Malaria Clinical Trial
Official title:
Effectiveness of Mass Drug Administration (MDA) for Reducing Seasonal Malaria Transmission Towards Its Elimination in Hotspot Areas in Zanzibar - a Cluster-randomised Controlled Trial
The overall aim of this study is to determine the effectiveness of two rounds of mass drug administration (MDA) with dihydroartemisinin-piperaquine (DHAp) + single low dose (SLD) primaquine for reducing seasonal malaria transmission in Shehias considered hotspots on Unguja Island, Zanzibar.
Study design: This is a cluster-randomised controlled study with two arms: an intervention
arm with two rounds of MDA with dihydroartemisinin-piperaquine (DHAp) + single low dose (SLD)
primaquine, and a control arm with no MDA.
Study site and study population: The study will be conducted in 16 hotspot Shehias (8 Shehias
randomly allocated to each arm), in three districts (West, Central and South districts) in
Unguja Island, Zanzibar. Hotspot Shehias [Shehia being the smallest administrative structure
in Zanzibar] are defined as Shehias with an annual malaria incidence of >0.8%, calculated as
the number of confirmed malaria infections notified at health facilities and during active
case detection in 2015 / Shehia projected population for 2015. The study population will
include all consenting residents of the selected Shehias, reaching approximately 24000
people.
Study implementation: Two rounds of MDA with DHAp (D-ARTEPP, Guilin Pharmaceutical (Shanghai)
Co., Ltd., China) and SLD (0.25mg/kg) primaquine (Primaquine, Remedica Ltd.,Cyprus ) will be
conducted approximately four weeks apart in the intervention Shehias, at the anticipated
lowest point of malaria transmission prior to the onset of malaria transmission associated
with the main rains in April-June 2016. The first drug dose including DHAp and SLD primaquine
will be given under supervision whenever possible; the other two doses of the standard once
daily DHAp regimen will be taken unsupervised at home. Labelled packets containing all three
doses will be left with the head of household with clear instructions for individuals not
present at the time of the household visit.
Study objectives: The primary objective of the study is to determine the effectiveness of two
rounds of MDA with DHAp + SLD primaquine for reducing seasonal malaria transmission in
Shehias considered hotspots on Unguja Island, Zanzibar. The secondary objectives of the study
include determining MDA coverage, compliance, and safety after one and two rounds of DHAp +
SLD primaquine.
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