Characteristic | Cohort 1: | Cohort 2: | RCT arm A: | RCT arm B: | P-valuei |
---|---|---|---|---|---|
ART (CD4 < 200) | ZDV plus sdNVP (CD4 > 500) | Triple ARV (CD4 200–500) | ZDV plus sdNVP (CD4 200–500) | ||
(n visits = 1514) | (n visits = 1371) | (n visits = 4467) | (n visits = 4381) | ||
Median weeks of antiretroviral use (IQR) | 112.8 | 5.9 | 22.1 | 6.7 | NA |
 | (85.1-117.7) | (4.7-6.8) | (10.6-32.4) | (4.6-8.9) |  |
Number of women who never initiated breastfeeding (formula only), n (%) | 46 (38.9) | 31 (24.2) | 104 (25.2) | 104 (25.2) | 0.899* |
Median weeks of breastfeeding if initiated (IQR) | 19.1 | 17.9 | 20.9 | 19.6 | 0.898 |
(11.9-23.2) | (12.1-24.7) | (11.9-24.9) | (11.3-25.0) | Â | |
Breastfeeding duration if initiated, n (%) | Â | Â | Â | Â | Â |
 <3 months | 28 (43.8) | 42 (46.1) | 120 (41.2) | 133 (44.8) |  |
 ≥3 months | 36 (56.2) | 49 (53.9) | 171 (58.8) | 164 (55.2) | 0.385 |
Median CD4 count [cells/mm3] (IQR) | Â | Â | Â | Â | Â |
 At enrolment | 134.5 (91–170) | 621.5 (559–810) | 335.5 (282–408) | 338.5 (267–408) | 0.428* |
 At delivery | 184 (129–277) | 742 (602.5-910) | 462.5 (383–603) | 415 (331–527) | <0.001* |
 At 6 months postpartum | 274 (207–364) | 731 (616–870) | 479 (369–597) | 374 (292–471) | <0.001* |
 At 12 months postpartum | 304 (228–419) | 683.5 (543–889) | 401 (319.5-518) | 378 (287–469) | 0.509* |
Median Hb [g/dL] (IQR) | Â | Â | Â | Â | Â |
 At enrolment | 9.9 (8.9-11.0) | 10.9 (9.9-12.7) | 10.2 (9.2-11.1) | 10.2 (9.1-11.1) | 0.440* |
 At delivery | 10.0 (8.9-11.8) | 11.3 (10.2-13.3) | 10.6 (9.6-11.6) | 10.6 (9.4-11.8) | 0.948* |
 At 6 months postpartum | 11.8 (11.1-13.0) | 13.1 (11.8-14.3) | 11.9 (11.1-12.8) | 11.7 (10.9-12.6) | 0.075* |
 At 12 months postpartum | 11.9 (11.0-12.9) | 12.5 (11.4-13.6) | 11.5 (10.7-12.5) | 11.3 (10.3-12.2) | 0.078* |
Median MCV [fL] (IQR) | Â | Â | Â | Â | Â |
 At enrolment | 86 (78–91) | 85 (78–91) | 87 (81–93) | 88.5 (82–94) | 0.866* |
 At delivery | 91 (84–98) | 88 (80–93) | 91 (83–99) | 93 (85–101) | 0.325* |
 At 6 months postpartum | 103 (96–110) | 82 (77–90) | 91 (83–100) | 85 (79–90) | <0.001* |
 At 12 months postpartum | 102 (95–110) | 82 (75–89) | 83 (77–89) | 84 (78–90) | 0.118* |
Proportion with macrocytosis (95% CI) | Â | Â | Â | Â | Â |
 At enrolment | 0.03 (0.01-0.08) | 0.05 (0.02-0.10) | 0.10 (0.07-0.13) | 0.07 (0.05-0.10) | 0.259** |
 At delivery | 0.21 (0.14-0.30) | 0.08 (0.04-0.15) | 0.23 (0.18-0.27) | 0.28 (0.24-0.33) | 0.112* |
 At 6 months postpartum | 0.63 (0.53-0.71) | 0.01 (0.00-0.07) | 0.26 (0.21-0.30) | 0.03 (0.02-0.06) | <0.001* |
 At 12 months postpartum | 0.61 (0.51-0.70) | 0.01 (0.00-0.07) | 0.06 (0.03-0.10) | 0.09 (0.06-0.14) | 0.144* |
Proportion with any anaemia (Hb < 11 g/dL) (95% CI) |  |  |  |  |  |
 At enrolment | 0.74 (0.65-0.82) | 0.55 (0.46-0.64) | 0.71 (0.66-0.75) | 0.72 (0.68-0.76) | 0.627* |
 At delivery | 0.71 (0.61-0.79) | 0.43 (0.33-0.52) | 0.61 (0.56-0.66) | 0.59 (0.54-0.64) | 0.561* |
 At 6 months postpartum | 0.25 (0.18-0.34) | 0.12 (0.06-0.2) | 0.23 (0.19-0.28) | 0.26 (0.21-0.30) | 0.398 |
 At 12 months postpartum | 0.21 (0.14-0.30) | 0.16 (0.09-0.25) | 0.32 (0.26-0.38) | 0.39 (0.34-0.45) | 0.228* |
Proportion with severe anaemia (Hb < 8 g/dL) (95% CI) |  |  |  |  |  |
 At enrolment | 0.09 (0.05-0.16) | 0.04 (0.01-0.09) | 0.06 (0.04-0.09) | 0.07 (0.04-0.09) | 0.671 |
 At delivery | 0.15 (0.09-0.23) | 0.06 (0.02-0.12) | 0.06 (0.04-0.09) | 0.10 (0.07-0.13) | 0.144* |
 At 6 months postpartum | 0.02 (0–0.06) | 0.01 (0.00-0.06) | 0.01 (0.00-0.03) | 0.02 (0.01-0.04) | 0.255 |
 At 12 months postpartum | 0.01 (0–0.04) | 0.00 (0.00-0.04) | 0.02 (0.00-0.08) | 0.03 (0.01-0.09) | 0.678 |
Cumulative incidence of severe anaemia (Hb < 8 g/dL) (95% CI) |  |  |  |  |  |
 At delivery | 0.14 (0.09-0.22) | 0.05 (0.03-0.11) | 0.09 (0.06-0.12) | 0.08 (0.06-0.11) | 0.512* |
 At 6 months postpartum | 0.30 (0.23-0.39) | 0.10 (0.06-0.16) | 0.16 (0.13-0.20) | 0.17 (0.14-0.21) | 0.436* |
 At 12 months postpartum | 0.33 (0.26-0.41) | 0.11 (0.06-0.17) | 0.18 (0.14-0.21) | 0.19 (0.16-0.23) | 0.712* |
 At 18 months postpartum | 0.34 (0.27-0.42) | 0.11 (0.06-0.17) | 0.18 (0.15-0.22) | 0.21 (0.17-0.25) | 0.356* |
Overall incidence of severe anaemia per person year (Hb < 8 g/dL) (95% CI) | 0.21 | 0.06 | 0.12 | 0.14 | 0.317* |
(0.16-0.27) | (0.04-0.10) | (0.10-0.15) | (0.12-0.18) | Â | |
Number of single failures only (Hb < 8 g/dL), n (%) | 28 (23.7) | 11 (8.6) | 49 (11.9) | 65 (15.8) | 0.129* |
Number of individuals with repeat failures (Hb < 8 g/dL), n (%) | 11 (9.3) | 2 (1.6) | 14 (3.6) | 14 (3.3) | 0.708* |
Summed ii number of repeat failures, n | 24 | 4 | 35 | 32 | --- |