Composition of the data monitoring committee, its role, and reporting structure {21a}
viral suppression
ADVERSE EVENTS
We will constitute a Data Safety and Monitoring Board (DSMB) who will meet every 6 months to review the available study data. The analysis will evaluate participant safety (SAEs and social harms) and available endpoint data and review the operational factors, specifically participant enrollment and follow-up, to assess safety and study execution. To examine whether the study design should be modified, we will conduct a conditional power analysis of the process outcomes (ART uptake and adherence) and early endpoint data (viral suppression) to assess the futility for each of the two treatment groups. We will compare the frequency of ART-related SAEs between the three study groups to assess safety, and review the serious adverse events to see if any could be prevented.