Table 3.
Population | Control | Intervention | Steptime adjusted | Multivariable adjusted | |||||||
---|---|---|---|---|---|---|---|---|---|---|---|
Number of Failures | Follow‐up time (person‐years) | Rate per person‐year | Number of Failures | Follow‐up time (person‐years) | Rate per person‐year | HR (95%CI) a | p‐value b | HR (95%CI) a | p‐value b | ||
Retention | |||||||||||
All enrolled participants | 316 | 1665.7 | 0.19 | 215 | 1364.6 | 0.16 | 1.60 (1.15 to 2.21) | 0.005 | 1.94 (1.33 to 2.82) c | 0.0006 | |
SoC‐ineligible | 150 | 851.7 | 0.18 | 48 | 399.6 | 0.12 | 1.89 (1.21 to 2.96) | 0.005 | 2.75 (1.69 to 4.50) d | <0.0001 | |
SoC‐eligible | 138 | 661.9 | 0.21 | 117 | 839.7 | 0.14 | 1.79 (1.20 to 2.66) | 0.004 | 1.84 (1.28 to 2.65) c | 0.0009 | |
Viral suppression six months post ART initiation | |||||||||||
All enrolled participants | 352 | 386.9 | 0.91 | 308 | 691.1 | 0.45 | 14.51 (7.31 to 28.79) | <0.0001 | 22.08 (7.91 to 61.59) e | <0.0001 | |
SoC‐ineligible | 114 | 121.9 | 0.94 | 65 | 232.7 | 0.28 | 13.79 (6.11 to 31.11) | <0.0001 | 19.91 (6.14 to 64.61) e | <0.0001 | |
SoC‐eligible | 225 | 249.5 | 0.90 | 205 | 428.4 | 0.48 | 16.18 (8.31 to 31.51) | <0.0001 | 30.86 (8.89 to 107.20) f | <0.0001 | |
Combined retention and viral suppression | |||||||||||
All enrolled participants | 723 | 1649.8 | 0.44 | 516 | 1332.2 | 0.39 | 4.88 (2.96 to 8.05) | 6.90 (3.11 to 15.31) g | |||
SoC‐ineligible | 275 | 847.8 | 0.32 | 110 | 395.2 | 0.28 | 4.17 (2.38 to 7.32) | 6.22 (2.71 to 14.30) c | |||
SoC‐eligible | 402 | 650.0 | 0.62 | 308 | 813.7 | 0.38 | 6.51 (4.07 to 10.42) | 9.25 (4.53 to 18.91) h |
HR compared to standard of care rates
Not adjusted for multiplicity
adjusted for steptime, age at study enrolment (18 to <20 years old, 20 to <30 years old, 30 to <40 years old, 40 to <50 years old, 50 to <60 years old, 60+ years old), sex, marital status (married, divorced/widowed, single), education (illiterate/primary, secondary, high school, tertiary), CD4 counts (<350, 350 to 500, >500), WHO stage (stage 1, stage 2, stage 3 or 4), BMI (<18.5, 18.5 to <25, 25 to <30, ≥30), screened for TB symptoms (yes, no), viral load (<5000, 5000 to 30‚000, >30‚000), treatment support (yes, no), level of clinic (Hospital, Clinic with maternity, Clinic without maternity), time from HIV tested positive to enrolment (≤1 year, 1 to ≤3 years, >3 years), clinic volume (Low: < median, High: ≥median
same as footnote 2, plus study enrolment date (continuous)
came as footnote 2, plus study enrolment date (2 knot restricted cubic splines). If CD4/WHO at 180 days post ART initiation was not available, use CD4/WHO at ART initiation if available, or CD4/WHO at study enrolment if available. For WHO stage at 180 days post ART initiation, which had too few missing to use the missing indicator method, the missings were assigned to the reference category.
same as footnote 4
same as footnote 2, plus study enrolment date (2 knots stepwise restricted cubic spline)
same as footnote 2, plus study enrolment date (3 knots stepwise restricted cubic spline).