Self-collected Vaginal Specimens Research Articles

Consistency in human papillomavirus type detection between self-collected vaginal specimens and physician-sampled cervical specimens.

With the rising need for accessible cervical cancer screening, self-sampling methods offer a promising alternative to traditional physician-led sampling. This study aims to evaluate the efficacy of the HygeiaTouch Self Sampling Kit for Women in detecting human papillomavirus (HPV) types and predicting cervical lesions. We studied the concordance in identifying high-risk HPV (hrHPV) types between samples collected by physicians and those self-collected by women using a self-sampling kit for validation. Women aged 21-65, fitting into specific categories based on their cervical health history were eligible. Cohen's kappa coefficient to gauge concordance between the two specimen types and relative accuracy metrics in identifying cervical intraepithelial neoplasia (CIN) were also calculated, with physician-sampled specimens serving as a reference. A total of 1210 participants from three institutes were involved. The self-sampling kit closely matched the physician-led method in terms of collecting valid specimens (100% vs. 100%), identifying hrHPV types (kappa: 0.75, 95% confidence interval [95% CI]: 0.72-0.79; agreement: 87.7%, 95% CI: 85.8-89.6) and predicting CIN grade 2 or worse (CIN2+) (relative sensitivity: 0.949, relative accuracy: 0.959). Kappa values varied between 0.71 and 0.83 for different hrHPV types and combinations, with an overall value 0.75 (95% CI: 0.72-0.79) signifying robust compatibility between the two methods. Our study underscores the potential of the HygeiaTouch Self Sampling Kit as a reliable, efficient, and user-friendly alternative to traditional sampling methods. This suggests that self-sampling could be pivotal in expanding cervical cancer screening accessibility and enhancing detection rates.

Preventive Oncology International: A brief history of HPV self-collected vaginal specimens for cervical cancer screening

Since 1998, Preventive Oncology International, Inc. (POI) has been at the forefront of studying human papillomavirus (HPV) self-collection for cervical cancer screening, with a significant focus in China. Through multiple clinical trials over the past 25 years, POI has explored various aspects related to self-collection methodologies. In 2004–2006, POI established that self-collection could be equivalent to direct endocervical samples. Subsequently, a large randomized trial involving 10,000 patients in 2010 further confirmed that self-collected vaginal specimens, tested for high-risk HPV (hrHPV) using a PCR-based assay with high analytic sensitivity, could effectively replace endocervical specimens with minimal loss of sensitivity and a slight decrease in specificity. Throughout the years, POI's research has encompassed several crucial topics, including patient acceptance, the development of new cost-effective, simpler, and faster assays, exploring different collection devices, devising efficient methods of specimen transport, and implementing population-based screening systems. The findings strongly support the integration of self-collection methodologies into cervical cancer control programs worldwide, particularly in medically underserved regions. As HPV self-collection continues to evolve, ongoing research and innovations are expected to play a pivotal role in achieving the global mission of combating cervical cancer.

Characterization of Vaginal Microbial Community Dynamics in the Pathogenesis of Incident Bacterial Vaginosis, a Pilot Study.

Despite more than 60 years of research, the etiology of bacterial vaginosis (BV) remains controversial. In this pilot study, we used shotgun metagenomic sequencing to characterize vaginal microbial community changes before the development of incident BV (iBV). A cohort of African American women with a baseline healthy vaginal microbiome (no Amsel criteria, Nugent score 0-3 with no Gardnerella vaginalis morphotypes) were followed for 90 days with daily self-collected vaginal specimens for iBV (≥2 consecutive days of a Nugent score of 7-10). Shotgun metagenomic sequencing was performed on select vaginal specimens from 4 women, every other day for 12 days before iBV diagnosis. Sequencing data were analyzed through Kraken2 and bioBakery 3 workflows, and specimens were classified into community state types. Quantitative polymerase chain reaction was performed to compare the correlation of read counts with bacterial abundance. Common BV-associated bacteria such as G. vaginalis , Prevotella bivia , and Fannyhessea vaginae were increasingly identified in the participants before iBV. Linear modeling indicated significant increases in G. vaginalis and F . vaginae relative abundance before iBV, whereas the relative abundance of Lactobacillus species declined over time. The Lactobacillus species decline correlated with the presence of Lactobacillus phages. We observed enrichment in bacterial adhesion factor genes on days before iBV. There were also significant correlations between bacterial read counts and abundances measured by quantitative polymerase chain reaction. This pilot study characterizes vaginal community dynamics before iBV and identifies key bacterial taxa and mechanisms potentially involved in the pathogenesis of iBV.

