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

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 t...

Descripción completa

Guardado en:

Detalles Bibliográficos
Autores principales:	Daniela Fusco, Raphäel Rakotozandrindrainy, Rivo Andry Rakotoarivelo, Mala Rakoto Andrianarivelo, Njary Rakotozandrindrainy, Tahinamandranto Rasamoelina, Dewi Ismajani Puradiredja, Philipp Klein, Karl Stahlberg, Marie Dechenaud, Eva Lorenz, Anna Jaeger, Andrea Kreidenweiss, Pytsje T. Hoekstra, Akim Ayola Adegnika, Elisa Sicuri, Paul L. A. M. Corstjens, Govert J. van Dam, Jürgen May, Norbert Georg Schwarz, on behalf of the freeBILy consortium
Formato:	article
Lenguaje:	EN
Publicado:	BMC 2021
Materias:	Schistosomiasis Pregnant women Children Mass drug administration Praziquantel Point of care-circulating cathodic antigen test Medicine (General) R5-920
Acceso en línea:	https://doaj.org/article/639b14698233424bb28438e1ca07d47d
Etiquetas:	Agregar Etiqueta Sin Etiquetas, Sea el primero en etiquetar este registro!

id	oai:doaj.org-article:639b14698233424bb28438e1ca07d47d
record_format	dspace
spelling	oai:doaj.org-article:639b14698233424bb28438e1ca07d47d2021-11-21T12:31:07ZA 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 Madagascar10.1186/s13063-021-05769-61745-6215https://doaj.org/article/639b14698233424bb28438e1ca07d47d2021-11-01T00:00:00Zhttps://doi.org/10.1186/s13063-021-05769-6https://doaj.org/toc/1745-6215Abstract 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 2019Daniela FuscoRaphäel RakotozandrindrainyRivo Andry RakotoariveloMala Rakoto AndrianariveloNjary RakotozandrindrainyTahinamandranto RasamoelinaDewi Ismajani PuradiredjaPhilipp KleinKarl StahlbergMarie DechenaudEva LorenzAnna JaegerAndrea KreidenweissPytsje T. HoekstraAkim Ayola AdegnikaElisa SicuriPaul L. A. M. CorstjensGovert J. van DamJürgen MayNorbert Georg Schwarzon behalf of the freeBILy consortiumBMCarticleSchistosomiasisPregnant womenChildrenMass drug administrationPraziquantelPoint of care-circulating cathodic antigen testMedicine (General)R5-920ENTrials, Vol 22, Iss 1, Pp 1-12 (2021)
institution	DOAJ
collection	DOAJ
language	EN
topic	Schistosomiasis Pregnant women Children Mass drug administration Praziquantel Point of care-circulating cathodic antigen test Medicine (General) R5-920
spellingShingle	Schistosomiasis Pregnant women Children Mass drug administration Praziquantel Point of care-circulating cathodic antigen test Medicine (General) R5-920 Daniela Fusco Raphäel Rakotozandrindrainy Rivo Andry Rakotoarivelo Mala Rakoto Andrianarivelo Njary Rakotozandrindrainy Tahinamandranto Rasamoelina Dewi Ismajani Puradiredja Philipp Klein Karl Stahlberg Marie Dechenaud Eva Lorenz Anna Jaeger Andrea Kreidenweiss Pytsje T. Hoekstra Akim Ayola Adegnika Elisa Sicuri Paul L. A. M. Corstjens Govert J. van Dam Jürgen May Norbert Georg Schwarz on behalf of the freeBILy consortium 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
description	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
format	article
author	Daniela Fusco Raphäel Rakotozandrindrainy Rivo Andry Rakotoarivelo Mala Rakoto Andrianarivelo Njary Rakotozandrindrainy Tahinamandranto Rasamoelina Dewi Ismajani Puradiredja Philipp Klein Karl Stahlberg Marie Dechenaud Eva Lorenz Anna Jaeger Andrea Kreidenweiss Pytsje T. Hoekstra Akim Ayola Adegnika Elisa Sicuri Paul L. A. M. Corstjens Govert J. van Dam Jürgen May Norbert Georg Schwarz on behalf of the freeBILy consortium
