Institute of Collective Health, Federal University of Bahia, Salvador, Bahia, Brazil
Institute of Collective Health, Federal University of Bahia, Salvador, Bahia, Brazil.
BMJ Open. 2023 Jun 23;13(6):e065009. doi: 10.1136/bmjopen-2022-065009.
Leptospirosis is a globally distributed zoonotic and environmentally mediated disease that has emerged as a major health problem in urban slums in developing countries. Its aetiological agent is bacteria of the genus , which are mainly spread in the urine of infected rodents, especially in an environment where adequate sanitation facilities are lacking, and it is known that open sewers are key transmission sources of the disease. Therefore, we aim to evaluate the effectiveness of a simplified sewerage intervention in reducing the risk of exposure to contaminated environments and infection and to characterise the transmission mechanisms involved.
This matched quasi-experimental study design using non-randomised intervention and control clusters was designed to assess the effectiveness of an urban simplified sewerage intervention in the low-income communities of Salvador, Brazil. The intervention consists of household-level piped sewerage connections and community engagement and public involvement activities. A cohort of 1400 adult participants will be recruited and grouped into eight clusters consisting of four matched intervention-control pairs with approximately 175 individuals in each cluster in baseline. The primary outcome is the seroincidence of infection assessed through five serological measurements: one preintervention (baseline) and four postintervention. As a secondary outcome, we will assess load in soil, before and after the intervention. We will also assess exposures before and after the intervention, through transmission modelling, accounting for residents' movement, contact with flooding, contaminated soil and water, and rat infestation, to examine whether and how routes of exposure for change following the introduction of sanitation.
This study protocol has been reviewed and approved by the ethics boards at the Federal University of Bahia and the Brazilian National Research Ethics Committee. Results will be disseminated through peer-reviewed publications and presentations to implementers, researchers and participating communities.
Brazilian Clinical Trials Registry (RBR-8cjjpgm).
钩端螺旋体病是一种分布广泛的人畜共患病和环境介导的疾病，已成为发展中国家城市贫民窟的一个主要卫生问题。其病原体为属细菌，主要通过受感染啮齿动物的尿液传播，特别是在环境卫生设施不足的环境中，并且众所周知，露天污水是该疾病的主要传播源。因此，我们旨在评估简化污水干预措施在降低接触受污染环境和感染风险方面的有效性，并描述所涉及的传播机制。
本研究采用非随机干预和对照集群的匹配准实验设计，旨在评估巴西萨尔瓦多低收入社区的城市简化污水干预措施的有效性。该干预措施包括家庭级别的管道污水连接以及社区参与和公众参与活动。将招募 1400 名成年参与者，并将其分为八个集群，每个集群由四个匹配的干预-对照对子组成，每个对子约有 175 人。主要结局是通过五次血清学测量评估的感染血清发生率：一次在干预前（基线）和四次在干预后。作为次要结局，我们将在干预前后评估土壤中的载量。我们还将通过传播建模评估干预前后的暴露情况，考虑到居民的移动、接触洪水、受污染的土壤和水以及老鼠滋生情况，以检查在引入卫生设施后暴露途径是否以及如何发生变化。
本研究方案已由巴伊亚联邦大学和巴西国家伦理委员会的伦理委员会审查和批准。结果将通过同行评议的出版物和向实施者、研究人员和参与社区的介绍进行传播。
巴西临床试验注册处（RBR-8cjjpgm）。
