Plasmodium Falciparum Molecular Surveillance in Mozambique to Monitor Markers of Antimalarial Drug Resistance, Rapid Tests Diagnostic Failure and Transmission in Mozambique: Phase 2
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 18,750
- 试验地点
- 1
- 主要终点
- Prevalence of molecular markers of antimalarial resistance at provincial level
研究概览
简要总结
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.
详细描述
The AIM of this project is to strengthen and scale Molecular Malaria Surveillance (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 impact at the individual and community level. The SPECIFIC AIMS and expected programmatic impacts are:
AIM 1: Real-time tracking of biological threats to ongoing NMCP strategies:
Address diagnostic failures, including gene deletions in RDT targets (HRP2/3) or non-falciparum infections. Programmatic impacts include updating RDT protocols based on prevalence thresholds of pfhrp2/3 deletions or non-falciparum species.
Assess therapeutic resistance through molecular markers of first-line ACT resistance and support from Therapeutic Efficacy Studies (TES), distinguishing recrudescence from new infections to inform efficacy estimates and containment measures.
Identify transmission sources locally and nationally through genetic case classification and outbreak monitoring, enhancing targeted interventions and source-sink dynamics.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 6 Months 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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)
排除标准
- •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
结局指标
主要结局
Prevalence of molecular markers of antimalarial resistance at provincial level
时间窗: Year 3
Prevalence of hrp2/3 deletions determined at regional level
时间窗: Year 3
Genetic relatedness between pairs of samples and populations by period, study area and population
时间窗: Year 3
Genetic diversity of the parasite population by period, study area and population
时间窗: Year 3
Genetic diversity in circumsporozoite protein C-terminal region encompassing T-cell epitopes
时间窗: Year 3
次要结局
未报告次要终点