Revitalising Informal Settlements and their Environments (RISE): Assessing health, social, and environmental outcomes following water-sensitive revitalisation of informal settlements in Indonesia and Fiji

• Register: ANZCTR
• Last refreshed on: 22 August 2022
• Main ID: ACTRN12618000633280
• Date of registration: 20/04/2018
• Prospective Registration: Yes
• Primary sponsor: Monash University
• 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
• Date of first enrolment: 01/11/2018
• Target sample size: 9000
• Recruitment status: Recruiting
• URL: https://anzctr.org.au/ACTRN12618000633280.aspx
• Study type: Interventional
• Study design: Purpose: Prevention; Allocation: Randomised controlled trial; Masking: Open (masking not used);Assignment: Parallel;Type of endpoint: Efficacy;
• Phase: Not Applicable

Countries of recruitment

Fiji, Indonesia

Contacts

• Name: Ms Candice Lever

• Name: Prof Rebekah Brown

Key inclusion & exclusion criteria

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
Exclusion criteria: - Settlements outside of the study area
- Individuals living outside of settlement areas
- Settlements which are not suitable building sites

Age minimum: No limit
Age maximum: No limit
Gender: Both males and females

Health Condition(s) or Problem(s) studied

Public Health - Epidemiology

Diarrhoea;Environmental enteropathy;
Diarrhoea
Environmental enteropathy

Intervention(s)

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 t

Primary Outcome(s)

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

Presence of bacterial, viral, and parasitic gastrointestinal pathogens in children less than 5 years of age (composite primary outcome)[Fecal samples from children under 5 at baseline and every 3 to 6 months until 2 years post intervention ]

Concentration of intestinal inflammation markers representing environmental enteropathy in children less than 5 years of age[Fecal samples from children under 5 at baseline and every 3 to 6 months until 2 years post intervention.]

Secondary Outcome(s)

Adult self-reported housing tenure and social cohesion – multiple dimensions (5 point rating scale) [Collected by questionnaire every 12 months]

Healthcare visits to local health clinics and hospitals in children under 5[Data collected via questionnaire at baseline and then every 3 to 6 months until 2 years post intervention.]

Self-reported / Caregiver reported wellbeing of adults and children
[Data collected via questionnaire at baseline and then every 3 to 6 months until 2 years post intervention.]

Adult self-reported life satisfaction – multiple dimensions (10 point rating scale) [Collected by questionnaire every 6 months]

Household expenditure (total household expenditure, medical expenditure and expenditure on water)[Collected twice (at commencement and completion of trial) ]

Major life events (e.g. death or serious illness of family/friend, victim of crime, natural disaster, job loss or divorce/separation). [Collected by questionnaire every 6 months using a questionnaire designed specifically for this study.]

Caregiver reported respiratory infection (in the 7 days prior to field worker visit) in children under 5 years of age
[Data collected via questionnaire at baseline and then every 3 to 6 months until 2 years post intervention.]

Subjective general health (5 point rating scale). Caregiver assessed for children <15 years and self-reported for adults. [Collected by questionnaire every 6 months]

How adults and children 5 to 15 years old use their time. Caregiver assessed for children <15 years and self-reported for adults.[Collected by questionnaire every 12 months]

C-reactive protein inflammatory marker in children under 5 years
[Blood collected every 12 months]

Caregiver reported febrile illness (in the 7 days prior to field worker visit) in children under 5 years of age[Data collected via questionnaire designed specifically for this study every 3 to 6 months until 2 years post intervention.]

Fecal contamination of the environment
[Monitored via environmental samples (water and soil) taken at baseline and then every 3 to 6 months until 2 years post intervention.]

Overall mortality in study population[Measured using questionnaire designed specifically for this study, administered to all consenting households annually]

Caregiver reported diarrhoea (in the 7 days prior to field worker visit) in children under 5 years of age
[Data collected via questionnaire at baseline and then every 3 to 6 months until 2 years post intervention.]

Self-reported adult mental health using the Center for Epidemiologic Studies Depression Scale (CES-D) (4 point rating scale)[Collected by questionnaire every 12 months]

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. [Collected by questionnaire every 6 months]

Hemoglobin level in children under 5[Blood collected every 12 months]

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

Diarrhea in children aged 5 to 15 years of age and adults. Caregiver reported in children and self-reported in adults.[Collected every 6 months.]

Ecological biodiversity at study sites and vertebrate and invertebrate population levels around settlement sites
[Continuous acoustic monitoring at listening sites around each settlement to measure animal life biodiversity and density before and after intervention. ]

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.[Evaluated in children under 5 annually.]

Secondary ID(s)

Nil known

Source(s) of Monetary Support

Ministry of Foreign Affairs and Trade Manatu Aorere, New Zealand

Wellcome Trust

Asian Development Bank

Australian Department of Foreign Affairs and Trade

Secondary Sponsor(s)

Emory University

Stanford University

Ethics review

Status: Approved
Approval date: 02/10/2017
Contact:

Monash University Human Research Ethics Committee (MUHREC)

Status: Approved
Approval date: 27/02/2018
Contact:

College Health Research Ethics Committee

Status: Approved
Approval date: 27/04/2018
Contact:

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

Status: Approved
Approval date: 07/05/2018
Contact:

Fiji National Health Research Ethics Committee