Nagel Corey L, Kirby Miles A, Zambrano Laura D, Rosa Ghislane, Barstow Christina K, Thomas Evan A, Clasen Thomas F
OHSU/PSU School of Public Health, Oregon Health & Science University, Portland, OR, USA.
Department of Disease Control, London School of Hygiene & Tropical Medicine, London, UK.
Contemp Clin Trials Commun. 2016 Aug 2;4:124-135. doi: 10.1016/j.conctc.2016.07.003. eCollection 2016 Dec 15.
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.
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.
This trial is registered at Clinicaltrials.gov (NCT02239250).
在卢旺达，肺炎和腹泻分别是五岁以下儿童死亡的首要和第二大原因。在传统炉灶上使用生物质燃料在室内做饭所导致的家庭空气污染（HAP）是肺炎的一个重要风险因素，而饮用受污染的水是腹泻病的主要病因。迄今为止，在低收入国家尚未有针对大规模推广改良炉灶或家用滤水器的项目进行大规模效果试验。在本文中，我们描述了一项整群随机试验的设计，以评估一项国家级项目的影响，该项目旨在向卢旺达最贫困的四分之一家庭分发并推广使用改良炉灶和先进滤水器。
方法/设计：我们将西部省的72个区（行政定义单位）随机分配到干预组，该省其余24个区作为对照组。在干预区，约10万户家庭通过一项针对全国最贫困四分之一家庭的政府资助项目获得了改良炉灶和家用滤水器。主要结局指标是五岁以下儿童急性呼吸道感染（ARI）和腹泻的发病率。在为期一年的监测期内，研究区域内卫生工作者确定的所有急性呼吸道感染（ARI）和腹泻病例将从卫生设施和社区卫生工作者（CHW）保存的记录中提取。此外，我们正在对研究区域内的随机抽样家庭进行密集的纵向数据收集，以深入评估覆盖率、使用情况、环境暴露和其他健康指标。
尽管先前的研究已经考察了提供家庭水处理和改良炉灶对儿童健康的影响，但尚未有关于在发展中国家大规模实施这些干预措施的国家级项目的研究。本研究作为大规模项目性炉灶或家用滤水器干预的首个随机对照试验，其结果将为全球减少腹泻病和肺炎导致的儿童发病率和死亡率的努力提供参考。
本试验已在Clinicaltrials.gov（NCT）注册。
