RecruitingNCT06529237

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


Sponsor

Centro de Investigacao em Saude de Manhica

Enrollment

18,750 participants

Start Date

Apr 1, 2024

Study Type

OBSERVATIONAL

Conditions

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.


Eligibility

Min Age: 6 Months

Inclusion Criteria13

  • A) CHILDREN AT HEALTH FACILITIES
  • 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)
  • 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
  • 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 Criteria15

  • 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
  • Unwilling to provide informed, written consent
  • Not resident in study area
  • Any symptoms of severe malaria
  • C) DENSE SAMPLING
  • 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

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DIAGNOSTIC_TESTLDH-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_TESTMalaria rapid diagnostic test

Routine malaria rapid diagnostic tests


Locations(1)

Centro de Investigaçao em Saúde de Manhiça

Manhiça, Maputo Province, Mozambique

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06529237


Related Trials