Plasmodium falciparum molecular surveillance to inform the Mozambican National Malaria Control Program strategy: Protocol

<ns3:p>Introduction Malaria molecular surveillance has the potential to generate information on biological threats that compromise the effectiveness of antimalarial interventions. This study aims to streamline surveillance activities to inform the new strategic plan of the Mozambican National Malaria Control Program (2023-2030) for malaria control and elimination. Methods and analyses This prospective genomic surveillance study aims to generate <ns3:italic>P. falciparum</ns3:italic> genetic data to monitor diagnostic failures due to <ns3:italic>pfhrp2/3</ns3:italic> deletions and molecular markers of antimalarial drug resistance, to characterize transmission sources, and to inform the implementation of new antimalarial approaches to be introduced in Mozambique (chemoprevention and child malaria vaccination). The study, to be conducted between 2024 and 2026, will use three sampling schemes: a multi-cluster probabilistic health facility survey in the 10 provinces of the country to detect pfhrp2/3 deletions and markers of antimalarial drug resistance; dense sampling of all clinical cases in representative districts in the south targeted for elimination to characterize malaria importation and identify sources of transmission; and testing of pregnant women for malaria at their first ANC visit to assess malaria burden and molecular trends. Using a multiplex amplicon-based sequencing approach, the study will target microhaplotypes informative of genomic diversity and relatedness, as well as key drug resistance-associated genes, <ns3:italic>hrp2/3</ns3:italic> deletion and malaria vaccine targets. Key genomic information will be visualized in a dashboard integrated into the DHIS2-based Malaria Information Storage System for programmatic use. Ethics and dissemination The protocol was reviewed and approved by the national ethics committees of Mozambique (Comité Nacional de Bioética para Saúde). Project results will be presented to all stakeholders using study-specific brochures and published in open-access journals. Study registration number This study was registered in ClinicalTrials.gov, under the registration number: NCT06529237 (31st July 2024).</ns3:p>