Clinton Health Access Initiative, Boston, MA, USA.
Duke Global Health Institute, Duke University, Durham, NC, USA.
Implement Sci. 2021 Jan 20;16(1):14. doi: 10.1186/s13012-020-01077-w.
A large proportion of artemisinin-combination therapy (ACT) anti-malarial medicines is consumed by individuals that do not have malaria. The over-consumption of ACTs is largely driven by retail sales in high malaria-endemic countries to clients who have not received a confirmatory diagnosis. This study aims to target ACT sales to clients receiving a confirmatory diagnosis using malaria rapid diagnostic tests (mRDTs) at retail outlets in Kenya and Nigeria.
This study comprises two linked four-arm 2 × 2 factorial cluster randomized controlled trials focused on malaria diagnostic testing and conditional ACT subsidies with the goal to evaluate provider-directed and client-directed interventions. The linked trials will be conducted at two contrasting study sites: a rural region around Webuye in western Kenya and the urban center of Lagos, Nigeria. Clusters are 41 and 48 participating retail outlets in Kenya and Nigeria, respectively. Clients seeking care at participating outlets across all arms will be given the option of paying for a mRDT-at a study-recommended price-to be conducted at the outlet. In the provider-directed intervention arm, the outlet owner receives a small monetary incentive to perform the mRDT. In the client-directed intervention arm, the client receives a free ACT if they purchase an mRDT and receive a positive test result. Finally, the fourth study arm combines both the provider- and client-directed interventions. The diagnosis and treatment choices made during each transaction will be captured using a mobile phone app. Study outcomes will be collected through exit interviews with clients, who sought care for febrile illness, at each of the enrolled retail outlets.
The primary outcome measure is the proportion of all ACTs that are sold to malaria test-positive clients in each study arm. For all secondary outcomes, we will evaluate the degree to which the interventions affect purchasing behavior among people seeking care for a febrile illness at the retail outlet.
If our study demonstrates that malaria case management can be improved in the retail sector, it could reduce overconsumption of ACTs and enhance targeting of publicly funded treatment reimbursements, lowering the economic barrier to appropriate diagnosis and treatment for patients with malaria.
ClinicalTrials.gov NCT04428307 , registered June 9, 2020, and NCT04428385 , registered June 9, 2020.
很大比例的青蒿素复方疗法（ACT）抗疟药物被没有疟疾的个体消耗。ACT 的过度消费在很大程度上是由高疟疾流行国家的零售销售驱动的，这些销售对象是未经确认诊断的客户。本研究旨在通过在肯尼亚和尼日利亚的零售点使用疟疾快速诊断检测（mRDT）针对接受确认诊断的客户销售 ACT。
本研究包括两项相互关联的四臂 2×2 析因群组随机对照试验，重点是疟疾诊断检测和有条件的 ACT 补贴，目的是评估面向提供者和面向客户的干预措施。这两项相互关联的试验将在两个截然不同的研究地点进行：肯尼亚西部 Webuye 周围的一个农村地区和尼日利亚拉各斯的城市中心。肯尼亚和尼日利亚的集群分别为 41 个和 48 个参与的零售点。所有手臂中在参与网点寻求护理的客户都可以选择支付网点进行的 mRDT-以研究推荐的价格。在面向提供者的干预手臂中，网点所有者会获得少量的货币激励来进行 mRDT。在面向客户的干预手臂中，如果客户购买 mRDT 并获得阳性检测结果，他们将获得免费的 ACT。最后，第四个研究手臂结合了提供者和客户导向的干预措施。每次交易中做出的诊断和治疗选择将使用移动电话应用程序捕获。研究结果将通过对每个参与的零售网点接受发热疾病护理的客户进行出口访谈收集。
主要结局衡量标准是每个研究手臂中销售给疟疾检测阳性客户的所有 ACT 的比例。对于所有次要结局，我们将评估这些干预措施在多大程度上影响了在零售网点寻求发热疾病护理的人群的购买行为。
如果我们的研究表明零售部门的疟疾病例管理可以得到改善，它可以减少 ACT 的过度消费，并增强对公共资助治疗报销的针对性，从而降低疟疾患者获得适当诊断和治疗的经济障碍。
ClinicalTrials.gov NCT04428307，于 2020 年 6 月 9 日注册，和 NCT04428385，于 2020 年 6 月 9 日注册。
