Primary and secondary study outcomes by group.
TB, AIDS, death, cancer, OI, Kaposi’s sarcoma, avium, deaths
CANCER, RENAL FAILURE, AIDS, TUBERCULOUS LYMPHADENITIS, GASTROENTERITIS
*Nine participants in the standard treatment and 7 in the same-day group attended 48-week visit without HIV-1 RNA testing.**These are mutually exclusive outcomes which include all 500 randomized participants.CI, confidence interval; RD, risk difference.Among the 220 participants in the standard and 211 in the same-day treatment group who received 48-week viral load testing, 159 in the standard group had HIV-1 RNA <50 copies/mL (72.3% of those tested; 63.6% of those randomized), compared with 137 in the same-day group (64.9% of those tested; 54.8% of those randomized). The same-day group was less likely than the standard group to achieve 48-week HIV-1 RNA <50 copies/mL (54.8% versus 63.6%; RD: −0.09; 95% CI: −0.17, −0.002)—see In the standard group, 21 participants (8.4%) were not retained in ART care at 48 weeks after enrollment. A total of 6 (2.4%) died, 10 (4.0%) were LTFU, 4 (1.6%) had a gap in care during the 48-week visit window with subsequent return to care, and 1 (0.4%) was transferred (see Three (1.2%) participants in the standard group were diagnosed with incident TB, 2 of these were treated empirically for pulmonary TB and 1 for extrapulmonary TB. One (0.04%) participant in the same-day group was diagnosed with incident TB (Xpert Ultra/culture-positive tuberculous lymphadenitis). No participant in either group was diagnosed with either unmasking or paradoxical IRIS during the first 12 weeks after ART initiation.Among the 6 participants in the standard group who died during the study period, 2 deaths were attributed to incident TB, 1 to mycobacterial avium complex, 1 to advanced AIDS with OI of unclear etiology, 1 to tear gas inhalation during a street protest, and 1 cause of death was unknown. Among the 9 participants who died in the same-day treatment group, 3 were attributed to advanced AIDS with OI of unclear etiology, 1 to advanced AIDS and gastroenteritis, 1 to Kaposi’s sarcoma diagnosed after enrollment, 1 to cancer, 1 to renal failure, and 2 were unknown.Among the participants who received 48-week viral load testing, 61.8% (136/220) in the standard and 65.9% (139/211) in the same-day group had adherence ≥90% by pharmacy refill; there were no differences in adherence between the 2 groups (RD: 0.04; 95% CI: −0.05, 0.13). Among participants with 48-week HIV-1 RNA ≥200 copies/mL, adherence was <90% among 76.9% (40/52) in the standard and 57.6% (34/59) in the same-day treatment group.Among the 245 participants in the standard group who initiated ART, 70 (28.6%) received only an EFV-based regimen, 83 (33.9%) initiated EFV and switched to a DTG-based regimen due to drug availability, 90 (36.7%) received only a DTG-based regimen, and 2 (0.8%) initiated EFV and switched to a second-line PI-based regimen. Among the 249 participants in the same-day treatment group who initiated ART, these numbers were 73 (29.3%), 75 (30.1%), 94 (37.8%), and 7 (2.8%), respectively. There was no difference between groups in switches to second-line ART (2.8% versus 0.8%; RD: 0.02; 95% CI: −0.004, 0.04; 