Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613000523707
Ethics application status
Approved
Date submitted
6/05/2013
Date registered
10/05/2013
Date last updated
5/02/2021
Date data sharing statement initially provided
5/02/2021
Date results information initially provided
5/02/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
The effectiveness and acceptability of the 'BALatrine': a culturally acceptable latrine intervention in resource limited environments.
Scientific title
Indonesian villagers' use of a new household latrine to reduce soil transmitted helminth infection and environmental contamination.
Secondary ID [1] 281731 0
Nil known
Universal Trial Number (UTN)
U1111-1142-5044
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Helminthiasis 289019 0
Gastroenteritis 289020 0
Condition category
Condition code
Public Health 289358 289358 0 0
Epidemiology
Public Health 289359 289359 0 0
Health promotion/education
Infection 289420 289420 0 0
Other infectious diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention is a household latrine (BALatrine) plus health education/promotion on hygiene and sanitation. The BALatrine is a simple squat latrine, usually constructed by the villagers themselves, at the side of a house. It comprises a 2 metre pit (with optional bamboo/concrete pipe strengthening); a base cover with raised footsteps (which can be used during dry periods); and a flushable U-bend porcelain bowl that may be removable. All can be made from local materials. All householders in the intervention village will construct one, with material support and advice from the researchers, if required. The intervention period is 12 months, after which the control villages will also receive the intervention. The Health education/health promotion intervention will be delivered via community meetings in each sub-village in the Intervention group of communities. Community meetings will be run by the local research team. A representative from all ‘dusun’ households will be invited to the meetings which will be held in the Village meeting hall.. The Health education/health promotion intervention will be implemented through 1 two-hour village wide mobilization meeting and 1 two-hour village wide meeting covering hygiene/sanitation educational inputs meeting after all latrines have been constructed.
After the baseline survey all cohort members (intervention and control villages) will receive a singe dose of Albendazole (400mg) in the form of an oral tablet, as per WHO guidelines. This will be administered during the national de-worming program delivered by local health officials and recorded onto a treatment registry. According to Indonesian guidelines, pregnant women will not be treated Albendazole.
The first meeting - to be implemented after the baseline questionnaire and prior to latrine construction-will be the project launch and mobilization of households (consciousness-raising and provision of general information about parasite infection and burden of STH). This will comprise description of the BALatrine intervention, its construction, maintenance and use. BALatrine construction workshops will assist village residents (particularly those with special needs) to plan, construct, use and maintain their latrines.
Leaflets supporting the meeting and summarising the health education content discussed will be distributed to each household.

The second meeting will present/discuss hygiene and sanitation educational inputs for each intervention household, plus information about cleaning, maintenance and use of the latrine. This meeting will cover behavioural change (hygiene and sanitation behaviour change) requirements. All aspects of the questionnaire relating to Knowledge, Attitudes and Behaviour associated with WASH will be covered in this meeting, either as revision of content presented in Meeting 1, or as new material.

Health Education content will comprise both general hygiene/sanitation topics that provide the context and background of the need for introduction and appropriate use of improved latrines, and topics specifically related to STH:

(a) Presentation and group discussion:
1. STH and other Gastro-intestinal diseases (types, definition, symptoms, treatment, complications, causes)
2. Prevention of STH and GI diseases (drinking water, defecation, sanitation, hand-washing, food safety, insects)
3. STH (definitions, lifecycle, types: Pinworms, Hookworms, Whipworms, Ascaris, Tapeworms,
4. Preventing STH infection (personal hygiene, sanitary environment)
5. Significance of the latrine (definition, types, characteristics of good latrine construction)
6. Water quality (characteristics of pure water, water purification – boil, solar, chlorine, storage)
7. Healthy wells (requirements,special layout, pollutants, structure, maintenance)
8. Animals in house (benefits, zoonotic diseases – toxoplasmosis, rabies, avian flu, worms, leptospirosis, prevention of animal-borne diseases)
9. Healthy food (definition, common food-borne diseases, digestion, infections in food)
10. Principles of food management (preparation, storage, processing, transporting)
11. Digestion and the normal gut (germs and pathogens).

(b) Leaflets
1. Similar information as (a) above
2. How to construct a BALatrine.

