Abstract:
Abstract
Background: 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.
Methods: 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.
Results: 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.
Conclusions: 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.
Trial registration: ClinicalTrials.gov NCT04428307, registered June 9, 2020, and NCT04428385, registered June9, 2020.
