Table 1.
Clinical, demographic, and behavioral epidemiological information for both participant groups (n = 315 and n = 90 for participant groups 1 and 2, respectively)
| Participant group |
Epidemiological variable |
Group 0: Lactobacillus unspecified |
Group 1: L. crispatus dominant |
Group 2: L. iners dominant |
Group 3: G. vaginalis dominant |
Group 4: polymicrobial/heterogeneous |
p value |
Statistical test |
|
|---|---|---|---|---|---|---|---|---|---|
| Participant group 1 |
total n = 315 |
n = 4 |
n = 52 |
n = 84 |
n = 93 |
n = 82 |
|||
| Participant group 2 | total n = 90 | n = 32 | n = 16 | n = 1 | n = 31 | n = 10 | |||
| Participant group 1 | Nugent score | 0 | 0 (0–2) | 0 (0–8) | 8 (0–10) | 8 (0–10) | 1.00E−15 | Kruskal-Wallis | |
| Participant group 2 | 0 (0–3) | 0 (0–2) | 0 | 3 (0–8) | 3 (0–7) | 2.26E−07 | |||
| Participant group 1 | BV diagnosis | positive (Nugent score 7–10) | 0 (0%) | 0 (0%) | 1 (1%) | 63 (68%) | 70 (85%) | 1.00E−15 | chi-squared |
| negative (Nugent score 0–3) | 4 (100%) | 52 (100%) | 80 (95%) | 21 (22%) | 11 (14%) | ||||
| intermediate (Nugent score 4–6) | 0 (0%) | 0 (0%) | 3 (4%) | 9 (10%) | 1 (1%) | ||||
| Participant group 2 | positive (Nugent score 7–10) | 0 | 0 | 0 | 6 (22%) | 1 (11%) | 5.50E−04 | ||
| negative (Nugent score 0–3) | 32 | 14 (100%) | 1 (100%) | 15 (56%) | 5 (45%) | ||||
| intermediate (Nugent score 4–6) | 0 | 0 | 0 | 6 (22%) | 3 (33%) | ||||
| Participant group 1 | age | 37.4 (33.3–41.3) | 35.1 (24.0–50.1) | 34.6 (19.8–47.1) | 34.1 (20.6–51.5) | 34.3 (18.3–48.9) | 0.8 | Kruskal-Wallis | |
| Participant group 2 | 37.8 (25.9–49.9) | 38.2 (28.1–45.7) | 25.4 | 36.6 (26.1–50.1) | 36.3 (27.0–51.6) | 0.33 | |||
| Participant group 1 | proportion of visits with unprotected sex | 0.011 (0–0.90) | 0.021 (0–0.95) | 0.066 (0–0.97) | 0.068 (0–0.95) | 0.048 (0–0.97) | 0.0408 | Kruskal-Wallis | |
| Participant group 2 | 0 (0–0.93) | 0.026 (0–0.52) | 0.057 | 0.027 (0–0.70) | 0.080 (0–0.45) | 0.90 | |||
| Participant group 1 | number of unprotected sex acts at visit | 0.5 (0–35) | 1 (0–41) | 2 (0–36) | 2 (0–37) | 1.5 (0–41) | 0.0432 | Kruskal-Wallis | |
| Participant group 2 | 0 (0–27) | 1 (0–14) | 2 | 1 (0–19) | 3 (0–15) | 0.84 | |||
| Participant group 1 | ever unprotected sex | no | 2 (50%) | 24 (46%) | 21 (25%) | 27 (29%) | 25 (30%) | 0.1006 | chi-squared |
| yes | 2 (50%) | 28 (54%) | 63 (75%) | 66 (71%) | 57 (70%) | ||||
| Participant group 2 | no | 17 (53%) | 8 (50%) | 0 (0%) | 14 (45%) | 4 (40%) | 0.8014 | ||
| yes | 15 (47%) | 8 (50%) | 1 (100%) | 17 (55%) | 6 (60%) | ||||
| Participant group 1 | HSV-2 at enrollment | positive | 2 (50%) | 41 (79%) | 67 (80%) | 78 (84%) | 71 (87%) | 0.5511 | chi-squared |
| negative | 2 (50%) | 8 (15%) | 13 (15%) | 11 (12%) | 9 (11%) | ||||
