Simplified sewerage to prevent urban leptospirosis transmission : a cluster non-randomised controlled trial protocol in disadvantaged urban communities of Salvador, Brazil

Cremonese, Cleber and Souza, Fabio Neves and Palma, Fabiana Almerinda Gonçalves and Sodré, Jonatas Fernandes Araújo and Brito, Ricardo Lustosa and Ribeiro, Priscyla dos Santos and Santana, Juliet Oliveira and Coelho, Rachel Helena and Ticona, Juan P Aguilar and Nazaré, Romero J and de Oliveira, Daiana and Silva, Cainã Queiroz and Eyre, Max T and Mendes, Vinícius de Araújo and Knee, Jackie and Ristow, Paula and Stauber, Christine E and López, Yeimi Alexandra Alzate and Giorgi, Emanuele and Diggle, Peter J and Reis, Mitermayer Galvão G and Cumming, Oliver and Ko, Albert and Costa, Federico (2023) Simplified sewerage to prevent urban leptospirosis transmission : a cluster non-randomised controlled trial protocol in disadvantaged urban communities of Salvador, Brazil. BMJ Open, 13 (6): e065009. ISSN 2044-6055

Abstract

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). [Abstract copyright: © Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY. Published by BMJ.]