FocaL Mass Drug Administration for Vivax Malaria Elimination (FLAME): a Pragmatic Cluster Randomized Controlled Trial in Peru
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.
• Cluster eligibility
‣ Within 8 hours transport of Iquitos
⁃ Incidence \<250/1000 and \>2 cases year prior to trial
⁃ Population size (\<650)
• Chloroquine (CQ) eligibility
‣ Resides in neighboring household but within 200 m of Pv index case in the past 2 years
⁃ Age ≥6 months old
⁃ Present for intervention
⁃ Adult ≥18 years old that provides informed consent
⁃ A child ≥8 years and \<18 years old that provides informed assent and has informed consent from their parents
⁃ A child ≥6 months old and \<8 years old that has informed consent from their parents
• Tafenoquine (TQ) eligibility
‣ Eligible to receive CQ
⁃ Age ≥16 years old
⁃ Adult ≥18 years old that provides informed consent
⁃ A child ≥16 years and \<18 years old that provides informed assent and has informed consent from their parents
• Primaquine eligibility
‣ Eligible to receive CQ and ineligible to receive TQ
⁃ Age ≥6 months old
⁃ Adult ≥18 years old that provides informed consent
⁃ A child ≥8 years and \<18 years old that provides informed assent and has informed consent from their parents
⁃ A child ≥6 months old and \<8 years old that has informed consent from their parents
• Baseline 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 weeks
• Eligibility for fMDA
‣ High-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 cycle
⁃ Villagers that were eligible but missed in the 1st round in a cycle, or become eligible in the next two months, will not be eligible to receive fMDA in the 2nd round in a cycle.