Baseline characteristics of study participants by group.
TB, fever, cough, sweats, extrapulmonary TB.Baseline TB, weight loss, pulmonary TB
TUBERCULOSIS
BMI, body mass index; IQR, interquartile range; TB, tuberculosis.Among participants with BAC+ TB, 64.7% (44/68) had a positive Xpert Ultra test on the spot specimen; 72.1% (49/68) had a positive Xpert Ultra test on the early-morning specimen; 80.1% (55/68) had at least 1 positive Xpert Ultra; 97.1% (66/68) were culture-positive; and 2 (2.9%) were Xpert Ultra positive but culture-negative. An additional 18 participants were empirically diagnosed with pulmonary TB, with negative sputum testing, and 2 participants were diagnosed with extrapulmonary TB.Baseline TB prevalence varied by reported symptoms. Among participants in both groups who reported cough, fever, night sweats, or weight loss, 35.0% (70/200), 33.0% (64/194), 44.4% (32/72), and 17.3% (85/491), respectively, were diagnosed with TB. Among participants in both groups who reported only weight loss, 3.8% (9/239) were diagnosed with TB.In the standard group, 33 of 40 (82.5%) participants diagnosed with baseline TB initiated treatment prior to ART initiation; of these, 30 (90.1%) initiated TB treatment within 7 days of enrollment, and all 33 initiated ART at a median time of 14 days (IQR: 13, 14) after TB treatment. Seven (17.5%) participants (with negative Xpert Ultra and positive mycobacterial cultures) initiated ART prior to TB diagnosis; TB treatment was initiated within a range of 14 to 128 days after ART. Among the 210 participants who were not diagnosed with baseline TB, 205 (97.6%) initiated ART at a median time of 7 days (IQR: 7, 10). Of these, 110 (53.7%) initiated ART within 7 days, 83 (40.5%) from 8 to 14 days and 12 (5.8%) >14 days after HIV diagnosis. Among all participants randomized to the standard group (regardless of TB status), ART was initiated a median of 9 days (IQR: 7, 12) after enrollment.In the same-day treatment group, 37 of 48 (77.1%) participants diagnosed with baseline TB initiated TB treatment on the day of HIV diagnosis; of these, 36 (97.3%) initiated ART at a median time of 14 days (IQR: 14, 15) after TB treatment, and one was LTFU prior to starting ART. Eleven (22.9%) participants initiated ART prior to TB treatment. Of these, 5 had negative spot but positive early morning Xpert Ultra tests and initiated TB treatment within a range of 7 to 18 days after ART; 6 had negative Xpert Ultra tests, but positive mycobacterial cultures, and initiated TB treatment within a range of 37 to 89 days after ART. All 202 participants who were not diagnosed with baseline TB initiated ART on the day of HIV diagnosis. Among all participants randomized to the same-day treatment group (regardless of TB status), ART was initiated at a median time of 0 days (IQR: 0, 0) after enrollment.Among the 250 participants in the standard group, 229 (91.6%) attended the 48-week visit, and 220 (88.0%) received HIV-1 RNA testing with the 48-week visit window; of these, 168 (76.4% of those tested; 67.2% of those randomized) had HIV-1 RNA <200 copies/mL (see 