Actively Recruiting

Age: 6Months +
All Genders
Healthy Volunteers
ID06529237

Plasmodium Falciparum Molecular Surveillance in Mozambique to Monitor Antimalarial Drug Resistance, RDT Failure, and Transmission: Phase 2

Led by Centro de Investigacao em Saude de Manhica · Updated on 2024-08-26

18750

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

Sponsors

C

Centro de Investigacao em Saude de Manhica

Lead Sponsor

B

Barcelona Institute for Global Health

Collaborating Sponsor

AI-Summary

What this Trial Is About

Mozambique faces a high burden of malaria, especially in the northern regions, requiring varied strategies for control and elimination. Researchers aim to strengthen and expand molecular malaria surveillance (MMS) to guide public health decisions under the National Malaria Control Program's 2023-2030 strategy. The study focuses on tracking diagnostic test effectiveness, antimalarial resistance, transmission sources, and vector control through genomic data. Participants include children, pregnant women, and individuals of all ages with suspected malaria symptoms. The study collects biological samples using finger-prick blood spots from health facility surveys, targeted sentinel sites, and antenatal clinics. Advanced genomic sequencing and molecular techniques analyze malaria parasites and mosquitoes to detect resistance markers, gene deletions, and transmission patterns. Data integration and continuous training enhance surveillance quality and use. Participants will undergo malaria rapid diagnostic testing, with additional LDH-based testing added in some cases. Researchers will perform molecular and epidemiological analyses to monitor resistance prevalence, parasite genetic diversity, and vaccine escape variants. Data collection uses digital tools and quality control measures. The study includes regular reporting, capacity building, and stakeholder engagement to ensure data informs malaria control efforts over approximately three years from 2024 to 2027.

CONDITIONS

Brief Title

Malaria Molecular Surveillance in Mozambique (Phase 2)

Who Can Participate

Age: 6Months +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Children aged 2 to 10 years with fever or recent history of fever and a positive malaria rapid diagnostic test
  • Pregnant women attending their first antenatal care visit, older than 12 years, residing in the study area
  • Individuals older than 6 months with fever or recent history of fever and a positive malaria rapid diagnostic test
  • Informed, written consent provided by participant or guardian
Not Eligible

You will not qualify if you...

  • Unwilling to provide informed, written consent
  • Children younger than 2 years or older than 10 years
  • Not residing in the study area
  • Presence of symptoms of severe malaria
  • Negative results on both HRP2 and LDH rapid diagnostic tests for malaria
  • History of antimalarial treatment in the last 14 days

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Surveillance

Duration - Up to 5 years

Participants provide finger-prick blood samples during health facility visits or antenatal care to enable molecular malaria surveillance, including testing for resistance markers and genetic analysis of malaria parasites and vectors.

Multiple visits depending on participant group and health facility attendance

Trial Site Locations

Total: 1 location

1

Centro de Investigaçao em Saúde de Manhiça

Manhiça, Maputo Province, Mozambique, 1929

Actively Recruiting

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Research Team

A

Alfredo Mayor, Professor

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

3

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Published Research Related To This Trial

Plasmodium falciparum molecular surveillance to inform the Mozambican National Malaria Control Programme strategy: protocol.

Clemente da Silva, Gloria Matambisso, Simone Boene...

https://pubmed.ncbi.nlm.nih.gov/39581722