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

Edgard Diniba Dabira; Harouna M. Soumare; Steven W. Lindsay; Bakary Conteh; Fatima Ceesay; John Bradley; Christian Kositz; Henk Broekhuizen; Balla Kandeh; Alexandra E. Fehr; Claudia Nieto-Sanchez; Joan Muela Ribera; Koen Peeters Grietens; Menno Roderick Smit; Chris Drakeley; Teun Bousema; Jane Achan; Umberto D'Alessandro

doi:10.2196/20904

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

Edgard Diniba Dabira^*, Harouna M. Soumare, Steven W. Lindsay, Bakary Conteh, Fatima Ceesay, John Bradley, Christian Kositz, Henk Broekhuizen, Balla Kandeh, Alexandra E. Fehr, Claudia Nieto-Sanchez, Joan Muela Ribera, Koen Peeters Grietens, Menno Roderick Smit, Chris Drakeley, Teun Bousema, Jane Achan, Umberto D'Alessandro

^*Corresponding author for this work

Athena Institute

Research output: Contribution to Journal › Article › Academic › peer-review

Abstract

Background: With a decline in malaria burden, innovative interventions and tools are required to reduce malaria transmission further. Mass drug administration (MDA) of 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 that is 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 study objective 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 in the Upper River Region of The Gambia and included 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 the buffer zones; control villages received standard malaria interventions according to the Gambian National Malaria Control Program plans. Results: The MDA campaigns were carried out from August to October 2018 for the first year and from July to September 2019 for the second year. 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. The results will provide evidence on the impact of MDA with IVM plus DP on malaria transmission.

Original language	English
Article number	20904
Journal	JMIR Research Protocols
Volume	9
Issue number	11
DOIs	https://doi.org/10.2196/20904
Publication status	Published - Nov 2020

Funding

The trial is jointly funded under the Joint Global Health Trials Scheme by the Medical Research Council (United Kingdom), the Department for International Development (DFID), and the Wellcome Trust. The funding institutions have not had nor will have any role in the study’s design, the collection, analysis, and interpretation of data, or writing the manuscript. We acknowledge the contribution of Thomas Mendy (data management) and Abdoulie Sillah (project management). Thanks to Guilin Pharmaceuticals for donating the dihydroartemisinin-piperaquine and to Elea Laboratories for providing ivermectin. The trial is jointly funded under the Joint Global Health Trials Scheme by the Medical Research Council (United Kingdom), the Department for International Development (DFID), and the Wellcome Trust. The funding institutions have not had nor will have any role in the study's design, the collection, analysis, and interpretation of data, or writing the manuscript.

Funders	Funder number
Abdoulie Sillah
Wellcome Trust
Medical Research Council
Department for International Development

Keywords

Cluster randomized trial
Dihydroartemisinin-piperaquine
Ivermectin
Malaria
Mass drug administration
The Gambia

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

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Dabira, E. D., Soumare, H. M., Lindsay, S. W., Conteh, B., Ceesay, F., Bradley, J., Kositz, C., Broekhuizen, H., Kandeh, B., Fehr, A. E., Nieto-Sanchez, C., Ribera, J. M., Grietens, K. P., Smit, M. R., Drakeley, C., Bousema, T., Achan, J., & D'Alessandro, U. (2020). 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. JMIR Research Protocols, 9(11), Article 20904. https://doi.org/10.2196/20904

Dabira, Edgard Diniba ; Soumare, Harouna M. ; Lindsay, Steven W. et al. / 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. In: JMIR Research Protocols. 2020 ; Vol. 9, No. 11.

