Study of Focal Mass Drug Administration to Prevent Plasmodium vivax Malaria in Loreto, Peru A Randomized Trial Comparing Standard Care to Targeted Drug Treatment

What this Trial Is About

Researchers are evaluating the effectiveness of focal mass drug administration fMDA in reducing the incidence of Plasmodium vivax malaria in the Loreto Department of Peru. This open-label cluster-randomized controlled trial compares standard malaria control interventions with additional targeted drug administration in high-risk village clusters. The study aims to assess the impact of fMDA on malaria transmission, safety, and cost-effectiveness over a three-year period in a low transmission setting. Participants live in villages randomized to either standard malaria control measures or fMDA. Standard interventions include insecticide-treated bednets, management of mosquito breeding sites, symptomatic case detection, and treatment. The fMDA group receives two rounds of targeted antimalarial drugs per cycle, repeated for three cycles. Drugs used include chloroquine, tafenoquine, and primaquine, with dosing based on age and G6PD status. High-risk individuals are those living within 200 meters of confirmed malaria cases in the past two years. Testing and counseling for G6PD deficiency are done before drug administration. Participants are monitored through baseline and endline surveys collecting dried blood spots and fever screening with treatment per national guidelines. Safety is evaluated by tracking severe adverse events and malaria cases. Cost-effectiveness and acceptability of the intervention are also measured. The primary outcome is the cumulative incidence of P. vivax infection over 36 months. The trial is conducted pragmatically through the existing health system with follow-up extending over four years.

FocaL Mass Drug Administration for Vivax Malaria Elimination