Self-collected Vaginal Swabs Research Articles

Sexually transmitted pathogens in asymptomatic women at Rethabile clinic, Limpopo, South Africa.

Health care for sexually transmitted infections (STIs) is often inadequate, especially for women, because of the asymptomatic nature of many STIs, which can lead to a false sense of health. Thus, there is limited data on the prevalence of STIs in pregnant women in low and middle-income countries. The study aimed to determine the prevalence of STIs in asymptomatic pregnant women attending antenatal Rethabile Community Health Centre, Limpopo, South Africa. A cross-sectional analysis of asymptomatic pregnant women at Rethabile Community Health Centre between March 2023 and November 2023 was conducted to determine the prevalence of seven STIs, detected from self-collected vaginal swab specimens using HAIN fluoroType STI-multiplex Polymerase Chain Reaction (PCR) test for nine targets covering seven major STIs. The study found that Ureaplasma urealyticum was the most prevalent pathogen (43%) followed by Chlamydia trachomatis (41%), and Trichomonas vaginalis (10%). The less common pathogens detected were Mycoplasma Genitalium (5%) and Neisseria gonorrhoeae (2%). High STI prevalence among asymptomatic pregnant women at Rethabile Community Health Centre necessitates diagnostic screening over syndromic management because of a lack of reporting for symptoms. The paper examines the epidemiology of STIs in Limpopo, South Africa, focusing on healthy, asymptomatic populations. It emphasises the need for laboratory screening, particularly in pregnant women, over empiric treatment because of high chances of missing infections.

'From women for women': A citizen science approach engaging women in the isolation and application of the vaginal health-associated bacterium Lactobacillus crispatus.

A vaginal microbiome rich in Lactobacillus crispatus is associated with good reproductive and sexual health outcomes. Dysbiosis, indicated by the loss of Lactobacillus crispatus, is a risk factor for urogenital infections, such as the clinical diagnosis of bacterial vaginosis (BV) or urinary tract infections. While many scientists have explored probiotics using a conventional pharmaceutical approach, concerns about accessibility and affordability prompt an investigation into a preventive approach using this naturally occurring bacterium. Our study aimed to explore a potential woman-friendly vaginal probiotic product using the naturally occurring bacterium, Lactobacillus crispatus. Citizen scientists actively participated in a two-day practicum and successfully performed the procedures using self-collected vaginal swabs. The practicum received positive responses from participants who demonstrated notable engagement and enthusiasm. With expert guidance, participants without a laboratory background were able to execute assigned tasks successfully. From the Dutch crispatus Citizen Science Collective of 48 women, 22 succeeded in isolating their own Lactobacillus crispatus strains using a Loop-Mediated Isothermal Amplification (LAMP) protocol for identification. Additionally, 48 metagenomes and 54 whole genomes from 22 individuals were sequenced for comparative analysis. This project effectively engaged a community of women in the isolation of Lactobacillus crispatus strains from their vaginal microbiota, followed by in vitro characterization experiments and a hackathon for the development of a probiotic product. Our citizen science approach opens up collaboration possibilities and new avenues for exploration of vaginal health, facilitating community involvement and the development of targeted interventions to enhance women's well-being.

Impact of single-dose HPV vaccination on HPV 16 and 18 prevalence in South African adolescent girls with and without HIV.

The World Health Organization has endorsed single-dose human papillomavirus (HPV) vaccination, but data on the impact on HPV prevalence in high HIV burden settings are limited. A single-dose bivalent HPV vaccine was delivered to adolescent girls in grade 10 in a schools-based campaign in 1 district in South Africa. Impact on HPV 16 and 18 prevalence was evaluated using repeat cross-sectional surveys. A clinic-based survey in girls aged 17-18 years established HPV 16 and 18 prevalence in a prevaccine population (n = 506, including 157 living with HIV) in 2019 and was repeated in the same age group and sites in a single-dose eligible population in 2021 (n = 892, including 117 with HIV). HPV DNA was detected on self-collected vaginal swabs using the Seegene Anyplex II HPV 28. Population impact was estimated overall and by HIV status using prevalence ratios adjusted for differences in sexual behavior between surveys. Single-dose vaccination campaign coverage was 72% (4807 of 6673) of eligible girls attending high school (n = 66) in the district. HPV 16 and 18 prevalence was 35% lower in the postvaccine survey overall (adjusted prevalence ratio = 0.65, 95% confidence interval [CI] = 0.51 to 0.83; P < .001) and 37% lower in those living with HIV (adjusted prevalence ratio = 0.63, 95% CI = 0.41 to 0.95; P = .026). No protective effect was seen for nonvaccine oncogenic HPV types 33, 35, 39, 51, 52, 56, 58, 59, or 68 overall (adjusted prevalence ratio = 1.14, 95% CI = 1.03 to 1.26; P = .011) or in those living with HIV (adjusted prevalence ratio = 1.00, 95% CI = 0.83 to 1.21. P = 0.99). These data provide reassuring evidence of single-dose impact on population-level HPV 16 and 18 prevalence in a South African population, irrespective of HIV status.

