Malaria Molecular Surveillance in Mozambique (Phase 2)

NCT06529237 | Recruiting

• 1 other identifier: GenMoz2
• Study Type: observational
• Target: 18,750
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Malaria; Falciparum Malaria; Malaria in Pregnancy

Keywords

drug resistance; Diagnostic resistance; Surveillance; Genomics; Importation; Genetic diversity; Plasmodium falciparum; Next Generation Sequencing

Outcome Measures

Primary Outcomes (5)

• Prevalence of molecular markers of antimalarial resistance at provincial level

  Year 3

• Prevalence of hrp2/3 deletions determined at regional level

  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

• Genetic diversity in circumsporozoite protein C-terminal region encompassing T-cell epitopes

  Year 3

Study Arms (3)

Children at Health Facilities

Finger-prick sampling (no internvention/clinical trail)

Diagnostic Test: LDH-based malaria rapid diagnostic test

Pregnant Women at ANC

Finger-prick sampling (no internvention/clinical trail)

Diagnostic Test: Malaria rapid diagnostic test

All ages

Finger-prick sampling (no internvention/clinical trail)

Diagnostic Test: Malaria rapid diagnostic test

Interventions

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

Children at Health Facilities

Malaria rapid diagnostic test DIAGNOSTIC_TEST

Routine malaria rapid diagnostic tests

All ages; Pregnant Women at ANC

Eligibility Criteria

• Age: 6 Months+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study 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.

You may qualify if:

• 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)

You may not qualify if:

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

Sponsors & Collaborators

• Centro de Investigacao em Saude de Manhica: lead
• Barcelona Institute for Global Health: collaborator
• University of California, San Francisco: collaborator
• National Malaria Control Program, Mozambique: collaborator

Study Sites (1)

Centro de Investigaçao em Saúde de Manhiça

Manhiça, Maputo Province, 1929, Mozambique

RECRUITING

Related Publications (1)

• da Silva C, Matambisso G, Boene S, Rovira-Vallbona E, Pujol A, Comiche K, Sanchez A, Greenhouse B, Chidimatembue A, Aranda-Diaz A, Arnaldo P, Ariani C, Walker P, Mbeve H, Ndimande N, Tembisse D, Ruybal-Pesantez S, Verity R, Rafael B, Candrinho B, Mayor A. Plasmodium falciparum molecular surveillance to inform the Mozambican National Malaria Control Programme strategy: protocol. BMJ Open. 2024 Nov 24;14(11):e092590. doi: 10.1136/bmjopen-2024-092590.

  PMID: 39581722 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Dried blood spots on filter paper and rapid diagnostic tests collected by finger-prick

MeSH Terms

Conditions

Malaria; Malaria, Falciparum

Condition Hierarchy (Ancestors)

Protozoan Infections; Parasitic Diseases; Infections; Mosquito-Borne Diseases; Vector Borne Diseases

Central Study Contacts

Alfredo Mayor, Professor

CONTACT

+34 686444183; alfredo.mayor@isglobal.org

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 26, 2024
• First Posted: July 31, 2024
• Study Start: April 1, 2024
• Primary Completion (Estimated): March 31, 2027
• Study Completion (Estimated): March 31, 2027
• Last Updated: August 26, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will share

Locations

MO (1)