Abstract

.This report summarizes the design and outcomes of randomized controlled operational research trials performed by the Bill & Melinda Gates Foundation–funded Schistosomiasis Consortium for Operational Research and Evaluation (SCORE) from 2009 to 2019. Their goal was to define the effectiveness and test the limitations of current WHO-recommended schistosomiasis control protocols by performing large-scale pragmatic trials to compare the impact of different schedules and coverage regimens of praziquantel mass drug administration (MDA). Although there were limitations to study designs and performance, analysis of their primary outcomes confirmed that all tested regimens of praziquantel MDA significantly reduced local Schistosoma infection prevalence and intensity among school-age children. Secondary analysis suggested that outcomes in locations receiving four annual rounds of MDA were better than those in communities that had treatment holiday years, in which no praziquantel MDA was given. Statistical significance of differences was obscured by a wider-than-expected variation in community-level responses to MDA, defining a persistent hot spot obstacle to MDA success. No MDA schedule led to elimination of infection, even in those communities that started at low prevalence of infection, and it is likely that programs aiming for elimination of transmission will need to add supplemental interventions (e.g., snail control, improvement in water, sanitation and hygiene, and behavior change interventions) to achieve that next stage of control. Recommendations for future implementation research, including exploration of the value of earlier program impact assessment combined with intensification of intervention in hot spot locations, are discussed.

Highlights

  • In 2009, the Bill & Melinda Gates Foundation (BMGF) funded the Schistosomiasis Consortium for Operational Research and Evaluation (SCORE), based at the University of Georgia

  • This report summarizes the design and outcomes of randomized controlled operational research trials performed by the Bill & Melinda Gates Foundation–funded Schistosomiasis Consortium for Operational Research and Evaluation (SCORE) from 2009 to 2019

  • This effect was obscured by the wider-than-expected variation in communitylevel response to mass drug administration (MDA), unmasking the persistent hot spot phenomenon.[23,33]

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Summary

INTRODUCTION

In 2009, the Bill & Melinda Gates Foundation (BMGF) funded the Schistosomiasis Consortium for Operational Research and Evaluation (SCORE), based at the University of Georgia. After extensive consultation in 2009 with program managers, field trial researchers, biostatisticians, and representatives of the WHO, SCORE designed multiyear, large-scale cluster-randomized trials to study options for program implementation in areas having 3 10% Schistosoma infection prevalence among school-age children (SAC).[1] At the time, WHO guidelines recommended every-other-year praziquantel treatment of all SAC in communities having SAC prevalence between 10% and 49%, and annual SAC treatment for communities having SAC prevalence 3 50%.9. A separate report in this issue[11] presents the results of separate SCORE studies that focused on “moving toward elimination” on Zanzibar and in S. haematobium–endemic areas of northern and central Cote d’Ivoire.[12]

SCHISTOSOMIASIS CONSORTIUM FOR OPERATIONAL RESEARCH AND EVALUATION STUDY DESIGNS
KING AND OTHERS
KEY FINDINGS FROM THE GAINING AND SUSTAINING CONTROL STUDIES
Findings
SUMMARY AND PUBLIC HEALTH IMPLICATIONS
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