SCORE Seasonal Transmission <i>S. haematobium</i> Cluster Randomized Trial

Related studies: SCORE S. mansoni Cluster Randomized Trial SCORE Mozambique S. haematobium Cluster Randomized Trial Background: Schistosomiasis is a parasitic disease caused by infection with blood flukes of the genus Schistosoma. Urogenital schistosomiasis, in which the bladder, genital tract and urethras are affected, is caused by infection with the species S. haematobium, which is prevalent mainly in Africa. Two species of freshwater snails (Bulinus truncatus and B. globosus) transmit urogenital schistosomiasis in Côte d'Ivoire. Due to two distinct seasons, with rainfall occurring between March and October and the dry period lasting from November to March, there is a strong seasonality in the presence of snails and schistosomiasis transmission. In northern and central Côte d'Ivoire, transmission of Schistosoma haematobium is seasonal and elimination might be achieved. Objectives: This study will reveal whether or not urogenital schistosomiasis transmission can indeed be interrupted in the targeted areas in northern and central parts of Côte d'Ivoire with a package of well-tailored and focussed interventions implemented over a 3-year period. Methodology Study Sites: The study will be carried out in six administrative regions of Côte d'Ivoire, four of which are located in the north (Tchologo, Bounkani, Poro and Hambol) and two in the centre of the country (Gbêkê and Bélier). Dates of Data Collection: 2015- 2018 Study Design: Cluster-randomized trial with three years of follow up. Study Arms: The 60 selected study sites were randomly assigned to four different intervention arms (15 villages per arm), with different schedules of mass drug administration (MDA) with praziquantel and albendazole. Arm 1=Annual MDA in November/December, before the peak transmission season of schistosomiasis Arm 2=Annual MDA in March/April, after the peak transmission season of schistosomiasis Arm 3=Two MDAs annually, before and after peak transmission of schistosomiasis Arm 4=Annual MDA in November/December, before peak transmission of schistosomiasis, coupled with chemical snail control using niclosamide. Data Collection: A single urine and stool sample was collected from 50 children aged 5-8 years, 100 children aged 9-12 years and 50 adults aged 20-55 years in each of the 60 study villages. Each urine sample was tested for visual detection for macrohaematuria and reagent strip testing for microhaematuria. S. haematobium eggs were quantified by urine filtration under a microscope . Two microscope slides were prepared per stool sample using the Kato-Katz technique for the detection of hookworm eggs and a second time after clearing for the detection of other soil-transmitted helminths and S. mansoni. ClinEpiDB Data Integration: Data files were provided to ClinEpiDB as cleaned .csv files with all personal identifiers removed. All dates were obfuscated per individual through the application of a random number algorithm that shifted dates no more than seven days to comply with the ethical conduct of human subjects research. Acknowledgements: We thank the technicians from different institutions of Mozambique for their support in the field and the laboratory. We are grateful to the health, education and village authorities of all districts for their contribution. Finally, we thank all the children, parents, teachers and village leaders who participated in this study. Financial Support: SCORE is funded by the Bill & Melinda Gates Foundation through a grant to the University of Georgia Research Foundation (UGARF). Ethics Statement: Informed consent was obtained from all individuals ≥18 years of age and from parents or legal guardians of children less than 18 years of age. The purpose of the study was explained to all schoolchildren and verbal assent was obtained from the children. Permission was also obtained from school headmasters. Ethical clearance was obtained from the National Bio-ethical Committee for Health of Mozambique (NBCHM), and the survey was conducted according to NBCHM guidelines (reference no. IRB00002657). The trial is registered with the International Standard Randomised Controlled Trial registry under ISRTC number 14117624 for Mozambique. The study protocol was also approved by Imperial College London (ICREC_10_2_2). Last Updated: March 9, 2021In order to assess the impact of different control strategies against Schistosoma haematobium in seasonal transmission foci in Côte d'Ivoire, villages were randomly assigned to four intervention arms comparing annual mass drug administration (MDA) before (arm 1) or after (arm 2) the peak transmission, biannual treatment with praziquantel before and after the peak transmission season (arm 3), and annual MDA before the peak transmission season, coupled with focal chemical snail control using molluscicides (arm 4). The primary outcome was change in prevalence and intensity of S. haematobium infection in each of the three study population age groups over the study period. In the first year follow-up survey, a significant decrease of S. haematobium prevalence was observed in all study arms.