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 WHOrecommended 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.

BackgroundIn Mozambique, schistosomiasis is highly endemic across the whole country. The Schistosomiasis Consortium for Operational Research and Evaluation (SCORE) coordinates a five-year study that has been implemented in various African countries, including Mozambique. The overall goal of SCORE was to better understand how to best apply preventive chemotherapy with praziquantel (PZQ) for schistosomiasis control by evaluating the impact of alternative treatment approaches.MethodsThis was a cluster-randomised trial that compared the impact of different treatment strategies in study areas with prevalence among school children of ≥21% S. haematobium infection by urine dipstick. Each village was randomly allocated to one of six possible combinations of community-wide treatment (CWT), school-based treatment (SBT), and/or drug holidays over a period of four years, followed by final data collection in the fifth year. The most intense intervention arm involved four years of CWT, while the least intensive arm involved two years of SBT followed by two consecutive years of PZQ holiday. Each study arm included 25 villages randomly assigned to one of the six treatment arms. The primary outcome of interest was change in prevalence and intensity of S. haematobium among 100 children aged 9-to-12-years that were sampled each year in every village. In addition to children aged 9-to-12 years, 100 children aged 5–8 years in their first-year of school and 50 adults (aged 20–55 years) were tested in the first and final fifth year of the study. Prevalence and intensity of S. haematobium infection was evaluated by two filtrations, each of 10mL, from a single urine specimen.Principal findingsIn total, data was collected from 81,167 individuals across 149 villages in ten districts of Cabo Delgado province, Northern Mozambique. Overall PZQ treatment resulted in a significant reduction in the prevalence of S. haematobium infection from Year 1 to Year 5, where the average prevalence went from 60.5% to 38.8%, across all age groups and treatment arms. The proportion of those heavily infected also reduced from 17.6% to 11.9% over five years. There was a significantly higher likelihood of males being infected than females at baseline, but no significant difference between the sexes in their response to treatment. The only significant response based on a study arm was seen in both the 9-to-12-year-old and first-year cross sections, where two consecutive treatment holidays resulted in a significantly higher final prevalence of S. haematobium than no treatment holidays. When the arms were grouped together, four rounds of treatment (regardless of whether it was CWT or SBT), however, did result in a significantly greater reduction in S. haematobium prevalence than two rounds of treatment (i.e. with two intermittent or consecutive holiday years) over a five-year period.ConclusionsAlthough PC was successful in reducing the burden of active infection, even among those heavily infected, annual CWT did not have a significantly greater impact on disease p...

Background Schistosomiasis affects nearly 220 million people worldwide, mainly in Sub-Saharan Africa (SSA). Preventive chemotherapy (PC) treatment, through regular mass-drug administration (MDA) of Praziquantel tablets remains the control measure of choice by Ministries of Health. Current guidelines recommend that 75% of school-aged children receive treatment. Many programmes, however, struggle to achieve this target. Given the risk of high reinfection rates, attaining sustained high levels of treatment coverage is essential. This study provides a comprehensive review of the barriers and facilitators operating at different levels of analysis, from the individual to the policy level, conditioning the uptake of PC for schistosomiasis in SSA. Methodology/Principal findings A systematic literature search was conducted in several databases for publications released between January 2002 and 2019 that examined factors conditioning the uptake of Praziquantel in the context of MDA campaigns in SSA. A total of 2,258 unique abstracts were identified, of which 65 were selected for full text review and 30 met all eligibility criteria. Joanna Briggs Institute’s Critical Appraisal and the Mixed-Methods Assessment tools were used to assess the strength of the evidence. This review was registered with PROSPERO (CRD42017058525). A meta-synthesis approach was used. Results indicated publication bias, with the literature focusing on East African rural settings and evidence at the individual and programmatic levels. The main influencing factors identified included material wellbeing, drug properties, knowledge and attitudes towards schistosomiasis and MDAs, fears of side effects, gender values, community and health systems support, alongside programme design features, like training, sensitisation, and provision of incentives for drug-distributors. The effect of these factors on determining Praziquantel uptake were explored in detail. Conclusions/Significance Multiple determinants of treatment uptake were found in each level of analysis examined. Some of them interact with each other, thus affecting outcomes directly and indirectly. The promotion of context-based transdisciplinary research on the complex dynamics of treatment uptake is not only desirable, but essential, to design effective strategies to attain high levels of treatment coverage.

