ANZCTR - Registration

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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]

Nil known

Universal Trial Number (UTN)

Trial acronym

RISE

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Diarrhoea

Environmental enteropathy

Condition category

Condition code

Public Health

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]

Prevention

Intervention code [2]

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]

Presence of bacterial, viral, and parasitic gastrointestinal pathogens in children less than 5 years of age (composite primary outcome)

Timepoint [1]

Fecal samples from children under 5 at baseline and every 3 to 6 months until 2 years post intervention

Primary outcome [2]

Concentration of intestinal inflammation markers representing environmental enteropathy in children less than 5 years of age

Timepoint [2]

Fecal samples from children under 5 at baseline and every 3 to 6 months until 2 years post intervention.

Primary outcome [3]

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]

Fecal samples from children under 5 at baseline and every 3 to 6 months until 2 years post intervention.

Secondary outcome [1]

Caregiver reported diarrhoea (in the 7 days prior to field worker visit) in children under 5 years of age

Timepoint [1]

Data collected via questionnaire at baseline and then every 3 to 6 months until 2 years post intervention.

Secondary outcome [2]

Caregiver reported respiratory infection (in the 7 days prior to field worker visit) in children under 5 years of age

Timepoint [2]

Data collected via questionnaire at baseline and then every 3 to 6 months until 2 years post intervention.

Secondary outcome [3]

Self-reported / Caregiver reported wellbeing of adults and children

Timepoint [3]

Data collected via questionnaire at baseline and then every 3 to 6 months until 2 years post intervention.

Secondary outcome [4]

Fecal contamination of the environment

Timepoint [4]

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]

Ecological biodiversity at study sites and vertebrate and invertebrate population levels around settlement sites

Timepoint [5]

Continuous acoustic monitoring at listening sites around each settlement to measure animal life biodiversity and density before and after intervention.

Secondary outcome [6]

Healthcare visits to local health clinics and hospitals in children under 5

Timepoint [6]

Data collected via questionnaire at baseline and then every 3 to 6 months until 2 years post intervention.

Secondary outcome [7]

C-reactive protein inflammatory marker in children under 5 years

Timepoint [7]

Blood collected every 12 months

Secondary outcome [8]

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]

Evaluated in children under 5 annually.

Secondary outcome [9]

Hemoglobin level in children under 5

Timepoint [9]

Blood collected every 12 months

Secondary outcome [10]

Weight measures (WAZ, weight-for-age Z-scores) in children under 5 using an electronic scale.

Timepoint [10]

Evaluated in children under 5 annually

Secondary outcome [11]

Caregiver reported febrile illness (in the 7 days prior to field worker visit) in children under 5 years of age

Timepoint [11]

Data collected via questionnaire designed specifically for this study every 3 to 6 months until 2 years post intervention.

Secondary outcome [12]

Overall mortality in study population

Timepoint [12]

Measured using questionnaire designed specifically for this study, administered to all consenting households annually

Secondary outcome [13]

Subjective general health (5 point rating scale). Caregiver assessed for children <15 years and self-reported for adults.

Timepoint [13]

Collected by questionnaire every 6 months

Secondary outcome [14]

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]

Collected by questionnaire every 6 months

Secondary outcome [15]

Adult self-reported life satisfaction – multiple dimensions (10 point rating scale)

Timepoint [15]

Collected by questionnaire every 6 months

Secondary outcome [16]

Major life events (e.g. death or serious illness of family/friend, victim of crime, natural disaster, job loss or divorce/separation).

Timepoint [16]

Collected by questionnaire every 6 months using a questionnaire designed specifically for this study.

Secondary outcome [17]

Self-reported adult mental health using the Center for Epidemiologic Studies Depression Scale (CES-D) (4 point rating scale)

Timepoint [17]

Collected by questionnaire every 12 months

Secondary outcome [18]

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]

Collected by questionnaire every 12 months

Secondary outcome [19]

Adult self-reported housing tenure and social cohesion – multiple dimensions (5 point rating scale)

Timepoint [19]

Collected by questionnaire every 12 months

Secondary outcome [20]

Household expenditure (total household expenditure, medical expenditure and expenditure on water)

Timepoint [20]

Collected twice (at commencement and completion of trial)

Secondary outcome [21]

Diarrhea in children aged 5 to 15 years of age and adults. Caregiver reported in children and self-reported in adults.

Timepoint [21]

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]

Indonesia

State/province [1]

Makassar, Indonesia

Country [2]

Fiji

State/province [2]

Suva, Viti Levu, Fiji

Funding & Sponsors

Funding source category [1]

Charities/Societies/Foundations

Name [1]

Wellcome Trust

Address [1]

Gibbs Building
215 Euston Road
London NW1 2BE
UK

Country [1]

United Kingdom

Funding source category [2]

Other Collaborative groups

Name [2]

Asian Development Bank

Address [2]

6 ADB Avenue, Mandaluyong City 1550, Metro Manila, Philippines

Country [2]

Philippines

Funding source category [3]

Government body

Name [3]

Ministry of Foreign Affairs and Trade Manatu Aorere, New Zealand

Address [3]

195 Lambton Quay
Private Bag 18 901
Wellington 6160, New Zealand

Country [3]

