TABLE 1.
Baseline characteristics and outcomes for participants at each site
| Characteristic | Categories | Peri-urban (RKK) (n = 500) [n (%) or mean (SD)] |
Rural (BTD) (n = 500) [n (%) or mean (SD)] |
p-value |
|---|---|---|---|---|
| Gender | Women | 280 (55.8) | 318 (63.6) | 0.014 |
| Age | Years | 34 (9.9) | 34 (10.2) | 0.734 |
| Education | Years | 9.7 (2.8) | 9.1 (3.6) | 0.002 |
| Education beyond matriculation | Years | 0.36 (0.8) | 0.22 (0.7) | 0.003 |
| Race | Black | 465 (92.6) | 500 (100) | < 0.001 |
| Coloured | 6 (1.2) | |||
| Indian | 31 (6.2) | |||
| Ethnicity | Zulu | 301 (60.2) | 488 (97.6) | < 0.001 |
| Xhosa | 109 (21.8) | 4 (0.8) | ||
| Other | 59 (11.8) | 8 (1.6) | ||
| Missing | 31 (6.2) | 0 (0.0) | ||
| Language | isiZulu | 470 (93.6) | 500 (100) | < 0.001 |
| English | 489 (97.4) | 376 (75.2) | < 0.001 | |
| Other | 239 (47.6) | |||
| Auditory impairment | Yes | 11 (2.2) | 20 (4.0) | 0.141 |
| Visual impairment | Yes | 27 (5.4) | 61 (12.2) | < 0.001 |
| No impairment | Yes | 465 (92.6) | 423 (84.6) | < 0.001 |
| Single dose nevirapine | Yes | 26 (9.3) | 53 (23.9) | 0.005 |
| Antiretroviral therapy | EFV/FTC/TDF | 492 (98.0) | 497 (99.3) | 0.095 |
| Other | 8 (2.0) | 3 (0.7) | ||
| Enrolment CD4 count | Cells/µL | 384 (284) | 355 (287) | 0.33 |
| Timing of viral load | ||||
| 6 monthsa | Log copies/ml (n = 917) | 3.7 (1.3) | 3.3 (1.1) | 0.001 |
| 12 monthsa | Log copies/ml (n = 755) | 3.7 (0.8) | 3.0 (0.9) | 0.004 |
| 18 monthsa | Log copies/ml (n = 431) | 3.7 (1.1) | 3.0 (0.9) | 0.023 |
| 24 monthsa | Log copies/ml (n = 141) | 3.9 (2.1) | 3.0 (0.9) | 0.012 |
| 30 monthsa | Log copies/ml (n = 5) | 5.3 (4.2) | 8.3 (4.2) | 0.73 |
| Percentage suppressed | ||||
| 6 monthsb | 55.8 | 38.2 | - | |
| 12 monthsb | 84.4 | 82.5 | - | |
| 18 monthsb | 90.6 | 88.8 | - | |
| 24 monthsb | 91.6 | 90.0 | - | |
| 30 monthsb | 92.2 | 90.0 | - | |
| Final disposition | In care | 416 (83.0) | 414 (82.8) | 0.89 |
| In study clinics | 344 (68.8) | 314 (62.8) | ||
| Lost to follow-up | 62 (12.4) | 72 (14.4) | ||
| Died | 22 (4.4) | 14 (2.8) | ||
| Resistance | One or more mutations | 23 (4.6) | 19 (3.8) | 0.72 |
| One or more mutations in two drug classes: NRTI, NNRTI or PI | 1 (0.02) | 3 (0.6) | 0.3 |
Abbreviations: BTD, rural site in KwaZulu-Natal; EFV, efavirenz; FTC, emtricitabine; NNRTI, nonnucleoside reverse transcriptase inhibitor; NRTI, nucleoside reverse transcriptase inhibitor; PI, protease inhibitor; RKK, peri-urban site in Durban; TDF, tenofovir disoproxil fumarate.
a
Median and standard deviation.
b
Percentage of 500 with intention to treat.