Malaria Molecular Surveillance in Mozambique (Phase 2)
Recruiting now
Conditions studied: Malaria, Falciparum Malaria, Malaria in Pregnancy
In brief
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.
Key facts
- Study ID
- NCT06529237
- Run by
- Centro de Investigacao em Saude de Manhica
- People needed
- 18750
- Starts
- 2024-04-01
- Expected to finish
- 2027-03-31
- Last updated by the study team
- 2024-08-26
Who can join
Age: 1 and older. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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)
You may not qualify if…
- Unwilling to provide informed, written consent
- Age <2 years or >10 years
- not resident in study area
- Any symptoms of severe malaria
- Negative of both (HRP2 and LDH) parasitological test for malaria via RDT
- History of antimalarial treatment in the last 14 days
- B) PREGNANT WOMEN AT ANC
- Inclusion Criteria:
- Pregnant women attending first antenatal care visit
- Resident in the study area
- Pregnant Women older than 12 years old
- Informed, written consent to participate from participant and/or guardian
- Exclusion Criteria:
- Unwilling to provide informed, written consent
- Not resident in study area
- Any symptoms of severe malaria
- C) DENSE SAMPLING
- Inclusion Criteria:
- People > 6 months of age
- Fever (axillary temperature ≥37.5ºC) or history of fever in the preceding 24 hours
- Positive parasitological test for malaria diagnosis via RDT
- Informed, written consent to participate from participant and/or guardian
- Exclusion Criteria:
- Any symptoms of severe malaria
- Negative parasitological test for malaria via RDT
Where it is running
- Centro de Investigaçao em Saúde de Manhiça — Manhiça, Maputo Province, Mozambique (enrolling)
Full record on ClinicalTrials.gov
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