New Zealand

Funding source category [4]

Government body

Name [4]

Australian Department of Foreign Affairs and Trade

Address [4]

501 Swanston Street, Melbourne, Victoria - 3000

Country [4]

Australia

Primary sponsor type

University

Name

Monash University

Address

Scenic Blvd, Clayton VIC 3800

Country

Australia

Secondary sponsor category [1]

University

Name [1]

Stanford University

Address [1]

450 Serra Mall, Stanford, CA 94305, USA

Country [1]

United States of America

Secondary sponsor category [2]

University

Name [2]

Emory University

Address [2]

201 Dowman Dr, Atlanta, GA 30322

Country [2]

United States of America

Other collaborator category [1]

University

Name [1]

Hassanudin University

Address [1]

Jl. Perintis Kemerdekaan Km. 10, Tamalanrea Indah, Kota Makassar, Sulawesi Selatan 90245, Indonesia

Country [1]

Indonesia

Other collaborator category [2]

University

Name [2]

Fiji National University

Address [2]

Samabula fiji, Lakeba Street, Samabula, Fiji

Country [2]

Fiji

Other collaborator category [3]

University

Name [3]

University of the South Pacific

Address [3]

Laucala Campus, Suva, Fiji

Country [3]

Fiji

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Monash University Human Research Ethics Committee (MUHREC)

Ethics committee address [1]

Monash Research Office, 26 Sports Walk, Monash University, Wellington Road, Clayton VIC 3800, Australia

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

02/10/2017

Ethics approval number [1]

Project Number: 9396

Ethics committee name [2]

College Health Research Ethics Committee

Ethics committee address [2]

College of Medicine, Nursing and Health Sciences Research Unit, Office of the Dean Hoodless House, Fiji National University, Suva, Fiji

Ethics committee country [2]

Fiji

Date submitted for ethics approval [2]

Approval date [2]

27/02/2018

Ethics approval number [2]

CHREC ID 137.19

Ethics committee name [3]

Fiji National Health Research Ethics Committee

Ethics committee address [3]

Ministry of Health, Dinem House, 88 Amy St, Suva, Fiji

Ethics committee country [3]

Fiji

Date submitted for ethics approval [3]

02/11/2017

Approval date [3]

07/05/2018

Ethics approval number [3]

2017.170 MC

Ethics committee name [4]

Komite etik penelitian kesehatan fakultas kedokteran Universitas Hasanuddin (Medical Research Ethics Committee of Hasanuddin University Medical Faculty)

Ethics committee address [4]

JL Perintis Kemerdekaan Kampus Tamalanrea KM. 10, Makassar 90245, Indonesia

Ethics committee country [4]

Indonesia

Date submitted for ethics approval [4]

07/03/2018

Approval date [4]

27/04/2018

Ethics approval number [4]

UN1802020110

Summary

Brief summary

Urbanisation is a major demographic trend globally. Informal settlements account for much urban growth, exacerbating the inextricably linked challenges of sanitation, water provision, and public health. The conventional ‘big pipes’ solution to these challenges has changed little in 150 years, comes at major financial, environmental, and social costs, and frequently overlooks informal settlements. We have pioneered an alternative, water-sensitive approach that integrates sustainable design with the management of the water-cycle, benefiting human health and urban ecosystems. This decentralised, climate-change sensitive approach provides financial flexibility for multistage developments and adaptability to future technologies. It promises a solution to the water services challenges of informal settlements, yet has only been demonstrated in developed world settings. We will examine whether the water-sensitive approach can be applied to revitalise developing-world informal settlements to improve environmental and public health outcomes. Our evidence-based assessment of its efficacy across 24 settlements, poorly served by water infrastructure in Makassar and Suva, will deliver the first public health and environmental data on the benefits and risks of water-sensitive approaches.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Prof Karin Leder

Address

Department of Epidemiology and Preventive Medicine, School of Public Health and Preventive Medicine, Monash University
553 St Kilda Road
Melbourne VIC 3004

Country

Australia

Phone

+61 3 9903 0444

Fax

[email protected]

Contact person for public queries

Name

Ms Candice Lever

Address

Monash Sustainable Development Institute, Monash Science Centre, 8 Scenic Boulevard, Clayton Campus

Country

Australia

Phone

+61 3 9905 9764

Fax

[email protected]

Contact person for scientific queries

Name

Prof Rebekah Brown

Address

Monash Sustainable Development Institute, Monash Science Centre, 8 Scenic Boulevard, Clayton Campus

Country

Australia

Phone

+61 3 9905 0124

Fax

[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.	Type	Citation	Link	Email
16898	Ethical approval			[email protected]
16899	Study protocol	Leder 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-2020-042850	https://doi.org/10.1136%2Fbmjopen-2020-042850
16900	Statistical analysis plan		https://doi.org/10.1136%2Fbmjopen-2020-042850
16901	Informed consent form			[email protected]

Results publications and other study-related documents

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Source	Title	Year of Publication	DOI
Embase	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.	2021	https://dx.doi.org/10.1136/bmjopen-2020-042850

N.B. These documents automatically identified may not have been verified by the study sponsor.

Trial Review

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