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Trial registered on ANZCTR


Registration number
ACTRN12618000633280
Ethics application status
Approved
Date submitted
13/04/2018
Date registered
20/04/2018
Date last updated
12/08/2022
Date data sharing statement initially provided
1/04/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Revitalising Informal Settlements and their Environments (RISE): Assessing health, social, and environmental outcomes following water-sensitive revitalisation of informal settlements in Indonesia and Fiji
Scientific title
Revitalising Informal Settlements and their Environments (RISE): A parallel-cluster randomised controlled trial of assessing health, social, and environmental outcomes following water-sensitive revitalisation of informal settlements in Indonesia and Fiji
Secondary ID [1] 294530 0
Nil known
Universal Trial Number (UTN)
Trial acronym
RISE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Diarrhoea 307303 0
Environmental enteropathy 307308 0
Condition category
Condition code
Public Health 306419 306419 0 0
Epidemiology

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Twenty-four informal settlements have been randomised to participate in the trial (12 located in Makassar, Indonesia; 12 located in Suva, Fiji). Twelve settlements will be intervention sites while the remaining sites will be control sites. Intervention and control sites will be equally distributed between the two main study locations.
Prior to the start of the trial, a baseline survey will be conducted to collect baseline demographics and health data in all settlements.
The intervention arm will involve delivery and construction of water-sensitive revitalisation infrastructure. These interventions will be site-specific but may include the installation of latrines and septic tanks, use of subsurface wetlands for sewage treatment, use of biofilters, building-scale rainwater harvesting, and installing street-scale drainage and storm water treatment facilities.
Design and architectural teams from Monash University will personalize all infrastructure to each settlement site. Construction of infrastructure will be carried out and monitored by respective government bodies at each site (City Government of Makassar in Indonesia and Department of Housing, under the Ministry of Local Government, Housing and the Environment in Fiji).
The first two years of the study will consist of protocol and intervention design, site selection, community and individual enrolment, community engagement, and community co-design of intervention. Construction at intervention sites will commence towards the end of the third year of the study and be completed by the end of year 4; leaving a monitoring period post-construction of 2 years (for a total study length of 5 years). However, the study was delayed by approximately 2years due to the COVID-19 pandemic. After the trial concludes, the twelve control settlements will receive the above water-sensitive infrastructure.
All settlement sites will receive a basic sanitation focused educational intervention. This will include posters relating to hand hygiene and safe water storage delivered to community centers and homes and trained field workers will provide house-by-house education on hygiene practices.
Once enrolled, and for the full duration of the trial, all communities will be visited by field workers at least every 6 months (this includes before and during the build of the intervention as well as after the installation of the intervention is completed). At that time, a range of health and wellbeing data will be collected using questionnaires. Field workers will collect fecal samples from children under 5 every 3 to 6 months and blood samples from children under 5 every 6 to 12 months.
Intervention code [1] 300829 0
Prevention
Intervention code [2] 300830 0
Behaviour
Comparator / control treatment
Control Treatment: Control settlements will not receive the water-sensitive revitalisation infrastructure until after the trial is complete (projected build date of 2025 in control settlements). At that time, they will receive all infrastructure previously provided to the intervention communities. Control communities will receive the same basic sanitation focused educational intervention as the intervention communities throughout the trial. Control communities will participate in the same data collection and sampling protocols as the intervention communities.
Control group
Active

