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Mass Drug Administration With High-Dose Ivermectin and Dihydroartemisinin-Piperaquine for Malaria Elimination in an Area of Low Transmission With High Coverage of Malaria Control Interventions: Protocol for the MASSIV Cluster Randomized Clinical Trial
Mass drug administration with high-dose ivermectin and dihydroartemisinin-piperaquine for malaria elimination in an area of low transmission with high coverage of malaria control interventions (MASSIV): a study protocol for a cluster-randomized clinical trial.
Edgard Dabira;
Harouna Soumare;
Steven Lindsay;
Bakary Conteh;
Fatima Ceesay;
John Bradley;
Christian Kositz;
Henk Broekhuizen;
Balla Kandeh;
Alexandra Fehr;
Claudia Nieto Sanchez;
Joan Muela Ribera;
Koen Peeters Grietens;
Menno Roderick Smit;
Chris Drakeley;
Teun Bousema;
Jane Achan;
Umberto D’Alessandro
ABSTRACT
Background:
With a declining malaria burden, innovative interventions and tools are required to further reduce the transmission of the disease. Mass drug administration (MDA) of an artemisinin-based combination therapy (ACT) has been identified as a potential tool to further reduce malaria transmission where coverage of vector control interventions is already high. However, the impact is limited in time. Combining an ACT with an endectocide treatment able to reduce vector survival such as ivermectin (IVM) could increase the impact of MDA and offer a new tool to reduce malaria transmission.
Objective:
The objective of the study is to evaluate the impact of MDA with IVM plus dihydroartemisinin-piperaquine (DP) on malaria transmission in an area with high coverage of malaria control interventions
Methods:
The study is a cluster-randomized trial carried out in Upper River Region of The Gambia and included a total of 32 villages, 16 control and 16 intervention. A buffer zone of ~ 2 km was created around all intervention clusters. MDA with IVM plus DP was implemented in all intervention villages and in the buffer zones; control villages received standard malaria interventions according to the Gambian National Malaria Control Program’s (NMCP) plans.
Results:
Recruitment started in August 2018. Enrolment was completed in September 2019 and laboratory samples were analysed in February 2020. Statistical analysis will commence once the database is completed, cleaned, and locked.
Conclusions:
This is the first cluster-randomized clinical trial of MDA with IVM plus DP. Its results will provide evidence on the impact of MDA with IVM plus DP on malaria transmission. Clinical Trial: Clinical trials.gov: NCT03576313
Mass Drug Administration With High-Dose Ivermectin and Dihydroartemisinin-Piperaquine for Malaria Elimination in an Area of Low Transmission With High Coverage of Malaria Control Interventions: Protocol for the MASSIV Cluster Randomized Clinical Trial