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

• Authors: Karin Leder, Monash University; John J Openshaw, Stanford University; Pascale Allotey, United Nations University; Ansariadi Ansariadi, Universitas Hasanuddin; Fiona F Barker, Monash University; SL Chown, Monash University; Kerrie Burge, Monash University; Thomas Clasen, Emory University; Grant A Duffy, Monash University; Peter A Faber, Monash University; Genie Fleming, Monash University; Andrew B Forbes, Monash University; Matthew French, Monash University; Chris Greening, Monash University; Rebekah Henry, Monash University; Ellen Higginson, University of Cambridge; David W Johnston, Monash University; Rachael Lappan, Monash University; Audrie Lin, University of California Berkeley; Stephen P Luby, Stanford University; David McCarthy, Monash University; Joanne E O'Toole, Monash University; Diego Ramirez-Lovering, Monash University; Daniel D Reidpath, Monash University; Julie A Simpson, University of Melbourne; Sheela Sinharoy, Emory University; Rohan Sweeney, Monash University; Ruzka R Taruc, Universitas Hasanuddin; Autiko Tela, Fiji National University; Amelia R Turagabeci, Fiji National University; Jane Wardani, Monash University; Tony Wong, Monash University; Rebekah Brown, Monash University
• Journal Title: BMJ OPEN
• Volume: Volume 11, Number 1
• Publisher: BMJ PUBLISHING GROUP | 2021-01-01, Pages e042850-e042850
• Type of Work: Article | Final Publisher PDF
• Publisher DOI: http://doi.org/10.1136/bmjopen-2020-042850
• Subjects: Health Sciences, Nursing; Health Sciences, Immunology; Health Sciences, Public Health; Health Sciences, Epidemiology
• Keywords: Science & Technology; Life Sciences & Biomedicine; Medicine, General & Internal; General & Internal Medicine; public health; gastrointestinal infections; epidemiology; tropical medicine; CHILD GROWTH; NUTRITIONAL INTERVENTIONS; CONSTRUCTED WETLANDS; POLLUTANT REMOVAL; URBAN SLUMS; DIARRHEA; SANITATION; URBANIZATION; ENTEROPATHY; PATHOGENS

Abstract

Introduction Increasing urban populations have led to the growth of informal settlements, with contaminated environments linked to poor human health through a range of interlinked pathways. Here, we describe the design and methods for the Revitalising Informal Settlements and their Environments (RISE) study, a transdisciplinary randomised trial evaluating impacts of an intervention to upgrade urban informal settlements in two Asia-Pacific countries. Methods and analysis RISE is a cluster randomised controlled trial among 12 settlements in Makassar, Indonesia, and 12 in Suva, Fiji. Six settlements in each country have been randomised to receive the intervention at the outset; the remainder will serve as controls and be offered intervention delivery after trial completion. The intervention involves a water-sensitive approach, delivering site-specific, modular, decentralised infrastructure primarily aimed at improving health by decreasing exposure to environmental faecal contamination. Consenting households within each informal settlement site have been enrolled, with longitudinal assessment to involve health and well-being surveys, and human and environmental sampling. Primary outcomes will be evaluated in children under 5 years of age and include prevalence and diversity of gastrointestinal pathogens, abundance and diversity of antimicrobial resistance (AMR) genes in gastrointestinal microorganisms and markers of gastrointestinal inflammation. Diverse secondary outcomes include changes in microbial contamination; abundance and diversity of pathogens and AMR genes in environmental samples; impacts on ecological biodiversity and microclimates; mosquito vector abundance; anthropometric assessments, nutrition markers and systemic inflammation in children; caregiver-reported and self-reported health symptoms and healthcare utilisation; and measures of individual and community psychological, emotional and economic well-being. The study aims to provide proof-of-concept evidence to inform policies on upgrading of informal settlements to improve environments and human health and well-being. Ethics Study protocols have been approved by ethics boards at Monash University, Fiji National University and Hasanuddin University. Trial registration number ACTRN12618000633280; Pre-results.