Prospective surveillance study to detect antimalarial drug resistance, gene deletions of diagnostic relevance and genetic diversity of Plasmodium falciparum in Mozambique: protocol

Introduction Genomic data constitute a valuable adjunct to routine surveillance that can guide programmatic decisions to reduce the burden of infectious diseases. However, genomic capacities remain low in Africa. This study aims to operationalise a functional malaria molecular surveillance system in...

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Main Authors: Alexandra Wharton-Smith, Caterina Guinovart, Pedro Aide, Francisco Saute, Alfredo Mayor, Bryan Greenhouse, Baltazar Candrinho, Joshua L Proctor, Arantxa Roca-Feltrer, Clemente da Silva, Eduard Rovira-Vallbona, Craig Bonnington, Caitlin Bever, Arlindo Chidimatembue, Maria Rodrigues, Neide Canana, Paulo Arnaldo, Simone Boene, Sonia Enosse
Format: Article
Language:English
Published: BMJ Publishing Group 2022-07-01
Series:BMJ Open
Online Access:https://bmjopen.bmj.com/content/12/7/e063456.full
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author Alexandra Wharton-Smith
Caterina Guinovart
Pedro Aide
Francisco Saute
Alfredo Mayor
Bryan Greenhouse
Baltazar Candrinho
Joshua L Proctor
Arantxa Roca-Feltrer
Clemente da Silva
Eduard Rovira-Vallbona
Craig Bonnington
Caitlin Bever
Arlindo Chidimatembue
Maria Rodrigues
Neide Canana
Paulo Arnaldo
Simone Boene
Sonia Enosse
author_facet Alexandra Wharton-Smith
Caterina Guinovart
Pedro Aide
Francisco Saute
Alfredo Mayor
Bryan Greenhouse
Baltazar Candrinho
Joshua L Proctor
Arantxa Roca-Feltrer
Clemente da Silva
Eduard Rovira-Vallbona
Craig Bonnington
Caitlin Bever
Arlindo Chidimatembue
Maria Rodrigues
Neide Canana
Paulo Arnaldo
Simone Boene
Sonia Enosse
author_sort Alexandra Wharton-Smith
collection DOAJ
description Introduction Genomic data constitute a valuable adjunct to routine surveillance that can guide programmatic decisions to reduce the burden of infectious diseases. However, genomic capacities remain low in Africa. This study aims to operationalise a functional malaria molecular surveillance system in Mozambique for guiding malaria control and elimination.Methods and analyses This prospective surveillance study seeks to generate Plasmodium falciparum genetic data to (1) monitor molecular markers of drug resistance and deletions in rapid diagnostic test targets; (2) characterise transmission sources in low transmission settings and (3) quantify transmission levels and the effectiveness of antimalarial interventions. The study will take place across 19 districts in nine provinces (Maputo city, Maputo, Gaza, Inhambane, Niassa, Manica, Nampula, Zambézia and Sofala) which span a range of transmission strata, geographies and malaria intervention types. Dried blood spot samples and rapid diagnostic tests will be collected across the study districts in 2022 and 2023 through a combination of dense (all malaria clinical cases) and targeted (a selection of malaria clinical cases) sampling. Pregnant women attending their first antenatal care visit will also be included to assess their value for molecular surveillance. We will use a multiplex amplicon-based next-generation sequencing approach targeting informative single nucleotide polymorphisms, gene deletions and microhaplotypes. Genetic data will be incorporated into epidemiological and transmission models to identify the most informative relationship between genetic features, sources of malaria transmission and programmatic effectiveness of new malaria interventions. Strategic genomic information will be ultimately integrated into the national malaria information and surveillance system to improve the use of the genetic information for programmatic decision-making.Ethics and dissemination The protocol was reviewed and approved by the institutional (CISM) and national ethics committees of Mozambique (Comité Nacional de Bioética para Saúde) and Spain (Hospital Clinic of Barcelona). Project results will be presented to all stakeholders and published in open-access journals.Trial registration number NCT05306067.