All community meeting attendees will be registered onto a meeting register.
Intervention code [1] 287062 0
Prevention
Intervention code [2] 287063 0
Behaviour
Intervention code [3] 287111 0
Lifestyle
Comparator / control treatment
A community based cluster-randomised intervention trial will be undertaken to determine the impact of the BALatrine on STH infection, in Central Java Province. Eight villages with no/or non-functioning latrines will be identified and randomly assigned intervention/control status (4 intervention; 4 control). matched as closely as possible, based on criteria related to transmission (infection levels; transmission ecology) into pairs to reduce confounding and increase statistical efficiency. One village within each pair will be randomly assigned intervention status (installation of the BALatrine) leaving the other as the control (no latrine). A fixed cohort (n=500) of people (aged >5 years, including equal numbers of males and females) in each village will be selected and followed up over 1 year (2 years if funding available) (total N=4000). All participants (including from the control group) will: participate in the baseline survey; provide a stool sample at the start and end of the study; and receive treatment (single oral tablet dose of 400mg/kg) after the baseline survey. All control villages will also receive the intervention once the study has concluded.
Control group
Active

Outcomes
Primary outcome [1] 289470 0
The main end-point for the study will be human soil-transmitted Helminth (STH) prevalence. A stool examination (with blinding of microscopists to intervention status) for infection status will be undertaken in all villages at baseline and at follow-up (month 18). We will use a faecal float method for human stool examination for the assessment of STH infection rates. A stool sample will be collected from each person. Microscopists will not be aware which village the slide was from and slides will be de-identified for reading so that they are read independently from each other. Quality control will be carried out by independent microscopists on 50% of the slides.
Timepoint [1] 289470 0
18 months
Secondary outcome [1] 302683 0
The secondary outcome of this study will be proportion of participants with improved health knowledge and hygiene and sanitation behaviour (i.e. the effect of the health education intervention on health knowledge, hygiene and sanitary behaviour). This will be assessed as a composite secondary outcome using data collected from a questionnaire (the Helminth, Education and Latrine Project (HELP) questionnaire) to be administered at the start of the study and during follow-up (12 months later).
Timepoint [1] 302683 0
9-12 months, follow up October 2017 and 2018.

Eligibility
Key inclusion criteria
1. Residing for the length of the project in 1 of the 8 study villages;
2. member of a fixed cohort (n=500) of people aged over 2 years, who agree to participate in the study;
3. member of a randomly selected household from each study village;
4. physically and mentally competent to answer the interview questions; and
5. consent to be included.
Minimum age
2 Years
Maximum age
100 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. Younger than 2 years
2. Have an 'improved' latrine

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)
Allocation is not concealed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
8 villages without latrines will be identified and matched as closely as possible, based on criteria related to transmission (infection levels; transmission ecology) into pairs to reduce confounding and increase statistical efficiency. One village within each pair will be randomly assigned intervention status (installation of the BALatrine) leaving the other as the control (no latrine)
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
A generalised linear model will be used for formal analyses 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. Clustering will be accounted for by analysing the combined intervention effect within the matched pairs. Potential confounders such as age and sex will be incorporated. Spearman correlation coefficients will be used to estimate correlations among behaviour, knowledge, and incidence. Sample size calculations were performed according to Donner and Klar; with an STH incidence of 8% (typical of communities with ~24% STH prevalence), an intervention efficacy of 30%, and a design effect (relating to paired differences) of 1.5; the study will have 80% power (alpha = 0.05) with a sample size of 8 intervention clusters (16 in total) and 400 participants per cluster at the end of the trial following a predicted annual 10% loss to follow-up. Total study population is 6400.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
3/06/2013
Actual
5/09/2016
Date of last participant enrolment
Anticipated
Actual
29/09/2016
Date of last data collection
Anticipated
31/10/2018
Actual
4/11/2018
Sample size
Target
4000
Accrual to date
Final
3479
Recruitment outside Australia
Country [1] 5068 0
Indonesia
State/province [1] 5068 0
Wonosobo, Central Java