Comparison of self-collected versus clinician collected cervicovaginal specimens for detection of high risk human papillomavirus among HIV infected women in Ethiopia

BackgroundIn order to meet the WHO 2030 cervical cancer elimination program, evaluation and utilization of sensitive testing method, and feasible sampling technique is a paradigm for enhancing cervical cancer screening coverage. Self-sampling for screening of HPV DNA testing is one of the easiest and sensitive techniques, though the evidence was limited in the Ethiopian context. This study aimed to compare the performance of self-collected vaginal specimen versus clinician collected cervical specimen for detection of HPV among HIV positive women in Ethiopia.MethodsWe conducted a comparative cross-sectional study design to collect cervicovaginal specimens among HIV positive women of age older than 24 years. Data were collected from six government hospitals from January to October 2021. A total of 994 cervicovaginal specimens was collected by clinicians and HIV positive women themselves in the cervical cancer screening unit using Abbott Cervi-Collect Specimen Collection Kit, and molecular HPV testing was conducted. Data were entered into an Excel spreadsheet and analyzed using SPSS version 25. Sensitivity, specificity and kappa were reported with p < 0.05 considered as statistically significant.ResultsThe prevalence of high-risk HPV was 29.4% among self-sampled specimen and 23.9% among clinician collected specimens. The overall concordance of the test result was 87.3%. Oncogenic HPV types, other than HPV16&18 were predominant in both sampling techniques, 19.9% from vaginal self-collected specimen and 16.7% of clinician collected cervical specimens. The sensitivity and specificity of self-sampled HPV test was 84.0% and 88.4%, respectively. The level of agreement was good (k = 0.68) and statistically significant (p < 0.001). The discriminatory power of the test as true positive and negative was excellent with an area under the curve of 0.86.ConclusionThe magnitude of oncogenic HPV was higher in self-collected samples than the clinician collected specimen with good agreement between the two sampling methods. Thus, we recommend the Ministry of Health in Ethiopia to expand utilization of the self-sampled technique and enhance the coverage of screening in the country.

Microbiological and behavioral determinants of genital HPV infections among adolescent girls and young women warrant the need for targeted policy interventions to reduce HPV risk.

BackgroundGenital human papillomavirus (HPV) is the most common sexually transmitted virus in most populations globally. Adolescent girls and young women (AGYW) remain a key population group at risk for HPV infection. However, the risk factors of HPV infection among AGYW, especially in sub-Saharan Africa, are a subject of little investigation in published literature. Here, we investigated the factors associated with HPV infection among unvaccinated South African AGYW with a high HPV burden (prevalence: 76.1%).MethodsWe retrospectively recruited 213 AGYW learners (aged 15–25 years) from a previous cross-sectional study, the HPV Education Intervention Study, conducted in the Eastern Cape, South Africa. Sexually transmitted infections (STIs), bacterial pathobionts, genital ulcers (due to infectious causes), candidiasis, and bacterial vaginosis (BV) in the self-collected vaginal specimens were determined using the Allplex™ Panel Assays. Statistical analyses were performed using STATA v16.1. Continuous and categorical variables were computed by t-test /Wilcoxon rank-sum test and Chi-square/Fisher's exact tests, respectively. Logistic regression was used to determine the univariable predictors of HPV infection.ResultsThe overall detection rate of any viral STI, bacterial STI, pathobiont, genital ulcer, candidiasis, and BV among the AGYW was 75.0, 34.4, 90.7, 14.4, 26.9, and 43.6%, respectively. The main factors associated with HPV infection were alcohol consumption (p = 0.005), infection with any and multiple Candida species (p = 0.011 and 0.006, respectively), Candida albicans infection (p = 0.010), Ureaplasma urealyticum pathobiont infection (p = 0.044), BV-associated bacteria (specifically Atopobium vaginae: p = 0.039, BV-associated bacteria 2: p = 0.021, Gardnerella vaginalis: p = 0.021, Megasphaera type 1: p = 0.037), and BV (p = 0.011).ConclusionsOur study, albeit not necessarily generalizable, found social behavior as well as specific vaginal microbes as correlates of HPV infection among AGYW in South Africa. There is a need to investigate HPV epidemiology in other AGYW populations. The factors associated with genital HPV infection among AGYW burdened with HPV infection necessitate the need to formulate and implement population-specific public health strategies for creating HPV awareness and reducing its risk.