Outcomes
Primary outcome [1] 305431 0
Presence of bacterial, viral, and parasitic gastrointestinal pathogens in children less than 5 years of age (composite primary outcome)
Timepoint [1] 305431 0
Fecal samples from children under 5 at baseline and every 3 to 6 months until 2 years post intervention
Primary outcome [2] 305432 0
Concentration of intestinal inflammation markers representing environmental enteropathy in children less than 5 years of age
Timepoint [2] 305432 0
Fecal samples from children under 5 at baseline and every 3 to 6 months until 2 years post intervention.
Primary outcome [3] 305433 0
Presence, abundance, and repertoire of drug-resistance genes and resistance phenotypes of GI flora of children less than 5 years of age (composite primary outcome)
Timepoint [3] 305433 0
Fecal samples from children under 5 at baseline and every 3 to 6 months until 2 years post intervention.
Secondary outcome [1] 345215 0
Caregiver reported diarrhoea (in the 7 days prior to field worker visit) in children under 5 years of age
Timepoint [1] 345215 0
Data collected via questionnaire at baseline and then every 3 to 6 months until 2 years post intervention.
Secondary outcome [2] 345216 0
Caregiver reported respiratory infection (in the 7 days prior to field worker visit) in children under 5 years of age
Timepoint [2] 345216 0
Data collected via questionnaire at baseline and then every 3 to 6 months until 2 years post intervention.
Secondary outcome [3] 345217 0
Self-reported / Caregiver reported wellbeing of adults and children
Timepoint [3] 345217 0
Data collected via questionnaire at baseline and then every 3 to 6 months until 2 years post intervention.
Secondary outcome [4] 345218 0
Fecal contamination of the environment
Timepoint [4] 345218 0
Monitored via environmental samples (water and soil) taken at baseline and then every 3 to 6 months until 2 years post intervention.
Secondary outcome [5] 345288 0
Ecological biodiversity at study sites and vertebrate and invertebrate population levels around settlement sites
Timepoint [5] 345288 0
Continuous acoustic monitoring at listening sites around each settlement to measure animal life biodiversity and density before and after intervention.
Secondary outcome [6] 345289 0
Healthcare visits to local health clinics and hospitals in children under 5
Timepoint [6] 345289 0
Data collected via questionnaire at baseline and then every 3 to 6 months until 2 years post intervention.
Secondary outcome [7] 345522 0
C-reactive protein inflammatory marker in children under 5 years
Timepoint [7] 345522 0
Blood collected every 12 months
Secondary outcome [8] 345523 0
Height measures (HAZ, height-for-age Z-scores) in children under 5. Length measured using an infant measuring board for children who cannot stand unassisted and height measured using a height rod in children who can stand unassisted.
Timepoint [8] 345523 0
Evaluated in children under 5 annually.
Secondary outcome [9] 345660 0
Hemoglobin level in children under 5
Timepoint [9] 345660 0
Blood collected every 12 months
Secondary outcome [10] 345782 0
Weight measures (WAZ, weight-for-age Z-scores) in children under 5 using an electronic scale.
Timepoint [10] 345782 0
Evaluated in children under 5 annually
Secondary outcome [11] 368894 0
Caregiver reported febrile illness (in the 7 days prior to field worker visit) in children under 5 years of age
Timepoint [11] 368894 0
Data collected via questionnaire designed specifically for this study every 3 to 6 months until 2 years post intervention.
Secondary outcome [12] 368895 0
Overall mortality in study population
Timepoint [12] 368895 0
Measured using questionnaire designed specifically for this study, administered to all consenting households annually
Secondary outcome [13] 368896 0
Subjective general health (5 point rating scale). Caregiver assessed for children <15 years and self-reported for adults.
Timepoint [13] 368896 0
Collected by questionnaire every 6 months
Secondary outcome [14] 368897 0
Caregiver assessed quality of life of children aged 5 years to <15 years using the Pediatric Quality of Life Inventory (PedsQL) generic score – emotional dimension, parental proxy instrument.
Timepoint [14] 368897 0
Collected by questionnaire every 6 months
Secondary outcome [15] 368898 0
Adult self-reported life satisfaction – multiple dimensions (10 point rating scale)
Timepoint [15] 368898 0
Collected by questionnaire every 6 months
Secondary outcome [16] 368899 0
Major life events (e.g. death or serious illness of family/friend, victim of crime, natural disaster, job loss or divorce/separation).
Timepoint [16] 368899 0
Collected by questionnaire every 6 months using a questionnaire designed specifically for this study.
Secondary outcome [17] 368900 0
Self-reported adult mental health using the Center for Epidemiologic Studies Depression Scale (CES-D) (4 point rating scale)
Timepoint [17] 368900 0
Collected by questionnaire every 12 months
Secondary outcome [18] 368901 0
How adults and children 5 to 15 years old use their time. Caregiver assessed for children <15 years and self-reported for adults.
Timepoint [18] 368901 0
Collected by questionnaire every 12 months
Secondary outcome [19] 368902 0
Adult self-reported housing tenure and social cohesion – multiple dimensions (5 point rating scale)
Timepoint [19] 368902 0
Collected by questionnaire every 12 months
Secondary outcome [20] 368903 0
Household expenditure (total household expenditure, medical expenditure and expenditure on water)
Timepoint [20] 368903 0
Collected twice (at commencement and completion of trial)
Secondary outcome [21] 368904 0
Diarrhea in children aged 5 to 15 years of age and adults. Caregiver reported in children and self-reported in adults.
Timepoint [21] 368904 0
Collected every 6 months.

