevalence and Intensity Of Intestinal Parasite Infections in a Controlled Clinical Trial.2016https://dx.doi.org/10.1371/journal.pntd.0004380
EmbaseWater, sanitation and hygiene related risk factors for soil-transmitted helminth and Giardia duodenalis infections in rural communities in Timor-Leste.2016https://dx.doi.org/10.1016/j.ijpara.2016.07.005
EmbaseAn environmental assessment and risk map of Ascaris lumbricoides and Necator americanus distributions in Manufahi District, Timor-Leste.2017https://dx.doi.org/10.1371/journal.pntd.0005565
EmbaseInvestigations into the association between soil-transmitted helminth infections, haemoglobin and child development indices in Manufahi District, Timor-Leste.2017https://dx.doi.org/10.1186/s13071-017-2084-x
Dimensions AIA novel, species-specific, real-time PCR assay for the detection of the emerging zoonotic parasite Ancylostoma ceylanicum in human stool2017https://doi.org/10.1371/journal.pntd.0005734
EmbaseUse of quantitative PCR to assess the efficacy of albendazole against Necator americanus and Ascaris spp. in Manufahi District, Timor-Leste.2018https://dx.doi.org/10.1186/s13071-018-2838-0
N.B. These documents automatically identified may not have been verified by the study sponsor.