author_facet	Daniela Fusco Raphäel Rakotozandrindrainy Rivo Andry Rakotoarivelo Mala Rakoto Andrianarivelo Njary Rakotozandrindrainy Tahinamandranto Rasamoelina Dewi Ismajani Puradiredja Philipp Klein Karl Stahlberg Marie Dechenaud Eva Lorenz Anna Jaeger Andrea Kreidenweiss Pytsje T. Hoekstra Akim Ayola Adegnika Elisa Sicuri Paul L. A. M. Corstjens Govert J. van Dam Jürgen May Norbert Georg Schwarz on behalf of the freeBILy consortium
author_sort	Daniela Fusco
title	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
title_short	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
title_full	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
title_fullStr	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
title_full_unstemmed	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
title_sort	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
publisher	BMC
publishDate	2021
url	https://doaj.org/article/639b14698233424bb28438e1ca07d47d
work_keys_str_mv	AT danielafusco aclusterrandomizedcontrolledtrialforassessingpocccatestbasedpraziquanteltreatmentforschistosomiasiscontrolinpregnantwomenandtheiryoungchildrenstudyprotocolofthefreebilyclinicaltrialinmadagascar AT raphaelrakotozandrindrainy aclusterrandomizedcontrolledtrialforassessingpocccatestbasedpraziquanteltreatmentforschistosomiasiscontrolinpregnantwomenandtheiryoungchildrenstudyprotocolofthefreebilyclinicaltrialinmadagascar AT rivoandryrakotoarivelo aclusterrandomizedcontrolledtrialforassessingpocccatestbasedpraziquanteltreatmentforschistosomiasiscontrolinpregnantwomenandtheiryoungchildrenstudyprotocolofthefreebilyclinicaltrialinmadagascar AT malarakotoandrianarivelo aclusterrandomizedcontrolledtrialforassessingpocccatestbasedpraziquanteltreatmentforschistosomiasiscontrolinpregnantwomenandtheiryoungchildrenstudyprotocolofthefreebilyclinicaltrialinmadagascar AT njaryrakotozandrindrainy aclusterrandomizedcontrolledtrialforassessingpocccatestbasedpraziquanteltreatmentforschistosomiasiscontrolinpregnantwomenandtheiryoungchildrenstudyprotocolofthefreebilyclinicaltrialinmadagascar AT tahinamandrantorasamoelina aclusterrandomizedcontrolledtrialforassessingpocccatestbasedpraziquanteltreatmentforschistosomiasiscontrolinpregnantwomenandtheiryoungchildrenstudyprotocolofthefreebilyclinicaltrialinmadagascar AT dewiismajanipuradiredja aclusterrandomizedcontrolledtrialforassessingpocccatestbasedpraziquanteltreatmentforschistosomiasiscontrolinpregnantwomenandtheiryoungchildrenstudyprotocolofthefreebilyclinicaltrialinmadagascar AT philippklein aclusterrandomizedcontrolledtrialforassessingpocccatestbasedpraziquanteltreatmentforschistosomiasiscontrolinpregnantwomenandtheiryoungchildrenstudyprotocolofthefreebilyclinicaltrialinmadagascar AT karlstahlberg aclusterrandomizedcontrolledtrialforassessingpocccatestbasedpraziquanteltreatmentforschistosomiasiscontrolinpregnantwomenandtheiryoungchildrenstudyprotocolofthefreebilyclinicaltrialinmadagascar AT mariedechenaud aclusterrandomizedcontrolledtrialforassessingpocccatestbasedpraziquanteltreatmentforschistosomiasiscontrolinpregnantwomenandtheiryoungchildrenstudyprotocolofthefreebilyclinicaltrialinmadagascar AT evalorenz aclusterrandomizedcontrolledtrialforassessingpocccatestbasedpraziquanteltreatmentforschistosomiasiscontrolinpregnantwomenandtheiryoungchildrenstudyprotocolofthefreebilyclinicaltrialinmadagascar