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临床试验/NCT02461628
NCT02461628已完成不适用

Innovative Partnership to Target Antimalarial Subsidies in the Retail Sector

Duke University1 个研究点 分布在 1 个国家目标入组 40,340 人开始时间: 2015年7月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
40,340
试验地点
1
主要终点
Number of Subjects With a Fever Who Receive a Malaria Test From Any Source

研究概览

简要总结

The overall objective of this study is to evaluate the public health impact of targeted antimalarials subsidies through scale-up by determining the community-wide effects of targeting an antimalarial subsidy through a partnership between Community Health Volunteers (CHVs) and the private retail sector. The primary hypothesis to be tested is that offering a fixed-price voucher that reduces the cost for artemisinin combination therapy (ACT) purchase in the retail sector conditional on a positive malaria test (targeted subsidy) can improve uptake of testing for malaria and will increase the proportion of fevers tested for malaria before treatment. The study will be carried out in two sub-counties in Kenya with similar malaria burden but different access to health services; the investigators will use a cluster-randomized design to assign community units (CUs) in each sub-county to either an intervention or control arm. CHVs will be trained to use malaria rapid diagnostic tests (RDTs) to diagnose malaria in household members with documented or reported fever; households in intervention CUs will be informed of the intervention and encouraged to contact the CHV for any febrile illness in the home. There are minimal risks associated with receiving an RDT. Households with a positive RDT will be given a serialized voucher that will entitle the holder to purchase a quality assured ACT in the retail sector at a reduced, fixed price. The primary and secondary outcome measures will be compared at baseline and 12 months post-baseline through population-based surveying. The primary aim is to determine whether there is significant difference between the 2 study arms in the proportion of clients with fever who are tested prior to any treatment after adjusting for relevant covariates.

研究设计

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

入排标准

年龄范围
1 Year 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

研究组 & 干预措施

Malaria RDT & conditional voucher

Experimental

In the intervention arm, trained community health volunteers (CHVs) will offer eligible household members a free malaria rapid diagnostic test (RDT) and a voucher allowing the purchase of a qualified artemisinin combination therapy (ACT) at a reduced fixed price in the retail sector conditional on a positive test.

干预措施: Malaria RDT & conditional voucher for ACT from retail sector (Behavioral)

Comparison Arm

No Intervention

Individuals in the comparison arm will only receive standard community health volunteer (CHV) visits.

结局指标

主要结局

Number of Subjects With a Fever Who Receive a Malaria Test From Any Source

时间窗: 6 months, 12 months, 18 months

次要结局

  • Number of Participants Using ACT Who Had a Positive Test(6 months, 12 months, 18 months)
  • Number of Participants Using an ACT Who Did Not Have a Test(6 months, 12 months, 18 months)
  • Number of Subjects Who Received a Correct Dose of AL (Artemether Lumefantrine)(6 months, 12 months, 18 months)
  • Number of Subjects With Fever That Received Correct Treatment(6 months, 12 months, 18 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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