| indeterminate/unavailable | 0 (0%) | 3 (6%) | 4 (5%) | 4 (4%) | 2 (2%) | ||||
| Participant group 2 | positive | 23 (72%) | 9 (56%) | 1 (100%) | 19 (70%) | 7 (70%) | 0.52 | ||
| negative | 6 (19%) | 6 (38%) | 0 (0%) | 12 (30%) | 3 (30%) | ||||
| indeterminate/unavailable | 3 (9%) | 1 (6%) | 0 (0%) | 0 (0%) | 0 (0%) | ||||
| Participant group 1 | HSV-2 at visit | positive | 2 (50%) | 41 (79%) | 68 (81%) | 81 (87%) | 73 (89%) | 0.0456 | chi-squared |
| negative | 0 (0%) | 4 (8%) | 10 (12%) | 6 (6%) | 3 (4%) | ||||
| unknown | 2 (50%) | 7 (13%) | 6 (7%) | 6 (6%) | 6 (7%) | ||||
| Participant group 2 | positive | 24 (75%) | 11 (69%) | 1 (100%) | 22 (71%) | 7 (70%) | 0.957 | ||
| negative | 0 (0%) | 0 (0%) | 0 (0%) | 0 (0%) | 0 (0%) | ||||
| unknown | 8 (25%) | 5 (31%) | 0 (0%) | 9 (29%) | 3 (30%) | ||||
| Participant group 1 | clinical site | Kenya | 2 (50%) | 15 (29%) | 20 (24%) | 17 (18%) | 19 (23%) | 0.4299 | chi-squared |
| Uganda | 2 (50%) | 37 (71%) | 64 (76%) | 76 (82%) | 63 (77%) | ||||
| Participant group 2 | Kenya | 22 (69%) | 13 (81%) | 0 (0%) | 21 (68%) | 7 (70%) | 0.49 | ||
| Uganda | 10 (31%) | 3 (19%) | 1 (100%) | 10 (32%) | 3 (30%) | ||||
| Participant group 1 | study arm (PrEP use) | treatment | 2 (50%) | 16 (31%) | 34 (40%) | 47 (51%) | 24 (29%) | 0.0368 | chi-squared |
| placebo | 2 (50%) | 36 (69%) | 50 (60%) | 46 (49%) | 58 (71%) | ||||
| Participant group 2 | treatment | 21 (66%) | 15 (94%) | 1 (100%) | 24 (77%) | 8 (80%) | 0.27 | ||
| placebo | 11 (34%) | 1 (6%) | 0 (0%) | 7 (23%) | 2 (20%) | ||||
| Participant group 1 | reported DMPA use | positive | 2 (50%) | 26 (50%) | 50 (60%) | 41 (44%) | 21 (26%) | 0.0002 | chi-squared |
| negative | 2 (50%) | 26 (50%) | 31 (37%) | 40 (43%) | 48 (58%) | ||||
| indeterminate | 0 (0%) | 0 (0%) | 3 (3%) | 12 (13%) | 13 (16%) | ||||
| Participant group 2 | positive | 5 (16%) | 1 (6%) | 1 (100%) | 1 (3%) | 1 (10%) | 9.80E−02 | ||
| negative | 17 (53%) | 8 (50%) | 0 (0%) | 19 (61%) | 7 (70%) | ||||
| indeterminate | 10 (31%) | 7 (44%) | 0 (0%) | 11 (36%) | 2 (20%) | ||||
| Participant group 1 | measured MPA levels | 0.024 (0–1.03) | 0.066 (0–2.10) | 0.041 (0–3.17) | 0.025 (0–2.24) | 0 (0–2.77) | 0.1056 | Kruskal-Wallis | |
| Participant group 2 | 0 (0–0.407) | 1.175 | 0 (0–0.104) | 0 (0–0.817) | 0 (0–0.826) | 1.70E−10 | |||
| Participant group 1 | last known partner plasma HIV-1 RNA level | 4.1 (0–5.4) | 3.9 (0–6.0) | 4.1 (0–6.2) | 4.0 (0–6.6) | 4.2 (0–6.2) | 0.95 | Kruskal-Wallis | |
| Participant group 2 | 2.8 (0–5.1) | 4.5 | 3.5 (0–5.1) | 3.2 (0–5.9) | 2.7 (0–5.5) | 0.62 | |||
| Participant group 1 | gonorrhea at enrollment | no | 4 (100%) | 45 (87%) | 76 (91%) | 87 (94%) | 74 (90%) | 0.7226 | chi-squared |
| yes | 0 (0%) | 1 (2%) | 2 (2%) | 0 (0%) | 3 (4%) | ||||
| not done | 0 (0%) | 6 (12%) | 6 (7%) | 6 (6%) | 5 (6%) | ||||
