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. Issue 1 (8th January 2021)

• Record Type: Journal Article
• Authors: Leder, Karin; Openshaw, John J; Allotey, Pascale; Ansariadi, Ansariadi; Barker, S Fiona; Burge, Kerrie; Clasen, Thomas F; Chown, Steven L; Duffy, Grant A; Faber, Peter A; Fleming, Genie; Forbes, Andrew B; French, Matthew; Greening, Chris; Henry, Rebekah; Higginson, Ellen; Johnston, David W; Lappan, Rachael; Lin, Audrie; Luby, Stephen P; McCarthy, David; O'Toole, Joanne E; Ramirez-Lovering, Diego; Reidpath, Daniel D; Simpson, Julie A; Sinharoy, Sheela S; Sweeney, Rohan; Taruc, Ruzka R; Tela, Autiko; Turagabeci, Amelia R; Wardani, Jane; Wong, Tony; Brown, Rebekah;
• Other Names: author non-byline.; Awaluddin Fitriyanty author non-byline.; Batagol Becky author non-byline.; Bata Lamiya author non-byline.; Bulachi Dieter author non-byline.; Cahan Bruce author non-byline.; Davis Brett author non-byline.; El-Sioufi Mohammed author non-byline.; Jovanovic Dusan author non-byline.; Prescott Michaela F author non-byline.; Ramsay Emma author non-byline.; Rogersh Briony author non-byline.; Saifuddaolah Maghfira author non-byline.; Schang Christelle author non-byline.; Tseng Chi-Wen author non-byline.; Vamosi Revoni author non-byline.; Vilsoni Silivia author non-byline.; Vakarewa Isoa author non-byline.; Zulkifli Andi author non-byline.
• Is Part Of: BMJ open. Volume 11:Issue 1(2021)
• Publication Date: 2021-01-08
• Subjects: public health -- gastrointestinal infections -- epidemiology -- public health -- tropical medicine; Medicine -- Research -- Periodicals; 610.72
• DOI: 10.1136/bmjopen-2020-042850
• Languages: English
• ISSNs: 2044-6055

Abstract

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.