Table 1.
Baseline Characteristics
| By Arm Analysesa (Conceptions Prior to 7 July 2015 Only) | Time-to-Event Analysesb (All Conceptions) | ||||
|---|---|---|---|---|---|
| Randomized at Delivery | Randomized After Breastfeeding | ||||
| Characteristic | ART at Conception (n = 97) | ART Reinitiation in Pregnancy (n = 121) | ART at Conception (n = 41) | ART Reinitiation in Pregnancy (n = 41) | All Mothers (N = 760) |
| Age, y, at estimated conception | |||||
| No. | 96 | 121 | 41 | 41 | 755 |
| No. missing | 1 | 0 | 0 | 0 | 5 |
| Min–Max | 19–41 | 19–39 | 21–37 | 21–39 | 19–43 |
| Median (Q1–Q3) | 27 (24–31) | 28 (25–32) | 28 (25–32) | 25 (23–28) | 28 (24–31) |
| Country | |||||
| India | 2 (2) | 3 (2) | 3 (7) | 3 (7) | 39 (5) |
| Malawi | 35 (36) | 43 (36) | 15 (37) | 17 (41) | 240 (32) |
| South Africa | 26 (27) | 26 (21) | 9 (22) | 4 (10) | 188 (25) |
| Tanzania | 2 (2) | 1 (1) | 0 (0) | 0 (0) | 10 (1) |
| Uganda | 21 (22) | 23 (19) | 8 (20) | 10 (24) | 135 (18) |
| Zambia | 0 (0) | 5 (4) | 0 (0) | 0 (0) | 15 (2) |
| Zimbabwe | 11 (11) | 20 (17) | 6 (15) | 7 (17) | 133 (18) |
| Race or ethnic group | |||||
| Black African | 95 (98) | 118 (98) | 38 (93) | 38 (93) | 719 (95) |
| Indian | 2 (2) | 3 (2) | 3 (7) | 3 (7) | 40 (5) |
| Other | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 1 (0) |
| Time, mo, between first PROMISE pregnancy outcome date and subsequent conception | |||||
| No. | 96 | 121 | 41 | 41 | 755 |
| No. missing | 1 | 0 | 0 | 0 | 5 |
| Min–Max | 1–46 | 2–45 | 6–44 | 4–39 | 1–57 |
| Median (Q1–Q3) | 16 (11–25) | 18 (11–24) | 22 (16–30) | 23 (16–28) | 22 (13–34) |
| BMI, kg/m2, at or before estimated conception | |||||
| No. | 95 | 121 | 41 | 41 | 753 |
| No. missing | 2 | 0 | 0 | 0 | 7 |
| Min–Max | 18–49 | 19–37 | 19–37 | 16–41 | 16–49 |
| Median (Q1–Q3) | 26 (23–29) | 26 (23–29) | 26 (22–28) | 25 (23–27) | 26 (23–29) |
| WHO stage at or before estimated conception | |||||
| Clinical stage I | 84 (88) | 112 (93) | 35 (85) | 36 (88) | 683 (90) |
| Clinical stage II | 11 (11) | 8 (7) | 6 (15) | 4 (10) | 61 (8) |
| Clinical stage III | 1 (1) | 1 (1) | 0 (0) | 1 (2) | 9 (1) |
| Clinical stage IV | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 2 (0) |
| CD4 count, cells/μL at or before estimated conception | |||||
| No. | 96 | 121 | 41 | 41 | 755 |
| Min–Max | 350–1545 | 306–1568 | 531–1545 | 350–1297 | 216–1908 |
| Median (Q1–Q3) | 818 (648–952) | 600 (485–729) | 771 (654–952) | 710 (519–843) | 692 (533–885) |
| Plasma HIV RNA, copies/mL, at or before estimated conception | |||||
| No. | 96 | 121 | 41 | 41 | 755 |
| Min–Max | 20–89 755 | 20–975 501 | 20–27 372 | 30–203 421 | 20–975 501 |
| Median (Q1–Q3) | 40 (40–1052) | 3726 (473–13 113) | 40 (40–40) | 565 (200–9498) | 200 (40–5277) |
| <400 | 62 (65) | 27 (22) | 37 (90) | 15 (37) | 413 (55) |
| History of alcohol or smoking at PROMISE entry | |||||
| Yes, one | 21(22) | 16 (13) | 4 (10) | 8 (20) | 114 (15) |
| Yes, both | 1 (1) | 1 (1) | 0 (0) | 1 (2) | 11 (1) |
| Hepatitis B–positive antigen result prior to first randomization in PROMISE | 7 (7) | 8 (7) | 5 (12) | 1 (2) | 36 (5) |
| Gravida prior to first subsequent pregnancy | |||||
| 1–2 | 52 (54) | 59 (49) | 22 (54) | 27 (66) | 413 (54) |
| 3–4 | 39 (40) | 53 (44) | 15 (37) | 13 (32) | 296 (39) |
| ≥5 | 6 (6) | 9 (7) | 4 (10) | 1 (2) | 51 (7) |
| Cohort participationc, No. | |||||
| A | 58 | 121 | 0 | 0 | … |
| B | 0 | 0 | 20 | 23 | … |
| A + B | 39 | 0 | 21 | 18 | … |
Data are presented as no. (%) unless otherwise indicated. Induced abortions, ectopic, or other nonviable pregnancies, and missing outcomes were excluded. Variables reported “at or before estimated conception” were based on the average of imputed term lengths for mothers with missing gestational ages.
Abbreviations: ART, antiretroviral therapy; BMI, body mass index; HIV, human immunodeficiency virus; PROMISE, Promoting Maternal and Infant Survival Everywhere; Q1, first quartile; Q3, third quartile; WHO, World Health Organization.
aCharacteristics for mothers analyzed in the by-arm analyses, limited to those with estimated conception dates after the comparison group randomization, and prior to the protocol change on 7 July 2015.
bCharacteristics for all PROMISE mothers with subsequent pregnancies.
cMothers could be randomized after delivery (A) and/or after breastfeeding (B) cessation. A total of 39 mothers were overlaps, undergoing both randomizations.