Increased reproductive tract infections among secondary school girls during the COVID-19 pandemic: associations with pandemic-related stress, mental health, and domestic safety.

Kenya, like many countries, shuttered schools during COVID-19, with subsequent increases in poor mental health, sexual activity, and pregnancy. We sought to understand how the COVID-19 pandemic may mediate the risk of reproductive tract infections. We analyzed data from a cohort of 436 secondary schoolgirls in western Kenya. Baseline and 6-, 12-, and 18-month study visits occurred from April 2018 to December 2019 (pre-COVID-19), and 30-, 36-, and 48-month study visits occurred from September 2020 to July 2022 (COVID-19 period). Participants self-completed a survey for sociodemographics and sexual activity and provided self-collected vaginal swabs for bacterial vaginosis (BV) testing, with sexually transmitted infection (STI) testing at annual visits. We hypothesized that greater COVID-19-related stress would mediate risk via mental health, feeling safe inside the home, and sexual exposure, given the pandemic mitigation-related impacts of school closures on these factors. COVID-19-related stress was measured with a standardized scale and dichotomized at the highest quartile. Mixed effects modeling quantified how BV and STI changed over time. Longitudinal mediation analysis quantified how the relationship between COVID-19 stress and increased BV was mediated. Analysis outcomes were BV and STI. BV and STI prevalence increased from 12.1% and 10.7% pre-COVID-19 to 24.5% and 18.1% during COVID-19, respectively. This equated to 26% (95% CI, 1.00-1.59) and 36% (95% CI, 0.98-1.88) higher relative prevalence of BV and STIs in the COVID-19 vs pre-COVID-19 periods, adjusted for numerous sociodemographic and behavioral factors. Higher COVID-19-related stress was associated with elevated depressive symptoms and feeling less safe inside the home, which were each associated with a greater likelihood of having a boyfriend. In mediation analyses, the direct effect of COVID-19-related stress on BV was small and nonsignificant, indicating that the increased BV was due to the constellation of factors that were affected during the COVID-19 pandemic. These results highlight factors to help maintain reproductive health for adolescent girls in future crises, such as anticipating and mitigating mental health impacts, domestic safety concerns, and maintaining sexual health services. Impacts of the COVID-19 pandemic on drivers of reproductive tract health among those who did not attend school or who live in different settings may differ. In this cohort of adolescent girls, BV and STIs increased following COVID-19-related school closures, and risk was mediated by depressive symptoms and feeling less safe in the home, which led to a higher likelihood of sexual exposures.

Evaluation of two alternative non-alcohol-based media for the suspension of self-collected vaginal swabs for HPV testing in cervical cancer screening

The introduction of Human Papillomavirus (HPV) testing in cervical cancer screening enhanced the opportunity to introduce self-collection as an innovative approach to improve coverage rates. Validation and standardization of the pre-analytical and analytical procedures are crucial for the quality assurance of HPV tests on self-collected samples.This study evaluated the analytical performance and the stability of self-collected vaginal samples resuspended in 5 mL of two non-alcohol-based media, eNat® and MSwab® compared to a professionally collected cervical sample, resuspended in 20 mL ThinPrep®, for the detection of high-risk HPV (hrHPV). The impact of the suspension volumes on analytical performance was also evaluated (2 and 5 ml).A good analytical concordance in hrHPV detection in cervical and vaginal self-collected swabs suspended in 5 ml of both non-alcohol-based media was demonstrated (eNat®: 91.2 %, k = 0.821; MSwab®: 91.4 %; k = 0.798). A similar analytical performance was found for samples resuspended in 2 mL (eNat®: 92.9 %, k = 0.811; MSwab®: 92.9 %, k = 0.811) compared to cervical samples.Good nucleic acid stability was demonstrated for vaginal samples stored at 20-25 °C and 37 °C for up to 4 weeks.Results of this preliminary study support the introduction of these media for vaginal self-sampling-based prevention programs. Nevertheless, further research is necessary to evaluate clinical accuracy in larger settings.