Point-of-care HPV DNA testing of self-collected specimens and same-day thermal ablation for the early detection and treatment of cervical pre-cancer in women in Papua New Guinea: a prospective, single-arm intervention trial (HPV-STAT)

WHO recommends human papillomavirus (HPV) testing and same-day treatment for cervical screening in low-income and middle-income countries (LMICs); however, few published data exist on the validity of the strategy. We aimed to evaluate the clinical performance, treatment completion rates, adverse events profile, and acceptability of a fully integrated strategy, comprising point-of-care HPV DNA testing of self-collected specimens and same-day thermal ablation, for screening of cervical cancer in women in Papua New Guinea. HPV-STAT was a large-scale, prospective, single-arm intervention trial conducted at two clinical sites in Papua New Guinea. Cervical screening clinics with an on-site consultant gynaecologist were selected in consultation with national and provincial health authorities, church health services, and local stakeholders. Eligible participants were women aged 30-59 years attending cervical screening services at the two clinics, who were willing to comply with study procedures and able to provide written informed consent. Women self-collected vaginal specimens for point-of-care GeneXpert testing (Cepheid, Sunnyvale, CA, USA) for oncogenic HPV types. Women testing positive for HPV underwent pelvic examination followed by same-day thermal ablation or referral for gynaecology review. All HPV-positive women and a 15% random sample of HPV-negative women provided a clinician-collected cervical specimen for liquid-based cytology. The primary outcome was clinical performance (ie, sensitivity, specificity, positive predictive value [PPV], and negative predictive value [NPV]) of the strategy for the detection of high-grade squamous intraepithelial lesion (HSIL) or worse. This trial is registered with ISRCTN, ISRCTN13476702. Between June 5, 2018, and Jan 6, 2020, we recruited 4285 women, 3638 (84·9%) of whom tested negative for HPV and 647 (15·1%) tested positive for one or more oncogenic HPV type. Sensitivity of the algorithm to detect HSIL or worse was 85·4% (95% CI 81·0-89·6), with specificity 89·6% (88·6-90·6), PPV 35·2% (31·6-39·0), and NPV 98·9% (98·6-99·2). Among HPV-positive women, 602 (93·0%) received same-day thermal ablation and 42 (6·5%) were referred for gynaecology review, 37 (88·1%) of whom attended. Acceptability was high among both HPV-positive and HPV-negative women. Among the 329 HPV-positive women who attended a 3-month follow-up visit, 51 (15·5%) reported mild adverse symptoms that resolved in all cases by the follow-up visit. There were no serious adverse events. We conducted the first real-world evaluation of a fully integrated point-of-care HPV self-collect, test, and treat strategy for same-day cervical screening in a LMIC and found it to be effective, acceptable, and safe when implemented at scale in primary health-care facilities in Papua New Guinea. Our findings support the introduction and scale-up of HPV screening and treatment for the control and elimination of cervical cancer in LMICs, as recommended by WHO. Australian National Health and Medical Research Council.

An Integrated Approach for the Early Detection of Endometrial and Ovarian Cancers (Screenwide Study): Rationale, Study Design and Pilot Study.

Screenwide is a case-control study (2017–2021) including women with incident endometrial and ovarian cancers (EC and OC), BRCA1/2 and MMR pathogenic variant carriers, and age-matched controls from three centers in Spain. Participants completed a personal interview on their sociodemographic factors, occupational exposure, medication, lifestyle, and medical history. We collected biological specimens, including blood samples, self-collected vaginal specimens, cervical pap-brush samples, uterine specimens, and, when available, tumor samples. The planned analyses included evaluation of the potential risk factors for EC/OC; evaluation of molecular biomarkers in minimally invasive samples; evaluation of the cost-effectiveness of molecular tests; and the generation of predictive scores to integrate different epidemiologic, clinical, and molecular factors. Overall, 182 EC, 69 OC, 98 BRCA pathogenic variant carriers, 104 MMR pathogenic variant carriers, and 385 controls were enrolled. The overall participation rate was 85.7%. The pilot study using 61 samples from nine EC cases and four controls showed that genetic variants at the variant allele fraction > 5% found in tumors (n = 61 variants across the nine tumors) were detected in paired endometrial aspirates, clinician-collected cervical samples, and vaginal self-samples with detection rates of 90% (55/61), 79% (48/61), and 72% (44/61) by duplex sequencing, respectively. Among the controls, only one somatic mutation was detected in a cervical sample. We enrolled more than 800 women to evaluate new early detection strategies. The preliminary data suggest that our methodological approach could be useful for the early detection of gynecological cancers.

