Background
Methods
Study setting
Data collection and patient characteristics
Ethics approval and consent to participate
Tuberculosis screening and diagnosis
Definition of prevalent TB and incident TB
Use of ART with IPT
Statistical methods
Results
Baseline prevalent TB
Characteristics | Total patients (n = 1904) | Prevalent TB at baseline | p-value | |
---|---|---|---|---|
No | Yes | |||
Total patients, n (%) | 1904 (100%) | 1267 (66.5%) | 637 (33.5%) | |
Age (years), Median (IQR) † | 40 (33.0, 46.0) | 40 (32.0, 47.0) | 40 (34.0, 46.0) | 0.491 |
Gender, n (%) | < 0.0001 | |||
Female | 654 (34.4%) | 507 (77.5%) | 147 (22.5%) | |
Male | 1250 (65.6%) | 760 (60.8%) | 490 (39.2%) | |
Ever Smoker, n (%) | 0.067 | |||
Yes | 221 (11.6%) | 135 (61.1%) | 86 (38.9%) | |
No | 1683 (88.4%) | 1132 (67.3%) | 551 (32.7%) | |
Ever Tobacco user, n (%) | < 0.0001 | |||
Yes | 840 (44.1%) | 482 (57.4%) | 358 (42.6%) | |
No | 1064 (55.9%) | 785 (73.8%) | 279 (26.2%) | |
Ever consumed Alcohol, n (%) | < 0.0001 | |||
Yes | 642 (33.7%) | 376 (58.6%) | 266 (41.4%) | |
No | 1262 (66.3%) | 891 (70.6%) | 371 (29.4%) | |
Hepatitis B positive, n (%) | 0.074 | |||
Yes | 51 (2.7%) | 28 (54.9%) | 23 (45.1%) | |
No | 1853 (97.3%) | 1239 (66.9%) | 614 (33.1%) | |
Prior Diabetes Mellitus, n (%) | 0.093 | |||
Yes | 84 (4.4%) | 63 (75.0%) | 21 (25.0%) | |
No | 1820 (95.6%) | 1204 (66.2%) | 616 (33.9%) | |
Haemoglobin at baseline (g/dl) (n = 1592)a, n (%) | < 0.0001 | |||
≤ 10 | 388 (24.4%) | 173 (44.6%) | 215 (55.4%) | |
> 10 | 1204 (75.6%) | 839 (69.7%) | 365 (30.3%) |
Characteristics | Total patients (n = 1904) | Prevalent TB at baseline | p-value | |
---|---|---|---|---|
No | Yes | |||
Total patients, n (%) | 1904 (100%) | 1267 (66.5%) | 637 (33.5%) | |
ART regimes (n = 1894)b, n (%) | 0.947 | |||
NNRTI based | 1482 (78.2%) | 983 (66.3%) | 499 (33.7%) | |
PI based | 413 (21.8%) | 275 (66.5%) | 138 (33.5%) | |
Duration since HIV diagnosis (Months), Median (IQR) a | 62 (36.0, 92.0) | 61 (34.0, 92.0) | 64 (36.0, 94.0) | 0.231 |
Duration on ART (Months), Median (IQR)a | 57 (32.0, 84.0) | 56 (32.0, 85.0) | 60 (32.0, 82.0) | 0.382 |
CD4 count at ART initiation, Median (IQR) a | 173 (83.0, 255.0) | 197 (112.0, 297.0) | 108 (58.0, 182.0) | < 0.0001 |
CD4 count NADIR, Median (IQR) a | 146 (72.0, 235.0) | 183 (88.0, 277.0) | 88 (49.0, 165.0) | < 0.0001 |
Current/updated CD4 count, Median (IQR) a | 402 (236, 620) | 440 (286, 664) | 331 (187, 521) | < 0.0001 |
Virologic condition on ART, n (%) | < 0.0001 | |||
Virologic failure (VF) | 297 (15.6%) | 166 (55.9%) | 131 (44.1%) | |
Virologic suppression (VS) | 1607 (84.4%) | 1101 (68.5%) | 506 (31.5%) | |
IPT on ART, n (%) | 0.001 | |||
ART plus IPT given | 358 (18.8%) | 264 (73.7%) | 94 (26.3%) | |
ART alone | 1546 (81.2%) | 1003 (64.9%) | 543 (35.1%) |
Characteristics | Entire Cohort (n = 1904) | Patients with NO baseline prevalent TB (n = 1267) | ||
---|---|---|---|---|
Number of patients (n) | Incidence rate (95% CI)per 100 person years | Number of patients (n) | Incidence rate (95% CI) per 100 person years | |
Total patients | 182 | 1.85 (1.604, 2.144) | 113 | 1.73 (1.436, 2.076) |
Age (years) | ||||
≤ 40 years | 100 | 1.83 (1.502, 2.223) | 63 | 1.75 (1.363, 2.233) |
> 40 years | 82 | 1.89 (1.521, 2.344) | 50 | 1.71 (1.292, 2.249) |