Evaluation of Pre-Analytical Variables for Human Papillomavirus Primary Screening from Self-Collected Vaginal Swabs

HPV primary screening is an effective approach to assessing cervical cancer risk. Self-collected vaginal swabs have shown promise to expand testing access, but there are limited data defining analytical performance criteria necessary for adoption of self-collected specimens, especially for those occurring outside the clinic where the swab remains dry during transport. Here, we evaluated the performance of self-collected vaginal swabs for HPV detection using the Roche Cobas 6800. There was insignificant variability between swabs self-collected by the same individual (n=15 participants collecting 5 swabs/participant), measured by amplification of HPV and human β-globin control DNA. Comparison of self-collected vaginal swab and provider-collected cervical samples (n=144 paired collections) proved highly concordant for HPV detection (total agreement=90.3%;PPA=84.2%). There was no relationship between the number of dry storage days and amplification of HPV (n=68, range 4-41days). Exposure of self-collected dry swabs to extreme summer and winter temperatures did not affect testing outcomes. We assessed a second internal control (RNAseP) in a subset and demonstrate that lack of amplification for β-globin from self-collected specimens was consistent with poor, but not absent, cellularity. These data suggest that self-collected vaginal samples enable accurate clinical HPV testing, and that extended ambient dry storage or exposure to extreme temperatures do not influence HPV detection. Further, lack of β-globin amplification in HPV negative samples accurately identified participants that required recollection.

Lessons learned from comparing self-collected vs. physician-collected vaginal swabs for diagnosing infections in resource-limited settings: a 24-year review

Introduction: Reproductive health is essential for women’s overall well-being, yet vaginal infections like Bacterial Vaginosis (BV), Candidiasis, and Trichomoniasis are prevalent and can lead to severe complications if left untreated. In high-income countries, healthcare systems are generally equipped to handle these infections; however, in resource-limited settings, barriers such as geographic isolation, financial constraints, and social stigmas hinder access to effective care. Self-collected vaginal swabs present a promising alternative to traditional physician-collected samples, offering potential benefits in these underserved regions. Objective: This study aims to evaluate the feasibility, diagnostic accuracy, and community acceptance of self-collected vaginal swabs compared to physician-collected samples for diagnosing bacterial vaginosis, candidiasis, and trichomoniasis in resource-limited settings, and to explore strategies for the broader implementation of this approach to improve women’s reproductive health. Methods: This narrative review synthesizes literature on the effectiveness, feasibility, and community acceptance of self-collected vaginal swabs compared to physician-collected samples for diagnosing BV, Candidiasis, and Trichomoniasis. A systematic search was conducted across PubMed, Google Scholar, and institutional repositories for studies from January 2000 to May 2024. The review encompasses various sections, including background on the significance of timely diagnosis, initiatives empowering women through self-collection, challenges and successes of these initiatives, and strategies for quality assurance and policy advocacy. Results: Self-collected vaginal swabs were found to be as accurate as physician-collected samples in diagnosing BV, Candidiasis, and Trichomoniasis. The method enhances accessibility and reduces stigma, showing potential for broader application in community health settings. Conclusion: Self-collected vaginal swabs represent a viable solution to reproductive health challenges in resource-limited settings. They offer comparable diagnostic accuracy, enhance accessibility, and can reduce cultural barriers to seeking care. Future efforts should focus on community education, technological innovations, and policy reforms to maximize the effectiveness and sustainability of this approach in improving global women’s health.

Point-of-care testing for sexually transmitted infections and HIV pre-exposure prophylaxis among pregnant women in South Africa, 2021–2022: randomised controlled trial

ObjectivePregnant and postpartum women (PPW) in Southern Africa are at increased risk of acquiring HIV and curable sexually transmitted infections (STIs). Oral pre-exposure prophylaxis (PrEP) is safe and effective to...