Effects of Menstrual Cycle on the Accumulation of Human Papillomavirus-Infected Cells Exfoliated from the Cervix That Drift into the Vagina.

Human papillomavirus (HPV) testing using self-collected vaginal specimens is the preferred choice to increase screening uptake. Although the HPV testing results of these samples depend on the cells that naturally exfoliate from the cervical lesion and drift into the vagina, the mechanism of when and how these exfoliated cells mix with the self-collected sample remains unclear. Hence, the study aimed to clarify the relationship between the vaginal drift of HPV-infected cells exfoliated from the cervix, and the menstrual cycle. A total of 180 scraped samples of the cervix and vagina were examined. The exfoliated cells were classified into two categories according to the HPV genotyping results of each sample: sufficient accumulation (same HPV types in cervical and vaginal samples) and insufficient accumulation (fewer HPV types in vaginal samples than in cervical samples, or HPV positivity in cervical samples and HPV negativity in vaginal samples). A moderately strong statistically significant association was observed between exfoliated cell accumulation and the menstrual cycle, and insufficient accumulation was statistically significantly increased at the early proliferative phases. Self-collection of vaginal samples at the early proliferation phase indicates insufficient sample quantities or lower viral load, thereby affecting HPV genotyping.

Human papillomavirus prevalence and risk factors among Australian women 9–12 years after vaccine program introduction

BackgroundIn Australia, high and widespread uptake of the quadrivalent human papillomavirus (HPV) vaccine has led to substantial population-level reductions in the prevalence of quadrivalent vaccine targeted HPV genotypes 6/11/16/18 in women aged ≤ 35 years. We assessed risk factors for HPV detection among 18–35 year old women, 9–12 years after vaccine program introduction. MethodsWomen attending health services between 2015 and 2018 provided a self-collected vaginal specimen for HPV genotyping (Roche Linear Array) and completed a questionnaire. HPV vaccination status was validated against the National Register. Adjusted odds ratios (aORs) and 95% confidence intervals (CI) were calculated for factors associated with HPV detection. ResultsAmong 1564 women (median age 24 years; IQR 21–27 years), Register-confirmed ≥ 1-dose vaccine coverage was highest at 69.3% and 68.1% among women aged 18–21 and 22–24 years respectively, decreasing to 42.9% among those aged 30–35 years. Overall prevalence of quadrivalent vaccine-targeted HPV types was very low (2.0%; 95% CI: 1.4–2.8%) and influenced only by vaccination status (5.5% among unvaccinated compared with 0.7% among vaccinated women; aOR = 0.13 (95% CI: 0.05–0.30)). Prevalence of remaining HPV types, at 40.4% (95% CI: 38.0–42.9%), was influenced by established risk factors for HPV infection; younger age-group (p-trend < 0.001), more recent (p < 0.001) and lifetime sexual partners (p-trend < 0.001), but not vaccination status. Prevalence of HPV31/33/45, which shared risk factors with that of non-vaccine targeted HPV types, was also lower among vaccinated (4%) compared with unvaccinated (7%) women (aOR = 0.51; 95% CI: 0.29–0.89), indicative of cross-protection. ConclusionVaccination has changed the epidemiology of HPV infection in Australian women, having markedly reduced the prevalence of vaccine-targeted types, including amongst women with known risk factors for infection. Vaccinated women appear to be benefiting from modest cross-protection against types 31/33/45 afforded by the quadrivalent HPV vaccine. These results reinforce the importance of HPV vaccination.

High human papillomavirus prevalence among females attending high school in the Eastern Cape Province of South Africa.

