Outcomes
viral failure, HIV drug resistance, viral suppression
To assess trial feasibility, we evaluated the proportion of potentially eligible participants who were enrolled, who completed follow-up, and who had same-day VL testing (point-of-care arm only). We obtained approvals to retrospectively assess routine, deidentified laboratory, and clinical data from PCZ CDC to determine the total number of potentially eligible participants during the study period, allowing us to calculate the proportion we managed to enroll. To provide exploratory estimates of the potential effect of point-of-care VL testing, we assessed the primary outcome of viral suppression <50 copies/mL at 24 weeks after enrolment in each arm according to intention-to-treat. Outcome VLs were measured retrospectively testing stored samples with the cobas HIV-1 assay on the cobas 6800 platform (Roche, Basel, Switzerland). Additional prespecified exploratory outcomes were HIV drug resistance in each arm at study exit, time to detection of viral failure (consecutive VLs ≥1000 copies/mL), switch to second-line ART, and appropriate switch/transition to dolutegravir-based ART.