Evaluation of the Effect of Targeted Mass Drug Administration and Reactive Case Detection on Malaria Transmission and Elimination in East Hararghe Zone, Oromia, Ethiopia
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 48,960
- 试验地点
- 10
- 主要终点
- Change in malaria annual parasite incidence (API)
研究概览
简要总结
Reactive and proactive case detection measures are widely implemented by national malaria elimination programs globally. Similarly, the Ethiopian Federal Ministry of Health decided to include reactive case detection (RCD) and targeted mass drug administration (tMDA) approaches as part of their elimination strategy, along with rigorous evaluation. This study aims to evaluate the impact on annual parasite incidence (API) and cost-effectiveness of implementing tMDA and RCD within a 100-meter radius of passively detected index case, compared with standard of care in the control arm. In addition, cross-sectional surveys will measure the change in malaria prevalence over the two-year study intervention period. The aim is to generate evidence to inform Ethiopia's national strategy for malaria elimination.
详细描述
Study design: Cluster randomized controlled trial
Primary aim: To compare the effect of targeted mass drug administration (tMDA) versus reactive case detection (RCD) on reducing malaria incidence
Study site: Elimination targeted areas within East Hararghe Zones, Oromia Regional State, which is comprised of 24 woredas/districts
Cluster or unit of randomization: Kebeles will be randomized to the control, RCD or tMDA arms using simple randomization
Evaluation methods: The primary outcome measure of annual parasite incidence (API) will be obtained through routine surveillance data at all health facilities (health centers and health posts).
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
- None
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
- 否
入选标准
- •Woreda-level: Of the 19 woredas with malaria risk, the ten woredas with the highest annual parasite incidence (API) in 2018 will be eligible for the study.
- •For Kebeles:
- •Kebeles in East Hararghe Zone targeted for implementation of elimination activities by the Ethiopian Federal Ministry of Health where there is ongoing PMI-supported malaria surveillance;
- •Kebeles with reported API between 1 and 50;
- •Kebeles in malarious districts with comparable optimization of malaria control interventions.
- •For individual participants:
- •All residents of the intervention study kebeles diagnosed with malaria at health facilities (index case) or reside within 100-meter radius with the index case and has NONE of the
排除标准
- •listed below
- •Able to provide informed written consent
- •Exclusion Criteria:
- •For kebeles: Kebeles planning on starting for the first time or discontinuing indoor residual spraying (IRS) campaigns in the next two years.
- •For individual participants:
- •Children less than 6 months of age or <5 kg
- •Known allergy or history of adverse reaction or chronic/congenital disease contra indicated to any of the intervention drugs: PQ, AL or CQ
- •Individuals with severe malnutrition or signs of severe disease, with evidence of any organ failure or Hgb level < 8gm/dl
- •Household members already covered by the intervention less or equal to one month before
- •In addition, the following individuals will be excluded from receiving primaquine:
- •Phenotypically G6PD deficient individuals
- •Pregnant women
- •Lactating women breastfeeding infants less than 6 months of age or with unknown G6PD status
结局指标
主要结局
Change in malaria annual parasite incidence (API)
时间窗: Two years
The effect of RCD or tMDA will be defined as a change in malaria API among residents measured by microscopy/RDT through health centers and health posts. The malaria API will be defined as all passively detected RDT or microscopy confirmed cases over a period of 12 months, who are residents of the kebele divided by the estimated population in the intervention kebele multiplied by 1000. The primary effectiveness endpoint will therefore be API among residents of the kebele at baseline and year 2 of each intervention group of study clusters, compared with the control clusters.
次要结局
- Malaria burden, measured by serology(Two years)
- Malaria burden, measured by antigen test(Two years)
- Malaria burden, measured by molecular testing(Two years)
- Costs(Two years)
- Cost-effectiveness(Two years)
- Ratio of imported to locally acquired incident cases(Two years)
- Adherence(Two years)
- Intervention coverage(Two years)
- Acceptability(Two years)
- Serious adverse events(Two years)
- Sensitivity and specificity of polymerase chain reaction (PCR)(Two years)