SCORE <i>S. mansoni</i> Cluster Randomized Trial

Related studies SCORE S. mansoni Kenya and Tanzania Cohort SCORE Mozambique S. haematobium Cluster Randomized Trial SCORE Niger S. haematobium Cluster Randomized Trial Background: Schistosomiasis is a parasitic disease caused by infection with blood flukes of the genus Schistosoma. An estimated 800 million people are at risk of infection and more than 200 million people are infected globally. 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. The Schistosomiasis Consortium for Operational Research and Evaluation (SCORE) was established in 2008 to answer strategic questions about schistosomiasis control. Objectives: In aiming to provide program managers and policy makers with better evidence for decision-making, SCORE's research objective for these studies was to generate data on the relative effectiveness of community-wide treatment versus school-based treatment and on the relative effectiveness of annual praziquantel drug delivery as compared with schedules that involve holiday years— that is, years without praziquantel MDA. Two types of SCORE treatment trials were developed to focus separately on communities having starting prevalence 10-24%, designated as sustaining control studies, and on communities having starting prevalence ≥ 25%, designated as gaining control studies. Methodology Study Sites: Sustaining control studies were conducted in western Côte d'Ivoire (75 villages) and in western Kenya (75 villages). Gaining control studies were performed in Kenya (150 villages) and in the Mwanza region of Tanzania (150 villages). The focus on sub-Saharan Africa was based on this region having the greatest burden of schistosomiasis globally and the greatest need for information about optimal implementations at national and subnational scales. Dates of Data Collection: 2011- 2016 Study Design: Cluster-randomized trial with five years of follow up. Study Arms: Villages were randomized to study arms that describe the treatment schedule received by the village over the 4 years of the intervention where s=school based treatment, c= community wide treatment, h=drug holiday. Sustaining Control Studies in Côte d'Ivoire and Kenya, conducted in villages with starting schistosomiasis prevalence 10-24%, had 3 study arms with 25 villages per arm: Arm 1 (ssss) villages received school-based MDA each year. Arm 2 (sshh) villages received 2 years of school-based MDA followed by 2 years of drug holiday. Arm 3 (shsh) villages received alternate years of school-based MDA and drug holidays. Gaining Control studies in Kenya and Tanzania, conducted in villages with starting schistosomiasis prevalence ≥ 25%, had 6 study arms with 25 villages per arm: Arm 1 (cccc) villages received community-wide MDA each year. Arm 2 (ccss) villages received 2 years of community-wide MDA followed by 2 years of school-based MDA. Arm 3 (cchh) villages received two years of school-based MDA followed by two years of drug holidays. Arm 4 (ssss) villages received school-based MDA each year. Arm 5 (sshh) villages received 2 years of school-based MDA followed by 2 years of drug holiday. Arm 6 (shsh) villages received alternate years of school-based MDA and drug holidays. Note that Arms 1, 2, 3 of the Sustaining Control Studies got the same treatment regimens as Arms 4, 5, 6 of the Gaining Control Studies. Data Collection: 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: A sample of 100 participants (9-12 year old children) were randomly selected from each study village per year. In addition, 50 children in the 5-8 year group and 50 adults were sampled from each village in the first and last year of the study. Demographic data on age and sex was collected from each participant. Up to three stool samples were collected from each individual on separate days in each study year. Stool samples were processed using the Kato-Katz stool exam to get data on prevalence and infection intensity of Schistosoma mansoni and on three soil-transmitted helminths (Ascaris, Trichuris and hookworm). 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 families who participated in these studies and the project field and laboratory staff for their professionalism and dedication. Financial Support: SCORE is funded by the Bill & Melinda Gates Foundation through a grant to the University of Georgia Research Foundation (UGARF). Ethics Statement: Written informed consent for participants in the Gaining and Sustaining Control studies was obtained from adults (including parents/legal guardians of children in the study) and assent was obtained from children less than 18 years old, except in places where village-level consent is the standard, in which case local requirements were met. Ethical review of research protocol was implemented by human subjects committee in each African country and by the institutional review board (IRB) of their respective northern partners. The trials have been registered with the International Standard Randomized Controlled Trial registry under ISRCT numbers 99401114 (Côte d'Ivoire), 14849830 (Kenya Sustaining Control), 16755535 (Kenya Gaining Control), and 95819193 (Tanzania) Last Updated: March 10, 2021The SCORE S. mansoni studies in Côte d'Ivoire, Kenya and Tanzania were community-level, cluster-randomized control trials designed to test optimal mass drug administration (MDA) regimens to control schistosomiasis. Villages with >10% S. mansoni prevalence were randomized to study arms that received a praziquantel MDA regimen that varied in the venue of MDA- either community-based or school-wide, and in the presence or absence of drug holidays during the four study years. 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.