Table 2 Characteristics of participants with microbiome data at crossover according to assigned study arm (intention-to-treat).

From: Hormonal contraception alters vaginal microbiota and cytokines in South African adolescents in a randomized trial

 

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

  1. 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.
  2. 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.
  3. aMissing data from two adolescents (COC: n = 1; Net-En: n = 0; CCVR: n = 1).
  4. bMissing data from 26 adolescents (COC: n = 5; Net-En: n = 10; CCVR: n = 11).
  5. cMissing data from nine adolescents (COC: n = 2; Net-En: n = 5; CCVR: n = 2).
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