SCORE Zanzibar <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. The Zanzibar archipelago of the United Republic of Tanzania, with the main islands Pemba and Unguja, has a history of schistosomiasis control that dates back to the 1980s. At that time, urogenital schistosomiasis caused by S. haematobium, was highly prevalent across both islands. Thirty years later, considerable progress had been made and the Zanzibar islands were one of the first areas in sub-Saharan Africa where elimination of urogenital schistosomiasis was considered as a feasible goal. The Zanzibar Elimination of Schistosomiasis Transmission (ZEST) alliance, consisting of various stakeholders and institutions, aimed to eliminate schistosomiasis as a public health problem from Pemba (<1% heavy infection intensities in all sentinel sites) and to interrupt transmission on Unguja (zero incidence in all sentinel sites) in 5 years. Moreover, it aimed to learn about the effectiveness of snail control and behavioral change interventions in addition to mass drug administration (MDA) with the drug praziquantel which is the mainstay of schistosomiasis control. Objectives: The objectives of this study were to assess biannual MDA applied alone or with complementary snail control or behaviour change interventions for the reduction of Schistosoma haematobium prevalence and infection intensity in children from Zanzibar and to compare the effect between the clusters. Methodology Study Sites: The study was conducted on the Zanzibar islands, Unguja and Pemba, United Republic of Tanzania. The study sites were primary schools and communities located in 45 shehias (smallest administrative area in Zanzibar) on each island, for a total of 90 shehias. Dates of Data Collection: 2011- 2017 Study Design: Cluster-randomized trial with six years of follow up. Study Arms: Stratified by island, the 90 study shehias were randomly allocated to one of three intervention arms in a 1:1:1 ratio. Fifteen shehias on each island received biannual MDA with praziquantel administered by the Neglected Tropical Diseases (NTD) Programme of the Zanzibar Ministry of Health across the archipelago (arm 1); 15 shehias received snail control in addition to biannual MDA (arm 2); and 15 shehias received behaviour change interventions in addition to biannual MDA (arm 3). Owing to the nature of the intervention, neither participants nor field or laboratory personnel were blinded to the intervention arms. Data Collection: A sample of 100 children aged 9-12 years in the main public primary school of each of the 90 study shehias was chosen. Demographic data on age and sex was collected from each participant. A single urine sample from each participant was visually examined for macrohaematuria, for microhaematuria by means of reagent strips, and for S. haematobium eggs, by means of the filtration method. 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 excellent and dedicated survey and intervention teams of the Neglected Tropical Diseases (NTD) Programme of the Zanzibar Ministry of Health and of the Public Health Laboratory—Ivo de Carneri. We acknowledge the time and effort of participants, teachers, headmasters, and community leaders (shehas) to support our study. We are particularly indebted to all members of the SCORE secretariat for valuable advice and input, the Zanzibar Elimination of Schistosomiasis Transmission partners (Zanzibar Ministry of Health, including the Zanzibar NTD Programme, the Public Health Laboratory-Ivo de Carneri Pemba, Zanzibar government agencies, WHO, Schistosomiasis Control Initiative, Natural History Museum, and Swiss Tropical and Public Health Institute) for support during the 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: Ethical approval was obtained from the Zanzibar Medical Research Ethics Committee in Stonetown, Zanzibar (ZAMREC; reference no. ZAMREC 0003/Sept/011), the Ethikkommission beider Basel (EKBB) in Basel, Switzerland (reference no. 236/11) and the Institutional Review Board of the University of Georgia in Athens, GA, USA (project no. 2012-10138-0). Written informed consent was obtained from the parents or guardians of participating children. Last Updated: March 9, 2021The Zanzibar Elimination of Schistosomiasis Transmission (ZEST) project aimed to assess biannual mass drug administration (MDA) applied alone or with complementary snail control or behavior change interventions for the reduction of Schistosoma haematobium prevalence and infection intensity in children from Zanzibar and to compare the effect between the clusters. Major outcomes were prevalence and intensity of schistosomiasis among 9 to 12 year old children, the highest risk group, at the end of the study. The study found that prevalence was significantly reduced in all study arms, but transmission was not interrupted.