Malaria Molecular Surveillance in Mozambique (Phase 2)

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age6+
SponsorCentro de Investigacao em Saude de Manhica

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

Qualifiers

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 design

Treatments tested in this trial

  • LDH-based malaria rapid diagnostic test
  • Malaria rapid diagnostic test

Treatment groups

18,750 Participants
are divided into 3 treatment groups

Sponsors and collaborators

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