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Trial registered on ANZCTR


Registration number
ACTRN12616001286437
Ethics application status
Approved
Date submitted
7/09/2016
Date registered
13/09/2016
Date last updated
3/06/2021
Date data sharing statement initially provided
3/06/2021
Date results provided
3/06/2021
Type of registration
Retrospectively registered

Titles & IDs
Public title
Evaluating the impact of hygiene and water interventions on diarrhoeal disease in India
Scientific title
A cluster randomised stepped-wedge trial assessing the impact of a community-level hygiene intervention and a water intervention using riverbank filtration technology on diarrhoeal prevalence in India
Secondary ID [1] 290108 0
NHMRC1083408 (Grant number from National Health and Medical Research Council Australia)
Universal Trial Number (UTN)
U1111-1187-3423
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Diarrhoea 300204 0
Respiratory infections 300205 0
Skin infections 300206 0
Condition category
Condition code
Infection 300087 300087 0 0
Other infectious diseases
Public Health 300088 300088 0 0
Epidemiology

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The study will be conducted over an 18-month period. As per the stepped wedge trial design, each of the four villages recruited for the trial will spend time in the control arm and the intervention arm of the study. Prior to the start of the control arm, a baseline survey will be conducted to collect baseline demographics and health data.

The control arm will involve delivery of a community-level hygiene education program and improved access to water at a community level (improved water quantity). The intervention arm will involve delivery of a community-level hygiene education program and access to water treated using riverbank filtration technology (RBF) at a community level (improved water quality). The intervention will be implemented by the non-governmental organisation The Energy and Resources Institute (TERI) in India.

Hygiene education including posters relating to hand hygiene and safe water storage will be delivered to individual households and public places and trained field workers will provide house-by-house education on hygiene practices. House-to-house education will consist of a verbal discussion of hygiene practices with the householder using educational posters. This will take approximately 10 minutes per household and will be delivered along with the baseline survey. Hygiene education messages will be reinforced by a trained field worker at each subsequent survey.

RBF-treated water will be delivered via newly built water delivery systems. RBF is an inexpensive water treatment technique that uses auto-regenerative, natural treatment processes to improve water quality. Contractors working with TERI will install new pipes, covered storage tanks and taps throughout each of the study villages. RBF wells will also be installed in each village.

All villages will start in the control arm and will receive piped unfiltered river water via new water delivery systems. Villages will then be randomised to receive the RBF intervention at three monthly intervals (3, 6, 9 and 12 months after the start of the control arm). Once a village is randomised to receive the intervention, piped RBF-treated water will be delivered to that village for the remainder of the study period.
Intervention code [1] 295859 0
Prevention
Intervention code [2] 295861 0
Behaviour
Comparator / control treatment
The control arm will involve delivery of a community-level hygiene education program and access to improved water quantity at a community level. New water delivery systems (pipes, tanks and taps), will be used to deliver piped untreated river water to improve spatial access to water for hygiene and drinking purposes. Piped untreated river water will continue to be delivered until the village is randomised to receive RBF-treated water.

Hygiene education including posters relating to hand hygiene and safe water storage will be delivered to individual households and public places and trained field workers will provide house-by-house education on hygiene practices.
Control group
Active

Outcomes
Primary outcome [1] 299565 0
Self-reported diarrhoea (7 day period prevalence)
Timepoint [1] 299565 0
At baseline and every three months for 18 months.
Secondary outcome [1] 327528 0
Self-reported respiratory infections (7 day period prevalence)
Timepoint [1] 327528 0
At baseline and and every three months for 18 months.
Secondary outcome [2] 327529 0
Self-reported skin infections (7 day period prevalence)
Timepoint [2] 327529 0
At baseline and and every three months for 18 months.
Secondary outcome [3] 327530 0
Self-reported hygiene practices
Timepoint [3] 327530 0
At baseline and and every three months for 18 months.
Secondary outcome [4] 327531 0
Self-reported preferred/adopted domestic water supply and household water consumption
Timepoint [4] 327531 0
At baseline and and every three months for 18 months.
Secondary outcome [5] 327532 0
Quantitative detection of E. coli in water samples assessed as most probable number using Colilert (Registered Trademark)
Timepoint [5] 327532 0
At baseline and weekly for 18 months.
Secondary outcome [6] 327533 0
Cost-effectiveness of RBF system installation in India measured and reported as cost per event prevented and cost per disability-adjusted life year (DALY) averted
Timepoint [6] 327533 0
At conclusion of study
Secondary outcome [7] 342797 0
Factors that influence domestic water source preferences assessed using the COM-B (capability, opportunity, motivation and behaviour) model.
Timepoint [7] 342797 0
At conclusion of the study
Secondary outcome [8] 342798 0
Examine attitudes towards the community-level water and hygiene interventions and barriers and enablers to intervention uptake using the Theoretical Framework of Acceptability
Timepoint [8] 342798 0
At conclusion of the study

Eligibility
Key inclusion criteria
Inclusion criteria for village selection:
- Villages in rural India currently using untreated river water as a primary source of drinking water
- Hydrogeologic conditions allowing construction of RBF systems
- Availability of suitable land for RBF system installation
- Community receptiveness to installation of RBF systems and commitment to ongoing operation and maintenance
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
- Villages with less than 500 households
- Villages where untreated river water was not a primary source of drinking water for most households
- Villages where hydrogeologic conditions were unsuitable or land was not available for RBF system installation

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)
Sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computerised sequence generation
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Stepped wedge cluster randomised design involving random and sequential crossover of clusters (villages) from the control to the intervention arm so that every cluster eventually receives the intervention. This pragmatic study design allows for analysis of seasonal effects and inter-village variation, and allows all villages within the study to eventually receive the intervention, thus improving equity and acceptability.

