Halliday Katherine E, Kepha Stella, Legge Hugo, Allen Elizabeth, Dreibelbis Robert, Elson Lynne, Kakoi Beatrice K, Mcharo Carlos, Muli Sharon, Mwongeli Jacinta, Njomo Doris, Njoroge Margaret M, Ochwal Victoria, Oswald William E, Rono Martin, Safari Tuva K, Filinger Ulrike, Kaluli James Wambua, Mwandawiro Charles S, Pullan Rachel L
Department of Disease Control, Faculty of Infectious and Tropical Diseases, London School of Hygiene & Tropical Medicine, London, UK
Eastern and Southern Africa Centre of International Parasite Control (ESACIPAC), Kenya Medical Research Institute, Nairobi, Kenya.
BMJ Open. 2025 Jun 6;15(6):e090464. doi: 10.1136/bmjopen-2024-090464.
Earthen floors are often damp or dusty and difficult to clean, providing an ideal environment for faecal pathogens and parasites. Observational studies have revealed associations between household flooring and health outcomes, but robust experimental evidence is scant. This study will evaluate the impact of an improved household flooring intervention on enteric infections, soil-transmitted helminth (STH) infections and tungiasis through implementation of a cluster-randomised trial in two rural settings in Kwale and Bungoma Counties, Kenya.
440 clusters (households) across both sites are allocated to control or intervention group, in which a low-cost, sealed, washable, cement-based floor is installed in eligible buildings of the dwelling, alongside a floor-care guide provided during an induction meeting. Following baseline assessments in both groups, all individuals over 1 year receive albendazole and those infected with tungiasis receive benzyl benzoate. Primary outcomes are as follows: prevalence of enteric infections in children under 5 years assessed via stool surveys and PCR; prevalence of tungiasis infection in children 1-14 years based on clinical exam; and prevalence of STH infection in all household members over 1 year assessed via Kato-Katz. Secondary outcomes include the following: intensity of STH and tungiasis infections; prevalence of caregiver-reported gastrointestinal illness in children under 5; quality of life and well-being measures; and environmental contamination. A process evaluation investigates intervention acceptability, durability, practicality and cost.
The protocol has been approved by ethics committees of The Kenya Medical Research Institute, The Kenya National Commission for Science Technology and Innovation, and The London School of Hygiene & Tropical Medicine. Following the 12-month implementation period and final assessments, control households are offered improved floors. Results will be disseminated within Kenya, to the Ministries of Health and of Lands, Public Works, Housing and Urban Development, and to subnational leadership and communities. Dissemination will also occur through publications and conference presentations.
NCT05914363.
泥土地面往往潮湿或布满灰尘，且难以清洁，为粪便病原体和寄生虫提供了理想的生存环境。观察性研究揭示了家庭地面与健康结果之间的关联，但有力的实验证据却很少。本研究将通过在肯尼亚夸莱县和邦戈马县的两个农村地区开展一项整群随机试验，评估一项改良家庭地面干预措施对肠道感染、土壤传播的蠕虫（STH）感染和穿皮潜蚤病的影响。
两个地点的440个群组（家庭）被分配到对照组或干预组，在干预组中，符合条件的住宅建筑内安装低成本、密封、可清洗的水泥地面，并在入职培训会上提供一份地面护理指南。在两组进行基线评估后，所有1岁以上的个体都接受阿苯达唑治疗，感染穿皮潜蚤病的个体接受苯甲酸苄酯治疗。主要结局如下：通过粪便调查和聚合酶链反应（PCR）评估5岁以下儿童肠道感染的患病率；根据临床检查评估1 - 14岁儿童穿皮潜蚤病感染的患病率；通过加藤厚涂片法评估所有1岁以上家庭成员土壤传播的蠕虫感染的患病率。次要结局包括：土壤传播的蠕虫和穿皮潜蚤病感染的强度；5岁以下儿童中照料者报告的胃肠道疾病患病率；生活质量和幸福感指标；以及环境污染情况。一项过程评估将调查干预措施的可接受性、耐用性、实用性和成本。
该方案已获得肯尼亚医学研究所、肯尼亚国家科学技术与创新委员会以及伦敦卫生与热带医学院伦理委员会的批准。在为期12个月的实施期和最终评估之后，为对照组家庭提供改良地面。研究结果将在肯尼亚境内向卫生部、土地、公共工程、住房和城市发展部、地方领导人和社区进行传播。研究结果还将通过出版物和会议报告进行传播。
NCT05914363。