The Prevalence of Candida Species among HIV-Positive Women in Aluu, Nigeria: A Call for Awareness

Background: The acquired immune deficiency syndrome (AIDS), which HIV brings on, is a major public health concern. The human immunodeficiency virus (HIV) is still a pandemic. Only 2.1% of HIV cases worldwide are recorded in Nigeria. Usually, under the control of the immune system, Candida infections may be dangerous for immunocompromised people, particularly those living with HIV/AIDS.&#x0D; Aim: At the Mbodo Health Centre in Aluu, Rivers State, Nigeria, this study aimed to assess the prevalence of Candida infections and their relationship to HIV-positive patients.&#x0D; Methods: Fifty HIV-positive women were chosen at random. Self-collected oral and vaginal swabs were used to gather data. To identify Candida species, biochemical testing, culture, and microscopy were used.&#x0D; Results: Eighty percent of the 50 individuals had positive candidiasis tests. Oral and vaginal mono/co-candidiasis were found to be common, with Candida albicans being the most common specie. Based on demographic parameters, statistical analysis did not show a significant difference in the prevalence of oral candidiasis. The frequency of vaginal candidiasis was much greater in those with secondary education and aged 31-40 years. The age group of 31 to 40 years old had a considerably greater co-occurrence rate of oral and vaginal candidiasis. Adult female HIV-positive patients at Mbodo Health Centre have a significant prevalence of candidiasis.&#x0D; Conclusion: The study sheds light on the distribution of Candida species and how demographic variables relate to them. These results highlight the significance of treating candidiasis as a serious health issue in people living with HIV. To improve overall health outcomes for HIV-positive people and reduce related risk factors, further research and treatments may be required.

Comparison of vaginal microbiota between women with inflammatory bowel disease and healthy controls.

The gut microbiota in patients with inflammatory bowel disease are perturbed in both composition and function. The vaginal microbiome and its role in the reproductive health of women with inflammatory bowel disease is less well described. We aim to compare the vaginal microbiota of women with inflammatory bowel disease to healthy controls. Women with inflammatory bowel disease enrolled in a longitudinal cohort study provided self-collected vaginal swabs. Healthy controls underwent provider-collected vaginal swabs at routine gynecologic exams. All participants completed surveys on health history, vulvovaginal symptoms and gastrointestinal symptoms, if applicable. Microbiota were characterized by sequencing the V4 region of the 16S rRNA gene. Associations between patient characteristics and microbial community composition were evaluated by PERMANOVA and Principal Components Analysis. Lactobacillus dominance of the microbial community was compared between groups using chi-square and Poisson regression. The cohort included 54 women with inflammatory bowel disease (25 Ulcerative colitis, 25 Crohn's Disease) and 26 controls. A majority, 72 (90%) were White; 17 (31%) with inflammatory bowel disease and 7 (27%) controls were postmenopausal. The composition of the vaginal microbiota did not vary significantly by diagnosis or severity of inflammatory bowel disease but did vary by menopausal status (p = 0.042). There were no significant differences in Shannon Diversity Index between healthy controls and women with IBD in premenopausal participants. There was no difference in proportion of Lactobacillus dominance according to diagnosis in premenopausal participants. A subgroup of postmenopausal women with Ulcerative colitis showed a significant higher alpha diversity and a lack of Lactobacillus dominance in the vaginal microbiome. Menopausal status had a larger impact on vaginal microbial communities than inflammatory bowel disease diagnosis or severity.

A-234 Self-collected Vaginal Swabs for High-risk HPV Testing in the us: Validation of Pre-analytical Variables

