• Data Management and Analysis: This study is being carried out at several clinical sites in Kenya. Clinical and laboratory data for each participant will be abstracted from routine clinical data forms into standardized trial files. These data will be entered weekly into a computer using a computerized database designed and maintained by the study investigators. Information will be cross checked for accuracy on a bi-weekly basis. All data, both hard and soft copy format, will be stored in locked cabinets with limited access by study staff only. Participants will be identified by a unique study ID number and the code linking the study ID to individual identifying information will be kept in a separate secure location by the principal investigator.