RECRUITINGOBSERVATIONAL

Malaria Molecular Surveillance in Mozambique (Phase 2)

Plasmodium Falciparum Molecular Surveillance in Mozambique to Monitor Markers of Antimalarial Drug Resistance, Rapid Tests Diagnostic Failure and Transmission in Mozambique: Phase 2

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.

Who May Be Eligible (Plain English)

A) CHILDREN AT HEALTH FACILITIES Who May Qualify: - 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) Who Should NOT Join This Trial: - 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 Who May Qualify: - 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 Who Should NOT Join This Trial: - Unwilling to provide informed, written consent - Not resident in study area - Any symptoms of severe malaria C) DENSE SAMPLING Who May Qualify: - 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 Who Should NOT Join This Trial: - Any symptoms of severe malaria - Negative parasitological test for malaria via RDT - Unwilling to provide informed, written consent - History of antimalarial treatment in the last 14 days Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language

A) CHILDREN AT HEALTH FACILITIES Inclusion Criteria: * 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) Exclusion Criteria: * 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 * Unwilling to provide informed, written consent * History of antimalarial treatment in the last 14 days

Treatments Being Tested

DIAGNOSTIC_TEST

LDH-based malaria rapid diagnostic test

Malaria testing using an LDH-based malaria rapid diagnostic test will be added to standard routine testing of suspected cases at health facilities

DIAGNOSTIC_TEST

Malaria rapid diagnostic test

Routine malaria rapid diagnostic tests

Locations (1)

Centro de Investigaçao em Saúde de Manhiça

Manhiça, Maputo Province, Mozambique