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GenMoz2
Plasmodium Falciparum Molecular Surveillance in Mozambique to Monitor Markers of Antimalarial Drug Resistance, Rapid Tests Diagnostic Failure and Transmission in Mozambique: Phase 2
Sponsor study identifier
observational
18,750
1 country
1
Study Start
April 1, 2024
Actual (reported)Primary Completion
December 31, 2025
Actual (reported)Study Completion
September 30, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Mozambique is among the ten countries with the highest burden of malaria worldwide, with an estimated 10.3 million cases in 2021. Malaria transmission is highly heterogeneous across the country, with high burden in the north and very low burden in the south, therefore requiring different strategies for effective control and potential elimination. The GenMoz study (NCT05306067, March 2021-Feb 2024) operationalized a functional malaria molecular surveillance (MMS) system to generate reliable and reproducible temporal genomic data to monitor the effectiveness of rapid diagnostic tests and antimalarials, as well as to continuously characterize transmission levels and sources. The National Malaria Control Program (NMCP) is starting a new strategic cycle (2023-2030) with a plan that includes genomic surveillance for guiding programmatic decisions on six key antimalarial tools : 1. Malaria diagnostics using rapid diagnostic tests (RDTs) based on histidine-rich protein 2 (HRP2); 2. Treatment with artemisinin-based combination therapies (ACTs), including diversification schemes to reduce emergence of resistance; 3. Chemoprevention for pregnant women and children; 4. R21/Matrix-M vaccine rollout; 5. Individual-level interventions in very low transmission settings and 6. Vector control. In Phase 2, the investigators aim to integrate MMS into this wider surveillance framework and scale MMS in Mozambique for quality, timely and appropriate optimization of the public health benefits of the NMCP 2023-2030 strategy in both a proactive and adaptive manner, selecting the combinations of interventions that maximize the impact at the individual and community level.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
September 30, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
April 1, 2024
Actual (reported)July 26, 2024
Actual (reported)July 31, 2024
Actual (reported)December 31, 2025
Actual (reported)September 30, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Prevalence of molecular markers of antimalarial resistance at provincial level
Year 3
Prevalence of hrp2/3 deletions determined at regional level
Year 3
Genetic diversity of the parasite population by period, study area and population
Year 3
Genetic relatedness between pairs of samples and populations by period, study area and population
Year 3
Finger-prick sampling (no internvention/clinical trail)
Finger-prick sampling (no internvention/clinical trail)
Finger-prick sampling (no internvention/clinical trail)
Malaria testing using an LDH-based malaria rapid diagnostic test will be added to standard routine testing of suspected cases at health facilities
Routine malaria rapid diagnostic tests
1. Children at Health Facilities: The first study group comprises children aged 2-10 years who present at health facilities with symptoms suggestive of malaria. 2. Pregnant Women at Antenatal Care (ANC) Visits: The second group includes pregnant women attending their first ANC visit. 3. General Population for Dense Sampling: The third study group involves a diverse population sample of individuals older than 6 months.
Centro de Investigaçao em Saúde de Manhiça
Manhiça, Maputo Province, 1929, Mozambique
da Silva C, Matambisso G, Boene S, Rovira-Vallbona E, Pujol A, Comiche K, Sanchez A, Greenhouse B, Chidimatembue A, Aranda-Diaz A, Arnaldo P, Ariani C, Walker P, Mbeve H, Ndimande N, Tembisse D, Ruybal-Pesantez S, Verity R, Rafael B, Candrinho B, Mayor A. Plasmodium falciparum molecular surveillance to inform the Mozambican National Malaria Control Programme strategy: protocol. BMJ Open. 2024 Nov 24;14(11):e092590. doi: 10.1136/bmjopen-2024-092590.
Dried blood spots on filter paper and rapid diagnostic tests collected by finger-prick
First Submitted
July 26, 2024
First Posted
July 31, 2024
Study Start
April 1, 2024
Actual (reported)Primary Completion
December 31, 2025
Actual (reported)Genetic diversity in circumsporozoite protein C-terminal region encompassing T-cell epitopes
Year 3
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Study Completion
September 30, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
October 21, 2026
Record last verified: 2026-10
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Source: ClinicalTrials.gov.
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