As part of the human papillomavirus (HPV) vaccination strategy in South Africa, it is essential to have information on HPV prevalence, and HPV types distribution among the unvaccinated population. Information on the prevalence of HPV and the distribution of HPV types in adolescents and young women in South Africa’s Eastern Cape Province is minimal. Therefore, this study investigates the prevalence, distribution of HPV types, and factors associated with HPV infection amongst unvaccinated female learners. A sample composed of 213 sexually active female learners attending high schools in the Eastern Cape Province of South Africa; median age 18 years, who provided self-collected vaginal specimens. Roche Linear Array HPV genotyping assay that detects 37 HPV genotypes was used to detect HPV infection. HPV infection was detected in 76.06% (162/213) of participants. Of these 14.55% (31/213) were positive for HPV types targeted by the Cervarix® HPV vaccine (HPV-16 and/or 18), 20.66% (44/213) by Gardasil®4 (HPV-6, -11, -16 and/or -18) and 37.09% (79/213) by Gardasil®9 (HPV-6, -11, -16, -18, -31, -33, -45, -52 and/or -58). HPV-35, commonly detected in cervical cancer cases among women of African ancestry, was frequently detected (9.40%). Participants who reported to have ever consumed alcohol had a significantly higher risk of HPV infection (OR: 2.91, 95% CI: 1.38–6.11, p = 0.005). High HPV prevalence was observed among participants. The high prevalence of HPV types targeted by the Gardasil®9 vaccine encourages the introduction of the Gardasil®9 vaccine. Data from this study will inform both vaccination campaigns and monitor the impact on HPV types after vaccination.

Acceptability of self- collection for human papillomavirus detection in the Eastern Cape, South Africa.

Human papillomavirus (HPV) testing on vaginal self-collected and cervical clinician-collected specimens shows comparable performance. Self-sampling on FTA cards is suitable for women residing in rural settings or not attending regular screening and increases participation rate in the cervical cancer screening programme. We aimed to investigate and compare high-risk (HR)-HPV prevalence in clinician-collected and self-collected genital specimens as well as two different HPV tests on the clinician collected samples. A total of 737 women were recruited from two sites, a community health clinic (n = 413) and a referral clinic (n = 324) in the Eastern Cape Province. Cervical clinician-collected (FTA cards and Digene transport medium) and vaginal self-collected specimens were tested for HR-HPV using the hpVIR assay (FTA cards) and Hybrid Capture-2 (Digene transport medium). There was no significant difference in HR-HPV positivity between clinician-collected and self-collected specimens among women from the community-based clinic (26.4% vs 27.9%, p = 0.601) or the referral clinic (83.6% vs 79.9%, p = 0.222). HPV16, HPV35, and HPV33/52/58 group were the most frequently detected genotypes at both study sites. Self-sampling for HPV testing received a high positive response of acceptance (77.2% in the community-based clinic and 83.0% in referral clinic). The overall agreement between hpVIR assay and HC-2 was 87.7% (k = 0.754). The study found good agreement between clinician-collected and self-collected genital specimens. Self-collection can have a positive impact on a cervical screening program in South Africa by increasing coverage of women in rural areas, in particular those unable to visit the clinics and women attending clinics where cytology-based programs are not functioning effectively.

High Prevalence of Vaginal and Rectal Mycoplasma genitalium Macrolide Resistance Among Female Sexually Transmitted Disease Clinic Patients in Seattle, Washington.

Rectal Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (GC) are increasingly recognized as common infections among women. Little is known about the prevalence of rectal Mycoplasma genitalium (MG), rectal MG/CT/GC coinfection, or MG antimicrobial resistance patterns among women. In 2017 to 2018, we recruited women at high risk for CT from Seattle's municipal sexually transmitted disease clinic. Participants self-collected vaginal and rectal specimens for CT/GC nucleic acid amplification testing. We retrospectively tested samples for vaginal and rectal MG using nucleic acid amplification testing and tested MG-positive specimens for macrolide resistance-mediating mutations (MRM) and ParC quinolone resistance-associated mutations (QRAMs). Of 50 enrolled women, 13 (26%) tested positive for MG, including 10 (20%) with vaginal MG and 11 (22%) with rectal MG; 8 (62%) had concurrent vaginal/rectal MG. Five (38%) were coinfected with CT, none with GC. Only 2 of 11 women with rectal MG reported anal sex in the prior year. Of MG-positive specimens, 100% of rectal and 89% of vaginal specimens had an MRM. There were no vaginal or rectal MG-positive specimens with ParC QRAMs previously associated with quinolone failure. Five MG-infected women received azithromycin for vaginal CT, 4 of whom had a MG MRM detected in their vaginal and/or rectal specimens. We observed a high prevalence of macrolide-resistant vaginal and rectal MG among a population of women at high risk for CT. This study highlights how the use of antimicrobials designed to treat an identified infection-in this case, CT-could influence treatment outcomes and antimicrobial susceptibility in other unidentified infections.

