Accepted for/Published in: JMIR Research Protocols
Date Submitted: Jul 19, 2022
Date Accepted: Jan 31, 2023
Repeat Ivermectin Mass Drug Administrations for Malaria Control II (RIMDAMAL II): protocol for a double-blind, cluster-randomized, placebo-controlled trial for integrated control of malaria
ABSTRACT
Background:
Malaria gains have stagnated since 2015, threatened further by increasing resistance to insecticides and antimalarials. Improvement in malaria control necessitates a multi-pronged strategy which includes the development of novel tools. One such tool is the mass drug administration (MDA) with endectocides, primarily ivermectin, which has shown promise in reducing malaria transmission through lethal and sublethal impacts on the mosquito vector.
Objective:
The primary objective of the study is to assess the impact of a combined approach of seasonal malaria chemoprevention (SMC) and bed net usage with or without repeated ivermectin MDA on malaria incidence in children age ≤ 10 years.
Methods:
Repeat ivermectin MDA for malaria control II (RIMDAMAL II) is a double-blind placebo-controlled cluster-randomized parallel-group trial conducted in a setting with intense seasonal malaria transmission in Southwest Burkina Faso. The study included 14 discrete villages: 7 randomized to receive standard measures (SMC for children ages 3 to 59 months and bed nets) plus placebo and 7 to receive standard measures plus ivermectin MDA over two successive rainy seasons.
Results:
The trial intervention (ivermectin MDA at 300 µg/kg for consecutive 3 days, provided under supervision to all eligible village inhabitants) was conducted from July to November in 2019 and 2020, with additional sampling of humans and mosquitoes occurring through February 2022 to assess for post-intervention changes in transmission patterns. Additional human and entomological assessments were performed over the two years in a subset of households from 6 cross-sectional villages. A subset of individuals underwent additional sampling in 2020 to characterize ivermectin pharmacokinetics/pharmacodynamics.
Conclusions:
Our trial represents the first study to directly assess the impact of a novel approach to malaria control, ivermectin MDA as an endectocide, layered into existing standard of care interventions. The study was designed to leverage current SMC deployment infrastructure and will provide evidence as to the additional benefit of ivermectin MDA in reducing malaria incidence in children. Clinical Trial: ClinicalTrials.gov Identifier: NCT03967054; Pan African Clinical Trials Registry (PACTR): PACT201907479787308
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