Malaria Molecular Surveillance in Mozambique (Phase 2)
Mozambique18,750 participantsStarted 2024-04-01
Plain-language summary
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 can participate
Age range
6 Months
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Prevalence of molecular markers of antimalarial resistance at provincial level
Timeframe: Year 3
2
Prevalence of hrp2/3 deletions determined at regional level
Timeframe: Year 3
3
Genetic diversity of the parasite population by period, study area and population
Timeframe: Year 3
4
Genetic relatedness between pairs of samples and populations by period, study area and population
Timeframe: Year 3
5
Genetic diversity in circumsporozoite protein C-terminal region encompassing T-cell epitopes