Effectiveness of Seasonal Malaria Chemoprevention in Nampula Province, Mozambique: Evaluated Using a Type Two Hybrid Implementation Science Observational Study
试验速览
- 阶段
- 4 期
- 状态
- 进行中（未招募）
- 入组人数
- 3,156
- 试验地点
- 2
- 主要终点
- Malaria Incidence
研究概览
简要总结
We describe a Type II hybrid effectiveness-implementation study design which evaluates the effects of a clinical intervention on relevant outcomes whilst collecting information on implementation. It is designed to determine feasibility and effectiveness of an innovative intervention, as well as the protective efficacy of the drugs used. The study consists of three components: 1) Conducting a cluster randomized controlled trial (cRCT) through household surveys establishing confirmed malaria cases in children; 2) Conducting a prospective cohort study to determine the chemoprevention efficacy of sulfadoxine-pyrimethamine and amodiaquine (SPAQ) and whether drug concentrations or parasite resistance influence the duration of protection; and 3) Conducting a resistance markers study in children 3-59 months to measure changes in resistance marker prevalence over time.
详细描述
This implementation research study uses a convergent mixed-methods approach. SMC will be implemented in four monthly cycles between December 2021 and February 2022. The research will involve the following components:
- Conducting a cluster randomized controlled trial (cRCT) through passive surveillance to establish confirmed malaria cases in children
- Conducting a prospective chemoprevention efficacy cohort study to determine if SPAQ provides 28 days of protection from infection and whether drug concentrations and/or resistance influence the duration of protection
- Conducting a resistance markers study in children 3-59 months in the two research districts plus the two standard intervention districts to measure changes in resistance marker prevalence over time.
Four districts will be involved in the study: the two intervention districts from phase 1 (Mecubúri and Malema) and two districts where SMC has not previously been implemented (Lalaua and Muecate). The cRCT will only be implemented in the two new districts. The chemoprevention efficacy cohort study will only be conducted in one of the two new districts, which will be selected based on operational feasibility. The estimated target population for SMC in the study districts is 114,000 children aged 3-59 months.
Methods
- Cluster randomized controlled trial (cRCT) To assess the effectiveness of SMC using a cluster randomized control trial (cRCT) in two districts in Nampula province.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 3 Months 至 59 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Children aged 3-59 months living in a SMC eligible area in Lalua or Mercate district in Nampula province in Mozambique.
排除标准
- •Children with HIV,
- •Children with a history of severe adverse reaction to SP or AQ, or
- •children who had used SP within the previous month before recruitment
研究组 & 干预措施
Control
SMC eligible kids aged 3-59 months who will not receive a standard SMC intervention of 4 cycles of SPAQ over 4 months.
干预措施: Control Test - no drugs given (Drug)
Intervention
SMC eligible kids aged 3-59 months who will receive a standard SMC intervention of 4 cycles of SPAQ over 4 months.
干预措施: Chemopreventive Agent - SPAQ (Drug)
结局指标
主要结局
Malaria Incidence
时间窗: Four months
RDT confirmed malaria cases in enrolled populations as reported through passive surveillance
Chemopreventive Efficacy
时间窗: One month
chemoprevention failure in the presence of adequate drug concentration
Prevalence of resistance markers
时间窗: Five months
Prevalence of relevant sulfadoxine-pyrimethamine (SP) or amodiaquine (AQ) or piperiquine associated antimalarial resistance markers
次要结局
- Severe anemia(Five months)
- Parestemia levels(Five months)
- Severe anemia levels(Five months)