Jhpiego through the Impact Malaria project funded by the US President’s Malaria Initiative (PMI) and in Collaboration with National Malaria Control Program-Ministry of Health, US Centers of Disease Control and Prevention (CDC), and the County Governments of Siaya and Bungoma plan to carry out a study to test how effective Artemether Lumefantrine (AL) and Dihydroartemisinin-Piperaquine (DHP) are still in the treatment of uncomplicated Plasmodium falciparum malaria in Siaya and Bungoma counties, Kenya. The purpose of the study is to assess whether these two medicines are currently still effective in the treatment of malaria. The selected project sites will include  one health facility in Siaya and one in Bungoma County. The primary sample will consist of children aged between 6 months and 59 months who are eligible and whom have been confirmed to have uncomplicated malaria and their parents have consented for them to be in the study. Participants who meet the study inclusion criteria will be enrolled, treated on site and monitored.

The results from the study will inform the Ministry of Health on effective current medicines used to treat malaria and if there is any growing resistance in Kenya.

In line with WHO recommendations, Kenya conducts Therapeutic Efficacy Studies (TES) for 1^st and 2^nd line antimalarial medicines to monitor the threat of emergence and spread of artemisinin resistance. The objective of this four-arm prospective study is to assess the efficacy of Artemether Lumefantrine (AL) and Dihydroartemisinin-Piperaquine (DHP) used for the treatment of uncomplicated P. falciparum malaria among febrile patients aged between 6 and 59 months, with confirmed uncomplicated P.Falciparum monoinfection at one selected site in both Siaya and Bungoma Counties with a high out-patient attendance of malaria patients. At each site, at least 100 patients will be enrolled per drug (200 patients per site, 400 patients total) between July and December 2020. Clinical and parasitological parameters will be monitored over a 28-day follow-up period to evaluate AL efficacy, and over a 42-day follow-up period to evaluate DHP efficacy. The study will determine proportion of patients with an adequate clinical and parasitological response (as indicators of efficacy). Recrudescence will be distinguished from re-infection by polymerase chain reaction (PCR) analysis. The study will further determine the polymorphism of molecular markers of drug resistance and evasion of diagnostic testing. The results will enable Ministry of Health (MOH) make timely update of its malaria treatment and diagnostic policies and ensure global exchange of resistance data.