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.

Sheela S Sinharoy, Rachael Lappan, Audrie Lin, Stephen P Luby, David McCarthy, Joanne E O'Toole, Diego Ramirez-Lovering, Daniel D Reidpath, Julie A Simpson, David W Johnston, Rohan Sweeney, Ruzka R Taruc, Autiko Tela, Amelia R Turagabeci, Jane Wardani, Tony Wong, Rebekah Brown, Karin Leder, Ellen Higginson, Rebekah Henry, Chris Greening, Matthew French, Andrew B Forbes, Genie Fleming, Peter A Faber, Grant A Duffy, Steven L Chown, Thomas F Clasen, Kerrie Burge, S Fiona Barker, Ansariadi Ansariadi, Pascale Allotey, John J Openshaw

Journal: BMJ open 2021;11(1):e042850

PMID: 33419917

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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.

Address: School of Public Health and Preventive Medicine, Faculty of Medicine, Nursing and Health Sciences, Monash University, Melbourne, Victoria, Australia [email protected].; Infectious Diseases and Geographic Medicine Division, Stanford University, Stanford, California, USA.; International Institute for Global Health, United Nations University, Kuala Lumpur, Malaysia.; Public Health Faculty, Hasanuddin University, Makassar, Sulawesi Selatan, Indonesia.; School of Public Health and Preventive Medicine, Faculty of Medicine, Nursing and Health Sciences, Monash University, Melbourne, Victoria, Australia.; CRC for Water Sensitive Cities, Monash University, Melbourne, Victoria, Australia.; Gangarosa Department of Environmental Health, Rollins School of Public Health, Emory University, Atlanta, Georgia, USA.; School of Biological Sciences, Monash University, Melbourne, Victoria, Australia.; Monash Sustainable Development Institute, Monash University, Melbourne, Victoria, Australia.; Department of Microbiology, Faculty of Medicine, Nursing and Health Sciences, Monash University, Melbourne, Victoria, Australia.; Civil Engineering, Monash University, Melbourne, Victoria, Australia.; Cambridge Institute for Therapeutic Immunology and Infectious Disease, University of Cambridge, Cambridge, Cambridgeshire, UK.; Centre for Health Economics, Monash Business School, Monash University, Melbourne, Victoria, Australia.; Division of Epidemiology and Biostatistics, School of Public Health, University of California Berkeley, Berkeley, California, USA.; Art, Design and Architecture, Monash University, Caulfield, Victoria, Australia.; Monash University - Malaysia Campus, Bandar Sunway, Selangor, Malaysia.; Centre for Epidemiology and Biostatistics, Melbourne School of Population and Global Health, University of Melbourne, Melbourne, Victoria, Australia.; Hubert Department of Global Health, Rollins School of Public Health, Emory University, Atlanta, Georgia, USA.; School of Public Health and Primary Care, Fiji National University, College of Medicine, Nursing and Health Sciences, Tamavua Campus, Suva, Rewa, Fiji.

DOI: 10.1136/bmjopen-2020-042850

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MeSH Terms: Asia, Child, Child, Preschool, Fiji, Humans, Indonesia, Urban Population, Water