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In this multicenter, randomized, placebo-controlled trial involving women with bacterial vaginosis who had completed a course of vaginal metronidazole gel, treatment with vaginally administered Lactobacillus crispatus CTV-05 (Lactin-V) resulted in a lower incidence of recurrence of bacterial vaginosis at 12 weeks than placebo.

The addition of combined oral and topical antimicrobial therapy for male partners to treatment of women for bacterial vaginosis resulted in a lower rate of recurrence within 12 weeks than treatment of the woman alone.

ObjectivesAs pelvic inflammatory disease (PID) aetiology is not completely understood, we examined the relationship between select novel bacteria, PID and long-term sequelae.MethodsFastidious bacterial vaginosis (BV)-associated bacteria (Sneathia (Leptotrichia) sanguinegens, Sneathia amnionii, Atopobium vaginae and BV-associated bacteria 1 (BVAB1)), as well as Ureaplasma urealyticum and Ureaplasma parvum were identified in cervical and endometrial specimens using organism-specific PCR assays among 545 women enrolled in the PID Evaluation and Clinical Health study. Risk ratios and 95% CIs were constructed to determine associations between bacteria, histologically confirmed endometritis, recurrent PID and infertility, adjusting for age, race, gonorrhoea and chlamydia. Infertility models were additionally adjusted for baseline infertility.ResultsPersistent detection of BV-associated bacteria was common (range 58% for A. vaginae to 82% for BVAB1) and elevated the risk for persistent endometritis (RRadj 8.5, 95% CI 1.6 to 44.6) 30 days post-cefoxitin/doxycycline treatment, independent of gonorrhoea and chlamydia. In models adjusted for gonorrhoea and chlamydia, endometrial BV-associated bacteria were associated with recurrent PID (RRadj 4.7, 95% CI 1.7 to 12.8), and women who tested positive in the cervix and/or endometrium were more likely to develop infertility (RRadj 3.4, 95% CI 1.1 to 10.4). Associations between ureaplasmas and PID sequelae were modest.ConclusionsTo our knowledge, this is the first prospective study to demonstrate that S. sanguinegens, S. amnionii, BVAB1 and A. vaginae are associated with PID, failure of the Centers for Disease Control and Prevention-recommended treatment to eliminate short-term endometritis, recurrent PID and infertility. Optimal antibiotic regimens for PID may require coverage of novel BV-associated microbes.

Nonhygienic products for managing menstruation are reported to cause reproductive tract infections. Menstrual cups are a potential solution. We assessed whether menstrual cups would reduce bacterial vaginosis (BV), vaginal microbiome (VMB), and sexually transmitted infections (STIs) as studies have not evaluated this. A cluster randomized controlled trial was performed in 96 Kenyan secondary schools, randomized (1:1:1:1) to control, menstrual cup, cash transfer, or menstrual cup plus cash transfer. This substudy assessing the impact of menstrual cups on BV, VMB, and STIs, included 6 schools from the control (3) and menstrual cup only (3) groups, both receiving BV and STI testing and treatment at each visit. Self-collected vaginal swabs were used to measure VMB (16S rRNA gene amplicon sequencing), BV (Nugent score), and STIs. STIs were a composite of Chlamydia trachomatis and Neisseria gonorrhoeae (nucleic acid amplification test) and Trichomonas vaginalis (rapid immunochromatographic assay). Participants were not masked and were followed for 30 months. The primary outcome was diagnosis of BV; secondary outcomes were VMB and STIs. Intention-to-treat blinded analyses used mixed effects generalized linear regressions, with random effects term for school. The study was conducted between May 2, 2018, and February 7, 2021. A total of 436 participants were included: 213 cup, 223 control. There were 289 BV diagnoses: 162 among control participants and 127 among intervention participants (odds ratio 0.76 [95% CI 0.59 to 0.98]; p = 0.038). The occurrence of Lactobacillus crispatus-dominated VMB was higher among cup group participants (odds ratio 1.37 [95% CI 1.06 to 1.75]), as was the mean relative abundance of L. crispatus (3.95% [95% CI 1.92 to 5.99]). There was no effect of intervention on STIs (relative risk 0.82 [95% CI 0.50 to 1.35]). The primary limitations of this study were insufficient power for subgroup analyses, and generalizability of findings to nonschool and other global settings. Menstrual cups with BV and STI testing and treatment benefitted adolescent schoolgirls through lower occurrence of BV and higher L. crispatus compared with only BV and STI testing and treatment during the 30 months of a cluster randomized menstrual cup intervention. ClinicalTrials.gov NCT03051789.

Background. Bacterial vaginosis (BV) recurrence posttreatment is common. Our aim was to determine if behaviors 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 estimate 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 inconsistent 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.