Eligibility
Key inclusion criteria
- Settlements located in the urban areas of Makassar, Indonesia and Suva, Fiji
- Settlements which are suitable building sites for architectural intervention
- Community receptiveness to intervention installations and commitment to ongoing study participation over five years
- All enrolled individuals must be a resident in a settlement area enrolled in the trial
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
- Settlements outside of the study area
- Individuals living outside of settlement areas
- Settlements which are not suitable building sites

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)
Central randomisation
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
Parallel
Other design features
This study has been designed as a parallel-cluster RCT design with stratified randomisation by tidal/non-tidal sites (i.e. settlements), with clustering at the settlement level.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Target enrollment numbers will allow for the detection of a 35% relative reduction in the prevalence of bacterial and parasitic GI infections and a 23% relative reduction in the average count of enteric pathogens/child at 6 months post-construction, and an absolute difference of 0.30 SDs in the average concentration of intestinal inflammation markers and average number (and average abundance) of antimicrobial resistance markers at 12 months post-construction. All sample size calculations reflect 80% power.

Analyses will be by intention to treat. Estimation of the effects of the intervention for each outcome will use generalised estimating equations with an exchangeable correlation structure and robust standard errors clustered at settlement level, scaled with a small-sample degrees-of-freedom adjustment. To enable temporal adjustment, indicator variables for seasonal patterns (e.g. rainy vs dry), local rainfall data for each site, and an indicator term for any major flood event at a particular site in a particular quarter will be included in the models. We will explore relationships between environmental changes and health outcomes by modelling health outcomes post-construction, using changes in environmental measures post-construction as principal covariates. We will estimate these effects using generalised estimating equations with pre-construction health and environmental parameters as baseline covariates aggregated at settlement-level, and will include interactions of environmental changes with water-sensitive intervention for effect-modification assessment, together with adjustment for potential confounders.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
26/04/2018
Actual
1/11/2018
Date of last participant enrolment
Anticipated
31/12/2025
Actual
Date of last data collection
Anticipated
31/12/2025
Actual
Sample size
Target
9000
Accrual to date
8281
Final
Recruitment outside Australia
Country [1] 10260 0
Indonesia
State/province [1] 10260 0
Makassar, Indonesia
Country [2] 10261 0
Fiji
State/province [2] 10261 0
Suva, Viti Levu, Fiji

Funding & Sponsors
Funding source category [1] 299128 0
Charities/Societies/Foundations
Name [1] 299128 0
Wellcome Trust
Country [1] 299128 0
United Kingdom
Funding source category [2] 299208 0
Other Collaborative groups
Name [2] 299208 0
Asian Development Bank
Country [2] 299208 0
Philippines
Funding source category [3] 312033 0
Government body
Name [3] 312033 0
Ministry of Foreign Affairs and Trade Manatu Aorere, New Zealand
Country [3] 312033 0
New Zealand
Funding source category [4] 312034 0
Government body
Name [4] 312034 0
Australian Department of Foreign Affairs and Trade
Country [4] 312034 0
Australia
Primary sponsor type
University
Name
Monash University
Address
Scenic Blvd, Clayton VIC 3800
Country
Australia
Secondary sponsor category [1] 298441 0
University
Name [1] 298441 0
Stanford University
Address [1] 298441 0
450 Serra Mall, Stanford, CA 94305, USA
Country [1] 298441 0
United States of America
Secondary sponsor category [2] 298442 0
University
Name [2] 298442 0
Emory University
Address [2] 298442 0
201 Dowman Dr, Atlanta, GA 30322
Country [2] 298442 0
United States of America
Other collaborator category [1] 280058 0
University
Name [1] 280058 0
Hassanudin University
Address [1] 280058 0
Jl. Perintis Kemerdekaan Km. 10, Tamalanrea Indah, Kota Makassar, Sulawesi Selatan 90245, Indonesia
Country [1] 280058 0
Indonesia
Other collaborator category [2] 280059 0
University
Name [2] 280059 0
Fiji National University
Address [2] 280059 0
Samabula fiji, Lakeba Street, Samabula, Fiji
Country [2] 280059 0
Fiji
Other collaborator category [3] 280060 0
University
Name [3] 280060 0
University of the South Pacific
Address [3] 280060 0
Laucala Campus, Suva, Fiji
Country [3] 280060 0
Fiji

