Table 1.
Characteristics of Mothers According to Study Arm
| Characteristics | Triple ARV (n = 384) | AZT/sdNVP (n = 405) | P Value |
|---|---|---|---|
| Study site | |||
| Bobo Dioulasso, Burkina Faso | 115 (30.0) | 122 (30.1) | .98 |
| Kwadabeka, South-Africa | 91 (23.7) | 91 (22.5) | |
| Mombasa, Kenya | 113 (29.3) | 120 (29.6) | |
| Nairobi, Kenya | 19 (5.0) | 24 (5.9) | |
| Somkhele, South-Africa | 46 (12.0) | 48 (11.9) | |
| Age in years, median (IQR) | 27.0 (24.0–31.0) | 27.0 (23.0–31.0) | .70 |
| Education | |||
| Never attended school | 53 (13.8) | 63 (15.6) | .41 |
| Completed primary school | 127 (33.1) | 146 (36.0) | |
| At least some secondary school education | 204 (53.1) | 196 (48.4) | |
| Occupation | |||
| Unemployed | 258 (67.2) | 294 (72.6) | .22 |
| Self-employed | 73 (19.0) | 68 (16.8) | |
| Salaried job | 53 (13.8) | 43 (10.6) | |
| Marital status | |||
| Married, monogamous | 152 (39.6) | 181 (44.7) | .15 |
| Married, polygamous | 40 (10.4) | 51 (12.6) | |
| Not married, regular partner | 173 (45.0) | 161 (39.7) | |
| Single | 19 (5.0) | 12 (3.0) | |
| Gravidity | |||
| Primigravida | 66 (17.2) | 70 (17.3) | .97 |
| Socioeconomic scorea | .44 | ||
| 1st quintile (lowest score) | 75 (19.5) | 76 (18.8) | |
| 2nd quintile | 70 (18.2) | 86 (21.2) | |
| 3rd quintile | 72 (18.8) | 89 (22.0) | |
| 4th quintile | 89 (23.2) | 77 (19.0) | |
| 5th quintile | 78 (20.3) | 77 (19.0) | |
| Duration of use of ARVs: | |||
| From enrollment until delivery, in weeks, median (IQR) | 6.0 (4.0–8.0) | 6.0 (4.0–9.0) | .07 |
| After delivery, in weeks, median (IQR) | 18.7 (5.9–27.3) | NA | |
| Breastfeeding (BF) | |||
| Ever BF | 287 (75.5) | 314 (78.3) | .36 |
| BF durationb (if BF), in weeks, median (IQR) | 21.4 (9.7–25.6) | 20.0 (9.1–25.8) | .79 |
| CD4+ count in cells/mm3c, median (IQR) | |||
| At enrollment | 334 (283–408) | 339 (268–408) | .55 |
| At delivery | 465 (383–603) | 415 (331–531) | <.0001 |
| At 6 months after delivery | 479 (367–597) | 377 (292–474) | <.0001 |
| At 12 months after delivery | 401 (320–519) | 380 (289–475) | .004 |
| At 18 months after delivery | 396 (301–493) | 362 (273–467) | .008 |
| At 24 months after delivery | 396 (289–490) | 331 (263–425) | .04 |
| Maternal viral loadd (VL) | |||
| At enrollment, log10e, median (IQR) | 4.19 (3.65–4.75) | 4.20 (3.56–4.74) | .97 |
| Undetectable VL (<300 copies/mL) | 18 (4.7) | 14 (3.5) | .38 |
| At delivery | |||
| log10e, median (IQR) | 0.00 (0.00–2.85) | 3.10 (2.10–3.73) | <.0001 |
| Undetectable VL | 221 (63.3) | 111 (29.9) | <.0001 |
| At 18 months postpartum | |||
| log10e, median (IQR) | 4.50 (3.97–5.10) | 4.53 (3.78–5.11) | .75 |
| Undetectable VL | 17 (5.4) | 12 (4.1) | .28 |
| Body mass indexf in Kg/m2, median (IQR) | |||
| At enrollment | 26.4 (24.1–29.4) | 26.0 (23.5–29.0) | .18 |
| At delivery | 24.2 (22.0–27.3) | 24.1 (21.9–27.0) | .66 |
| At 6 months after delivery | 24.0 (21.5–27.7) | 23.6 (21.3–26.9) | .43 |
| At 12 months after delivery | 24.4 (21.6–28.0) | 23.5 (21.2–26.8) | .04 |
| At 18 months after delivery | 24.6 (21.5–28.8) | 23.7 (21.3–27.0) | .07 |
| At 24 months after delivery | 23.7 (20.9–27.6) | 23.0 (20.8–25.5) | .22 |
Data are no. (%) unless otherwise specified.
Abbreviations: ARV, antiretroviral; AZT/sdNVP, zidovudine until delivery with single-dose nevirapine without postpartum prophylaxis; IQR, interquartile range; NA, not applicable; Triple ARV, zidovudine, lamivudine, and lopinavir/ritonavir during pregnancy and breastfeeding.
a Calculated by multiple correspondence analysis using 8 household assets (electricity, refrigerator, radio, television, telephone/cell phone, source of water, type of toilets, type of fuel). Quintiles were defined within each country (Burkina Faso, Kenya, South Africa). Higher socioeconomic scores denote people with more assets.
b Available for 280 of 287 in the triple ARV group and 309 of 314 in the AZT/sdNVP group.
c Available for 384 women at randomization, 361 of 384 at delivery, 363 of 382 at 6 months after delivery, 347 of 359 at 12 months, 303 out of 340 at 18 months, and 76 of 96 at 24 months in the triple ARV group and 405, 377 of 405, 360 of 385, 330 of 341, 286 of 329, and 73 of 93 in the AZT/sdNVP group.
d Available for 382 of 384 women at randomization, 349 of 384 at delivery, and 313 out of 325 at 18 months in the triple ARV group and 403 of 405, 371 of 405, and 293 of 306 in the AZT/sdNVP group.
e Viral loads below the detection level (<300 copies/mL) were assigned a value of 1 copy/mL (0 in log10 scale).
f Available for 379 of 384 women at randomization, 373 of 384 at delivery, 370 of 383 at 6 months after delivery, 351 of 369 at 12 months, 303 out of 351 at 18 months, and 83 out of 94 at 24 months in the triple ARV group and 402 of 405, 382 of 405, 369 of 393, 352 of 372, 299 of 345, and 85 of 95 in the AZT/sdNVP group.