About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Informed, written consent to participate from the guardian
Children 2-10 years of age
Fever (axillary temperature ≥37.5ºC) or history of fever in the preceding 24 hours
At least one positive parasitological test for malaria diagnosis via RDT (HRP2 or LDH)
Disqualifiers
Unwilling to provide informed, written consent
Age <2 years or >10 years
not resident in study area
Any symptoms of severe malaria
Trial population
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.
Trial design
Case-only
Cross-sectional
Treatments tested in this trial
LDH-based malaria rapid diagnostic test
Diagnostic testMalaria testing using an LDH-based malaria rapid diagnostic test will be added to standard routine testing of suspected cases at health facilities
Malaria rapid diagnostic test
Diagnostic testRoutine malaria rapid diagnostic tests
Treatment groups
Trial outcomes
Primary outcomes
Prevalence of molecular markers of antimalarial resistance at provincial level
Prevalence of hrp2/3 deletions determined at regional level
Genetic diversity of the parasite population by period, study area and population
Genetic relatedness between pairs of samples and populations by period, study area and population
Sponsors and contacts
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Centro de Investigacao em Saude de Manhica
Lead sponsor
Barcelona Institute for Global Health
Collaborator
University of California, San Francisco
Collaborator
National Malaria Control Program
Collaborator