Malaria Diagnostic Testing and Conditional Subsidies to Target ACTs in the Retail Sector: the TESTsmART Trial AIM 1
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 842
- 试验地点
- 1
- 主要终点
- Number of Participants That Purchase an mRDT (Malaria Rapid Diagnostic Test)
研究概览
简要总结
The TESTsmART Trial consists of two main aims. The overall goal of the two aims is to investigate the impact of malaria rapid diagnostic test (mRDT) subsidies and conditional artemisinin combination therapy (ACT) subsidies on the testing and treatment behavior of participants seeking care for their febrile illness in the private retail sector. Conditional ACT subsidies are discounts on quality-assured ACTs which are linked to the results of a malaria rapid diagnostic test administered at the retail outlet; only participants with a positive test will have access to an additional discount on a quality-assured ACT.
The main objective of Aim 1 of this study is to identify a combination of conditional ACT and RDT subsidies that maximizes the proportion of participants that choose to have a malaria diagnostic test before taking a drug. The investigators will test two levels of conditional ACT subsidy (100% subsidy versus ~67% subsidy) and two levels of RDT subsidy (0% subsidy and 50% subsidy) in a factorial designed experiment. Because dose size and therefore the price of an ACT course are dependent upon patient age, the ACT subsidy amount will also be scaled with patient age. These subsidy levels were chosen to keep the estimated program cost of the combined subsidy within $0.30-0.60 USD per person (assuming 100% testing uptake and between 20-40% of participants having a positive RDT). These estimates represent an upper bound since testing is unlikely to reach 100%. Current subsidy levels for ACT costs the program between 1.30-2.50 USD per treatment, with more than a third of that investment spent on individuals without malaria.
Individuals presenting to a retail outlet for a treatment of a fever or suspected malaria illness will be randomized to one of the four groups in equal proportions. A total of 840 participants will be enrolled (210 per arm). Their choices concerning uptake of testing and drug purchase will be recorded. The main outcome will be the proportion of participants that choose to take a test. Secondary outcomes include the proportion of participants who adhered to the results of the RDT among those who were tested (used ACT when positive and did not use an ACT when negative or without a test). The results of this study will be used to inform the subsidy levels in the intervention for Aim 2 of this trial.
详细描述
RATIONALE:
From previous studies and implementation experiences, we know that consumption of ACTs increases as the price declines. Declining prices of ACTs create a trade-off between access and targeting; lower prices improve uptake of effective therapies by those with malaria but also increase inappropriate use by those without malaria. Curbing inappropriate use and targeting ACTs to malaria cases requires parasitological diagnosis which is virtually absent in the retail sector. It has also been shown that RDTs can be safely deployed in the retail sector. Most clients will agree to have an RDT if it is free. However, uptake of RDTs is sensitive to the price of the RDT. Previous work has not specifically evaluated the relationship between the price of the drug and the price of the test, but available evidence suggests that uptake of the RDT is sensitive to the price of the ACT as well.
In this work, we will link these two commodities through a diagnosis-dependent ACT subsidy. Access to the additional ACT subsidy depends on having a positive RDT. What we need to understand before scaling up a conditional subsidy is how the price of these two commodities should be related. Should the conditionally-subsidized ACT be less expensive than the RDT? Must the RDT be considerably less expensive than the retail price of ACT in order to motivate people to purchase a test?
OBJECTIVES:
In this study (Aim 1) we will use an individually-randomized experiment conducted among customers at medicine retail outlets to identify the combination of RDT subsidy-level and conditional ACT subsidy-level that maximizes uptake of diagnostic testing. We choose to focus on diagnostic testing because this is the first step to achieving the downstream goals of ACT targeting and rational use.
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
- 1 Year 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants with fever or history of fever or malaria like illness
- •Individual with malaria-like illness must be present at recruitment
- •1 year of age or older
排除标准
- •Any individual with signs of severe illness requiring immediate referral
- •Individuals who have taken an antimalarial in the last seven days, including for the current illness
- •Individuals who already have a prescription from a facility or medical provider
- •Pregnant women will be enrolled and offered an mRDT, but will be advised to seek treatment through a health care provider.
结局指标
主要结局
Number of Participants That Purchase an mRDT (Malaria Rapid Diagnostic Test)
时间窗: At the end of a participant's visit to participating retail outlet, up to 1 hour
This outcome will be evaluated once for each customer
次要结局
- Number of Participants With a Positive mRDT That Purchased an ACT (Artemisinin-based Combination Therapy)(At the end of a participant's visit to participating retail outlet, up to 1 hour)
- Number of Participants With a Negative mRDT That Did Not Purchase an ACT(At the end of a participant's visit to participating retail outlet, up to 1 hour)
- Number of Participants That Did Not Purchase an mRDT and Did Not Purchase an ACT(At the end of a participant's visit to participating retail outlet, up to 1 hour)