dihydroartemisinin-piperaquine for seasonal malaria chemoprophylaxis in tanzania

Conditions: Malaria; Chemoprophylaxis; Underfive Children

Summary: background: malaria prevalence has declined globally following the scale-up of the interventions, including insecticide-treated bed-net, indoor residual spraying, and prompt diagnosis and treatment with artemisinin-based combination therapy (act). despite the gained success in the control, malaria has remained a major public health problem, particularly affecting children aged \< 5 years in sub-saharan africa. most of the malaria transmissions occur during the rainy season, a relatively short period. intervention using antimalarial chemotherapy in children during the transmission season has been shown to prevent malaria-related morbidity and mortality. the world health organization has recommended seasonal malaria chemoprevention (smc) using sulphadoxine-pyrimethamine (sp) plus amodiaquine (aq) in children aged 3-59 months in areas with highly seasonal malaria transmission. however, sp-aq resistance is widespread in tanzania. therefore, this study will assess the effectiveness of dihydroartemisinin-piperaquine (dha-pq) as smc for the control of malaria among children in tanzania. methods: afebrile children aged 3-59 months from nanyumbu and masasi districts in the mtwara region will be enrolled in an open cluster randomized clinical trial, administered monthly with a full course of dha-pq for three or four consecutive months during the high malaria transmission season of the three consecutive years. three approaches of dha-pq smc administration will be tested; a door-to-door approach using community health workers (chws), outreach visits using local health facilities clinicians/nurses, and village health posts using selected chws. study participants will then be followed-up to evaluate the impact of the intervention on all-course of malaria morbidity and mortality; adverse events associated with the intervention; acceptability, adherence, coverage, and cost-effectiveness of the intervention; treatment-seeking behavior; and the risk of rebound after the withdrawal of the intervention. the primary outcome will be a prevalence of clinical malaria defined as the presence of fever (axillary temperature of 37.5 degrees celsius) or a history of fever in the past 24 hours and the presence of p. falciparum asexual parasitemia at any density. findings: the findings will be disseminated through community meetings, seminars, local and international conferences, and publication in international journals. impact: the findings from this study will provide information on the effectiveness of dha-pq for seasonal prevention of malaria morbidity and mortality in children aged \< 5 years in tanzania.


Eligibility criteria:
inclusion criteria: * being afebrile, * willing to participate in the trial, and * the ability to swallow oral medications. exclusion criteria: * a presence of an acute febrile illness or severe illness that impairs the ability to take oral medication * hiv-positive child receiving cotrimoxazole prophylaxis, * a child who has received a dose of antimalarial drug including dihydroartemisinin-piperaquine during the past month; and * a history of allergy to dha-pq.