Ethics approval and consent to participate
The study was conducted according to the Declaration of Helsinki, local regulatory requirements, and Protection of Human Subjects (45 CFR 46). The protocol has been reviewed and approved by the Institutional Review \Boards (IRBs) or Independent Ethics Committees (IECs) of the following organizations:• The Kenya Medical Research Institute (KEMRI), which includes The.◦ Center for Clinical Research (CCR) Scientific Committee (SC) and the.◦ KEMRI Scientific and Ethics Review Unit (SERU) (0026/3246);• The WRAIR IRB (#2330; RV 465; HRPO Log Number: A-17044.46);• The BU Medical Campus IRB (H-35152).The study protocol was previously published [