ObjectivesConduct a feasibility study on the effect of menstrual hygiene on schoolgirls' school and health (reproductive/sexual) outcomes.Design3-arm single-site open cluster randomised controlled pilot study.Setting30 primary schools in rural western Kenya, within a Health and Demographic Surveillance System.ParticipantsPrimary schoolgirls 14–16 years, experienced 3 menses, no precluding disability, and resident in the study area.Interventions1 insertable menstrual cup, or monthly sanitary pads, against ‘usual practice’ control. All participants received puberty education preintervention, and hand wash soap during intervention. Schools received hand wash soap.Primary and secondary outcome measuresPrimary: school attrition (drop-out, absence); secondary: sexually transmitted infection (STI) (Trichomonas vaginalis, Chlamydia trachomatis, Neisseria gonorrhoea), reproductive tract infection (RTI) (bacterial vaginosis, Candida albicans); safety: toxic shock syndrome, vaginal Staphylococcus aureus.ResultsOf 751 girls enrolled 644 were followed-up for a median of 10.9 months. Cups or pads did not reduce school dropout risk (control=8.0%, cups=11.2%, pads=10.2%). Self-reported absence was rarely reported and not assessable. Prevalence of STIs in the end-of-study survey among controls was 7.7% versus 4.2% in the cups arm (adjusted prevalence ratio (aPR) 0.48, 0.24 to 0.96, p=0.039), 4.5% with pads (aPR=0.62; 0.37 to 1.03, p=0.063), and 4.3% with cups and pads pooled (aPR=0.54, 0.34 to 0.87, p=0.012). RTI prevalence was 21.5%, 28.5% and 26.9% among cup, pad and control arms, 71% of which were bacterial vaginosis, with a prevalence of 14.6%, 19.8% and 20.5%, per arm, respectively. Bacterial vaginosis was less prevalent in the cups (12.9%) compared with pads (20.3%, aPR=0.65, 0.44 to 0.97, p=0.034) and control (19.2%, aPR=0.67, 0.43 to 1.04, p=0.075) arm girls enrolled for 9 months or longer. No adverse events were identified.ConclusionsProvision of menstrual cups and sanitary pads for ∼1 school-year was associated with a lower STI risk, and cups with a lower bacterial vaginosis risk, but there was no association with school dropout. A large-scale trial on menstrual cups is warranted.Trial registrationISRCTN17486946; Results

Hormonal contraception has been associated with a reduced risk of vaginal dysbiosis, which in turn has been associated with reduced prevalence of sexually transmitted infections (STIs), including HIV. Vaginal rings are used or developed as delivery systems for contraceptive hormones and antimicrobial drugs for STI and HIV prevention or treatment. We hypothesized that a contraceptive vaginal ring (CVR) containing oestrogen enhances a lactobacilli-dominated vaginal microbial community despite biomass accumulation on the CVR's surface. We enrolled 120 women for 12 weeks in an open-label NuvaRing® study at Rinda Ubuzima, Kigali, Rwanda. Vaginal and ring microbiota were assessed at baseline and each ring removal visit by Gram stain Nugent scoring (vaginal only), quantitative PCR for Lactobacillus species, Gardnerella vaginalis and Atopobium vaginae, and fluorescent in situ hybridization to visualize cell-adherent bacteria. Ring biomass was measured by crystal violet staining. Bacterial vaginosis (BV) prevalence was 48% at baseline. The mean Nugent score decreased significantly with ring use. The presence and mean log10 concentrations of Lactobacillus species in vaginal secretions increased significantly whereas those of G. vaginalis and presence of A. vaginae decreased significantly. Biomass accumulated on the CVRs with a species composition mirroring the vaginal microbiota. This ring biomass composition and optical density after crystal violet staining did not change significantly over time. NuvaRing® promoted lactobacilli-dominated vaginal microbial communities in a population with high baseline BV prevalence despite the fact that biomass accumulated on the rings.

