Design, Implementation, and Coordination of Malaria Therapeutic Efficacy Studies in Nigeria in 2018

Adeola Yetunde Olukosi Nigerian Institute of Medical Research, Lagos, Nigeria;
EKO University of Medical and Health Sciences, Lagos, Nigeria;

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Adesola Zaidat Musa Nigerian Institute of Medical Research, Lagos, Nigeria;

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Nnenna Ogbulafor National Malaria Elimination Program, Abuja, Nigeria;

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Oluwagbemiga Aina Nigerian Institute of Medical Research, Lagos, Nigeria;

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Olugbenga Mokuolu University of Ilorin, Kwara, Nigeria;

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Stephen Oguche University of Jos, Plateau, Nigeria;

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Robinson Wammanda Ahmadu Bello University, Zaria, Nigeria;

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Henrietta Okafor University of Nigeria Teaching Hospital, Enugu, Nigeria;

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Sabdat Ozichu Ekama Nigerian Institute of Medical Research, Lagos, Nigeria;

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Agatha Nkiru David Nigerian Institute of Medical Research, Lagos, Nigeria;

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Christian Tientcha Happi Redeemer’s University Ede, Osun, Nigeria;

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Lynda Ozor WHO, Abuja, Nigeria

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Seye Babatunde WHO, Abuja, Nigeria

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Simon N. Ijezie National Malaria Elimination Program, Abuja, Nigeria;

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Perpetua E. Uhomoibhi National Malaria Elimination Program, Abuja, Nigeria;

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Samson Taiwo Awolola Nigerian Institute of Medical Research, Lagos, Nigeria;

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Audu Bala Mohammed National Malaria Elimination Program, Abuja, Nigeria;

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Babatunde Lawal Salako Nigerian Institute of Medical Research, Lagos, Nigeria;

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ABSTRACT.

Prior to 2018, malaria therapeutic efficacy studies (TESs) in Nigeria were implemented separately at different sites, as assigned by the National Malaria Elimination Program (NMEP). In 2018, however, the NMEP engaged the Nigerian Institute of Medical Research to coordinate the 2018 TESs in 3 of 14 sentinel sites with the objective of standardizing their conduct across all three sites: Enugu, Kano, and Plateau states in three of six geopolitical zones. Artemether–lumefantrine and artesunate–amodiaquine, the two first-line drugs for treatment of acute uncomplicated malaria in Nigeria, were tested in both Kano and Plateau states. In Enugu State, however, artemether–lumefantrine and dihydroartemisinin–piperaquine were the test drugs, with dihydroartemisinin–piperaquine being tested for potential inclusion in Nigerian treatment policy. The TES was conducted in 6-month to 8-year-old children and was funded by the Global Fund with additional support from the WHO. A multipartite core team comprised of the NMEP, the WHO, the U.S. Presidential Malaria Initiative, academia, and the Nigerian Institute of Medical Research was set up to oversee the execution of the 2018 TES. This communication reports best practices adopted to guide its coordination, and lessons learned during in the process, including applying developed standard operating procedures, powering the sample size adequately for each site to report independently, training the investigating team for fieldwork, facilitating stratification of decisions, determining efficiencies derived from monitoring and quality assessment, and optimizing logistics. The planning and coordination of the 2018 TES activities is a model of a consultative process for the sustainability of antimalarial resistance surveillance in Nigeria.

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Author Notes

Address correspondence to Adeola Yetunde Olukosi, Department of Biochemistry and Nutrition, Nigerian Institute of Medical Research, 6, Edmund Crescent, Yaba, Lagos, Nigeria. E-mail: yaolukosi@yahoo.co.uk

Financial support: Support for this work was provided by the Global Fund, the WHO, and the U.S. Presidential Malaria Initiative. The Global Fund was the major funder of the 2018 therapeutic efficacy study.

Disclosure: The study protocol was approved by the Nigerian National Health Research Ethics Committee (NHREC). Additional ethical clearance was obtained from the PI’s host institutional review committees; social approvals were obtained from the states. Written informed consent was obtained from the parents and guardians of enlisted participants, and were also obtained 7- and 8-year-old children. All core team members, monitors, and investigators in the TES were required to take the online course, Protection of Human Research Participants, and submit a clearance certificate to the TES director at the NIMR. This also formed part of the documents and requirements for ethical approval at the NHREC.

Authors’ addresses: Adeola Yetunde Olukosi, Nigerian Institute of Medical Research, Lagos, Nigeria, and EKO University of Medical and Health Sciences, Lagos, Nigeria, E-mail: yaolukosi@nimr.gov.ng. Adesola Zaidat Musa, Oluwagbemiga Aina, Sabdat Ozichu Ekama, Agatha Nkiru David, Samson Taiwo Awolola, and Babatunde Lawal Salako, Nigerian Institute of Medical Research, Lagos, Nigeria, E-mails: sola_dele@yahoo.com, gbengaaina2003@yahoo.com, sabdatekama@gmail.com, nkiru_d@yahoo.com, awololas@hotmail.com, and tundesalako@hotmail.com. Nnenna Ogbulafor, Simon N. Ijezie, Perpetua E. Uhomoibhi, and Audu Bala Mohammed, National Malaria Elimination Program, Abuja, Nigeria, E-mails: nnennanco@yahoo.com, ijeziensimon@gmail.com, puhomoibhi@yahoo.com, and balamohd1988@gmail.com. Olugbenga Mokuolu, University of Ilorin, Kwara, Nigeria, E-mail: mokuolu@gmail.com. Stephen Oguche, University of Jos, Plateau, Nigeria, E-mail: soguche2001@yahoo.com. Robinson Wammanda, Ahmadu Bello University, Zaria, Nigeria, E-mail: wammanda@yahoo.com. Henrietta Okafor, University of Nigeria Teaching Hospital, Enugu, Nigeria, E-mail: huche57@yahoo.com. Christian Tientcha Happi, Redeemer’s University Ede, Osun, Nigeria, E-mail: happic@run.edu.ng. Lynda Ozor and Seye Babatunde, WHO, Abuja, Nigeria, E-mails: ozorl@who.int and babatundeo@who.int.

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