Dihydroartemisinin-piperaquine for Seasonal Malaria Chemoprophylaxis in Tanzania
Condition: Malaria; Chemoprophylaxis; Underfive Children
MeSH terms: Malaria
Study type: Interventional

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.
    


Intervention name(s): Dihydroartemisinin-piperaquine
Intervention type(s): Drug
Intervention description(s): The drug will be administered once a day for three consecutive days for three months (March, April, and May)
Intervention MeSH terms: Piperaquine; Artenimol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention