FocaL Mass Drug Administration for Vivax Malaria Elimination

FLAME is an open-label cluster-randomized controlled trial that aims to determine the effectiveness of focal mass drug administration (fMDA) to reduce the incidence of Plasmodium vivax malaria in the Loreto Department in Peru. Standard interventions, including symptomatic and asymptomatic screening for malaria infections, provision of insecticide-treated bednets, and environmental transmission monitoring, will be compared to clusters of villages randomized to receive anti-malarial drugs.

Inclusion Criteria:Cluster eligibilityWithin 8 hours transport of IquitosIncidence <500/1000 and >2 cases year prior to trialPopulation size (<1000)Chloroquine (CQ) eligibilityResides in neighboring household but within 200 m of Plasmodium vivax index case in the past 2 yearsAge ≥6 months oldPresent for interventionProvides informed consentTafenoquine (TQ) eligibilityEligible to receive CQAge ≥16 years oldProvides informed consentPrimaquine eligibilityEligible to receive CQ and ineligible to receive TQAge ≥6 months oldProvides informed consentBaseline evaluation and informed consent-Villagers will be eligible to participate in surveys if they slept in a household in cluster randomized to control or focal mass drug administration (fMDA) for at least one night in the past four weeksEligibility for fMDAHigh-risk villagers are defined as individuals residing in households that are within 200 meters of a Plasmodium vivax index case households from the prior 2 years (including individuals in the index case household) will be eligible to receive fMDA that study year in August and October.Villagers that were eligible but missed in the 1st annual round, or become eligible in the next two months, can receive fMDA in the 2nd annual round.Exclusion Criteria:Chloroquine eligibilityRetinal or visual field changesKnown hypersensitivity or adverse reaction to CQCurrently taking CQIneligible for TQ or PQTafenoquine eligibilityGlucose 6 phosphate dehydrogenase (G6PD) deficiency (defined as activity <70% per SD biosensor)G6PD status unknown or refusal of G6PD status testAcute illness or severe malariaPregnancy (known or identified by pregnancy test)Refusal of pregnancy test if 14 years of age and femaleBreastfeeding child that is G6PD deficient or with unknown G6PD statusKnown hypersensitivity or adverse reaction to TQ or PQCurrently taking mefloquine (i.e. artesunate- mefloquine), TQ or PQ, or other antimalarialPrimaquine eligibilityG6PD deficiency (defined as activity <70% per SD biosensor)G6PD status unknown or refusal of G6PD status testAcute illness or severe malariaPregnancy (known or identified by pregnancy test)Refusal of pregnancy test if 14 years of age and femaleBreastfeeding child that is G6PD deficient or with unknown G6PD statusKnown hypersensitivity or adverse reaction to TQ or PQCurrently taking mefloquine (i.e. artesunate- mefloquine), TQ or PQ, or other antimalarial