Table 1.
Baseline characteristics by trial arm and site.
| Overall (N = 2180) | Site | |||||||
| Entebbe | Masaka | |||||||
| CTX (N = 1089) | Placebo (N = 1091) | CTX (N = 501) | Placebo (N = 501) | Total (N = 1002) | CTX (N = 588) | Placebo (N = 590) | Total (N = 1178) | |
| Age | P = 0.002a | |||||||
| <30 | 85 (7.8) | 83 (7.6) | 47 (9.4) | 38 (7.6) | 85 (8.4) | 38 (6.5) | 45 (7.6) | 83 (7.0) |
| 30–34 | 148 (13.6) | 189 (17.3) | 75 (15.0) | 104 (20.8) | 179 (17.9) | 73 (12.4) | 85 (14.4) | 158 (13.4) |
| 35–39 | 232 (21.3) | 235 (21.5) | 112 (22.3) | 107 (21.3) | 219 (21.9) | 120 (20.4) | 128 (21.7) | 248 (21.1) |
| 40–44 | 262 (24.1) | 221 (20.3) | 116 (23.1) | 100 (20.0) | 216 (21.6) | 146 (24.8) | 121 (20.5) | 267 (22.7) |
| 45–49 | 198 (18.2) | 190 (17.4) | 87 (17.4) | 91 (18.1) | 178 (17.8) | 111 (18.9) | 99 (16.8) | 210 (17.8) |
| ≥50 | 164 (15.1) | 173 (15.9) | 64 (12.8) | 61 (12.2) | 125 (12.4) | 100 (17.0) | 112 (19.0) | 212 (18.0) |
| Mean age (SD) | 41.0 (8.0) | 40.7 (8.3) | 40.0 (8.0) | 41.5 (8.3) | ||||
| CD4+ cell count stratum | P = 0.001 | |||||||
| 250–<500 cells/μl | 563 (56.2) | 577 (49.0) | 282 (56.3) | 281 (56.1) | 563 (56.2) | 288 (49.0) | 289 (49.0) | 577 (49.0) |
| ≥500 cells/μl | 439 (43.8) | 601 (51.0) | 219 (43.7) | 220 (43.9) | 439 (43.8) | 300 (51.0) | 301 (51.0) | 601 (51.0) |
| Time on ART (years) | P < 0.001 | |||||||
| <1 | 73 (6.7) | 82 (7.5) | 46 (9.2) | 43 (8.6) | 89 (8.9) | 27 (4.6) | 39 (6.6) | 66 (5.6) |
| 1–2 | 144 (13.2) | 160 (14.7) | 71 (14.2) | 79 (15.8) | 150 (15.0) | 73 (12.4) | 81 (13.7) | 154 (13.1) |
| 2–5 | 508 (46.7) | 480 (44.0) | 261 (52.0) | 255 (50.9) | 516 (51.5) | 247 (42.0) | 225 (38.2) | 472 (40.1) |
| >5 | 364 (33.4) | 369 (33.8) | 123 (24.6) | 124 (24.7) | 247 (24.6) | 241 (41.0) | 245 (41.5) | 486 (41.3) |
| Sex | P = 0.520 | |||||||
| Man | 286 (26.3) | 283 (25.9) | 130 (26.0) | 125 (25.0) | 255 (25.5) | 156 (26.5) | 158 (26.8) | 314 (26.7) |
| Women | 803 (73.7) | 808 (74.1) | 371 (74.0) | 376 (75.0) | 747 (74.6) | 432 (73.5) | 432 (73.2) | 864 (73.3) |
| Education level | P < 0.001 | |||||||
| None | 111 (10.2) | 113 (10.4) | 46 (9.2) | 37 (7.4) | 83 (8.3) | 65 (11.2) | 76 (12.9) | 141 (11.9) |
| Primary | 649 (59.6) | 660 (60.5) | 259 (51.7) | 281 (56.1) | 540 (53.9) | 390 (66.3) | 379 (64.2) | 769 (65.3) |
| Secondary | 276 (25.3) | 268 (24.6) | 160 (31.9) | 157 (31.3) | 317 (31.6) | 116 (19.7) | 111 (18.8) | 227 (19.3) |
| Tertiary | 53 (4.9) | 50 (4.6) | 36 (7.2) | 26 (5.2) | 62 (6.2) | 17 (2.8) | 24 (4.1) | 41 (3.5) |
| Socio-economic status | P < 0.001 | |||||||
| Low | 486 (44.6) | 474 (43.4) | 197 (39.3) | 213 (42.5) | 410 (40.9) | 289 (49.1) | 261 (44.2) | 550 (46.7) |
| Medium | 318 (29.2) | 329 (30.2) | 117 (23.4) | 113 (22.6) | 230 (23.0) | 201 (34.2) | 216 (36.6) | 417 (35.4) |
| High | 285 (26.2) | 288 (26.4) | 187 (37.3) | 175 (33.9) | 362 (36.1) | 98 (16.7) | 113 (19.2) | 211 (17.9) |
| Marital status | P = 0.32 | |||||||
| Married/cohabiting | 473 (43.4) | 465 (42.6) | 213 (42.5) | 210 (41.9) | 423 (42.2) | 260 (44.2) | 255 (43.2) | 515 (43.7) |
| Divorced/separated/widowed | 577 (53.0) | 577 (52.9) | 271 (54.1) | 273 (54.5) | 544 (54.3) | 306 (52.0) | 304 (51.3) | 610 (51.8) |
| Single | 39 (3.6) | 49 (4.5) | 17 (3.4) | 18 (3.6) | 35 (3.5) | 22 (3.7) | 31 (5.3) | 53 (4.5) |
ART, antiretroviral therapy; CTX, cotrimoxazole.
aP value for comparison between sites, by χ2 test.