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Title: A cluster randomised controlled trial of two rounds of mass drug administration in Zanzibar, a malaria pre-elimination setting - High coverage and safety, but no significant impact on transmission
Authors: Ulrika Morris
Mwinyi I. Msellem
Humphrey Mkali
Atiqul Islam
Berit Aydin-Schmidt
Irina Jovel
Shija Joseph Shija
Mwinyi Khamis
Safia Mohammed Ali
Lamija Hodzic
Ellinor Magnusson
Eugenie Poirot
Adam Bennett
Michael C. Sachs
Joel Tarning
Andreas Mårtensson
Abdullah S. Ali
Anders Björkman
Ministry of Health and Social Welfare Dar es Salaam
University of California, San Francisco
Karolinska University Hospital
Mahidol University
Karolinska Institutet
Nuffield Department of Clinical Medicine
Uppsala Universitet
Keywords: Medicine
Issue Date: 10-Dec-2018
Citation: BMC Medicine. Vol.16, No.1 (2018)
Abstract: © 2018 The Author(s). Background: Mass drug administration (MDA) has the potential to interrupt malaria transmission and has been suggested as a tool for malaria elimination in low-endemic settings. This study aimed to determine the effectiveness and safety of two rounds of MDA in Zanzibar, a pre-elimination setting. Methods: A cluster randomised controlled trial was conducted in 16 areas considered as malaria hotspots, with an annual parasite index of > 0.8%. The areas were randomised to eight intervention and eight control clusters. The intervention included two rounds of MDA with dihydroartemisinin-piperaquine and single low-dose primaquine 4 weeks apart in May-June 2016. Primary and secondary outcomes were cumulative confirmed malaria case incidences 6 months post-MDA and parasite prevalences determined by PCR 3 months post-MDA. Additional outcomes included intervention coverage, treatment adherence, occurrence of adverse events, and cumulative incidences 3, 12, and 16 months post-MDA. Results: Intervention coverage was 91.0% (9959/10944) and 87.7% (9355/10666) in the first and second rounds, respectively; self-reported adherence was 82.0% (881/1136) and 93.7% (985/1196). Adverse events were reported in 11.6% (147/1268) and 3.2% (37/1143) of post-MDA survey respondents after both rounds respectively. No serious adverse event was reported. No difference in cumulative malaria case incidence was observed between the control and intervention arms 6 months post-MDA (4.2 and 3.9 per 1000 population; p = 0.94). Neither was there a difference in PCR-determined parasite prevalences 3 months post-MDA (1.4% and 1.7%; OR = 1.0, p = 0.94), although having received at least the first MDA was associated with reduced odds of malaria infection (aOR = 0.35; p = 0.02). Among confirmed malaria cases at health facilities, 26.0% and 26.3% reported recent travel outside Zanzibar in the intervention and control shehias (aOR ≥ 85; p ≤ 0.001). Conclusions: MDA was implemented with high coverage, adherence, and tolerability. Despite this, no significant impact on transmission was observed. The findings suggest that two rounds of MDA in a single year may not be sufficient for a sustained impact on transmission in a pre-elimination setting, especially when the MDA impact is restricted by imported malaria. Importantly, this study adds to the limited evidence for the use of MDA in low transmission settings in sub-Saharan Africa. Trial registration:, NCT02721186 (registration date: March 29, 2016)
ISSN: 17417015
Appears in Collections:Scopus 2018

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