A Cluster Randomised Controlled Trial for Assessing POC-CCA Test Based Praziquantel Treatment for Schistosomiasis Control in Pregnant Women and Their Young Children: Study Protocol of the Freebily Clinical Trial in Madagascar
Abstract
Abstract Background: Mass 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 diagnosis. Diagnostic tools identifying infections at 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. Methods : A two-armed, cluster-randomised, 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 at 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. Discussion : This 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 registration : Retrospectively registered with the Pan-African Clinical Trial Register PACTR201905784271304 (15/05/2019)
Authors 20
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Bernhard Nocht Institute for Tropical Medicine
Affiliation as printed
Bernhard-Nocht-Institut fur Tropenmedizin
: Department of Infectious Diseases Epidemiology, Bernhard Nocht Institute for Tropical Medicine (BNITM), Bernhard-Nocht-Strasse 74, D-20359 Hamburg, Germany
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Affiliation as printed
Universite d'Antananarivo
: Department of Microbiology and Parasitology, University of Antananarivo, Antananarivo 101, Madagascar
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Affiliation as printed
Universite de Fianarantsoa
: Department of Infectious Diseases, University of Fianarantsoa Andrainjato, Fianarantsoa 301, Madagascar
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Affiliation as printed
Centre d'Infectiologie Charles Merieux
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Affiliation as printed
Universite d'Antananarivo
: Department of Microbiology and Parasitology, University of Antananarivo, Antananarivo 101, Madagascar
: UPFR in Parasitology-Mycology of University Hospital Joseph Ravoahangy Andrianavalona Ampefiloha, Antananarivo 101, Madagascar
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Affiliation as printed
Centre d'Infectiologie Charles Merieux
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Bernhard Nocht Institute for Tropical Medicine
Affiliation as printed
Bernhard-Nocht-Institut fur Tropenmedizin
: Department of Infectious Diseases Epidemiology, Bernhard Nocht Institute for Tropical Medicine (BNITM), Bernhard-Nocht-Strasse 74, D-20359 Hamburg, Germany
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Bernhard Nocht Institute for Tropical Medicine
Affiliation as printed
Bernhard-Nocht-Institut fur Tropenmedizin
: Department of Infectious Diseases Epidemiology, Bernhard Nocht Institute for Tropical Medicine (BNITM), Bernhard-Nocht-Strasse 74, D-20359 Hamburg, Germany
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Bernhard Nocht Institute for Tropical Medicine
Affiliation as printed
Bernhard-Nocht-Institut fur Tropenmedizin
: Department of Infectious Diseases Epidemiology, Bernhard Nocht Institute for Tropical Medicine (BNITM), Bernhard-Nocht-Strasse 74, D-20359 Hamburg, Germany
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Bernhard Nocht Institute for Tropical Medicine
Affiliation as printed
Bernhard-Nocht-Institut fur Tropenmedizin
: Department of Infectious Diseases Epidemiology, Bernhard Nocht Institute for Tropical Medicine (BNITM), Bernhard-Nocht-Strasse 74, D-20359 Hamburg, Germany
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Johannes Gutenberg University Mainz · Bernhard Nocht Institute for Tropical Medicine
Affiliation as printed
Bernhard-Nocht-Institut fur Tropenmedizin
: Department of Infectious Diseases Epidemiology, Bernhard Nocht Institute for Tropical Medicine (BNITM), Bernhard-Nocht-Strasse 74, D-20359 Hamburg, Germany
: Institute of Medical Biostatistics, Epidemiology and Informatics, University Medical Centre of the
Johannes Gutenberg University Mainz, Germany
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Bernhard Nocht Institute for Tropical Medicine
Affiliation as printed
Bernhard-Nocht-Institut fur Tropenmedizin
: Department of Infectious Diseases Epidemiology, Bernhard Nocht Institute for Tropical Medicine (BNITM), Bernhard-Nocht-Strasse 74, D-20359 Hamburg, Germany
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Affiliation as printed
Universitatsklinikum Tubingen
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Pytsje T. Hoekstra Aachen
Leiden University · Leiden University Medical Center
Affiliation as printed
Leiden University Medical Center: Leids Universitair Medisch Centrum
: Department of Parasitology, Leiden University Medical Center, Albinusdreef 2, 2333 ZA Leiden, the Netherlands
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Ayôla Akim Adégnika Aachen
Leiden University Medical Center · Universitätsklinikum Tübingen
Affiliation as printed
Universitätsklinikum Tübingen: Universitatsklinikum Tubingen
: Department of Parasitology, Leiden University Medical Center, Albinusdreef 2, 2333 ZA Leiden, the Netherlands
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Barcelona Institute for Global Health
Affiliation as printed
ISGLOBAL: Instituto de Salud Global de Barcelona
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Leiden University · Leiden University Medical Center
Affiliation as printed
University of Leiden: Universiteit Leiden
: Department of Cell and Chemical Biology, Leiden University Medical Center, Albinusdreef 2, 2333 ZA Leiden, the Netherlands
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Govert J. van Dam Aachen
Leiden University · Leiden University Medical Center
Affiliation as printed
Leiden University: Universiteit Leiden
: Department of Parasitology, Leiden University Medical Center, Albinusdreef 2, 2333 ZA Leiden, the Netherlands
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Bernhard Nocht Institute for Tropical Medicine
Affiliation as printed
Bernhard-Nocht-Institut fur Tropenmedizin
: Department of Infectious Diseases Epidemiology, Bernhard Nocht Institute for Tropical Medicine (BNITM), Bernhard-Nocht-Strasse 74, D-20359 Hamburg, Germany
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Bernhard Nocht Institute for Tropical Medicine
Affiliation as printed
Bernhard-Nocht-Institut fur Tropenmedizin
: Department of Infectious Diseases Epidemiology, Bernhard Nocht Institute for Tropical Medicine (BNITM), Bernhard-Nocht-Strasse 74, D-20359 Hamburg, Germany
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