Feasibility and Impact of Malaria Rapid Diagnostic Tests in the African Retail Sector
2012年7月27日 更新者:Jessica Cohen、Harvard School of Public Health (HSPH)
Evaluation of the Feasibility and Impact of Introducing Malaria Rapid Diagnostic Tests in the Retail Sector: A Randomized Controlled Trial in Eastern Uganda
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.
研究概览
研究类型
介入性
注册 (实际的)
2800
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。
学习地点
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Kampala、乌干达
- Clinton Health Access Initiative
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Kampala、乌干达
- Innovations for Poverty Action-Uganda
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参与标准
研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 及以上 (成人、年长者)
接受健康志愿者
是的
有资格学习的性别
全部
描述
Inclusion Criteria:
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
Exclusion Criteria:
Drug Shops:
- Drug Shop not registered with Ugandan National Drug Authority
- Female household head is under 18
学习计划
本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。
研究是如何设计的?
设计细节
- 主要用途:卫生服务研究
- 分配:随机化
- 介入模型:阶乘赋值
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
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无干预:控制
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实验性的:RDT Training and Subsidy Offered
Licensed drug shops within villages selected randomly to be in this arm will be invited to training on RDTs and offered access to subsidized RDTs available for purchase at a local wholesale pharmacy in Mbale, Uganda.
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实验性的:Information/Education Campaign
Community meetings describing RDTs and encouraging community members to be diagnosed prior to taking malaria treatment will be held in villages randomly assigned to this treatment arm.
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实验性的:RDT Training/Subsidy + Information/Education Campaign
Includes both the training and subsidy component and the information/education campaign component.
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
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Fraction of Illnesses Diagnosed for Malaria
大体时间:Up To One Year
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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.
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Up To One Year
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Mean RDT Price Charged by Shops
大体时间:Up to One Year
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Up to One Year
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Mean RDTs Purchased by Shops from Wholesaler
大体时间:Up To One Year
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Up To One Year
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Fraction of Monitoring Checklist Items Performed Correctly by Shops
大体时间:Up To One Year
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Up To One Year
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Fraction of Illnesses for which an Antimalarial/ACT/Antibiotic is Taken
大体时间:Up To One Year
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Up To One Year
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
合作者
调查人员
- 首席研究员:Jessica Cohen, PhD、Harvard School of Public Health (HSPH)
- 首席研究员:Gunther Fink, PhD、Harvard School of Public Health (HSPH)
- 首席研究员:William Dickens, PhD、Northeastern University
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2011年3月1日
初级完成 (实际的)
2012年6月1日
研究完成 (实际的)
2012年6月1日
研究注册日期
首次提交
2012年7月24日
首先提交符合 QC 标准的
2012年7月27日
首次发布 (估计)
2012年7月30日
研究记录更新
最后更新发布 (估计)
2012年7月30日
上次提交的符合 QC 标准的更新
2012年7月27日
最后验证
2012年7月1日
更多信息
与本研究相关的术语
其他研究编号
- 19371-106
- HS805 (其他标识符:Uganda National Council for Science and Technology)
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.