Feasibility of a community-based cervical cancer screening with "test and treat" strategy using self-sample for an HPV test: Experience from rural Cameroon, Africa.

To achieve higher coverage and effectiveness in limited-resource settings, World Health Organization (WHO) guidelines for cervical cancer prevention recommend a screen-and-treat strategy with high-risk human papillomavirus (HPV) testing. We piloted a real-word project to examine the feasibility of this approach in rural Cameroon. Nurses from the Women's Health Program (WHP) of the Cameroon Baptist Convention Health Services (CBCHS) educated women in remote villages on cervical cancer prevention. At a follow-up visit, they explained to nonpregnant women aged 30-65 how to self-collect vaginal specimens for HPV testing with the careHPV assay. The cytobrush specimens were transported in coolers to a CBCHS laboratory for analysis. The nurses returned to villages to inform women of their results, examined HPV-positive women in the primary health centers (PHCs) using visual inspection with acetic acid and Lugol's iodine (VIA/VILI) enhanced by digital cervicography (DC) to guide treatment. Of the 1,270 eligible women screened (mean age: 44.7 years), 196 (15.4%) were HPV-positive, of whom 185 (94.4%) were examined, 16 (8.6%) were VIA/VILI-positive, 8 (4.3%) were VIA/VILI-inadequate, one (0.5%) was VIA/VILI-uncertain and 161 (87.0%) were treated with thermal ablation. One woman had LEEP, and another woman with invasive cancer was treated at a referral facility. The cytobrushes broke off in the vaginas of two women (removed in the village) and in the bladder of another (surgically removed). Community-based cervical cancer screening with self-collected specimens for HPV testing is feasible in rural Cameroon. Education on the proper sampling procedure and follow-up of women who are HPV-positive are essential.

Evaluation of p16/Ki-67 dual-stain cytology performed on self-collected vaginal and clinician-collected cervical specimens for the detection of cervical pre-cancer

ObjectivesTo compare the performance of dual immunostaining of p16INK4a and Ki-67 proteins performed on self-collected vaginal specimens and clinician-collected cervical specimens, and to evaluate the performance of this technique in predicting high-grade disease. MethodsWomen aged 30–59 years (n = 1005) were recruited at two well-women clinics in Papua New Guinea. Each woman provided both cervical and vaginal specimens that were tested for high-risk human papillomavirus (hrHPV) DNA using the Xpert HPV Test (Cepheid) at point of care. A subset of paired cervical and vaginal specimens (n = 243) were selected to undergo CINTec® PLUS (Roche) p16/Ki-67 dual-stain cytology and liquid-based cytology (LBC). ResultsFifty-five pairs (22%) were excluded from further analysis because the smears were not assessable. Of the 189 remaining paired specimens, 74 pairs (39.1%) were positive for one or more hrHPV genotypes. When comparing results of the dual stain, the overall percent agreement, positive and negative percent agreements and κ value between the cervical and vaginal specimens were 87.8% (CI 82.3–92.1%), 64.6% (CI 49.5–77.8%), 95.7% (CI 91.0–98.0%) and 0.65 (CI 0.51–0.79%) respectively. The sensitivity of the dual stain performed on the cervical specimen to predict high-grade disease, determined by LBC, was superior to that of the dual stain performed on the vaginal specimen: 100% (CI 84.6–100%) versus 68.2% (CI 45.1–86.1%). ConclusionAlthough further evaluation may be warranted, these findings indicate that dual-stain testing of vaginal specimens cannot be advocated as part of cervical screening programmes in low- and middle-income countries. However, dual-stain cytology performed on cervical specimens may have a role in quality assurance in such settings.