Abstract Introduction Several clinical trials have illustrated that primary HPV screening with unsupervised self-collected vaginal swabs is clinically appropriate; however, there is little data regarding quantitative changes imposed by pre-analytical components when samples are self-collected. Here we took a detailed analysis of the variables related to self-collected vaginal swabs to calculate analytical acceptability metrics and to identify limitations that can be improved to aid in modern cervical cancer screening pathways. Methods HPV was evaluated in self-collected dry vaginal swabs or paired self-collected vaginal/provider-collected endocervical swabs using an assay that is FDA-approved for provider-collected HPV primary screening. The assay includes amplification of endogenous hemoglobin subunit beta gene (HBB;beta-globin) as an internal control. Paired provider/self-collected samples (n = 144) were compared for HPV and beta-globin detection. Self-collected dry vaginal swabs (n = 15 participants;5 swabs/participant) were used to calculate intra-individual variability in cycle threshold (Ct) between swabs. A second set of self-collected swabs (n = 20 participants;3 swabs/participant) were challenged using winter or summer simulation with temperature cycling designed to mimic extreme seasonal fluctuations. Ct values for seasonal challenges were compared to unchallenged swabs. Various approaches were used to optimize collections: (1) a time course to see if the number of hours a self-collected vaginal swab remained dry before suspending in buffer influenced detection; (2) an alternate internal control (protein only RNase P catalytic subunit gene, PRORP) was amplified to exclude sample-specific inhibitor(s); (3)participants were provided an instructional video to aid collection. Results Most samples were concordant between provider and self-collect (n = 60 HPV positive; n = 60 HPV negative). There were 20 discrepant samples: 12 negative for HPV with provider-collected, but positive for HPV using self-collected swabs and 4 positive for HPV with provider-collected, but negative for HPV using self-collected swabs. All discrepancies were due to low viral load; for provider and self-collected swabs the average Ct (SD) in discrepant samples was 31.4 (3.5) and 33.1 (2.7), respectively, for HPV and 25.8 (2.1) and 27.1 (2.6), respectively, for beta-globin. The average self-collected intra-individual % CV for HPV and beta-globin was 3.5% and 2.7%, respectively. The average HPV Ct for swabs that cycled through the summer, winter or unchallenged conditions was 28.3 (SD = 5.9), 27.2 (SD = 7.1), and 25.7 (SD = 3.1), respectively. The average beta-globin Ct for swabs that cycled through the summer, winter or unchallenged conditions was 26.8 (SD = 2.7), 26.7 (SD = 3.0), and 26.0 (SD = 2.2), respectively. The time a sample remained dry did not influence detection. RNAse P amplification indicated results with invalid beta-globin were a function of cellularity not inhibition. The instructional video improved collection by ∼8.5%; 61/64 (95.3%) 125/144 (86.8%) were valid with and without the video, respectively. Conclusions Self-collected vaginal samples are a convenient and discreet way to screen for cervical cancer. Understanding the pre-analytical/analytical limitations can improve HPV detection.

Changes in the Vaginal Microbiome During Pregnancy and the Postpartum Period in South African Women: a Longitudinal Study

Pregnant women in sub-Saharan Africa have high rates of maternal morbidity. There is interest in the impact of the vaginal microbiome on maternal health, including HIV and sexually transmitted infection (STI) acquisition. We characterized the vaginal microbiota of South African women ≥ 18 years with and without HIV in a longitudinal cohort over two visits during pregnancy and one visit postpartum. At each visit, we obtained HIV testing and self-collected vaginal swabs for point-of-care testing for STIs and microbiota sequencing. We categorized microbial communities and evaluated changes over pregnancy and associations with HIV status and STI diagnosis. Across 242 women (mean age 29, 44% living with HIV, 33% diagnosed with STIs), we identified four main community state types (CSTs): two lactobacillus-dominant CSTs (dominated by Lactobacillus crispatus and Lactobacillus iners respectively) and two diverse, non-lactobacillus-dominant CSTs (one dominated by Gardnerella vaginalis and one by diverse facultative anaerobes). From the first antenatal visit to the third trimester (24–36 weeks gestation), 60% of women in the Gardnerella-dominant CST shifted to lactobacillus-dominant CSTs. From the third trimester to postpartum (mean 17 days post-delivery), 80% of women in lactobacillus-dominant CSTs shifted to non-lactobacillus-dominant CSTs with a large proportion in the facultative anaerobe-dominant CST. Microbial composition differed by STI diagnosis (PERMANOVA R2 = 0.002, p = 0.004), and women diagnosed with an STI were more likely to be categorized as L. iners-dominant or Gardnerella-dominant CSTs. Overall, we found a shift toward lactobacillus dominance during pregnancy and the emergence of a distinct, highly diverse anaerobe-dominant microbiota profile in the postpartum period.

Detecting human cytomegalovirus in urine, vagina and saliva: Impact of biological fluids and storage durations and temperatures on CMV DNA recovery.