Gender | ||||
Female | 50 | 1.49 (1.132, 1.971) | 35 | 1.34 (0.961, 1.865) |
Male | 132 | 2.04 (1.721, 2.421) | 78 | 1.98 (1.589, 2.478) |
History of prior TB at baseline | ||||
Yes | 69 | 2.11 (1.666, 2.671) | ||
No | 113 | 1.73 (1.436, 2.076) | ||
Haemoglobin at baseline (g/dl) | (n = 156) | (n = 88) | ||
≤ 10 | 53 | 2.84 (2.171, 3.719) | 65 | 2.79 (1.853, 4.196) |
> 10 | 103 | 1.58 (1.304, 1.919) | 23 | 1.43 (1.125, 1.830) |
Virologic status on ART | ||||
Virologic failure (VF) | 105 | 8.51 (7.030, 10.307) | 71 | 10.23 (8.107, 12.910) |
Virologic suppression (VS) | 77 | 0.90 (0.717, 1.122) | 42 | 0.72 (0.530, 0.972) |
IPT | ||||
ART plus IPT | 5 | 0.20 (0.081, 0.469) | 2 | 0.11 (0.026, 0.423) |
ART alone | 177 | 2.44 (2.106, 2.828) | 111 | 2.38 (1.979, 2.872) |
Duration of ART (months) | ||||
≤ 12 | 33 | 24.32 (17.293, 34.215) | 23 | 25.58 (16.998, 38.492) |
13–36 | 52 | 5.46 (4.162, 7.167) | 29 | 4.32 (3.005, 6.223) |
37–60 | 44 | 2.54 (1.890, 3.413) | 28 | 2.41 (1.666, 3.495) |
> 60 | 53 | 0.75 (0.579, 0.992) | 33 | 0.72 (0.507, 1.004) |
Pre ART CD4 count (cells/mm3) | ||||
≤ 50 | 32 | 2.28 (1.612, 3.224) | 18 | 2.57 (1.621, 4.085) |
51–200 | 108 | 2.20 (1.824, 2.660) | 59 | 1.98 (1.537, 2.560) |
201–500 | 41 | 1.28 (0.943, 1.740) | 35 | 1.35 (0.967, 1.875) |
> 500 | 1 | 0.32 (0.045, 2.303) | 1 | 0.36 (0.052, 2.625) |
Current/ updated CD4 count (cells/mm3) | ||||
≤ 200 | 107 | 7.36 (6.090, 8.896) | 65 | 8.35 (6.548, 10.648) |
201–350 | 36 | 1.75 (1.265, 2.432) | 22 | 1.64 (1.078, 2.486) |
351–500 | 20 | 1.03 (0.667, 1.602) | 12 | 0.97 (0.552, 1.711) |
> 500 | 19 | 0.43 (0.277, 0.681) | 14 | 0.44 (0.260, 0.741) |
ART duration and rate of incident TB
Characteristics | Univariate analysis | Multivariate analysis | ||
---|---|---|---|---|
Hazard ratio (95% CI) | p-value | Adjusted Hazard ratio (95% CI) | p-value | |
Age > 40 years (Ref: ≤ 40 years) | 1.07 (0.794, 1.432) | 0.668 | 1.01 (0.746, 1.375) | 0.935 |
Male (Ref: Female) | 1.36 (0.978, 1.877) | 0.068 | 0.96 (0.616, 1.495) | 0.855 |
Ever Tobacco user (Ref: not used tobacco) | 1.90 (1.413, 2.560) | < 0.0001 | 1.08 (0.737, 1.584) | 0.690 |
Ever consumed Alcohol (Ref: not consume alcohol) | 1.39 (1.036, 1.866) | 0.028 | 1.10 (0.770, 1.572) | 0.599 |
History of baseline prevalent TB (Ref: No baseline prevalent TB) | 1.23 (0.909, 1.656) | 0.181 | ||
Haemoglobin at baseline ≤10 g/dl (n = 1592)(Ref: > 10 g/dl)a | 1.80 (1.290, 2.504) | 0.001 | ||
Virologic failure on ART (VF)(Ref: Virologic success (VS)) | 9.51 (7.078, 12.786) | < 0.0001 | 3.05 (2.094, 4.454) | < 0.0001 |
ART alone (Ref: ART plus IPT) | 12.71 (5.217, 30.943) | < 0.0001 | 8.24 (3.358, 20.204) | < 0.0001 |
Pre ART CD4+ ≤ 200 cells/mm3(Ref: > 200 cells/mm3) | 1.87 (1.326, 2.647) | < 0.0001 | 1.18 (0.816, 1.714) | 0.377 |
Pre ART CD4+ (Ref: > 500 cells/mm3) | ||||
≤ 50 | 6.87 (0.937, 50.321) | 0.058 | ||
51–200 | 6.60 (0.921, 47.370) | 0.060 | ||
201–500 | 3.79 (0.521, 27.596) | 0.188 | ||
Current/updated CD4+ (Ref: > 500 cells/mm3) | ||||
≤ 200 | 17.60 (10.783, 28.716) | < 0.0001 | 6.62 (3.678, 11.915) | < 0.0001 |
201–350 | 4.19 (2.401, 7.313) | < 0.0001 | 3.22 (1.808, 5.746) | < 0.0001 |
351–500 | 2.43 (1.297, 4.555) | < 0.0001 | 2.05 (1.083, 3.888) | 0.027 |