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
Stephen P Luby,
Andrew B Forbes,
David McCarthy,
Pascale Allotey,
Thomas F Clasen,
Karin Leder,
John J Openshaw,
Ansariadi Ansariadi,
S Fiona Barker,
Kerrie Burge,
Steven L Chown,
Grant A Duffy,
Peter A Faber,
Genie Fleming,
Matthew French,
Chris Greening,
Rebekah Henry,
Ellen Higginson,
David W Johnston,
Rachael Lappan,
Audrie Lin
Affiliations
Stephen P Luby
2 Infectious Diseases and Geographic Medicine Division, Stanford University, Stanford, California, USA
Andrew B Forbes
1 School of Public Health and Preventive Medicine, Faculty of Medicine, Nursing and Health Sciences, Monash University, Melbourne, Victoria, Australia
David McCarthy
10 Civil Engineering, Monash University, Melbourne, Victoria, Australia
Pascale Allotey
3 International Institute for Global Health, United Nations University, Kuala Lumpur, Malaysia
Thomas F Clasen
6 Gangarosa Department of Environmental Health, Rollins School of Public Health, Emory University, Atlanta, Georgia, USA
Karin Leder
1 School of Public Health and Preventive Medicine, Faculty of Medicine, Nursing and Health Sciences, Monash University, Melbourne, Victoria, Australia
John J Openshaw
2 Infectious Diseases and Geographic Medicine Division, Stanford University, Stanford, California, USA
Ansariadi Ansariadi
4 Public Health Faculty, Hasanuddin University, Makassar, Sulawesi Selatan, Indonesia
S Fiona Barker
1 School of Public Health and Preventive Medicine, Faculty of Medicine, Nursing and Health Sciences, Monash University, Melbourne, Victoria, Australia
Kerrie Burge
5 CRC for Water Sensitive Cities, Monash University, Melbourne, Victoria, Australia
Steven L Chown
7 School of Biological Sciences, Monash University, Melbourne, Victoria, Australia
Grant A Duffy
7 School of Biological Sciences, Monash University, Melbourne, Victoria, Australia
Peter A Faber
7 School of Biological Sciences, Monash University, Melbourne, Victoria, Australia
Genie Fleming
7 School of Biological Sciences, Monash University, Melbourne, Victoria, Australia
Matthew French
8 Monash Sustainable Development Institute, Monash University, Melbourne, Victoria, Australia
Chris Greening
9 Department of Microbiology, Faculty of Medicine, Nursing and Health Sciences, Monash University, Melbourne, Victoria, Australia
Rebekah Henry
10 Civil Engineering, Monash University, Melbourne, Victoria, Australia
Ellen Higginson
11 Cambridge Institute for Therapeutic Immunology and Infectious Disease, University of Cambridge, Cambridge, Cambridgeshire, UK
David W Johnston
12 Centre for Health Economics, Monash Business School, Monash University, Melbourne, Victoria, Australia
Rachael Lappan
9 Department of Microbiology, Faculty of Medicine, Nursing and Health Sciences, Monash University, Melbourne, Victoria, Australia
Audrie Lin
13 Division of Epidemiology and Biostatistics, School of Public Health, University of California Berkeley, Berkeley, California, USA
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.