Sample collection, transport and storage conditions vary in the human cytomegalovirus (CMV) shedding literature. Currently, limited data exist on the impact of biological fluids and pre-analytical sample handling on the detection of CMV DNA. To evaluate CMV DNA recovery from urine, vaginal fluid and saliva stored in different conditions, adult urine, vaginal and saliva fluids and swabs, stored with or without selected nucleic acid preservation media at various durations and temperatures, was compared by polymerase chain reaction (PCR) quantitation of spiked samples and self-collected urine (n = 45) and vaginal swabs (n = 58) from CMV seropositive pregnant women. There was a time-dependent reduction in CMV DNA recovery from urine, urine diluted in phosphate-buffered saline, and saliva stored at 2-8°C, but not from urine preserved in cobas® PCR transport media (CPM) (urine/CPM). For vaginal fluid, a reduction in recovery was evident after 7 days storage at 2-8°C. CMV DNA recovery over 91 days was similar between -80°C and -20°C storage for urine and vaginal swabs preserved in CPM, and saliva swabs preserved in eNAT® PCR transport media. A statistically significant change in CMV DNA recovery after 25 months storage (median) at -80°C was not observed for self-collected urine/CPM and vaginal swab/CPM from pregnant women. Taken together, recovery of CMV DNA is dependent on fluid type and storage conditions. To improve the validity and reliability of detection at different storage durations and temperatures, the use of nucleic acid preserving transport media at the point of collection for urine, vaginal fluid and saliva may be essential.

Effectiveness of Clinic-Based Patient-Led Human Papillomavirus DNA Self-Sampling among HIV-Infected Women in Uganda.

In Uganda, the uptake of cervical cancer (CC) screening services is low, at 46.7%, among HIV-infected women, and only 9% of these women adhere to annual CC screening. Some studies have evaluated the possibility of community or home-based human papillomavirus (HPV) self-collected vaginal swabs, but not clinic-based HPV self-collected vaginal swabs. Therefore, we propose a study to determine the efficacy of clinic-based versus home-based HPV DNA self-sampling among HIV-infected women attending a rural HIV clinic in Uganda. We believe that a randomized, single-blinded trial would achieve this objective, and so we have chosen it to guide the study. Including a total of 382 participants from a rural HIV clinic, randomized into a ratio of 1:1 for clinic- and home-based HPV self-sampling, would allow us to appropriately ascertain the difference in the uptake of HPV self-sampling between the two arms. The Integrated Biorepository of H3 Africa Uganda Laboratory would be used as a reference laboratory for the HPV DNA extraction, typing, and sequencing. At baseline, modified Poisson regression models would be used to measure factors associated with the prevalence of HPV and uptake in both arms at baseline. Visual inspection under acetic acid (VIA), as a gold-standard test for CC to grade for CIN, would be performed at 0 and 6 months among a random sample of 75 women with a self-collected HPV sample. The difference in uptake could be determined using the intention-to-treat analysis. The difference in the groups by each variable would be summarized as the standardized mean difference (i.e., the mean difference divided by the pooled standard deviation). The predictors of the time for which participants would continue with HPV self-sampling in both arms, recovery, and Cox proportional hazards regression would be used. At the bivariate level, the associations between each independent variable and time, with the time of continuing HPV self-sampling, would be computed. Crude hazard ratios and their 95% confidence interval would be used in the presentation of the results, with p-values < 0.05 considered significant at the bivariate level. Incremental cost-effectiveness analysis (CEA) using a Markov model would be used to determine the cost of clinic-based HPV self-sampling. We believe that screening approaches to disease stratification could provide an insight into the merits and limitations of current approaches to the diagnosis of cervical cancer, and how these could eventually be implemented into HIV clinics in Uganda and other developing African countries. It is anticipated that the findings would guide the development of step-by-step guidelines for the HPV self-sampling approach.

Effectiveness and Costs of Molecular Screening and Treatment for Bacterial Vaginosis to Prevent Preterm Birth