AT annajaeger aclusterrandomizedcontrolledtrialforassessingpocccatestbasedpraziquanteltreatmentforschistosomiasiscontrolinpregnantwomenandtheiryoungchildrenstudyprotocolofthefreebilyclinicaltrialinmadagascar AT andreakreidenweiss aclusterrandomizedcontrolledtrialforassessingpocccatestbasedpraziquanteltreatmentforschistosomiasiscontrolinpregnantwomenandtheiryoungchildrenstudyprotocolofthefreebilyclinicaltrialinmadagascar AT pytsjethoekstra aclusterrandomizedcontrolledtrialforassessingpocccatestbasedpraziquanteltreatmentforschistosomiasiscontrolinpregnantwomenandtheiryoungchildrenstudyprotocolofthefreebilyclinicaltrialinmadagascar AT akimayolaadegnika aclusterrandomizedcontrolledtrialforassessingpocccatestbasedpraziquanteltreatmentforschistosomiasiscontrolinpregnantwomenandtheiryoungchildrenstudyprotocolofthefreebilyclinicaltrialinmadagascar AT elisasicuri aclusterrandomizedcontrolledtrialforassessingpocccatestbasedpraziquanteltreatmentforschistosomiasiscontrolinpregnantwomenandtheiryoungchildrenstudyprotocolofthefreebilyclinicaltrialinmadagascar AT paullamcorstjens aclusterrandomizedcontrolledtrialforassessingpocccatestbasedpraziquanteltreatmentforschistosomiasiscontrolinpregnantwomenandtheiryoungchildrenstudyprotocolofthefreebilyclinicaltrialinmadagascar AT govertjvandam aclusterrandomizedcontrolledtrialforassessingpocccatestbasedpraziquanteltreatmentforschistosomiasiscontrolinpregnantwomenandtheiryoungchildrenstudyprotocolofthefreebilyclinicaltrialinmadagascar AT jurgenmay aclusterrandomizedcontrolledtrialforassessingpocccatestbasedpraziquanteltreatmentforschistosomiasiscontrolinpregnantwomenandtheiryoungchildrenstudyprotocolofthefreebilyclinicaltrialinmadagascar AT norbertgeorgschwarz aclusterrandomizedcontrolledtrialforassessingpocccatestbasedpraziquanteltreatmentforschistosomiasiscontrolinpregnantwomenandtheiryoungchildrenstudyprotocolofthefreebilyclinicaltrialinmadagascar AT onbehalfofthefreebilyconsortium aclusterrandomizedcontrolledtrialforassessingpocccatestbasedpraziquanteltreatmentforschistosomiasiscontrolinpregnantwomenandtheiryoungchildrenstudyprotocolofthefreebilyclinicaltrialinmadagascar AT danielafusco clusterrandomizedcontrolledtrialforassessingpocccatestbasedpraziquanteltreatmentforschistosomiasiscontrolinpregnantwomenandtheiryoungchildrenstudyprotocolofthefreebilyclinicaltrialinmadagascar AT raphaelrakotozandrindrainy clusterrandomizedcontrolledtrialforassessingpocccatestbasedpraziquanteltreatmentforschistosomiasiscontrolinpregnantwomenandtheiryoungchildrenstudyprotocolofthefreebilyclinicaltrialinmadagascar AT rivoandryrakotoarivelo clusterrandomizedcontrolledtrialforassessingpocccatestbasedpraziquanteltreatmentforschistosomiasiscontrolinpregnantwomenandtheiryoungchildrenstudyprotocolofthefreebilyclinicaltrialinmadagascar AT malarakotoandrianarivelo clusterrandomizedcontrolledtrialforassessingpocccatestbasedpraziquanteltreatmentforschistosomiasiscontrolinpregnantwomenandtheiryoungchildrenstudyprotocolofthefreebilyclinicaltrialinmadagascar AT njaryrakotozandrindrainy clusterrandomizedcontrolledtrialforassessingpocccatestbasedpraziquanteltreatmentforschistosomiasiscontrolinpregnantwomenandtheiryoungchildrenstudyprotocolofthefreebilyclinicaltrialinmadagascar AT tahinamandrantorasamoelina