Study design of a cluster-randomized controlled trial to evaluate a large-scale distribution of cook stoves and water filters in Western Province, Rwanda

• Type of Material: Article
• Authors: Corey L. Nagel, Oregon Health and Science University; Miles A. Kirby, London School of Hygiene & Tropical Medicine; Laura D. Zambrano, Emory University; Ghislane Rosa, London School of Hygiene & Tropical Medicine; Christina K. Barstow, University of Colorado at Boulder; Evan A. Thomas, Portland State University; Thomas Clasen, Emory University
• Language: English
• Date: 2016-12-15
• Publisher: Elsevier: Creative Commons Attribution Non-Commercial No-Derivatives License
• Publication Version: Final Published Version
• Copyright Statement: © 2016 The Authors
• License: Creative Commons Attribution-NonCommercial-NoDerivs 4.0 International
• Final Published Version (URL): http://dx.doi.org/10.1016/j.conctc.2016.07.003
• Title of Journal or Parent Work: Contemporary Clinical Trials Communications
• ISSN: 2451-8654
• Volume: 4
• Start Page: 124
• End Page: 135
• Grant/Funding Information: This study is funded by DelAgua Health, a for-profit company that implements the intervention in Rwanda in conjunction with the Rwanda Ministry of Health.
• Keywords: Household water treatment; MOLG, Rwandan Ministry of Local Government; MOH, Rwanda Ministry of Health; HAP, household air pollution; DBSS, dried blood spot samples; Diarrhea; MFI, mean fluorescence intensity; CHW, community health worker; Rwanda; Improved stoves; H-PEM, Harvard Personal Exposure Monitor; IMCI, Integrated Management of Childhood Illness; Cluster randomized controlled trial; ARI, acute respiratory infection; RCT, randomized controlled trial; Acute respiratory infection; ICCM, Integrated Community Case Management of Childhood Illness
• Research Categories: Health Sciences, Public Health; Health Sciences, Hygiene; Health Sciences, Epidemiology

Abstract

Background In Rwanda, pneumonia and diarrhea are the first and second leading causes of death, respectively, among children under five. Household air pollution (HAP) resultant from cooking indoors with biomass fuels on traditional stoves is a significant risk factor for pneumonia, while consumption of contaminated drinking water is a primary cause of diarrheal disease. To date, there have been no large-scale effectiveness trials of programmatic efforts to provide either improved cookstoves or household water filters at scale in a low-income country. In this paper we describe the design of a cluster-randomized trial to evaluate the impact of a national-level program to distribute and promote the use of improved cookstoves and advanced water filters to the poorest quarter of households in Rwanda. Methods/Design We randomly allocated 72 sectors (administratively defined units) in Western Province to the intervention, with the remaining 24 sectors in the province serving as controls. In the intervention sectors, roughly 100,000 households received improved cookstoves and household water filters through a government-sponsored program targeting the poorest quarter of households nationally. The primary outcome measures are the incidence of acute respiratory infection (ARI) and diarrhea among children under five years of age. Over a one-year surveillance period, all cases of acute respiratory infection (ARI) and diarrhea identified by health workers in the study area will be extracted from records maintained at health facilities and by community health workers (CHW). In addition, we are conducting intensive, longitudinal data collection among a random sample of households in the study area for in-depth assessment of coverage, use, environmental exposures, and additional health measures. Discussion Although previous research has examined the impact of providing household water treatment and improved cookstoves on child health, there have been no studies of national-level programs to deliver these interventions at scale in a developing country. The results of this study, the first RCT of a large-scale programmatic cookstove or household water filter intervention, will inform global efforts to reduce childhood morbidity and mortality from diarrheal disease and pneumonia. Trial registration This trial is registered at Clinicaltrials.gov (NCT02239250).