Bacterial vaginosis (BV) is a well-known risk factor for preterm birth. Molecular diagnosis of BV is now available. Its impact in the screening and treatment of BV during pregnancy on preterm births has not been evaluated to date. To evaluate the clinical and economic effects of point-of-care quantitative real-time polymerase chain reaction screen and treat for BV in low-risk pregnant women on preterm birth. The AuTop trial was a prospective, multicenter, parallel, individually randomized, open-label, superiority trial conducted in 19 French perinatal centers between March 9, 2015, and December 18, 2017. Low-risk pregnant women before 20 weeks' gestation without previous preterm births or late miscarriages were enrolled. Data were analyzed from October 2021 to November 2022. Participants were randomized 1:1 to BV screen and treat using self-collected vaginal swabs (n = 3333) or usual care (n = 3338). BV was defined as Atopobium vaginae (Fannyhessea vaginae) load of 108 copies/mL or greater and/or Gardnerella vaginalis load of 109 copies/mL or greater, using point-of-care quantitative real-time polymerase chain reaction assays. The control group received usual care with no screening of BV. Overall rate of preterm birth before 37 weeks' gestation and total costs were calculated in both groups. Secondary outcomes were related to treatment success as well as maternal and neonate health. Post hoc subgroup analyses were conducted. Among 6671 randomized women (mean [SD] age, 30.6 [5.0] years; mean [SD] gestational age, 15.5 [2.8] weeks), the intention-to-treat analysis of the primary clinical and economic outcomes showed no evidence of a reduction in the rate of preterm birth and total costs with the screen and treat strategy compared with usual care. The rate of preterm birth was 3.8% (127 of 3333) in the screen and treat group and 4.6% (153 of 3338) in the control group (risk ratio [RR], 0.83; 95% CI, 0.66-1.05; P = .12). On average, the cost of the intervention was €203.6 (US $218.0) per participant, and the total average cost was €3344.3 (US $3580.5) in the screen and treat group vs €3272.9 (US $3504.1) in the control group, with no significant differences being observed. In the subgroup of nulliparous women (n = 3438), screen and treat was significantly more effective than usual care (RR, 0.62; 95% CI, 0.45-0.84; P for interaction = .003), whereas no statistical difference was found in multiparous (RR, 1.30; 95% CI, 0.90-1.87). In this clinical trial of pregnant women at low risk of preterm birth, molecular screening and treatment for BV based on A vaginae (F vaginae) and/or G vaginalis quantification did not significantly reduce preterm birth rates. Post hoc analysis suggests a benefit of screen and treat in low-risk nulliparous women, warranting further evaluation in this group. ClinicalTrials.gov Identifier: NCT02288832.

Prevotella and Gardnerella Are Associated With Treatment Failure Following First-line Antibiotics for Bacterial Vaginosis.

Bacterial vaginosis (BV) is a common vaginal dysbiosis that often recurs following first-line antibiotics. We investigated if vaginal microbiota composition was associated with BV recurrence. We analyzed samples and data from 121 women who participated in 3 published trials evaluating novel interventions for improving BV cure, including concurrent antibiotic treatment of regular sexual partners (RSPs). Women diagnosed with BV received first-line antibiotics and self-collected vaginal swabs pretreatment and the day after finishing antibiotics (immediately posttreatment). 16S rRNA gene sequencing was performed on vaginal samples. Logistic regression explored associations between BV recurrence and features of the vaginal microbiota pre- and posttreatment. Sixteen women (13% [95% confidence interval {CI}, 8%-21%]) experienced BV recurrence within 1 month of treatment. Women with an untreated RSP were more likely to experience recurrence than women with no RSP (P = .008) or an RSP who received treatment (P = .011). A higher abundance of Prevotella pretreatment (adjusted odds ratio [AOR], 1.35 [95% CI, 1.05-1.91]) and Gardnerella immediately posttreatment (AOR, 1.23 [95% CI, 1.03-1.49]) were associated with increased odds of BV recurrence. Having specific Prevotella spp prior to recommended treatment and persistence of Gardnerella immediately posttreatment may contribute to the high rates of BV recurrence. Interventions that target these taxa are likely required to achieve sustained BV cure.