| Participant group 2 | no | 32 (100%) | 16 (100%) | 1 (100%) | 30 (97%) | 10 (100%) | 0.7496 | ||
| yes | 0 (0%) | 0 (0%) | 0 (0%) | 0 (0%) | 0 (0%) | ||||
| not done | 0 (0%) | 0 (0%) | 0 (0%) | 1 (3%) | 0 (0%) | ||||
| Participant group 1 | Chlamydia at enrollment | no | 4 (100%) | 45 (87%) | 76 (91%) | 86 (92%) | 77 (94%) | 0.8404 | chi-squared |
| yes | 0 (0%) | 1 (2%) | 2 (2%) | 1 (1%) | 0 (0%) | ||||
| not done | 0 (0%) | 6 (12%) | 6 (7%) | 6 (6%) | 5 (6%) | ||||
| Participant group 2 | no | 30 (94%) | 15 (94%) | 1 (100%) | 28 (90%) | 10 | 0.9526 | ||
| yes | 2 (6%) | 1 (6%) | 0 (0%) | 2 (6.5%) | 0 (0%) | ||||
| not done | 0 (0%) | 0 (0%) | 0 (0%) | 1 (3.2%) | 0 (0%) | ||||
| Participant group 1 | Trichomonas at enrollment | no | 4 (100%) | 48 (92%) | 72 (86%) | 83 (89%) | 71 (87%) | 0.864 | chi-squared |
| yes | 0 (0%) | 2 (4%) | 7 (8%) | 8 (9%) | 8 (10%) | ||||
| not done | 0 (0%) | 2 (4%) | 5 (6%) | 2 (2%) | 3 (4%) | ||||
| Participant group 2 | no | 30 (94%) | 16 (100%) | 1 (100%) | 29 (94%) | 10 (100%) | 0.8831 | ||
| yes | 2 (6%) | 0 (0%) | 0 (0%) | 1 (3%) | 0 (0%) | ||||
| not done | 0 (0%) | 0 (0%) | 0 (0%) | 1 (3%) | 0 (0%) | ||||
| Participant group 1 | gonorrhea at visit | no | 4 (100%) | 44 (85%) | 66 (79%) | 72 (77%) | 63 (77%) | 0.8968 | chi-squared |
| yes | 0 (0%) | 0 (0%) | 2 (2%) | 2 (2%) | 1 (1%) | ||||
| not done | 0 (0%) | 8 (15%) | 16 (19%) | 19 (20%) | 18 (22%) | ||||
| Participant group 2 | no | 11 (34%) | 5 (31%) | 0 (0%) | 11 (35%) | 4 (40%) | 0.7493 | ||
| yes | 0 (0%) | 0 (0%) | 0 (0%) | 0 (0%) | 0 (0%) | ||||
| not done | 21 (66%) | 11 (69%) | 1 (100%) | 20 (65%) | 6 (60%) | ||||
| Participant group 1 | Chlamydia at visit | no | 4 (100%) | 44 (85%) | 67 (80%) | 74 (80%) | 63 (77%) | 0.8762 | chi-squared |
| yes | 0 (0%) | 0 (0%) | 1 (1%) | 0 (0%) | 1 (1%) | ||||
| not done | 0 (0%) | 8 (15%) | 16 (19%) | 19 (20%) | 18 (22%) | ||||
| Participant group 2 | no | 11 (34%) | 5 (31%) | 0 (0%) | 11 (35%) | 4 (40%) | 0.7493 | ||
| yes | 0 (0%) | 0 (0%) | 0 (0%) | 0 (0%) | 0 (0%) | ||||
| not done | 21 (66%) | 11 (69%) | 1 (100%) | 20 (65%) | 6 (60%) | ||||
| Participant group 1 | Trichomonas at visit | no | 4 (100%) | 41 (79%) | 65 (77%) | 70 (75%) | 60 (73%) | 0.9733 | chi-squared |
| yes | 0 (0%) | 2 (4%) | 3 (4%) | 5 (5%) | 4 (5%) | ||||
| not done | 0 (0%) | 9 (17%) | 16 (19%) | 18 (19%) | 18 (22%) | ||||
| Participant group 2 | no | 11 (34%) | 5 (31%) | 0 (0%) | 11 (35%) | 4 (40%) | 0.7493 | ||
| yes | 0 (0%) | 0 (0%) | 0 (0%) | 0 (0%) | 0 (0%) | ||||
| not done | 21 (66%) | 11 (69%) | 1 (100%) | 20 (65%) | 6 (60%) | ||||
Comparisons were made between women who had one of five different vaginal microbiome groups. p value statistical results and tests performed are indicated in the right-hand columns. See Table S1 for LD vs. nLD comparisons.