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Background. Bacterial vaginosis (BV) recurrence posttreatment is common. Our aim was to determine if be-
haviors were associated with BV recurrence in women in a randomized controlled trial (RCT).
Methods. Symptomatic 18- to 50-year-old females with BV (≥3 Amsel criteria and Nugent score
[NS] = 4–10) were enrolled in a 3-arm randomized double-blind RCT Melbourne Sexual Health Centre, Australia,
in 2009–2010. All 450 participants received oral metronidazole (7 days) and were equally randomized to vaginal
clindamycin, lactobacillus-vaginal probiotic or vaginal placebo. At 1, 2, 3, and 6 months, participants self-collected
vaginal smears and completed questionnaires. Primary endpoint was NS = 7–10. Cox regression was used to esti-
mate hazard ratios (HRs) for risk of BV recurrence associated with baseline and longitudinal characteristics.
Results. Four hundred four (90%) women with postrandomization data contributed to analyses. Cumulative
6-month BV recurrence was 28% (95% confidence interval [CI], 24%–33%) and not associated with treatment.
After stratifying for treatment and adjusting for age and sex frequency, recurrence was associated with having the
same pre-/posttreatment sexual partner (adjusted HR [AHR] = 1.9; 95% CI, 1.2–3.0), inconsistent condom use
(AHR = 1.9; 95% CI, 1.0–3.3), and being non-Australian (AHR = 1.5; 95% CI, 1.0–2.1), and halved with use of
an estrogen-containing contraceptive (AHR = 0.5; 95% CI, .3–.8).
Conclusions. Risk of BV recurrence was increased with the same pre-/posttreatment sexual partner and in-
consistent condom use, and halved with use of estrogen-containing contraceptives. Behavioral and contraceptive
practices may modify the effectiveness of BV treatment.
Clinical Trials Registration. ACTRN12607000350426.
Keywords. bacterial vaginosis; contraceptive use; estrogen; sexual partner; condom use.
Unadjusted hazard ratios are stratified by treatment group, bolded text indicates significant associations at the level p < 0.05.
Abbreviations: BV, bacterial vaginosis; CI, confidence interval; ECC, estrogen-containing contraceptive; HR, hazard ratio; py, person-years; RSP, regular sexual
partner.
a
Each variable is comprised of behaviors reported longitudinally by participants at each study interval.
b
Receptive oral sex is defined as being given oral sex.
c
Or no penile-vaginal sex.
d
Same pre-/posttreatment RSP, defined as same sexual partner pretreatment and in the 2 months posttreatment.
e
Sex with females is having received oral sex, sex with males is penile-vaginal sex.
2.99), and having the same pre-/posttreatment RSP (male or recurrence (HR = 2.18; 95% CI, 1.19–4.01 and HR = 1.96; 95%
female) (HR = 1.84; 95% CI, 1.25–2.73). Current or recent use CI, 1.09–3.52, respectively); however, there was no dose re-
of an ECC (oral contraceptive pill = 108, NuvaRing = 2) was sponse between increased frequency of sexual activity and risk
protective against BV recurrence (HR = 0.62; 95% CI, .40–.95). of recurrence. Frequency of penile-vaginal sex and/or any
Of the 110 women using an ECC at baseline, 80 (72%) had sexual activity with MSPs and FSPs were examined as contin-
continuous ECC use, and 30 (28%) inconsistent ECC use uous variables and at a number of cut points: there was no
during follow-up. Because ovulation can be delayed for several significant association with increased sexual activity and in-
months after ceasing ECC, ECC use was analyzed longitudi- creased risk of recurrence using these methods (data not
nally as “current/recent” or “not recent.” Few women (n = 33) shown). No association was found between BV recurrence and
used progesterone-only methods of contraception, which a new sexual partner, FSPs, smoking, douching, or engaging
limited our power to examine their association with recur- in sex work.
rence; however, use of any hormonal contraception was not Factors associated with BV recurrence by univariate analysis
significantly protective against recurrence (HR = 0.83; 95% CI, were included in multivariate analyses and stratified for treat-
.56–1.24). ment group. This included country of birth, ECC use, same
We explored the association between BV recurrence and pre-/posttreatment RSP, and condom use for penile-vaginal
frequency of sexual activity with partners (male and female) sex (Table 5). Age was included owing to reported associations
and then with frequency of penile-vaginal sex alone. Com- with BV and sexual/contraceptive practices. Frequency of
pared with no sexual activity, sexual contact with partners ≤4 sexual activity was included to determine whether it exerted
times per month or >4 times per month was associated with an independent effect on recurrence after adjusting for RSP.