Vitamin D supplementation in bacterial vaginosis

Research objectives: to evaluate the effect of vitamin D supplementation (Olidetrim) in the complex anti-relapse therapy of bacterial vaginosis (BV) in women of reproductive age.Materials and methods. The study included 63 women of reproductive age with BV and with a level of 25-hydroxyvitamin D below 75 nmol/l, who were divided into groups: the main group included 32 women who were prescribed standard therapy (metronidazole 500 mg twice a day for 7 days) and cholecalciferol (Olidetrim) 4000 IU/day with subsequent continuation of its intake in a dose 2000 IU/day for up to 6 months; the comparison group included 31 women, who were not intake vitamin D preparation during the standard therapy and during the next 6 months of observation.After treatment, women provided completed questionnaires and self-collected vaginal swabs 1, 3, and 6 months after beginning of the study or before BV relapse. Evaluation of Gram-stained smears was carried out by microscopy according to Hay/Ison criteria, where BV corresponded to type III. The level of 25-hydroxyvitamin D in blood serum was determined by the chemiluminescent immunoassay method before the start of thestudy and at 3 and 6 months of follow-up.The primary endpoint was BV recurrence at any post-treatment interval; the patients were offered a second treatment in this case.Results. Vitamin D deficiency at the beginning of the study was detected in 12 (37.5%) patients of the main group and in 13 (41.94%) women of the comparison group, an insufficient level – in 20 (62.5%) patients of the main group and in 58.06% women of the comparison group.Patients complained of pathological vaginal discharge, itching, burning and dyspareunia lasting from 1 week to 2 months. At the seven-day course of basic BV therapy all participants noted the normalization of discharge and the absence of vaginal discomfort. Positive dynamics were also observed according to the gynecological examination.One month after the treatment, 4 (12.5%) participants of the main and 6 (19.36%) women of the comparison group noted the recovery of symptoms. Absence of BV recurrence after 3 months was noted by 25 (78.12%) women of the main group and 16 (51.61%) women of the comparison group (p = 0.054), that was confirmed by the laboratory tests. At the same time, the level of 25-hydroxyvitamin D in the main group increased by 43.37% (p = 0.05), and in the comparison group it did not differ from the initial level. There were no complaints in 24 (75.0%) patients after 6 months, however, a laboratory-confirmed normal state of the vaginal microbiome was observed in 22 (70.96%) participants of the main group and in 14 (45.16%, p = 0.07) women of the comparison group. Continuation of vitamin D intake at a dose of 2000 IU/day for the next 3 months demonstrated maintenance of the 25-hydroxyvitamin D level within normal values (81.7 ± 6.23 nmol/l in the main group vs. 38.51 ± 5.43 nmol/l in comparison group, p = 0.05).Conclusions. A decrease in the frequency of BV recurrences in women during support a normal level of vitamin D was found, which allows recommending the inclusion of cholecalciferol supplementation (Olidetrim) in the standard treatment. In patients with recurrent BV a long-term monitoring of the serum level of vitamin D is advisable in order to timely prescribe supplementation.

Two self-sampling strategies for HPV primary cervical cancer screening compared with clinician-collected sampling: an economic evaluation

ObjectiveTo compare the costs and effects of three sampling strategies for human papillomavirus (HPV) primary screening.DesignCost-consequence analysis from a health system perspective using a deterministic decision tree model.SettingEngland.ParticipantsA cohort of...

Age-specific and genotype-specific carcinogenic human papillomavirus prevalence in a country with a high cervical cancer burden: results of a cross-sectional study in Estonia

ObjectivesTo describe age-specific and type-specific carcinogenic human papillomavirus (HPV) prevalence prior to large-scale effect of HPV vaccines in Estonia and to analyse the risk factors associated with carcinogenic HPV.DesignCross-sectional study...

Prevalence of Human Papillomavirus in Different Mucous Membranes in HIV Concordant Couples in Rwanda.

The prevalence of human papillomavirus (HPV) infections in other anatomical sites besides the uterine cervix is unknown in East Africa. Here, we assessed the prevalence and concordance of HPVs in different anatomical sites in HIV concordant couples in Rwanda. Fifty HIV-positive concordant male-female couples at the HIV clinic at the University Teaching Hospital of Kigali in Rwanda were interviewed, swabbed from the oral cavity (OC), oropharynx (OP), anal canal (AC), vagina (V), uterine cervix (UC) and penis. A pap smear test and a self-collected vaginal swab (Vself) were taken. Twelve high-risk (HR)-HPVs were analyzed. HR-HPVs occurred in 10%/12% in OC, 10%/0% in OP and 2%/24% in AC (p = 0.002) in men and women, respectively. HR-HPVs occurred in 24% of UC, 32% of Vself, 30% of V and 24% of P samples. Only 22.2% of all HR-HPV infections were shared by both partners (κ -0.34 ± 0.11; p = 0.004). The type-specific HR-HPV concordance was significant between male to female OC-OC (κ 0.56 ± 0.17), V-VSelf (κ 0.70 ± 0.10), UC-V (κ 0.54 ± 0.13), UC-Vself (κ 0.51 ± 0.13) and UC-female AC (κ 0.42 ± 0.15). HPV infections are prevalent in HIV-positive couples in Rwanda but concordance within couples is low. Vaginal self-sampling for HPV is representative of cervical HPV status.