Table 6.
Correlates of pathobionts detection, relative abundance, and estimated concentration.
| Rwanda VMB study screening, HARP baseline, and HELIUS samples | All samples | |||||||
|---|---|---|---|---|---|---|---|---|
| Independent variablesa |
<1% (% of N = 957) |
≥1% (% of N = 196) |
OR (95% CI)b | Pc | Mean relative abundance (95% CI); N = 2,044 | Pc | Mean estimated concentration log10 cells/μl (95% CI); N = 379 | Pc |
| Potentially influenced by interventions:d | ||||||||
| - Yes - No |
NAd | NAd | NAd | NAd | 0.07 (0.04–0.09) 0.03 (0.03–0.04) |
0.032 | 2.28 (1.99–2.57) 2.04 (1.69–2.38) |
0.318 |
| Age categories: - 18–24 - 25–29 - 30–34 - 35–44 - 45–50 |
19.8 25.7 31.5 20.5 2.6 |
21.4 27.6 29.6 17.9 3.6 |
Reference 0.99 (0.63–1.54) 0.87 (0.56–1.34) 0.80 (0.49–1.31) 1.26 (0.51–3.11) |
0.719 |
0.08 (0.06–0.11) 0.04 (0.03–0.05) 0.03 (0.02–0.03) 0.03 (0.02–0.04) 0.02 (0.01–0.04) |
<0.001 |
3.09 (2.56–3.62) 2.29 (1.80–2.78) 2.01 (1.66–2.35) 1.63 (1.19–2.06) NA |
<0.001 |
| Study or ethnicity: - VMB Rwanda - HARP South Africa - HELIUS sub - Saharan African - HELIUS Turkish, Moroccan, South - Asian - HELIUS Dutch |
14.2 38.6 16.9 21.2 9.1 |
13.3 38.8 10.7 31.1 6.1 |
1.39 (0.66–2.89) 1.49 (0.78–2.87) 0.94 (0.44–2.00) 2.18 (1.12–4.25) Reference |
0.013 |
0.06 (0.04–0.07) 0.03 (0.02–0.04) 0.03 (0.01–0.05) 0.04 (0.03–0.06) 0.01 (0.00–0.03) |
<0.001 |
2.18 (1.96–2.40) NA NA NA NA |
NA |
| Contraceptive use: - None or condom use only - Any oral contraception - Progestin-only injectable - Progestin-only implant - Any IUD (copper or hormonal) - Contraceptive ring - NA (currently pregnant) |
N = 954 58.0 20.7 11.9 3.1 5.7 0.6 0.6 |
61.2 19.4 8.2 5.6 4.6 1.0 0 |
Reference 0.89 (0.60–1.33) 0.65 (0.37–1.14) 1.74 (0.84–3.58) 0.76 (0.37–1.59) 1.53 (0.30–7.66) ND |
0.309 |
N = 1,768 0.03 (0.02–0.03) 0.03 (0.02–0.04) 0.05 (0.03–0.07) 0.04 (0.02–0.06) 0.01 (0.00–0.03) 0.02 (−0.02–0.05) 0 (0–0) |
0.026 |
N = 252
1.53 (1.11–1.95) 2.89 (1.93–3.86) 2.37 (1.86–2.88) 2.58 (2.00–3.17) 1.55 (0.05–3.04) NA 1.27 (−4.21–6.75) |
0.014 |
| Any hormonal contraception or pregnant: - Yes - No |
N = 902 38.4 61.6 |
N = 188 35.6 64.4 |
0.87 (0.63–1.21) Reference |
0.415 |
N = 1,768 0.04 (0.03–0.05) 0.03 (0.02–0.03) |
0.026 |
N = 252 2.50 (2.15–2.85) 1.53 (1.13–1.93) |
<0.001 |
| Current smoker: - Yes - No |
N = 819
15.5 84.5 |
N = 170
13.5 86.5 |
0.85 (0.53–1.38) Reference |
0.508 |
N = 1,413 0.01 (0.00–0.03) 0.03 (0.02–0.04) |
0.960 |
NA |
NA |
| Sample taken:e
- During or within 7 days after menses - Not during or within 7 days after menses |
NA |
NA |
NA |
NA |