Gardnerella vaginalis Clade Distribution Is Associated With Behavioral Practices and Nugent Score in Women Who Have Sex With Women.

Gardnerella vaginalis is detected in women with and without bacterial vaginosis (BV). Identification of 4 G. vaginalis clades raised the possibility that pathogenic and commensal clades exist. We investigated the association of behavioral practices and Nugent Score with G. vaginalis clade distribution in women who have sex with women (WSW). Longitudinal self-collected vaginal specimens were analyzed using established G. vaginalis species-specific and clade-typing polymerase chain reaction assays. Logistic regression assessed factors associated with detection of G. vaginalis clades, and multinomial regression assessed factors associated with number of clades. Clades 1, 2, and 3 and multiclade communities (<2 clades) were associated with Nugent-BV. Clade 1 (odds ratio [OR], 3.36; 95% confidence interval [CI], 1.65-6.84) and multiclade communities (relative risk ratio [RRR], 9.51; 95% CI, 4.36-20.73) were also associated with Lactobacillus-deficient vaginal microbiota. Clade 4 was neither associated with Nugent-BV nor Lactobacillus-deficient microbiota (OR, 1.49; 95% CI, 0.67-3.33). Specific clades were associated with differing behavioral practices. Clade 1 was associated with increasing number of recent sexual partners and smoking, whereas clade 2 was associated with penile-vaginal sex and sharing of sex toys with female partners. Our results suggest that G. vaginalis clades have varying levels of pathogenicity in WSW, with acquisition occurring through sexual activity. These findings suggest that partner treatment may be an appropriate strategy to improve BV cure.

Self-Collected Samples in Cervical Cancer Screening: Results of HPV and Pap Self-Collected Samples Compared to Physician-Obtained Specimens

Objective: In order to increase overall participation in cervical cancer screening, several investigators propose a concept of introducing self-tests. The study presented here compared test results of the Pap test and 4 different HPV test systems of self-collected and physician-collected vaginal specimens. Study Design: 208 patients of a colposcopy clinic had physician-taken and self-taken vaginal samples. All cell samples enabled a liquid-based Pap test and testing for carcinogenic HPV genotypes. In addition, all patients had a colposcopy with or without cervical biopsy and/or conisation. Results: 99 patients had the histological diagnosis of CIN2+. The HPV test sensitivity of self-collected samples differed significantly in this patient group depending on the test system performed. The sensitivity of the self-collected Pap test was significantly lower than HPV testing, but the positive predictive value of the Pap self-test was very high. Conclusion: The results of this study indicate that under the circumstances of self-testing HPV test systems differ in test sensitivity and specificity. Self-collected Pap tests can provide a test result with a very high positive predictive value and introduce therapeutic strategies. In order to improve screening strategies, it could be an opportunity to combine HPV and Pap tests in self-taken vaginal samples, especially in countries with a low income level. In countries with a good medical infrastructure, self-testing has to be introduced with caution.

Recurrent/Intermittent Vaginal and Rectal Chlamydial Infection Following Treatment: A Prospective Cohort Study Among Female Sexually Transmitted Disease Clinic Patients.

Rectal Chlamydia trachomatis (CT) is common among clinic-attending women, but little is known about clearance and health implications of rectal CT. At the municipal sexually transmitted disease clinic in Seattle, Washington, in 2017-2018, we enrolled women at high risk for urogenital CT into an 8-week prospective study. Women received standard CT treatment at enrollment. Women self-collected daily rectal and vaginal specimens for nucleic acid amplification tests (NAATs) and completed weekly sexual exposure diaries. We performed CT culture on the enrollment rectal specimen. We enrolled 50 women; 13 (26%) tested positive for vaginal (n = 11) and/or rectal (n = 11) CT. Sixty percent of women with rectal CT per NAAT were also culture positive. Median time to CT clearance after azithromycin treatment was 8.0 days for vaginal CT and 7.0 days for rectal CT. Eight women with rectal CT at enrollment had at least 1 rectal CT-positive NAAT after clearance of the initial infection; none reported anal sex. Most NAAT-positive rectal infections were culture positive, suggesting active infection. Time to NAAT clearance of rectal and genital tract CT was similar, and intermittent rectal CT positivity was common in the absence of anal sexual exposure. The cause of recurrent/intermittent rectal CT and the clinical implications of these infections require further study.