Funding & Sponsors
Funding source category [1] 287240 0
Charities/Societies/Foundations
Name [1] 287240 0
UBS Optimus Foundation
Country [1] 287240 0
Switzerland
Funding source category [2] 299669 0
Government body
Name [2] 299669 0
National Health and Medical Research Council (Australia)
Country [2] 299669 0
Australia
Primary sponsor type
University
Name
Griffith University
Address
170 Kessels Rd, Nathan,
Brisbane,
Qld 4111.
Country
Australia
Secondary sponsor category [1] 285990 0
University
Name [1] 285990 0
Diponegoro University
Address [1] 285990 0
Rectorat Building, Prof. Soedarto, SH street,
Tembalang Campus, Kotak Pos,
Semarang, 1269
Central Java
Country [1] 285990 0
Indonesia
Secondary sponsor category [2] 298996 0
Government body
Name [2] 298996 0
Australian National University
Address [2] 298996 0
Acton, ACT 2601
Country [2] 298996 0
Australia
Secondary sponsor category [3] 298997 0
Charities/Societies/Foundations
Name [3] 298997 0
Yayasan Wahana Bakti Sejatera (YWBS) Foundation
Address [3] 298997 0
Jl. Fortunately Soerapatti 445
Semarang
Central Java
Country [3] 298997 0
Indonesia
Secondary sponsor category [4] 298998 0
University
Name [4] 298998 0
QIMR Berghofer Medical Research Institute
Address [4] 298998 0
300 Herston Rd,
Herston
QLD 4006
Country [4] 298998 0
Australia
Secondary sponsor category [5] 298999 0
University
Name [5] 298999 0
Queensland University of Technology
Address [5] 298999 0
2 George St
Brisbane City
QLD 4000
Country [5] 298999 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289219 0
Griffith University Human Research Ethics Comittee
Ethics committee address [1] 289219 0
Office for Research
170 Kessels Rd,
Bray Centre, Nathan Campus
Griffith University
Qld 4111
Ethics committee country [1] 289219 0
Australia
Date submitted for ethics approval [1] 289219 0
19/08/2016
Approval date [1] 289219 0
05/09/2016
Ethics approval number [1] 289219 0
2016/442

Summary
Brief summary
This project will be a definitive study to assess the efficacy of the household latrines on STH infections. Our study design requires the intervention sample to have an effective household latrine (the BALatrine) installed plus supporting health education; the control sample will not receive this intervention package. All participants will receive deworming medication (Albendazole). A cluster RCT allows us to undertake systematic and scientific testing of the efficacy and acceptability of the BALatrine and to investigate its health benefits. The efficacy of the latrine in reducing STH infection will be measured by comparing human STH incidence across intervention and control populations. We hypothesise that there will be a significant reduction in human infection rates and a lower infection intensity in the intervention sample.

A community based cluster-randomised intervention trial will be undertaken to determine the impact of the BALatrine on STH infection in sub-villages (‘dusuns’) located in Wonosobo, Central Java Province. Eight sub-villages/Dusunss (4 intervention; 4 control) with low levels of household latrine ownership will be identified. They will be stratified by topography (mountain: 4 Dusuns; Hillsides: 4 Dusuns). Two dusuns within each topography type will be randomly selected as the intervention group (ALB + installation of the BALatrine + health education) leaving the other 2 as the controls (ALB only). Following the baseline survey all study participants will receive Albendazole (ALB) treatment by the local STH control program. A fixed cohort (n=500) of people aged > 2 years, including equal numbers of males and females, in each dusun will be selected and followed up over 12 months. The main end-point for the study will be human STH incidence. Secondary endpoints include knowledge, attitudes and practices relating to hygiene behaviour.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 36846 0
Prof Donald Stewart
Address 36846 0
Room 4.07 / S07 - South Bank Campus
Griffith University, PO Box 3370
South Brisbane, QLD 4101
Country 36846 0
Australia
Phone 36846 0
+61 - 7 373 53218
Fax 36846 0
Email 36846 0
[email protected]
Contact person for public queries
Name 36847 0
Prof Donald Stewart
Address 36847 0
Room 4.07 / S07 - South Bank Campus
Griffith University, PO Box 3370
South Brisbane, QLD 4101
Country 36847 0
Australia
Phone 36847 0
+61 - 7 373 53218
Fax 36847 0
Email 36847 0
[email protected]
Contact person for scientific queries
Name 36848 0
Prof Donald Stewart
Address 36848 0
Room 4.07 / S07 - South Bank Campus
Griffith University, PO Box 3370
South Brisbane, QLD 4101
Country 36848 0
Australia
Phone 36848 0
+61 - 7 373 53218
Fax 36848 0
Email 36848 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Participants were not notified that data may be made publicly available and therefore no informed consent was provided by respondents.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Plain language summaryNo Results are still being analysed and therefore not... [More Details]

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseImpact of the "balatrine" intervention on soil-transmitted helminth infections in central Java, Indonesia: A pilot study.2019https://dx.doi.org/10.3390/tropicalmed4040141
EmbaseInterventions to improve disposal of child faeces for preventing diarrhoea and soil-transmitted helminth infection.2019https://dx.doi.org/10.1002/14651858.CD011055.pub2
N.B. These documents automatically identified may not have been verified by the study sponsor.