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临床试验/NCT01652365
NCT01652365已完成不适用

Evaluation of the Feasibility and Impact of Introducing Malaria Rapid Diagnostic Tests in the Retail Sector: A Randomized Controlled Trial in Eastern Uganda

Harvard School of Public Health (HSPH)2 个研究点 分布在 1 个国家目标入组 2,800 人开始时间: 2011年3月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
2,800
试验地点
2
主要终点
Fraction of Illnesses Diagnosed for Malaria

研究概览

简要总结

The purpose of this study is to assess the feasibility and impact of introducing subsidized malaria rapid diagnostic tests (RDTs) into retail sector drug shops in Uganda. This is a randomized controlled trial at the village level, taking place in 6 districts in Eastern Uganda. Licensed drug shops in selected villages were trained in proper RDT storage, administration, interpretation and disposal and were given access to subsidized RDTs for sale. This study explores whether drug shop owners--when given access to training and subsidized RDTs--will choose to promote and sell RDTs to customers and, if so, at what volume and what price. The investigators also explore whether shops will safely store, administer, interpret and dispose of RDTs and to what extent they will use RDT results to guide treatment recommendations. Finally, the study explores whether making RDTs available for sale in local drug shops has a community level impact on diagnostic testing and appropriate treatment for malaria.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Factorial
主要目的
Health Services Research
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Drug Shops:
  • Licensed and registered as a Drug Shop with the Ugandan National Drug Authority
  • Households:
  • Live in the village of participating drug shop
  • Female household head is 18 or over

排除标准

  • Drug Shops:
  • Drug Shop not registered with Ugandan National Drug Authority
  • Female household head is under 18

结局指标

主要结局

Fraction of Illnesses Diagnosed for Malaria

时间窗: Up To One Year

Comparison of the rate of malaria diagnosis in treatment vs. control. Comparison will be at the village level and at the shop level. Denominator will be: all illnesses, febrile illnesses only or suspected malaria episodes only.

次要结局

  • Mean RDT Price Charged by Shops(Up to One Year)
  • Mean RDTs Purchased by Shops from Wholesaler(Up To One Year)
  • Fraction of Monitoring Checklist Items Performed Correctly by Shops(Up To One Year)
  • Fraction of Illnesses for which an Antimalarial/ACT/Antibiotic is Taken(Up To One Year)

研究者

发起方
Harvard School of Public Health (HSPH)
申办方类型
Other
责任方
Principal Investigator
主要研究者

Jessica Cohen

Assistant Professor

Harvard School of Public Health (HSPH)

研究点 (2)

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