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spelling doaj-art-973c8c755ccf4153acfc32b92ebc8cf42025-01-31T06:05:10ZengBMJ Publishing GroupBMJ Open2044-60552022-07-0112710.1136/bmjopen-2022-063456Prospective surveillance study to detect antimalarial drug resistance, gene deletions of diagnostic relevance and genetic diversity of Plasmodium falciparum in Mozambique: protocolAlexandra Wharton-Smith0Caterina Guinovart1Pedro Aide2Francisco Saute3Alfredo Mayor4Bryan Greenhouse5Baltazar Candrinho6Joshua L Proctor7Arantxa Roca-Feltrer8Clemente da Silva9Eduard Rovira-Vallbona10Craig Bonnington11Caitlin Bever12Arlindo Chidimatembue13Maria Rodrigues14Neide Canana15Paulo Arnaldo16Simone Boene17Sonia Enosse18Malaria Consortium, London, UKBarcelona Institute for Global Health, Hospital Clínic-Universitat de Barcelona, Barcelona, SpainCentro de Investigação em Saúde de Manhiça, Manhiça, Maputo, MozambiqueCentro de Investigação em Saúde de Manhiça, Maputo, Mozambique9 Faculdade de Medicina, Universidade Eduardo Mondlane, Maputo, MozambiqueDepartment of Medicine, University of California San Francisco, San Francisco, California, USA7 National Malaria Control Program, Ministry of Health, Maputo, MozambiqueBill & Melinda Gates Foundation, Seattle, Washington, USAMalaria Consortium, London, UK1 Centro de Investigação em Saúde de Manhiça (CISM), Manhiça, Mozambique2 ISGlobal, Barcelona, SpainMalaria Consortium, London, UKBill & Melinda Gates Foundation, Seattle, Washington, USA1 Centro de Investigação em Saúde de Manhiça (CISM), Manhiça, MozambiqueMalaria Consortium, London, UKMalaria Consortium, London, UK4 Instituto Nacional de Saúde, Maputo, Mozambique1 Centro de Investigação em Saúde de Manhiça (CISM), Manhiça, MozambiqueMalaria Consortium, London, UKIntroduction Genomic data constitute a valuable adjunct to routine surveillance that can guide programmatic decisions to reduce the burden of infectious diseases. However, genomic capacities remain low in Africa. This study aims to operationalise a functional malaria molecular surveillance system in Mozambique for guiding malaria control and elimination.Methods and analyses This prospective surveillance study seeks to generate Plasmodium falciparum genetic data to (1) monitor molecular markers of drug resistance and deletions in rapid diagnostic test targets; (2) characterise transmission sources in low transmission settings and (3) quantify transmission levels and the effectiveness of antimalarial interventions. The study will take place across 19 districts in nine provinces (Maputo city, Maputo, Gaza, Inhambane, Niassa, Manica, Nampula, Zambézia and Sofala) which span a range of transmission strata, geographies and malaria intervention types. Dried blood spot samples and rapid diagnostic tests will be collected across the study districts in 2022 and 2023 through a combination of dense (all malaria clinical cases) and targeted (a selection of malaria clinical cases) sampling. Pregnant women attending their first antenatal care visit will also be included to assess their value for molecular surveillance. We will use a multiplex amplicon-based next-generation sequencing approach targeting informative single nucleotide polymorphisms, gene deletions and microhaplotypes. Genetic data will be incorporated into epidemiological and transmission models to identify the most informative relationship between genetic features, sources of malaria transmission and programmatic effectiveness of new malaria interventions. Strategic genomic information will be ultimately integrated into the national malaria information and surveillance system to improve the use of the genetic information for programmatic decision-making.Ethics and dissemination The protocol was reviewed and approved by the institutional (CISM) and national ethics committees of Mozambique (Comité Nacional de Bioética para Saúde) and Spain (Hospital Clinic of Barcelona). Project results will be presented to all stakeholders and published in open-access journals.Trial registration number NCT05306067.https://bmjopen.bmj.com/content/12/7/e063456.full
spellingShingle Alexandra Wharton-Smith
Caterina Guinovart
Pedro Aide
Francisco Saute
Alfredo Mayor
Bryan Greenhouse
Baltazar Candrinho
Joshua L Proctor
Arantxa Roca-Feltrer
Clemente da Silva
Eduard Rovira-Vallbona
Craig Bonnington
Caitlin Bever
Arlindo Chidimatembue
Maria Rodrigues
Neide Canana
Paulo Arnaldo
Simone Boene
Sonia Enosse
Prospective surveillance study to detect antimalarial drug resistance, gene deletions of diagnostic relevance and genetic diversity of Plasmodium falciparum in Mozambique: protocol
BMJ Open
title Prospective surveillance study to detect antimalarial drug resistance, gene deletions of diagnostic relevance and genetic diversity of Plasmodium falciparum in Mozambique: protocol
title_full Prospective surveillance study to detect antimalarial drug resistance, gene deletions of diagnostic relevance and genetic diversity of Plasmodium falciparum in Mozambique: protocol
title_fullStr Prospective surveillance study to detect antimalarial drug resistance, gene deletions of diagnostic relevance and genetic diversity of Plasmodium falciparum in Mozambique: protocol
title_full_unstemmed Prospective surveillance study to detect antimalarial drug resistance, gene deletions of diagnostic relevance and genetic diversity of Plasmodium falciparum in Mozambique: protocol
title_short Prospective surveillance study to detect antimalarial drug resistance, gene deletions of diagnostic relevance and genetic diversity of Plasmodium falciparum in Mozambique: protocol
title_sort prospective surveillance study to detect antimalarial drug resistance gene deletions of diagnostic relevance and genetic diversity of plasmodium falciparum in mozambique protocol
url https://bmjopen.bmj.com/content/12/7/e063456.full
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