Ethics approval and consent to participate
The study design was consistent with the requirements of the Declaration of Helsinki. It was approved by the Maseno University Ethics Review Committee and the National Commission for Science, Technology, and Innovation. Per Maseno University Ethics Review Committee ethics procedures, informed consent was obtained from the parent and/or legal guardian of all participants who were under 16. Before screening, all participants provided written informed consent or assent. This study was registered prior to participant enrollment in the Pan-African Clinical Trials Registry (PACTR201906525818462), registered 20/06/2019, 