Table 2.
Characteristics of participants with microbiome data at crossover according to assigned study arm (intention-to-treat).
| COC (n = 37) | Net-En (n = 33) | CCVR (n = 34) | P value | |
|---|---|---|---|---|
| CST distributiona | 0.029 | |||
| CST-I | 7 (18.9%) | 13 (39.4%) | 7 (20.6%) | |
| CST-III | 17 (45.9%) | 4 (12.1%) | 11 (32.4%) | |
| CST-IV | 13 (35.1%) | 16 (48.5%) | 16 (47.1%) | |
| Vaginal pH, mean (sd) | 4.7 (4.2–5.1) | 4.8 (4.2–5.5) | 5.0 (4.5–5.5) | 0.101 |
| >4.5 | 21 (56.8%) | 22 (66.7%) | 25 (73.5%) | 0.327 |
| Shannon Index (SI), median (IQR) | 0.90 (0.35–1.54) | 1.64 (0.75–2.22) | 1.66 (0.79–1.95) | 0.004 |
| Median change in SI from baseline (IQR) | −0.27 (−0.90–0.25) | −0.08 (−1.04–0.46) | 0.14 (−0.33–0.70) | 0.130 |
| HSV-2 serology | 13 (35.1%) | 10 (30.3%) | 13 (38.2%) | 0.790 |
| Yeast cells present | 4 (10.8%) | 6 (18.2%) | 6 (17.6%) | 0.629 |
| BV prevalence | 0.522 | |||
| BV positive | 13 (35.1%) | 16 (48.5%) | 14 (41.2%) | |
| BV intermediate | 3 (8.11%) | 0 (0.0%) | 1 (2.94%) | |
| BV negative | 21 (56.8%) | 17 (51.5%) | 19 (55.9%) | |
| STI incidence | ||||
| Any STI(s) | 7 (18.9%) | 9 (27.3%) | 13 (38.2%) | 0.192 |
| Ct | 4 (10.8%) | 4 (11.8%) | 8 (23.5%) | 0.273 |
| Ng | 2 (5.41%) | 1 (2.94%) | 7 (20.6%) | 0.057 |
| Tv | 1 (2.70%) | 1 (2.94%) | 1 (2.94%) | 1.000 |
| Mg | 1 (2.70%) | 3 (9.38%) | 0 (0.0%) | 0.161 |
| Inflammation categorya | 0.149 | |||
| High | 16 (44.4%) | 16 (48.5%) | 22 (66.7%) | |
| Low | 20 (55.6%) | 17 (51.5%) | 11 (33.3%) | |
| Antibiotic use since the last visit | 16 (45.7%) | 14 (42.4%) | 10 (29.4%) | 0.416 |
| Days since the last menstrual period, median (IQR)b | 21 (12–78) | 51 (15–157) | 27 (13–70) | 0.354 |
| Sexual risk behavior since the last visitc | ||||
| Any sexual partners, n (%) | 32 (91.4%) | 25 (89.3%) | 29 (90.6%) | 1.000 |
| Multiple sexual partners, n | 1 (2.86%) | 1 (3.57%) | 0 (0.00%) | 0.749 |
| New partner, n | 2 (5.71%) | 1 (3.7%) | 0 (0.0%) | 0.503 |
| Sex acts per week, median (IQR) | 1 (1–2) | 1 (1–2) | 1 (1–2) | 0.260 |
| Condom use | 0.260 | |||
| Never | 6 (17.1%) | 7 (25.0%) | 8 (25.0%) | |
| Less than half the time | 6 (17.1%) | 1 (3.57%) | 3 (9.38%) | |
| Half the time | 16 (45.7%) | 12 (42.9%) | 7 (21.9%) | |
| More than half the time | 3 (8.6%) | 2 (7.14%) | 4 (12.5%) | |
| Always | 4 (11.4%) | 6 (21.4%) | 10 (31.3%) | |
| Condom use during the last PV intercourse | 0.407 | |||
| Yes | 21 (60.0%) | 13 (46.4%) | 20 (62.5%) | |
| Intergenerational sex with the older partner (≥5 years) | 0.103 | |||
| Yes | 1 (2.86%) | 3 (10.7%) | 0 (0.00%) | |
| Unsure | 0 (0.00%) | 0 (0.00%) | 0 (0.00%) | |
| No | 34 (97.1%) | 24 (89.3%) | 32 (100%) | |
| Transactional sex | 0 (0.00%) | 0 (0.00%) | 0 (0.00%) | NA |
| Penile–anal intercourse | 0 (0.00%) | 0 (0.00%) | 0 (0.00%) | NA |
BV: bacterial vaginosis, CCVR: combined contraceptive vaginal ring, COC: combined oral contraceptives, CST: community-state type, Ct: Chlamydia trachomatis, Ng: Neisseria gonorrhoeae, Tv: Trichomonas vaginalis, Mg: Mycoplasma genitalium, sd: standard deviation, IQR: interquartile range.
Chi-squared test (Fisher’s exact test when expected values < 5) for the assessment of association of frequency among groups, unpaired Mann–Whitney U test for comparison of medians, and unpaired Student’s t test for comparison of means.
aMissing data from two adolescents (COC: n = 1; Net-En: n = 0; CCVR: n = 1).
bMissing data from 26 adolescents (COC: n = 5; Net-En: n = 10; CCVR: n = 11).
cMissing data from nine adolescents (COC: n = 2; Net-En: n = 5; CCVR: n = 2).