A cluster randomized 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
Trials, vol. 22, pp. 822
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 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. METHODS: A 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. 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: Pan-African Clinical Trial Register PACTR201905784271304. Retrospectively registered on 15 May 2019.
Authors 35
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German Center for Infection Research · Bernhard Nocht Institute for Tropical Medicine
Affiliation as printed
Department of Infectious Diseases Epidemiology, Bernhard Nocht Institute for Tropical Medicine (BNITM), Bernhard-Nocht-Strasse 74, D-20359, Hamburg, Germany
German Center for Infection Research (DZIF), Hamburg-Borstel-, Lübeck, Riems, Germany
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Affiliation as printed
Department of Microbiology and Parasitology, University of Antananarivo, 101, Antananarivo, Madagascar
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Affiliation as printed
Department of Infectious Diseases, University of Fianarantsoa Andrainjato, 301, Fianarantsoa, Madagascar
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Affiliation as printed
Centre d'Infectiologie Charles Mérieux (CICM), University of Antananarivo, PO Box 4299, 101, Antananarivo, Madagascar
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Affiliation as printed
Department of Microbiology and Parasitology, University of Antananarivo, 101, Antananarivo, Madagascar
UPFR in Parasitology-Mycology of University Hospital Joseph Ravoahangy Andrianavalona Ampefiloha, 101, Antananarivo, Madagascar
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Affiliation as printed
Centre d'Infectiologie Charles Mérieux (CICM), University of Antananarivo, PO Box 4299, 101, Antananarivo, Madagascar
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Bernhard Nocht Institute for Tropical Medicine
Affiliation as printed
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
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
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
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 · University Medical Center of the Johannes Gutenberg University Mainz · German Center for Infection Research · Bernhard Nocht Institute for Tropical Medicine
Affiliation as printed
Department of Infectious Diseases Epidemiology, Bernhard Nocht Institute for Tropical Medicine (BNITM), Bernhard-Nocht-Strasse 74, D-20359, Hamburg, Germany
German Center for Infection Research (DZIF), Hamburg-Borstel-, Lübeck, Riems, Germany
Institute of Medical Biostatistics, Epidemiology and Informatics, University Medical Centre of the Johannes Gutenberg University Mainz, Mainz, Germany
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German Center for Infection Research · Bernhard Nocht Institute for Tropical Medicine
Affiliation as printed
Department of Infectious Diseases Epidemiology, Bernhard Nocht Institute for Tropical Medicine (BNITM), Bernhard-Nocht-Strasse 74, D-20359, Hamburg, Germany
German Center for Infection Research (DZIF), Hamburg-Borstel-, Lübeck, Riems, Germany
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German Center for Infection Research · University of Tübingen
Affiliation as printed
German Center for Infection Research (DZIF), partner site Tübingen, Wilhelmstrasse 27, D-72074, Tübingen, Germany
Institut für Tropenmedizin, Universität Tübingen, Wilhelmstrasse 27, D-72074, Tübingen, Germany
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Leiden University Medical Center
Affiliation as printed
Department of Parasitology, Leiden University Medical Center, Albinusdreef 2, 2333 ZA, Leiden, the Netherlands
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Leiden University Medical Center · Centre de Recherche Médicales de Lambaréné · German Center for Infection Research · University of Tübingen
Affiliation as printed
Centre de Recherches Médicales de Lambaréné, 242, Lambarene, BP, Gabon
Department of Parasitology, Leiden University Medical Center, Albinusdreef 2, 2333 ZA, Leiden, the Netherlands
German Center for Infection Research (DZIF), partner site Tübingen, Wilhelmstrasse 27, D-72074, Tübingen, Germany
Institut für Tropenmedizin, Universität Tübingen, Wilhelmstrasse 27, D-72074, Tübingen, Germany
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Hospital Clínic de Barcelona · Barcelona Institute for Global Health · Universitat de Barcelona
Affiliation as printed
ISGlobal, Hospital Clínic - Universitat de Barcelona, Spain C/ Rosselló, 132, 5th 2nd, 08036, Barcelona, Spain
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Leiden University Medical Center
Affiliation as printed
Department of Cell and Chemical Biology, Leiden University Medical Center, Albinusdreef 2, 2333 ZA, Leiden, the Netherlands
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Leiden University Medical Center
Affiliation as printed
Department of Parasitology, Leiden University Medical Center, Albinusdreef 2, 2333 ZA, Leiden, the Netherlands
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German Center for Infection Research · Bernhard Nocht Institute for Tropical Medicine
Affiliation as printed
Department of Infectious Diseases Epidemiology, Bernhard Nocht Institute for Tropical Medicine (BNITM), Bernhard-Nocht-Strasse 74, D-20359, Hamburg, Germany
German Center for Infection Research (DZIF), Hamburg-Borstel-, Lübeck, Riems, Germany
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German Center for Infection Research · Bernhard Nocht Institute for Tropical Medicine
Affiliation as printed
Department of Infectious Diseases Epidemiology, Bernhard Nocht Institute for Tropical Medicine (BNITM), Bernhard-Nocht-Strasse 74, D-20359, Hamburg, Germany
German Center for Infection Research (DZIF), Hamburg-Borstel-, Lübeck, Riems, Germany
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German Center for Infection Research
Affiliation as printed
German Center for Infection Research (DZIF), partner site Tübingen, Wilhelmstrasse 27, D-72074, Tübingen, Germany
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Affiliation as printed
Department of Infectious Diseases, University of Fianarantsoa Andrainjato, 301, Fianarantsoa, Madagascar
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Leiden University Medical Center
Affiliation as printed
Department of Cell and Chemical Biology, Leiden University Medical Center, Albinusdreef 2, 2333 ZA, Leiden, the Netherlands
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Affiliation as printed
UPFR in Parasitology-Mycology of University Hospital Joseph Ravoahangy Andrianavalona Ampefiloha, 101, Antananarivo, Madagascar
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Affiliation as printed
Centre d'Infectiologie Charles Mérieux (CICM), University of Antananarivo, PO Box 4299, 101, Antananarivo, Madagascar
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Leiden University Medical Center
Affiliation as printed
Department of Cell and Chemical Biology, Leiden University Medical Center, Albinusdreef 2, 2333 ZA, Leiden, the Netherlands
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