clusterrandomizedcontrolledtrialforassessingpocccatestbasedpraziquanteltreatmentforschistosomiasiscontrolinpregnantwomenandtheiryoungchildrenstudyprotocolofthefreebilyclinicaltrialinmadagascar AT dewiismajanipuradiredja clusterrandomizedcontrolledtrialforassessingpocccatestbasedpraziquanteltreatmentforschistosomiasiscontrolinpregnantwomenandtheiryoungchildrenstudyprotocolofthefreebilyclinicaltrialinmadagascar AT philippklein clusterrandomizedcontrolledtrialforassessingpocccatestbasedpraziquanteltreatmentforschistosomiasiscontrolinpregnantwomenandtheiryoungchildrenstudyprotocolofthefreebilyclinicaltrialinmadagascar AT karlstahlberg clusterrandomizedcontrolledtrialforassessingpocccatestbasedpraziquanteltreatmentforschistosomiasiscontrolinpregnantwomenandtheiryoungchildrenstudyprotocolofthefreebilyclinicaltrialinmadagascar AT mariedechenaud clusterrandomizedcontrolledtrialforassessingpocccatestbasedpraziquanteltreatmentforschistosomiasiscontrolinpregnantwomenandtheiryoungchildrenstudyprotocolofthefreebilyclinicaltrialinmadagascar AT evalorenz clusterrandomizedcontrolledtrialforassessingpocccatestbasedpraziquanteltreatmentforschistosomiasiscontrolinpregnantwomenandtheiryoungchildrenstudyprotocolofthefreebilyclinicaltrialinmadagascar AT annajaeger clusterrandomizedcontrolledtrialforassessingpocccatestbasedpraziquanteltreatmentforschistosomiasiscontrolinpregnantwomenandtheiryoungchildrenstudyprotocolofthefreebilyclinicaltrialinmadagascar AT andreakreidenweiss clusterrandomizedcontrolledtrialforassessingpocccatestbasedpraziquanteltreatmentforschistosomiasiscontrolinpregnantwomenandtheiryoungchildrenstudyprotocolofthefreebilyclinicaltrialinmadagascar AT pytsjethoekstra clusterrandomizedcontrolledtrialforassessingpocccatestbasedpraziquanteltreatmentforschistosomiasiscontrolinpregnantwomenandtheiryoungchildrenstudyprotocolofthefreebilyclinicaltrialinmadagascar AT akimayolaadegnika clusterrandomizedcontrolledtrialforassessingpocccatestbasedpraziquanteltreatmentforschistosomiasiscontrolinpregnantwomenandtheiryoungchildrenstudyprotocolofthefreebilyclinicaltrialinmadagascar AT elisasicuri clusterrandomizedcontrolledtrialforassessingpocccatestbasedpraziquanteltreatmentforschistosomiasiscontrolinpregnantwomenandtheiryoungchildrenstudyprotocolofthefreebilyclinicaltrialinmadagascar AT paullamcorstjens clusterrandomizedcontrolledtrialforassessingpocccatestbasedpraziquanteltreatmentforschistosomiasiscontrolinpregnantwomenandtheiryoungchildrenstudyprotocolofthefreebilyclinicaltrialinmadagascar AT govertjvandam clusterrandomizedcontrolledtrialforassessingpocccatestbasedpraziquanteltreatmentforschistosomiasiscontrolinpregnantwomenandtheiryoungchildrenstudyprotocolofthefreebilyclinicaltrialinmadagascar AT jurgenmay clusterrandomizedcontrolledtrialforassessingpocccatestbasedpraziquanteltreatmentforschistosomiasiscontrolinpregnantwomenandtheiryoungchildrenstudyprotocolofthefreebilyclinicaltrialinmadagascar AT norbertgeorgschwarz clusterrandomizedcontrolledtrialforassessingpocccatestbasedpraziquanteltreatmentforschistosomiasiscontrolinpregnantwomenandtheiryoungchildrenstudyprotocolofthefreebilyclinicaltrialinmadagascar AT onbehalfofthefreebilyconsortium clusterrandomizedcontrolledtrialforassessingpocccatestbasedpraziquanteltreatmentforschistosomiasiscontrolinpregnantwomenandtheiryoungchildrenstudyprotocolofthefreebilyclinicaltrialinmadagascar
_version_	1718418947019112448

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

Ejemplares similares