N = 462 0.05 (0.02–0.09) 0.08 (0.06–0.10) |
0.236 |
N = 310 2.12 (1.63–2.62) 2.25 (1.97–2.53) |
0.606 |
| Any type of vaginal cleansing: - Yes - No |
N = 871 30.7 69.4 |
N = 190
27.9 72.1 |
0.88 (0.62–1.24) Reference |
0.462 |
N = 1,320 0.03 (0.01–0.04) 0.04 (0.03–0.05) |
0.805 |
N = 310 2.47 (1.82–3.11) 2.18 (1.92–2.44) |
0.417 |
| Number of sex partners prior to sampling: - None - One - Two or more |
21.4 57.1 21.4 |
25.6 52.3 22.1 |
Reference 0.77 (0.53–1.11) 0.86 (0.55–1.35) |
0.379 |
N = 1,775 0.04 (0.02–0.06) 0.03 (0.01–0.03) 0.04 (0.02–0.05) |
0.008 |
N=249 1.81 (−21.19–24.82) 1.82 (1.21–2.43) 2.17 (1.87–2.48) |
0.571 |
| Frequency of condom use: - Never - Inconsistent - Consistent - NA (no sexual partner) |
20.5 30.8 26.8 21.9 |
18.4 28.6 27.6 25.5 |
Reference 1.04 (0.66–1.64) 1.15 (0.72–1.82) 1.30 (0.81–2.09) |
0.659 |
N = 1,473
0.03 (0.01–0.04) 0.03 (0.02–0.04) 0.03 (0.02–0.05) 0.04 (0.02–0.06) |
0.006 |
N=369 2.04 (1.19–2.89) 2.19 (1.90–2.47) 2.17 (1.76–2.58) NA |
0.955 |
| Any antibiotic use in past 14 days: - Yes - No |
N = 587 2.4 97.6 |
N = 119
4.2 95.8 |
1.80 (0.63–5.08) Reference |
0.293 |
N = 1,173 0.10 (0.06–0.14) 0.04 (0.03–0.05) |
0.048 |
2.32 (1.94–2.69) 2.10 (1.83–2.38) |
0.363 |
| Current urogenital symptom: - Yes - No |
N = 588 42.7 57.3 |
N = 120 42.5 57.5 |
0.99 (0.67–1.48) Reference |
0.970 |
N = 1,044 0.03 (0.02–0.05) 0.04 (0.03–0.05) |
0.655 |
2.33 (1.71–2.95) 2.15 (1.91–2.39) |
0.481 |
| Current unusual vaginal discharge: - Yes - No |
N = 588 17.7 82.3 |
N = 120
12.5 87.5 |
0.66 (0.37–1.19) Reference |
0.153 |
N = 1,044 0.02 (0.00–0.04) 0.04 (0.03–0.05) |
0.371 |
2.65 (1.21–4.08) 2.16 (1.94–2.38) |
0.386 |
| Tested HIV-positive:f
- Yes - No |
40.0 60.0 |
39.8 60.2 |
0.99 (0.72–1.36) Reference |
0.953 |
N = 1,641 0.03 (0.02–0.03) 0.03 (0.02–0.04) |
<0.001 |
N = 126 1.91 (−22.4–26.2) 1.84 (1.45–2.22) |
0.983 |
| Nugent score categories:f - 0–3 - 4–6 - 7–10 |
N = 477 38.2 16.6 45.3 |
N = 96 17.7 40.6 41.7 |
Reference 5.29 (2.82–9.90) 1.98 (1.09–3.62) |
<0.001 |
N = 893 0.01 (0.01–0.02) 0.06 (0.04–0.09) 0.02 (0.01–0.03) |
<0.001 |
N = 364 1.61 (1.29–1.94) 2.78 (2.16–3.40) 2.25 (1.92–2.59) |
0.001 |
| Yeasts by microscopy:f - Yes - No |
N = 477 8.0 92.0 |
N = 98
8.2 91.8 |
1.03 (0.46–2.27) Reference |
0.948 |
N = 905 0.02 (0.00–0.04) 0.03 (0.03–0.04) |
0.846 |
N = 374
2.21 (1.33–3.08) 2.18 (1.94–2.41) |
0.912 |
|
Trichomonas vaginalis by culture/NAAT:f
- Yes - No |
N = 935 7.7 92.3 |
N = 194 11.3 88.7 |
1.53 (0.93–2.54) Reference |
0.108 |
N = 1,462 0.02 (0.01–0.04) 0.03 (0.03–0.04) |
0.806 |