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abstract = "Background: With a decline in malaria burden, innovative interventions and tools are required to reduce malaria transmission further. Mass drug administration (MDA) of 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 that is 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 study objective 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 in the Upper River Region of The Gambia and included 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 the buffer zones; control villages received standard malaria interventions according to the Gambian National Malaria Control Program plans. Results: The MDA campaigns were carried out from August to October 2018 for the first year and from July to September 2019 for the second year. 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. The results will provide evidence on the impact of MDA with IVM plus DP on malaria transmission.",

keywords = "Cluster randomized trial, Dihydroartemisinin-piperaquine, Ivermectin, Malaria, Mass drug administration, The Gambia",

author = "Dabira, {Edgard Diniba} and Soumare, {Harouna M.} and Lindsay, {Steven W.} and Bakary Conteh and Fatima Ceesay and John Bradley and Christian Kositz and Henk Broekhuizen and Balla Kandeh and Fehr, {Alexandra E.} and Claudia Nieto-Sanchez and Ribera, {Joan Muela} and Grietens, {Koen Peeters} and Smit, {Menno Roderick} and Chris Drakeley and Teun Bousema and Jane Achan and Umberto D'Alessandro",

year = "2020",

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doi = "10.2196/20904",

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journal = "JMIR Research Protocols",

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Dabira, ED, Soumare, HM, Lindsay, SW, Conteh, B, Ceesay, F, Bradley, J, Kositz, C, Broekhuizen, H, Kandeh, B, Fehr, AE, Nieto-Sanchez, C, Ribera, JM, Grietens, KP, Smit, MR, Drakeley, C, Bousema, T, Achan, J & D'Alessandro, U 2020, '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', JMIR Research Protocols, vol. 9, no. 11, 20904. https://doi.org/10.2196/20904

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. / Dabira, Edgard Diniba; Soumare, Harouna M.; Lindsay, Steven W. et al.
In: JMIR Research Protocols, Vol. 9, No. 11, 20904, 11.2020.

Research output: Contribution to Journal › Article › Academic › peer-review

TY - JOUR

T1 - 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

T2 - Protocol for the massiv cluster randomized clinical trial

AU - Dabira, Edgard Diniba

AU - Soumare, Harouna M.

AU - Lindsay, Steven W.

AU - Conteh, Bakary

AU - Ceesay, Fatima

AU - Bradley, John

AU - Kositz, Christian

AU - Broekhuizen, Henk

AU - Kandeh, Balla

AU - Fehr, Alexandra E.

AU - Nieto-Sanchez, Claudia

AU - Ribera, Joan Muela

AU - Grietens, Koen Peeters

AU - Smit, Menno Roderick

AU - Drakeley, Chris

AU - Bousema, Teun

AU - Achan, Jane

AU - D'Alessandro, Umberto

PY - 2020/11

Y1 - 2020/11

N2 - Background: With a decline in malaria burden, innovative interventions and tools are required to reduce malaria transmission further. Mass drug administration (MDA) of 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 that is 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 study objective 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 in the Upper River Region of The Gambia and included 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 the buffer zones; control villages received standard malaria interventions according to the Gambian National Malaria Control Program plans. Results: The MDA campaigns were carried out from August to October 2018 for the first year and from July to September 2019 for the second year. 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. The results will provide evidence on the impact of MDA with IVM plus DP on malaria transmission.

AB - Background: With a decline in malaria burden, innovative interventions and tools are required to reduce malaria transmission further. Mass drug administration (MDA) of 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 that is 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 study objective 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 in the Upper River Region of The Gambia and included 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 the buffer zones; control villages received standard malaria interventions according to the Gambian National Malaria Control Program plans. Results: The MDA campaigns were carried out from August to October 2018 for the first year and from July to September 2019 for the second year. 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. The results will provide evidence on the impact of MDA with IVM plus DP on malaria transmission.

KW - Cluster randomized trial

KW - Dihydroartemisinin-piperaquine

KW - Ivermectin

KW - Malaria

KW - Mass drug administration

KW - The Gambia

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Dabira ED, Soumare HM, Lindsay SW, Conteh B, Ceesay F, Bradley J et al. 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. JMIR Research Protocols. 2020 Nov;9(11):20904. doi: 10.2196/20904

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

Abstract

Funding

Keywords

UN SDGs

Access to Document

Persistent URL (handle)

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