Abstract
BackgroundMass drug administration (MDA) of praziquantel is one of the main control measures against human schistosomiasis. Although there are claims for including pregnant women, infants and children under the age of 5 years in high-endemic regions in MDA campaigns, they are usually not treated without a diagnosis. Diagnostic tools identifying infections at the primary health care centre (PHCC) level could therefore help to integrate these vulnerable groups into control programmes. freeBILy (fast and reliable easy-to-use-diagnostics for eliminating bilharzia in young children and mothers) is an international consortium focused on implementing and evaluating new schistosomiasis diagnostic strategies. In Madagascar, the study aims to determine the effectiveness of a test-based schistosomiasis treatment (TBST) strategy for pregnant women and their infants and children up until the age of 2 years.MethodsA two-armed, cluster-randomized, controlled phase III trial including 5200 women and their offspring assesses the impact of TBST on child growth and maternal haemoglobin in areas of medium to high endemicity of Schistosoma mansoni. The participants are being tested with the point of care-circulating cathodic antigen (POC-CCA) test, a commercially available urine-based non-invasive rapid diagnostic test for schistosomiasis. In the intervention arm, a POC-CCA-TBST strategy is offered to women during pregnancy and 9 months after delivery, for their infants at 9 months of age. In the control arm, study visit procedures are the same, but without the POC-CCA-TBST procedure. All participants are being offered the POC-CCA-TBST 24 months after delivery. This trial is being integrated into the routine maternal and child primary health care programmes at 40 different PHCC in Madagascar’s highlands. The purpose of the trial is to assess the effectiveness of the POC-CCA-TBST for controlling schistosomiasis in young children and mothers.DiscussionThis trial assesses a strategy to integrate pregnant women and their children under the age of 2 years into schistosomiasis control programmes using rapid diagnostic tests. It includes local capacity building for clinical trials and large-scale intervention research.Trial registrationPan-African Clinical Trial Register PACTR201905784271304. Retrospectively registered on 15 May 2019
Highlights
Human schistosomiasis is a neglected tropical disease (NTD) caused by trematode flatworms [1]
The overall aims of this study are to assess the potential impact of a point of care (POC)-cathodic antigen (CCA) testbased schistosomiasis treatment (TBST) strategy on maternal and infant health and demonstrate the effectiveness of integrating the strategy at the primary health care level
Mass drug administration (MDA) of PZQ is one of the main control measures against human schistosomiasis, but the success of MDA programmes is often hampered by low compliance with treatment, limited drug availability and misclassification of areas selected for MDA
Summary
Human schistosomiasis is a neglected tropical disease (NTD) caused by trematode flatworms [1]. Among the NTDs, schistosomiasis ranks highest in terms of disability-adjusted life years (3.3 million DALYs), with more than 230 million people infected and 600 million being at risk of infection worldwide [2] It is of particular public health importance in Africa where both intestinal and urinary forms of the disease caused by Schistosoma mansoni and Schistosoma haematobium, respectively, are prevalent. The WHO recommends annual treatment of school-age children with praziquantel (PZQ) in areas of high endemicity. This is often put into practice via mass drug dministration (MDA) campaigns [5]. In Madagascar, the study aims to determine the effectiveness of a testbased schistosomiasis treatment (TBST) strategy for pregnant women and their infants and children up until the age of 2 years.
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