Malaria Diagnostic Testing and Conditional Subsidies to Target ACTs in the Retail Sector: the TESTsmART Trial Aim 2
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 5,696
- 试验地点
- 1
- 主要终点
- ACT (Artemisinin Combination Therapy) Consumption by True Malaria Cases
研究概览
简要总结
Highly subsidized first-line antimalarials (artemisinin combination therapy or ACT) are available over the counter in the private retail sector in most malaria-endemic countries. Overconsumption of ACTs purchased over the counter is rampant due to their low price, high perceived efficacy, and absence of diagnostic tools to guide drug use. The ultimate goal of the proposed work is to improve antimalarial stewardship in the retail sector, which is responsible for distributing the majority of antimalarials in sub-Saharan Africa. Through a combination of diagnosis and treatment subsidies and provider-directed incentives, this approach will align provider and customer incentives with appropriate case management and thereby improve health outcomes.
The main objective of this study (Aim 2) is to test two key interventions in a random sample of private medicine retail outlets in Kenya. This will be a cluster-randomized controlled trial where the cluster is a private retail outlet that stocks and sells WHO quality-assured ACTs. This three-arm study will test 1) a consumer-directed intervention in the form of a diagnosis-dependent ACT subsidy, 2) both a provider-directed incentive for testing and a client-directed intervention in combination against 3) a comparison arm. Outlets in all three arms will offer malaria diagnostic testing to customers who wish to purchase one. Information for the primary and secondary outcomes will be collected during exit interviews with eligible customers. The primary outcome will be the proportion of ACTs sold to customers with a positive diagnostic test. The main secondary outcome will be the proportion of suspected malaria cases presenting to the retail outlet that are tested. Other secondary outcomes include adherence to the RDT result amongst those tested (defined as taking a quality-assured ACT following a positive test and refraining from taking an ACT following a negative test) and appropriate case management for all suspected malaria cases (proportion tested and adhered among all suspected cases).
详细描述
RATIONALE:
The investigators hypothesize that decision-making in the retail sector is influenced primarily by price (or profit) supplemented by individual beliefs or preferences. Information from a diagnostic test, when available, plays only a minor role in the decision-making landscape. In response to this, the investigators propose to test a scalable, policy-relevant strategy that integrates testing and treatment subsidies and makes ACT subsidies available only to customers with a positive malaria test. Differential pricing based on the results of the diagnostic test will align consumer and provider incentives (price and profit) with testing and appropriate ACT use. This approach will also ensure that public subsidies are directed at confirmed malaria cases thereby enhancing the sustainability of such programs. By allocating subsidy dollars across both testing and conditional treatment (rather than universal, treatment-only subsidies), the investigators can reduce the cost of subsidizing malaria treatment and improve targeting of ACTs without compromising access.
OBJECTIVES:
This goal of the proposed work is to improve antimalarial stewardship in the retail sector, which has the largest market share of antimalarials in sub-Saharan Africa. In this study (Aim 2) the investigators will use a cluster randomized controlled trial to measure the impact of two innovative interventions - a provider-directed incentive for offering malaria rapid diagnostic tests to suspected malaria cases and a consumer-directed diagnosis dependent ACT subsidy (conditional ACT subsidy). The unit of randomization will be the private medicine outlet (cluster).
STUDY DESIGN:
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
- Single (Outcomes Assessor)
盲法说明
Interviewers assessing outcomes and statisticians will be blinded to arm assignment
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 in the last 48 hours, or suspects they may have malaria
- •Individual with malaria-like illness must be present at recruitment
- •Older than one year of age
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
- •Patients <18 years without a parent or legal guardian present
结局指标
主要结局
ACT (Artemisinin Combination Therapy) Consumption by True Malaria Cases
时间窗: Day of enrollment
Number of participants who purchased ACTs and were malaria test-positive. Malaria test-positivity was based on mRDT testing testing at the outlet or documented testing brought to the facility.
次要结局
- Adherence to the RDT (Rapid Diagnostic Test) Result Among All Those Tested in the Shop(Day of enrollment)
- Use of Malaria Rapid Diagnostic Test(Day of enrollment)
- Appropriate Case Management(Day of enrollment)
- ACT (Artemisinin Combination Therapy) Use Among Untested Clients(Day of enrollment)