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 300060 0
Monash University Human Research Ethics Committee (MUHREC)
Ethics committee address [1] 300060 0
Ethics committee country [1] 300060 0
Australia
Date submitted for ethics approval [1] 300060 0
Approval date [1] 300060 0
02/10/2017
Ethics approval number [1] 300060 0
Project Number: 9396
Ethics committee name [2] 300134 0
College Health Research Ethics Committee
Ethics committee address [2] 300134 0
Ethics committee country [2] 300134 0
Fiji
Date submitted for ethics approval [2] 300134 0
Approval date [2] 300134 0
27/02/2018
Ethics approval number [2] 300134 0
CHREC ID 137.19
Ethics committee name [3] 300135 0
Fiji National Health Research Ethics Committee
Ethics committee address [3] 300135 0
Ethics committee country [3] 300135 0
Fiji
Date submitted for ethics approval [3] 300135 0
02/11/2017
Approval date [3] 300135 0
07/05/2018
Ethics approval number [3] 300135 0
2017.170 MC
Ethics committee name [4] 300136 0
Komite etik penelitian kesehatan fakultas kedokteran Universitas Hasanuddin (Medical Research Ethics Committee of Hasanuddin University Medical Faculty)
Ethics committee address [4] 300136 0
Ethics committee country [4] 300136 0
Indonesia
Date submitted for ethics approval [4] 300136 0
07/03/2018
Approval date [4] 300136 0
27/04/2018
Ethics approval number [4] 300136 0
UN1802020110

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

Contacts
Principal investigator
Name 82430 0
Prof Karin Leder
Address 82430 0
Department of Epidemiology and Preventive Medicine, School of Public Health and Preventive Medicine, Monash University
553 St Kilda Road
Melbourne VIC 3004
Country 82430 0
Australia
Phone 82430 0
+61 3 9903 0444
Fax 82430 0
Email 82430 0
[email protected]
Contact person for public queries
Name 82431 0
Candice Lever
Address 82431 0
Monash Sustainable Development Institute, Monash Science Centre, 8 Scenic Boulevard, Clayton Campus
Country 82431 0
Australia
Phone 82431 0
+61 3 9905 9764
Fax 82431 0
Email 82431 0
[email protected]
Contact person for scientific queries
Name 82432 0
Rebekah Brown
Address 82432 0
Monash Sustainable Development Institute, Monash Science Centre, 8 Scenic Boulevard, Clayton Campus
Country 82432 0
Australia
Phone 82432 0
+61 3 9905 0124
Fax 82432 0
Email 82432 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
De-identified data will be available.
When will data be available (start and end dates)?
Immediately following publication of final results, no end date
Available to whom?
Only researchers who provide a methodologically sound proposal
Available for what types of analyses?
Any purpose
How or where can data be obtained?
Access subject to approvals by Principal Investigators. Data available by emailing the Principal Investigators: [email protected]


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
16898Ethical approval  [email protected]
16899Study protocolLeder K, Openshaw JJ, Allotey P, et al. Study design, rationale and methods of the Revitalising Informal Settlements and their Environments (RISE) study: a cluster randomised controlled trial to evaluate environmental and human health impacts of a water-sensitive intervention in informal settlements in Indonesia and Fiji. BMJ Open. 2021;11(1):e042850. Published 2021 Jan 8. doi:10.1136/bmjopen-2020-042850https://doi.org/10.1136%2Fbmjopen-2020-042850 
16900Statistical analysis plan https://doi.org/10.1136%2Fbmjopen-2020-042850 
16901Informed consent form  [email protected]



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseStudy design, rationale and methods of the Revitalising Informal Settlements and their Environments (RISE) study: A cluster randomised controlled trial to evaluate environmental and human health impacts of a water-sensitive intervention in informal settlements in Indonesia and Fiji.2021https://dx.doi.org/10.1136/bmjopen-2020-042850
N.B. These documents automatically identified may not have been verified by the study sponsor.