Table 2.
Clinical correlates of VMB clusters.
| Correlates | KRST-I n (%) N = 19 | KRST-II n (%) N = 136 | KRST-pIII-V n (%) N = 53 | p value * | |
|---|---|---|---|---|---|
| Self reported symptoms at screening | |||||
| Vaginal discharge reported: | |||||
| No | 18 (8.9) | 135 (66.5) | 50 (24.6) | 0.05 | |
| Yes | 1 (20.0) | 1 (20.0) | 3 (60.0) | ||
| Clinician observed findings at screening | |||||
| Cervical mucusab†: | |||||
| No | 5 (4.2) | 82 (69.5) | 31 (26.3) | 0.04 | |
| Mild | 11 (14.1) | 48 (61.5) | 19 (24.4) | ||
| Abundant | 2 (28.6) | 3 (42.9) | 2 (28.6) | ||
| Cervical and/or vaginal epithelial abnormalities: | |||||
| No | 15 (8.0) | 124 (66.3) | 48 (25.7) | 0.26 | |
| Yes | 4 (19.0) | 12 (57.1) | 5 (23.8) | ||
| Ectopy: | |||||
| No | 11 (9.4) | 73 (62.4) | 33 (28.2) | 0.57 | |
| Yes | 8 (8.8) | 63 (69.2) | 20 (22) | ||
| Any colposcopy finding?: | |||||
| No | 17 (9.4) | 119 (65.7) | 45 (24.9) | 0.90 | |
| Yes | 2 (7.4) | 17 (63.0) | 8 (29.6) | ||
| Laboratory-confirmed reproductive and urinary tract infections | |||||
| HIV serology | |||||
| Negative | 19 (100.0) | 128 (94.8) | 50 (94.3) | 0.78 | |
| Positive | 0 (0.0) | 7 (5.2) | 3 (5.7) | Trend: 0.44 | |
| HSV-2 serology | |||||
| Negative | 15 (78.9) | 85 (62.5) | 33 (62.3) | 0.36 | |
| Positive | 4 (21.1) | 51 (37.5) | 20 (37.7) | Trend: 034 | |
| Bacterial STIc | |||||
| Negative | 17 (94.4) | 116 (83.3) | 41 (77.4) | 0.20 | |
| Positive | 1 (5.6) | 20 (14.7) | 12 (22.6) | Trend: 0.07 | |
| BV by Nugent score | |||||
| 0-3 | 15 (93.8) | 93 (76.2) | 2 (4.2) | <0.01 | |
| 4-6 | 1 (6.2) | 15 (12.3) | 3 (6.3) | ||
| 7-10 | 0 (0.0) | 14 (11.5) | 43 (89.6) | ||
| BV by Amsel criteria | |||||
| Negative | 18 (94.7) | 128 (94.1) | 37 (69.8) | <0.01 | |
| Positive | 1 (5.3) | 8 (5.9) | 16 (30.2) | ||
| Candidiasis on wet mountd | |||||
| Negative | 16 (84.2) | 113 (83.1) | 50 (94.3) | 0.11 | |
| Positive | 3 (15.8) | 23 (16.9) | 3 (5.7) | Trend: 0.09 | |
| Urinary tract infection by diptstick test | |||||
| Negative | 4 (100.0) | 4 (44.4) | 132 (76.3) | 0.06 | |
| Positive | 0 (0.0) | 5 (55.6) | 41 (23.7) | ||
| Treatment in the 14 days prior to enrollment | |||||
| Any systemic antibioticsd: | |||||
| No | 18 (10.5) | 115 (66.9) | 39 (22.7) | 0.10 | |
| Yes | 1 (2.8) | 21 (58.3) | 14 (38.9) | ||
| Any vaginal antibiotics: No | |||||
| No | 19 (9.2) | 136 (66) | 51 (24.8) | 0.12 | |
| Yes | 0 (0) | 0 (0) | 2 (100) | ||
| Bacterial vaginosis requiring treatment: | |||||
| No | 19 (9.7) | 130 (66.3) | 47 (24.0) | 0.16 | |
| Yes | 0 (0) | 6 (50.0) | 6 (50.0) | ||
| Candidiasis requiring treatmente: | |||||
| No | 17 (9.5) | 116 (64.8) | 46 (25.7) | 0.10 | |
| Yes | 0 (0) | 10 (100) | 0 (0) | ||
Abbreviations: KRST Kenya, Rwanda, South Africa, and Tanzania.
*Fisher’s exact test, Trend = Chi-squared test for trend.
a4/208 values missing.
bNo association (p = 0.95) was found when the data were analyzed with a binary outcome (i.e. clusters KRST-I and KRST-II combined vs. cluster KRST-pIII-V).
cBacterial STIs includes syphilis (by serology), chlamydia and gonorrhea (by PCR), and trichomoniasis (by InPouch culture test).
dStronger evidence of association was observed when data were analyzed with a binary outcome (i.e. clusters KRST-I and II combined vs. cluster KRST-pIII-V) (p = 0.06) and when pregnant women and Tanzanian women (phase in the menstrual cycle at the time of sampling not known) were excluded (p = 0.04).
e19/208 values missing.
†Women who had mild/moderate cervical mucus (OR = 0.27; 95% CI 0.09, 0.81) and women who had abundant cervical mucus (OR = 0.09; 95% CI 0.01, 0.68) were more likely to belong to cluster KRST-II vs. KRST-I compared to women with no cervical mucus. Women who had mild cervical mucus compared to no cervical mucus were less likely to belong to cluster KRST-pIII-V vs. KRST-I (OR = 0.28; 95% CI 0.08, 0.93), while there was no statistically significant difference between having abundant cervical mucus and no cervical mucus.