At the conclusion of the stepped wedge trial, a short qualitative sub-study will be performed. We will purposively sample 15-20 households (4-5 from each village) and invite them to participate in semi-structured interviews of approximately one hour duration. We will also invite study surveyors (field data collectors) to participate in focus group discussions. The aim of this sub-study is to identify factors that influence domestic water source preferences, to examine attitudes towards the interventions, and to identify barriers and enablers to intervention uptake.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Sample size estimates were based on detecting an absolute difference in the 7-day period prevalence of diarrhoea (primary outcome) with 80% power and an alpha value of 0.05. Estimates were obtained from pilot work conducted in Karnataka, India. Using these parameters, we estimated that 430 households (average household size of 5 persons) will need to be recruited from each village to detect a 30% reduction from a baseline diarrhoeal prevalence of 3%. To allow for attrition across repeat surveys, we plan to approach and recruit up to 750 households per village at baseline to ensure that adequate power will be retained for analysis of the primary outcome.

The data will be summarised using simple prevalences of diarrhoea for each cell in the stepped wedge design. Analyses will be conducted using a linear mixed model approach to estimate absolute reduction (with 95% confidence intervals) in overall prevalence of diarrhoea in the intervention periods (RBF-treated water) compared to control periods (piped unfiltered river water), taking into account trends over time common to all villages and clustering of individuals within villages.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
25/02/2016
Date of last participant enrolment
Anticipated
2/10/2017
Actual
19/05/2016
Date of last data collection
Anticipated
1/01/2018
Actual
12/01/2018
Sample size
Target
8600
Accrual to date
Final
10378
Recruitment outside Australia
Country [1] 8207 0
India
State/province [1] 8207 0
Karnataka

Funding & Sponsors
Funding source category [1] 294479 0
Government body
Name [1] 294479 0
National Health and Medical Research Council
Country [1] 294479 0
Australia
Primary sponsor type
Individual
Name
Professor Karin Leder
Address
Department of Epidemiology and Preventive Medicine,
School of Public Heath and Preventive Medicine,
Monash University
Level 6 The Alfred Centre,
99 Commercial Road,
Melbourne VIC 3004
Country
Australia
Secondary sponsor category [1] 293350 0
Individual
Name [1] 293350 0
Professor Tom Boving
Address [1] 293350 0
Department of Geosciences & Department of Civil and Environmental Engineering
University of Rhode Island
Woodward Hall Rm. 314
Kingston, Rhode Island 02881
Country [1] 293350 0
United States of America
Other collaborator category [1] 279208 0
Other Collaborative groups
Name [1] 279208 0
The Energy and Resources Institute
Address [1] 279208 0
6C Darbari Seth Block
India Habitat Centre
Lodhi Road
New Delhi 110003
Country [1] 279208 0
India

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 295918 0
Monash University Human Research Ethics Committee (MUHREC)
Ethics committee address [1] 295918 0
Ethics committee country [1] 295918 0
Australia
Date submitted for ethics approval [1] 295918 0
23/08/2017
Approval date [1] 295918 0
30/08/2017
Ethics approval number [1] 295918 0
CF15/522-2015000248
Ethics committee name [2] 295920 0
TERI Institutional Ethics Committee
Ethics committee address [2] 295920 0
Ethics committee country [2] 295920 0
India
Date submitted for ethics approval [2] 295920 0
22/04/2015
Approval date [2] 295920 0
02/07/2015
Ethics approval number [2] 295920 0
CF/15/522-2015000248

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

Contacts
Principal investigator
Name 68886 0
Prof Karin Leder
Address 68886 0
Department of Epidemiology and Preventive Medicine,
School of Public Health and Preventive Medicine,
Monash University
Level 6 The Alfred Centre
99 Commercial Road,
Melbourne VIC 3004
Country 68886 0
Australia
Phone 68886 0
+61 3 9903 0577
Fax 68886 0
Email 68886 0
karin.leder@monash.edu
Contact person for public queries
Name 68887 0
Sarah McGuinness
Address 68887 0
Department of Epidemiology and Preventive Medicine,
School of Public Health and Preventive Medicine,
Monash University
Level 6 The Alfred Centre
99 Commercial Road,
Melbourne VIC 3004
Country 68887 0
Australia
Phone 68887 0
+61 3 9903 0118
Fax 68887 0
Email 68887 0
sarah.mcguinness@monash.edu
Contact person for scientific queries
Name 68888 0
Sarah McGuinness
Address 68888 0
Department of Epidemiology and Preventive Medicine,
School of Public Health and Preventive Medicine,
Monash University
Level 6 The Alfred Centre
99 Commercial Road,
Melbourne VIC 3004
Country 68888 0
Australia
Phone 68888 0
+61 3 9903 0118
Fax 68888 0
Email 68888 0
sarah.mcguinness@monash.edu

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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
EmbaseProtocol for a cluster randomised stepped wedge trial assessing the impact of a community-level hygiene intervention and a water intervention using riverbank filtration technology on diarrhoeal prevalence in India.2017https://dx.doi.org/10.1136/bmjopen-2016-015036
N.B. These documents automatically identified may not have been verified by the study sponsor.