Methods in analysis to handle protocol non-adherence and any statistical methods to handle missing data {20c}
The primary analysis will be modified intent-to-treat (mITT) restricted to participants who are not lost to follow-up and have complete endpoint data at the 18-month follow-up (inclusion in the mITT analysis will be determined separately for each outcome). As a sensitivity study, we will repeat all analyses as intent-to-treat (ITT), including all randomized participants and imputing missing endpoint data as follows: (i) individuals lost to follow-up will be assumed not to be virally suppressed, (ii) individuals lost to follow-up prior to initiating ART will be assumed to have never initiated ART, and (iii) for individuals lost to follow-up, the proportion of missed clinic visits and medication follow-ups will be calculated for all available months in the final 12 months of follow-up and will be assumed to be one in the remaining months.