Study Design
This study was part of a multicountry project with harmonized research protocols. In Uganda, we conducted an open-label, 2-arm, multicenter, randomized controlled trial. Study participants were randomized to either an intervention or control group using a 1:1 scheme using varying block sizes of 64, 96, or 128 in random order. Randomization lists for each health facility, which included consecutive identification numbers with corresponding random arm assignments, were computer-generated from the FIND Geneva. Randomized codes that corresponded to the 2 (intervention and control) arms were also generated using permuted variable-sized blocks. At each study site, each consecutive identification number with its corresponding treatment code was placed in a sealed envelope and kept in that order. Each consecutive participant was assigned an ID number and study arm from the next available envelope during randomization.