Plasmodium Falciparum Genomic Intelligence in Mozambique
GenMoz
A Prospective Surveillance Study to Detect Antimalarial Drug Resistance, Gene Deletions of Diagnostic Relevance and Genetic Diversity of Plasmodium Falciparum in Mozambique
1 other identifier
observational
21,848
1 country
1
Brief Summary
Mozambique is among the ten countries with the highest burden of malaria worldwide, with an estimated 9.3 million cases in 2018, and constitutes a core target for the World Health Organization (WHO) and the Roll Back Malaria Partnership to End Malaria's country-led 'high burden to high impact' initiative. At the same time, the National Malaria Control Program (NMCP) of Mozambique seeks to accelerate elimination in the south, where transmission is lowest. NMCP is currently working with partners (Malaria Consortium, PMI, Global Fund) to set up a high-resolution surveillance system that can drive decision-making across all transmission strata through strengthening of routine data quality, data use and data to action packages. However, decisions become more complex as control reveals heterogeneity and better tools are required for a strategic use of information to drive impact. The overall objective of the study is to operationalize a functional malaria molecular surveillance (MMS) system that generates reliable and reproducible genomic data over time for programmatic decisions. The integration of genomic data into routine surveillance activities has the potential to increase the actionable intelligence for making programmatic decisions on the optimal mix of control and elimination measures in Mozambique by:
- 1.Informing drug and diagnostic choices through the monitoring of antimalarial drug resistance and diagnostic resistance (hrp2/3 deletions);
- 2.Targeting the reservoirs sustaining transmission through the use of transmission network models to quantify parasite importation, identify sources and characterize local transmission in near-elimination settings;
- 3.Improving stratification, monitoring and impact evaluations in different epidemiological and health system contexts through the use of measures of P. falciparum genetic diversity (routinely from positive cases) to supplement traditional surveillance, especially where it is sparse;
- 4.Using alternative, cost-effective, approaches targeting easy-access populations (e.g. pregnant women at antenatal care clinics) to monitor transmission and antimalarial/diagnostic resistance.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Oct 2021
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 12, 2021
CompletedFirst Submitted
Initial submission to the registry
March 15, 2022
CompletedFirst Posted
Study publicly available on registry
March 31, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
March 31, 2024
CompletedAugust 27, 2024
August 1, 2024
2.2 years
March 15, 2022
August 26, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Prevalence of molecular markers of diagnostic resistance and antimalarial drug resistance by period, study area and population
Year 3
Genetic diversity of the parasite population by period, study area and population
Year 3
Genetic relatedness between pairs of samples and populations by period, study area and population
Year 3
Study Arms (4)
Children at low transmission health facilities
Children at medium-to-high transmission health facilities
Pregnant women at low transmission ANC
Pregnant women at medium-to-high transmission transmission ANC
Interventions
Malaria testing using an LDH-based malaria rapid diagnostic test will be added to standard routine testing of suspected cases at health facilities
All pregnant women attending their first routine antenatal visit will be tested for malaria using routine malaria rapid diagnostic tests
Eligibility Criteria
In low transmission areas, people of any age (\> 6 months of age), with clinical symptoms of malaria and a parasitologically confirmed malaria diagnosis via RDT or microscopy will be invited to participate in the study, along with any household contacts of these malaria index cases, if they test P. falciparum positive with an RDT. Malaria-positive index cases of all ages from Magude and Matutuine will be also recruited, as well as individuals crossing the Matutuine Ponta d'Ouro border post who have a malaria positive RDT. In medium-to-high transmission areas, children under 2-10 years old, with clinical symptoms of malaria and a P. falciparum positive RDT will be invited to participate. Pregnant women attending their first antenatal care visit (any trimester) will be invited to participate in both trasnmission areas.
You may qualify if:
- Any age
- Fever (axillary temperature ≥37.5ºC) or history of fever in the preceding 24 hours
- Positive parasitological test for malaria diagnosis via RDT or microscopy OR
- Household contact of someone with fever/history of fever and Pf positive RDT
- Positive parasitological test for malaria diagnosis via RDT OR
- Pregnant women attending first antenatal care visit AND
- Informed, written consent to participate from participant and/or guardian
You may not qualify if:
- Any symptoms of severe malaria
- Negative parasitological test for malaria via RDT or microscopy (except any women at their first ANC visit, who will be recruited before testing for malaria with an RDT)
- Unwilling to provide informed, written consent
- History of antimalarial treatment in the last 14 days
- B) MEDIUM-TO-HIGH TRANSMISSION AREAS
- Children 2-10 years of age
- Fever (axillary temperature ≥37.5ºC) or history of fever in the preceding 24 hours
- Positive parasitological test for malaria diagnosis via RDT or microscopy OR
- Pregnant women attending first antenatal care visit AND
- Informed, written consent to participate from participant and/or guardian
- Any symptoms of severe malaria
- Negative parasitological test for malaria via RDT or microscopy (except any women at their first ANC visit, who will be recruited before testing for malaria with an RDT)
- Unwilling to provide informed, written consent
- History of antimalarial treatment in the last 14 days
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Centro de Investigacao em Saude de Manhicalead
- National Malaria Control Program, Mozambiquecollaborator
- Malaria Consortiumcollaborator
- Barcelona Institute for Global Healthcollaborator
- University of California, San Franciscocollaborator
Study Sites (1)
Centro de Investigaçao em Saúde de Manhiça
Manhiça, Maputo Province, 1929, Mozambique
Related Publications (1)
Mayor A, da Silva C, Rovira-Vallbona E, Roca-Feltrer A, Bonnington C, Wharton-Smith A, Greenhouse B, Bever C, Chidimatembue A, Guinovart C, Proctor JL, Rodrigues M, Canana N, Arnaldo P, Boene S, Aide P, Enosse S, Saute F, Candrinho B. Prospective surveillance study to detect antimalarial drug resistance, gene deletions of diagnostic relevance and genetic diversity of Plasmodium falciparum in Mozambique: protocol. BMJ Open. 2022 Jul 12;12(7):e063456. doi: 10.1136/bmjopen-2022-063456.
PMID: 35820756DERIVED
Related Links
Biospecimen
Dried blood spot onto filter paper and rapid diagnostic tests collected by finger-prick.
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 15, 2022
First Posted
March 31, 2022
Study Start
October 12, 2021
Primary Completion
December 31, 2023
Study Completion
March 31, 2024
Last Updated
August 27, 2024
Record last verified: 2024-08