N = 373 2.92 (1.89-3.95) 2.15 (1.92-2.37) |
0.133 |
|
Chlamydia trachomatis by NAAT:f
- Yes - No |
N = 936
6.5 93.5 |
N = 194 4.6 94.4 |
0.70 (0.34–1.43) Reference |
0.307 |
N = 1,195
0.02 (0.00-0.05) 0.03 (0.02-0.03) |
0.930 |
N = 126 2.74 (1.81-3.67) 1.60 (1.19-2.01) |
0.019 |
|
Neisseria gonorrhoeae by NAAT:f
- Yes - No |
N = 936 2.2 97.8 |
N = 194 2.6 97.4 |
1.15 (0.43–3.10) Reference |
0.781 |
N = 1,195 0.01 (0–0.03) 0.03 (0.02–0.03) |
0.650 |
N = 126 2.78 (1.67–3.89) 1.68 (1.28–2.08) |
0.043 |
|
Mycoplasma genitalium by NAAT:f
- Yes - No |
N = 369 8.9 91.1 |
N = 76 6.6 93.4 |
0.72 (0.27–1.90) Reference |
0.489 |
N = 445 0.02 (0.00–0.03) 0.03 (0.02–0.04) |
0.896 |
NA |
NA |
| Herpes simplex virus type 2 by serology:f
- Yes - No |
N = 503 87.1 12.9 |
N = 102 91.2 8.8 |
1.53 (0.74–3.19) Reference |
0.232 |
N = 627 0.02 (0.01–0.03) 0.02 (0.00–0.04) |
0.054 |
N = 87 2.03 (1.33–2.74) 1.67 (1.02–2.33) |
0.410 |
| Active syphilis by serology:f
- Yes - No |
N = 502 2.8 97.2 |
N = 102
2.0 98.0 |
0.70 (0.16–3.12) Reference |
0.622 |
N = 668 0.01 (−0.01–0.03) 0.02 (0.02–0.03) |
0.293 |
N = 126 1.87 (−1.33–5.07) 1.84 (1.45–2.22) |
0.918 |
| High-risk HPV by PCR:f
- Yes - No |
N = 821 52.5 47.5 |
N = 170 50.6 49.4 |
0.93 (0.67–1.29) Reference |
0.650 |
N = 1,415 0.03 (0.02–0.03) 0.03 (0.02–0.04) |
0.107 |
NA |
NA |
CI, confidence interval; HPV, human papilloma virus; IUD, intrauterine device; NA, not applicable; NAAT, nucleic acid amplification test; ND, not determinable; OR, odds ratio; PCR, polymerase chain reaction.
a
Refer to the footnotes of Table 2 for other details regarding the independent variables tested in these logistic regression models.
b
Logistic regression analysis with total pathobionts relative abundance (≥1 vs. <1%) as the outcome. All models contained the outcome and one independent variable.
c
By Kruskall–Wallis test, comparing mean pathobionts relative abundances or estimated concentrations between independent variable categories. For age, Spearman's rank correlation was used, correlating age as a continuous variable with pathobionts relative abundances or estimated concentrations as continuous variables.
d
VMB study samples collected at the screening and Month 6 visits in all randomization groups, and at the Month 1 and Month 2 visits in the no-intervention group, and all HARP and HELIUS samples, were considered not influenced by interventions.
e
Menses data are only available for follow-up visits in the Rwanda VMB study.
f
Includes samples from all study visits at which this outcome was tested (excluding invalid results, if applicable).