Ethics approval and consent to participate
All study procedures were carried out in accordance with relevant guidelines and regulations. Written informed consent was obtained from all participants enrolled in HPTN 074. The study protocol was approved by the following institutional review boards: Ukrainian Institute on Public Health Policy IRB#1 (Ukraine); Ethical Review Board for Biomedical Research Hanoi School of Public Health (Vietnam); Ethics Committee of Faculty of Medicine, University of Indonesia/Cipto Mangunkusumo Hospital (Indonesia); and the Institutional Review Board at the University of North Carolina-Chapel Hill.