Statistical analysis
virologic failure, VL suppression
REGRESSION, REGRESSIONS
We categorized VL as suppressed (< 1,000 copies/ml) or unsuppressed (≥ 1,000 copies/ml). Age was categorized into 3 groups: <10 years, 10–15 years and 16–24 years. We grouped primary caregivers as both parents, single parent and other non-parent relatives. We summarized baseline characteristics using frequencies and proportions for categorical variables and medians for continuous variables stratified by intervention arms. We compared baseline characteristics between the study arms using chi-square tests for categorical variables and Wilcoxon rank-sum tests for continuous variables. We examined baseline characteristics independently associated with viral suppression at enrolment using multivariable logistic regression.To estimate the effect of the clinic-based SAMBA assay versus SOC VL testing on 12-month viral suppression rate, analyses were based on two approaches (per protocol analysis and intention to treat (ITT) analysis). In the first approach, we included only participants with 12-month virologic outcomes as assigned to study group, with inverse probability of missingness weighting to account for imbalances in baseline characteristics due to differential missingness between study arms (weighted per protocol analysis). In the second approach we used ITT analysis in which all randomized participants were included, with those missing 12-month virologic outcomes imputed to virologic failure (ITT Missing VL—failure). In all the analyses we estimated the effect of the clinic-based SAMBA assay and 95% confidence interval using logistic regression. We further examined characteristics associated with 12-month VL suppression using multivariable logistic regression. Variables associated with VL suppression with p< 0.20 in univariable logistic regressions and clinically relevant variables were included in the multivariable model.Confirmatory VL testing and test result TAT, drug switching and VL suppression at 12 months were estimated and compared by treatment arm using chi-square tests or Wilcoxon rank-sum tests as appropriate. All statistical analyses were performed using Stata 15.1 (College Station, Tx).