The Schistosomiasis Consortium for Operational Research and Evaluation (SCORE) was created to conduct research that could inform programmatic decision-making related to schistosomiasis. SCORE included several large cluster randomized field studies involving mass drug administration (MDA) with praziquantel. The largest of these were studies of gaining or sustaining control of schistosomiasis, which were conducted in five African countries. To enhance relevance for routine practice, the MDA in these studies was coordinated by or closely aligned with national neglected tropical disease (NTD) control programs. The study protocol set minimum targets of at least 90% for coverage among children enrolled in schools and 75% for all school-age children. Over the 4 years of intervention, an estimated 3.5 million treatments were administered to study communities. By year 4, the median village coverage was at or above targets in all studies except that in Mozambique. However, there was often a wide variation behind these summary statistics, and all studies had several villages with very low or high coverage. In studies where coverage was estimated by comparing the number of people treated with the number eligible for treatment, denominator estimation was often problematic. The SCORE experiences in conducting these studies provide lessons for future efforts that attempt to implement strong research designs in real-world contexts. They also have potential applicability to country MDA campaigns against schistosomiasis and other NTDs, most of which are conducted with less logistical and financial support than was available for the SCORE study efforts.

BackgroundSchistosomiasis affects more than 800 million people, mostly in sub-Saharan Africa. A baseline sentinel site study was conducted in the Western half of Madagascar to determine the prevalence and intensity of schistosomiasis and soil-transmitted helminth (STH) infections prior to mass drug administration, and to explore the associations between infection and school attendance, and access to water, sanitation and hygiene (WASH) facilities.MethodsA three-stage, cluster-randomised cross-sectional study was conducted in 29 sentinel sites in October 2015. Twenty school attending and 4 non-attending children in each of the age groups from 7 to 10 years old were randomly selected at each site for detection of Schistosoma haematobium eggs in a single urine slide by filtration, and of S. mansoni, Ascaris lumbricoides, Trichuris trichiura and hookworm eggs in duplicate Kato-Katz slides from a single stool sample. School attendance was registered individually, and school-level access to WASH facilities was scored through pre-defined observed and reported factors. Logistic regression analysis was performed, adjusting for gender, age and study site. School-level WASH status was analysed using Spearman’s rank correlation coefficient.ResultsA total of 1,958 children were included. The prevalence of S. haematobium infection and heavy-intensity infection was 30.5 % and 15.1 %, respectively. The prevalence of S. mansoni infection and heavy-intensity infection was 5.0 % and 0.9 %, respectively. The prevalence of any STH infection was 4.7 %. There was no significant difference in prevalence of infection or heavy-intensity infection of either schistosome species between attending and non-attending children, apart from heavy-intensity S. mansoni infection that was significantly more common in children who did not attend school regularly (aOR = 7.5 (95 % CI = 1.1-49.5); p = 0.037). Only a minority of schools had adequate access to WASH facilities, and in this study, we found no significant association between school-level WASH status and schistosomiasis.ConclusionsThis study found an alarmingly high prevalence and intensity of schistosomiasis, and the results warrant urgent scale-up of the national NTD control programme that will need to include both non-attending and attending school-age children in order to reach WHO roadmap targets for the control of schistosomiasis by 2020.Electronic supplementary materialThe online version of this article (doi:10.1186/s13071-016-1337-4) contains supplementary material, which is available to authorized users.