A Cluster Randomized Controlled Trial of Pro-active Community Case Management for Malaria in Chadiza District, Eastern Province, Zambia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 10,890
- 试验地点
- 1
- 主要终点
- Parasite Prevalence
研究概览
简要总结
To study if a proactive strategy of weekly household visits by community health workers (CHWs) to identify people with malaria symptoms, offer diagnostic testing, and treatment for those with positive tests in Chadiza District, Eastern Province, can decrease malaria incidence and prevalence compared to conventional community case management.
详细描述
This study will be a two arm, cluster-randomized controlled trial to determine whether year round weekly household visits by CHWs to detect and test people of all ages with fever or history of fever with RDTs (and offer diagnosis and referral or treatment of diarrhea and pneumonia for children under 5 years), and offer treatment with an ACT for those who test positive compared to standard passive iCCM by CHWs (which includes malaria case management for all ages in Zambia), is associated with a greater reduction in confirmed malaria cases and parasite prevalence over a 2-year follow-up period.
Randomization will occur at the level of the CHW catchment areas. Thirty-three clusters will be enrolled in each arm for a total of 66 clusters. Primary study outcomes will be evaluated based on household-level cross-sectional surveys conducted at baseline and end-line and confirmed malaria case data collected through the health system throughout the study period.
Primary objectives:
- Assess whether year-round weekly proactive iCCM compared to passive iCCM with malaria case management for all ages reduces the prevalence of patent (by rapid diagnostic test (RDT)) and subpatent (by PCR) parasitemia detected at the household level in cross sectional household surveys.
- Determine whether the confirmed malaria case incidence (detected by CHWs (either proactively or passively) and at health facilities) decreases over time in communities with weekly proactive iCCM compared to passive iCCM by comparing the difference in slope of confirmed malaria incidence in proactive vs routine arms using an interrupted time series analysis
Secondary objectives:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Parasite Prevalence
时间窗: 24 months
1\) Difference in parasite prevalence in intervention vs control clusters over time measured by RDT and PCR among all age groups (stratified by \< 15 and 15+ years), detected through baseline and endline cross-sectional surveys conducted at the end of the transmission season.
Confirmed malaria case incidence
时间窗: 24 months
2\) Difference in slope of trend lines of total numbers of febrile patients detected and malaria cases diagnosed monthly (CHWs + HF) in intervention vs control clusters (CHWs + HF)
次要结局
未报告次要终点