SCORE Niger <i>S. haematobium</i> Cluster Randomized Trial

Related studies: SCORE Mozambique S. haematobium Cluster Randomized Trial SCORE S. mansoni Cluster Randomized Trial Background: Schistosomiasis is a parasitic disease caused by infection with blood flukes of the genus Schistosoma. It is estimated that 3.2 million people are infected with schistosomiasis in Niger. Mass drug administration (MDA) with the drug praziquantel is the mainstay of schistosomiasis control. Existing thresholds for implementation of mass treatment for schistosomiasis needed refinement and a better evidence base to establish the relative benefits of different age-group coverage formats and different schedules of targeted mass praziquantel delivery. There was interest in finding out whether, when compared with school-based treatment, using one or more years of community-wide treatment would have a greater impact on the prevalence and intensity of infection if, for example, community-wide treatment could achieve better coverage of school-aged children who did not attend school or better coverage of high-risk adults. There also was a lack of data as to whether every-other-year delivery of MDA could be sufficient for morbidity control. Objectives: The primary research question addressed in this study is which MDA strategy- annual versus biannual school-based treatment or community-wide treatment - provided the greatest reduction in prevalence and intensity of S. haematobium infection among 9-12 year-olds after four years of intervention. In addition, the impact of treatment on first-year students and adults was also assessed. Methodology Study Sites: The study was conducted in 225 villages in nine districts in Western Niger along the Niger River Valley- the region of Tillabery (Kollo, Say, Tera, Filingué and Tillabery districts), Dosso (Loga district) and Niamey (districts 1-3). Dates of Data Collection: 2011- 2015 Study Design: Cluster-randomized trial Data Collection Sampling: A total of 225 villages were enrolled in the study, with 100 children aged 9-12 years tested each year per village. In addition, systematic random sampling was used in each village to select a further 100 first-year students (aged 5-8 years) in all 225 villages at the first and fifth years only. A convenience sample of 50 adults (aged 22-50 years) were sampled in the first and last year of villages with a starting S. haematobium prevalence over 25%. Village-level data: Data was collected from each study village on geographic location (latitude, longitude) and data related to MDA coverage- total village population, population treated by MDA, number of school-aged children, number of school-aged children treated by MDA. Individual-level data: Demographic data on age and sex was collected from each participant. A single urine sample was collected from each individual in the study for assessment of the S. haematobium egg burden by urine filtration and microscopy. 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 are grateful to the Schistosomiasis Control Initiative for providing praziquantel for the study, through the donation to the Ministry of Health in Niger. We thank the technicians 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: The study protocol has been approved by the National Ethics Committee in Niger (ref 012/2010/CCNE) and Imperial College Research Ethics Committee (ref ICREC_8_2_2). In addition to these, the University of Georgia institutional review board IRB implemented an administrative human subjects review and issued additional approval 10533-0 for Niger. Informed consent was obtained from parents or legal guardians of all pupils involved in the study and verbal consent was also obtained from all adults included. The purpose of the study was explained to education and health authorities. All results in the datasets were anonymous and coded to prevent association with the individual participant. Last Updated: March 8, 2021To provide an evidence base for cost-effective schistosomiasis control, a five-year study cluster-randomised trial in Niger investigated six possible combinations of annual or biannual community-wide treatment, school-based treatment, and holidays from mass treatment over four years. The primary outcome of interest was prevalence and intensity of Schistosoma haematobium among 100 children aged 9-12 years sampled each year in each village. The relative reduction of prevalence was greater in biannual compared with annual treatment across all arms; however, the only significant difference was seen in areas with a high starting prevalence.