Novel mHealth Platform to Ensure Quality of Community-based Malaria Diagnosis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Percent of RDTs with correct administration and interpretation by CHVs compared across the first and tenth tests
研究概览
简要总结
The investigators propose to implement a new mobile interface that automatically reads and troubleshoots malaria rapid diagnostic test (RDT) cassettes. This device, called a Deki reader (DR), will allow the investigators to establish an extensive quality assurance program of malaria diagnosis performed by trained community health volunteers (CHVs). The study will lease 10 DRs and rotate them amongst 200 CHVs performing community-based malaria diagnosis through rapid diagnostic testing. The study setting is Bungoma East subcounty and Kiminini subcounty in Kenya. The overall goal is to measure and improve the quality of malaria diagnosis by CHVs using malaria RDTs. The investigators aim for every CHW to exceed 90% sensitivity and specificity and zero operator errors within six months. There are no appreciable risks to the CHV associated with evaluation by the DR device. The investigators' analysis will focus on descriptive statistics of RDT use and accuracy amongst all participating CHVs.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •All community health volunteers in 10 community units in Bungoma East and 6 community units in Kiminini that have been trained to provide community-based malaria diagnosis through rapid diagnostic testing are eligible.
排除标准
- •Any person not meeting the inclusion criteria.
结局指标
主要结局
Percent of RDTs with correct administration and interpretation by CHVs compared across the first and tenth tests
时间窗: 6 months (during which each consenting CHV of the 200 eligible will conduct 10 tests)
The percent of RDTs that were properly conducted and interpreted by CHVs, according to Deki Reader results, comparing across the first and tenth RDTs read with the Deki Reader for each CHV.
次要结局
- Percent of RDTs with a false negative reading by CHVs compared across the first and tenth tests(6 months)
- Percent of RDTs with a false positive reading by CHVs compared across the first and tenth tests(6 months)
- Overall specificity (measured as the proportion of negative tests as determined by the DR which the CHVs correctly identify).(6 months)
- Percent of invalid RDTs not properly identified by CHVs compared across the first and tenth tests(6 months)
- Percent of RDTs that CHVs performed with an improper test procedure compared across the first and tenth tests.(6 months)
- Overall sensitivity (measured as the proportion of positive tests as determined by the DR which the CHVs correctly identify).(6 months)