Interim analyses {21b}
ADVERSE EVENTS
Interim analyses will include summaries of demographic data and whether participants were living with HIV who have a detectable viral load at enrollment or were not engaged in care at baseline. We will also summarize the numbers of adverse events and individuals lost to follow-up. All summaries will be conducted overall and broken down by randomization group (first- and second-stage randomization). These summaries will be calculated at times that align with meetings of the DSMB and will be shared with the DSMB. Aside from group-specific information about adverse events and loss to follow-up, summaries will also be shared with the SMART ART investigator team. Operational futility will be monitored to ensure trial resources are not squandered.