Khaemba, Christabel http://orcid.org/0000-0003-0543-9920
Barry, Abbie http://orcid.org/0000-0002-3859-3660
Omondi, Wyckliff P. http://orcid.org/0000-0002-6011-2253
Kirui, Elvis http://orcid.org/0000-0002-4981-2697
Oluka, Margaret http://orcid.org/0000-0002-4881-8667
Parthasarathi, Gurumurthy http://orcid.org/0000-0002-5997-1157
Njenga, Sammy M. http://orcid.org/0000-0001-6309-476X
Guantai, Anastacia
Aklillu, Eleni http://orcid.org/0000-0002-9788-0790
Funding for this research was provided by:
European and Developing Countries Clinical Trials Partnership (CSA2016S-1618)
Styrelsen för Internationellt Utvecklingssamarbete (CSA2016S-1618)
Karolinska Institute
Article History
Accepted: 18 July 2023
First Online: 8 August 2023
Declarations
:
: This study was conducted as part of the pharmacovigilance infrastructure and post-marketing surveillance system capacity building for regional medicine regulatory harmonization in East Africa (PROFORMA) project funded by the European and Developing Countries Clinical Trials Partnership (EDCTP-2) program supported by the European Union (grant number CSA2016S-1618) and the Swedish International Development Cooperation Agency (Sida).
: Christabel Khaemba, Abbie Barry, Wyckliff P. Omondi, Elvis Kirui, Margaret Oluka, Gurumurthy Parthasarathi, Sammy M. Njenga, Anastacia Guantai, and Eleni Aklillu have no conflicts of interest that are directly relevant to the content of the article.
: This study was approved by the Kenyatta National Hospital-University of Nairobi Ethics and Research Committee (Ref. No. KNH-ERC/A/413).
: Participant consent was documented on a written informed consent form, which was accompanied by written information for parents/guardians and the informed consent forms were approved by the same ethics committees that approved this protocol.
: Not applicable.
: All data generated or analyzed during this study are included in this article.
: Not applicable.
: CK, AB, PG, AG, MO, and EA participated in the conception and design of the study. CK, AB, AG, MO, WPO, MM, SMN, and EA participated in material preparation and investigation. AG, SMN, MO, and EA supervised the implementation of the project. CK and EK performed the data curation. CK, AB, EK, and EA performed the data analysis and interpretation. CK prepared the original manuscript and AB, PG, AG, SMN, MO, WPO, MM, and EA edited and reviewed the manuscript. PG, SMN, and WPO provided technical advice. All authors read and approved the final version.