Statistical analysis
SECONDARY
The prespecified target sample size was 600. For the primary outcome, a sample size of 388 was calculated to provide at least 80% power to detect an absolute difference of 14% in the proportion of participants with 48-week HIV-1 RNA <200 copies/mL (51% in the standard and 65% in the same-day treatment group), assuming a (two-sided) significance level of 0.05, using the Chi-square test; these estimates were based on a prior study of same-day ART conducted by our team at GHESKIO [Baseline characteristics were summarized using simple frequencies and proportions for categorical variables and medians with interquartile ranges (IQRs) for continuous variables by treatment group. We compared the proportion of participants with 48-week HIV-1 RNA <200 copies/mL (primary endpoint) and binary secondary outcomes using the Chi-square test (Fisher exact test was used instead for sparse data). For all comparisons, we presented unadjusted risk difference (RD) with 95% confidence interval (CI) and For all analyses, an intention-to-treat approach was used, in which all participants were analyzed according to their assigned group. We did all analyses with SAS version 9.4. The study was registered with 