Innovative Public-private Partnership to Target Subsidized Antimalarials in the Retail Sector
2015年12月14日 更新者:Duke University
There are compelling medical and public health reasons to reduce unnecessary consumption of antimalarials and strong evidence to support the use of RDTs in malaria case management.
The primary study hypothesis to be tested is that clients who know they will receive a subsidy conditional on a positive test are more likely to opt for testing before deciding which drug to buy.
The primary endpoint is whether subjects choose to be tested for malaria with a rapid diagnostic test.
The secondary endpoint is whether they purchased an artemisinin combination therapy (ACT) or not.
The primary outcome of interest is to compare the proportion of participants who choose to receive a free malaria diagnostic test when they can receive a subsidy for a discounted drug conditional on a positive test (Group A compared to Group B) compared to those without the offer of a conditional subsidy.
The investigators will use an experimental design that randomly assigns clients to one of four groups.
Field workers will canvas households in the study area looking for individuals who have fever or history of fever or illness in the last 24 hours (current illness) who have not yet taken drugs or sought treatment outside the home.
Clients who meet the inclusion criteria and give verbal consent to participate will be randomly assigned to one of the four groups.
They will be given the location and contact information for their local community health worker who can provide a malaria rapid diagnostic test if they choose to be tested.
They will also complete a survey tool.
One week later, the field worker will return to interview the participant and determine whether they were tested, what action they took for their illness, what medicine they purchased and how much they paid.
The investigators will summarize clients' choice by the four randomized study groups.
研究概览
地位
完全的
研究类型
介入性
注册 (实际的)
444
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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Eldoret、肯尼亚
- Moi University
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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
1年 及以上 (孩子、成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- Client is older than 1 year
- Client has fever or history of fever or feeling unwell with a malaria-like illness within the last 24 hours
- Client or their parent/legal guardian consents to participate
Exclusion Criteria:
- Client has signs of severe disease or other problem requiring immediate referral to a community health worker (CHW) / health facility
- Client has already sought treatment, purchased medicine or taken medicine for the current illness.
Note:
If more than one febrile person who meet the inclusion criteria are found in a single household, all of the individuals will be enrolled in the same group, but only one individual (the first enrolled) will be used for the purposes of the analysis.
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:并行分配
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
其他:test only (free)
The participant is entitled to a free malaria rapid diagnostic test, but no ACT voucher.
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Malaria RDT is offered free if patients choose to be tested
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其他:test (free) & conditional ACT voucher
The participant is entitled to a free malaria rapid diagnostic test, and an ACT voucher conditional on a positive test result.
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Malaria RDT is offered free if patients choose to be tested
Participants will be eligible to receive a drug subsidy for a set amount (in the form of a voucher) conditional on a positive malaria test.
When a conditional subsidy is offered, it is valid for use on a "Green Leaf" approved malaria drug.
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其他:test only (not free)
The participant is entitled to a malaria rapid diagnostic test for a charge (i.e., not for free), but no ACT voucher.
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Participants can receive a malaria RDT for a set amount (i.e., not for free).
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其他:test (not free) & conditional ACT voucher
The participant is entitled to a malaria rapid diagnostic test for a charge (i.e., not for free), and an ACT voucher conditional on a positive test result.
|
Participants will be eligible to receive a drug subsidy for a set amount (in the form of a voucher) conditional on a positive malaria test.
When a conditional subsidy is offered, it is valid for use on a "Green Leaf" approved malaria drug.
Participants can receive a malaria RDT for a set amount (i.e., not for free).
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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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Effect of conditional drug subsidy on proportion of participants who choose to receive a free malaria diagnostic test
大体时间:Within two days of group assignment
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The primary outcome of interest is to compare the proportion of participants who choose to receive a free malaria diagnostic test when they can receive a subsidy for a discounted drug conditional on a positive test compared to those without the offer of a conditional subsidy.
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Within two days of group assignment
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次要结果测量
结果测量 |
大体时间 |
|---|---|
|
Effect of malaria RDT subsidy on the uptake of testing (free versus paid RDT)
大体时间:Within 2 days of group assignment
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Within 2 days of group assignment
|
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Effect of a conditional ACT subsidy on uptake of testing when the RDT is not free.
大体时间:Within 2 days of group assignment
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Within 2 days of group assignment
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其他结果措施
结果测量 |
大体时间 |
|---|---|
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Percent of clients with a negative test, a positive test or no test who choose to purchase an ACT in all four groups.
大体时间:Within 2 days of test results
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Within 2 days of test results
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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。
调查人员
- 首席研究员:Wendy O'Meara, PhD、Duke University
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
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
2014年6月1日
初级完成 (实际的)
2015年7月1日
研究完成 (实际的)
2015年7月1日
研究注册日期
首次提交
2014年7月22日
首先提交符合 QC 标准的
2014年7月23日
首次发布 (估计)
2014年7月25日
研究记录更新
最后更新发布 (估计)
2015年12月15日
上次提交的符合 QC 标准的更新
2015年12月14日
最后验证
2015年12月1日
更多信息
与本研究相关的术语
其他研究编号
- Pro00052602
- 1R01AI110478-01 (美国 NIH 拨款/合同)
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.