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

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 con...

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Bibliographic Details
Published in:	Contemporary clinical trials communications Vol. 4; no. C; pp. 124 - 135
Main Authors:	Nagel, Corey L, Kirby, Miles A, Zambrano, Laura D, Rosa, Ghislane, Barstow, Christina K, Thomas, Evan A, Clasen, Thomas F
Format:	Journal Article
Language:	English
Published:	Netherlands Elsevier Inc 15-12-2016 Elsevier
Subjects:	Acute respiratory infection Cluster randomized controlled trial Diarrhea Household water treatment Improved stoves Other Rwanda DBSS RCT community health worker Improved stoves Acute respiratory infection MFI CHW Household water treatment household air pollution mean fluorescence intensity dried blood spot samples ICCM Rwanda MOH Rwanda Ministry of Health Diarrhea IMCI randomized controlled trial Rwandan Ministry of Local Government Integrated Management of Childhood Illness HAP Integrated Community Case Management of Childhood Illness ARI Harvard Personal Exposure Monitor MOLG Cluster randomized controlled trial H-PEM H-PEM, Harvard Personal Exposure Monitor ARI, acute respiratory infection ICCM, Integrated Community Case Management of Childhood Illness CHW, community health worker MOLG, Rwandan Ministry of Local Government DBSS, dried blood spot samples MOH, Rwanda Ministry of Health HAP, household air pollution MFI, mean fluorescence intensity RCT, randomized controlled trial IMCI, Integrated Management of Childhood Illness
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Summary:	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).
ISSN:	2451-8654 2451-8654
DOI:	10.1016/j.conctc.2016.07.003