Dihydroartemisinin-piperaquine for Seasonal Malaria Chemoprophylaxis in Tanzania
Status:
Completed
Trial end date:
2021-06-30
Target enrollment:
Participant gender:
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.
Phase:
N/A
Details
Lead Sponsor:
Richard Mwaiswelo
Collaborators:
Hubert Kairuki Memorial University Muhimbili University of Health and Allied Sciences National Institute for Medical Research, Tanzania