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

This trial accepts healthy volunteers

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 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

Design model

Case-only

Time perspective

Cross-sectional

Treatments tested in this trial

  • LDH-based malaria rapid diagnostic test

    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

  • Malaria rapid diagnostic test

    Diagnostic test

    Routine malaria rapid diagnostic tests

Treatment groups

18,750 Participants
are divided into 3 treatment groups
Group A: Children at Health Facilities1 intervention
Group B: Pregnant Women at ANC1 intervention
Group C: All ages1 intervention

Trial outcomes

Primary outcomes

1

Prevalence of molecular markers of antimalarial resistance at provincial level

Time frame
Year 3
2

Prevalence of hrp2/3 deletions determined at regional level

Time frame
Year 3
3

Genetic diversity of the parasite population by period, study area and population

Time frame
Year 3
4

Genetic relatedness between pairs of samples and populations by period, study area and population

Time frame
Year 3

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

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