BACKGROUNDThe vaginal microbiota may play a role in mediating susceptibility to sexually transmitted infections, including Trichomonas vaginalis (TV). METHODSData were analyzed from HIV-1-seronegative women participating in HIV Prevention Trials Network Protocol 035. At quarterly visits for up to 30 months, participants completed structured interviews and specimens were collected for genital tract infection testing. T. vaginalis was detected by saline microscopy. Bacterial vaginosis (BV) was characterized by Gram stain using the Nugent score (BV = 7–10; intermediate = 4–6; normal = 0–3 [reference group]). Cox proportional hazards models stratified by study site were used to assess the association between Nugent score category at the prior quarterly visit and TV acquisition. RESULTSIn this secondary analysis, 2920 participants from Malawi, South Africa, United States, Zambia, and Zimbabwe contributed 16,259 follow-up visits. Bacterial vaginosis was detected at 5680 (35%) visits, and TV was detected at 400 (2.5%) visits. Adjusting for age, marital status, hormonal contraceptive use, unprotected sex in the last week and TV at baseline, intermediate Nugent score, and BV at the prior visit were associated with an increased risk of TV (intermediate scoreadjusted hazard ratio [aHR], 1.73; 95% confidence interval [CI], 1.21–2.19; BVaHR, 2.40; 95% CI, 1.92–3.00). Sensitivity analyses excluding 211 participants with TV at baseline were similar to those from the full study population (intermediate scoreaHR, 1.54; 95% CI, 1.10–2.14; BVaHR, 2.23; 95% CI, 1.75–2.84). CONCLUSIONSWomen with a Nugent score higher than 3 were at an increased risk for acquiring TV. If this relationship is causal, interventions that improve the vaginal microbiota could contribute to reductions in TV incidence.

ObjectivesYoung women in sub-Saharan Africa are at high risk of STIs and unintended pregnancies, yet hormonal contraceptive (HC) use may affect STI risk. We compared the influence of three HCs on the incidence and prevalence of STIs and bacterial vaginosis (BV) in South African adolescents.MethodsOne hundred and thirty adolescents between 15 and 19 years were randomised to the injectable norethisterone enanthate (Net-En), combined oral contraceptives (COC) (Triphasil or Nordette) or a combined contraceptive vaginal ring (CCVR; NuvaRing) for 16 weeks (clinicaltrials.gov/NCT02404038). Vaginal samples were collected at baseline and 16 weeks post contraceptive initiation for STI and BV testing.ResultsIn an intention-to-treat analysis, no significant differences in BV prevalence were found between study arms. The overall incidence of any STI at follow-up was high: 16.2% in the COC arm; 25.7% in the Net-En arm; and 37.1% in the CCVR arm. The incidence rate (IR) of any STI was similar between Net-En (IR 0.74 (95% CI 0.34 to 1.41)) and the oestrogen-containing contraceptives (IR 0.78 (95% CI 0.47 to 1.22)). A lower IR of Chlamydia trachomatis (incidence rate ratio (IRR) 0.68 (95% CI 0.19 to 1.99)) and Neisseria gonorrhoeae (IRR 0.25 (95% CI 0.01 to 1.35)) but a higher IR of Mycoplasma genitalium (IRR 16.0 (95% CI 2.96 to 400)), was observed in the Net-En arm compared with the oestrogen-containing contraceptives, although the overall incidence of M. genitalium was low (4.7%). In an exploratory analysis, the risk of any STI and N. gonorrhoeae was lower in the COC arm compared with CCVR. A per-protocol analysis yielded similar results.ConclusionOur results suggest that use of Net-En may be associated with increased risk of M. genitalium compared with oestrogen-containing contraceptives but not with overall STI risk. COC use may decrease STI risk relative to CCVR.

Background. Bacterial vaginosis (BV) may increase women's susceptibility to sexually transmitted infections (STIs). In a randomized trial of periodic presumptive treatment (PPT) to reduce vaginal infections, we observed a significant reduction in BV. We further assessed the intervention effect on incident Chlamydia trachomatis, Neisseria gonorrhoeae, and Mycoplasma genitalium infection. Methods. Nonpregnant, human immunodeficiency virus–uninfected women from the United States and Kenya received intravaginal metronidazole (750 mg) plus miconazole (200 mg) or placebo for 5 consecutive nights each month for 12 months. Genital fluid specimens were collected every other month. Poisson regression models were used to assess the intervention effect on STI acquisition. Results. Of 234 women enrolled, 221 had specimens available for analysis. Incidence of any bacterial STI (C. trachomatis, N. gonorrhoeae, or M. genitalium infection) was lower in the intervention arm, compared with the placebo arm (incidence rate ratio [IRR], 0.54; 95% confidence interval [CI], .32–.91). When assessed individually, reductions in STI incidences were similar but not statistically significant (IRRs, 0.50 [95% confidence interval {CI}, .20–1.23] for C. trachomatis infection, 0.56 [95% CI, .19–1.67] for N. gonorrhoeae infection, and 0.66 [95% CI, .38–1.15] for M. genitalium infection). Conclusions. In addition to reducing BV, this PPT intervention may also reduce the risk of bacterial STI among women. Because BV is highly prevalent, often persists, and frequently recurs after treatment, interventions that reduce BV over extended periods could play a role in decreasing STI incidence globally.