Performance of clinical screening algorithms comprising point-of-care HPV-DNA testing using self-collected vaginal specimens, and visual inspection of the cervix with acetic acid, for the detection of underlying high-grade squamous intraepithelial lesions in Papua New Guinea

The performance of different clinical screening algorithms comprising point-of-care HPV-DNA testing using self-collected vaginal (‘V’) specimens, and visual inspection of the cervix with acetic acid (VIA) was evaluated in Papua New Guinea.Women aged 30–59 years provided V specimens that were tested at point-of-care using the Xpert HPV Test (Cepheid, Sunnyvale, CA). A clinician-collected cervical (‘C’) specimen was then collected for point-of-care Xpert testing, and liquid-based cytology (LBC). Following this, VIA examination was conducted, blind to HPV test results, and ablative cervical cryotherapy provided if indicated. Detection of high-grade squamous intraepithelial lesion (HSIL) by LBC was the reference standard used to evaluate clinical screening algorithms.Of 1005 women, 36 had HSIL+. Xpert HPV Test performance using V specimens (sensitivity 91.7%, specificity 87.0%, PPV 34.0%, NPV 99.3%) was superior to VIA examination alone (51.5%, 81.4%, 17.5%, 95.6% respectively) in predicting underlying HSIL+. A screening algorithm comprising V specimen HPV testing followed by VIA examination had low sensitivity (45.5%) but comparable specificity, PPV and NPV to HPV testing alone (96.3%, 45.5%, 96.3% respectively).A ‘test-and-treat’ screening algorithm based on point-of-care HPV testing of V specimens had superior performance compared with either VIA examination alone, or a combined screening algorithm comprising HPV testing plus VIA.

Evaluation of self-collected vaginal specimens for the detection of high-risk human papillomavirus infection and the prediction of high-grade cervical intraepithelial lesions in a high-burden, low-resource setting

ObjectivesTo compare the performance of self-collected vaginal (V) specimens with clinician-collected cervical (C) specimens for detection of high-risk human papillomavirus (hrHPV) and cervical disease using the Cepheid Xpert HPV, Roche Cobas 4800 HPV and Hologic Aptima HPV assays. MethodsWomen aged 30–59 years (n = 1005) were recruited at two clinics in Papua New Guinea, and they provided specimens for testing at point-of-care using the Xpert HPV Test, and for subsequent testing using the Cobas HPV (n = 981) and Aptima HPV (n = 983) assays. Liquid-based cytology was performed on C specimens to predict underlying high-grade squamous intraepithelial lesions (HSIL). V specimen results of each assay were evaluated against a constructed reference standard and for detection of HSIL or worse. ResultsThere was substantial (κ >0.6) agreement in hrHPV detection between V and C specimens across all three assays. The sensitivity, specificity, and positive and negative predictive values of Xpert HPV using self-collected V specimens for the detection of HPV type 16 according to the constructed reference standard were 92.1%, 93.1%, 63.6% and 98.9%, respectively; compared with 90.4%, 94.3%, 67.8% and 98.7% for Cobas 4800 HPV; and 63.2%, 97.2%, 75.0% and 95.3% for Aptima HPV. Similar results were observed for all hrHPV types (combined) and for HPV types 18/45, on all three assays. The detection of any hrHPV using self-collected specimens had high sensitivity (86%–92%), specificity (87%–94%) and negative predictive value (>98%) on all assays for HSIL positivity. ConclusionsXpert HPV, using self-collected vaginal specimens, has sufficient accuracy for use in point-of-care ‘test-and-treat’ cervical screening strategies in high-burden, low-resource settings.

Identification of Key Bacteria Involved in the Induction of Incident Bacterial Vaginosis: A Prospective Study.

The sequence of events preceding incident bacterial vaginosis (iBV) is unclear. African American women who have sex with women, who had no Amsel criteria and Nugent scores of 0-3, were followed for 90 days to detect iBV (defined as a Nugent score of 7-10 on at least 2-3 consecutive days), using self-collected vaginal swab specimens. For women with iBV (cases) and women maintaining normal vaginal flora (healthy women), 16S ribosomal RNA gene sequencing targeting V4 was performed. Longitudinal vaginal microbiome data were analyzed. Of 204 women screened, 42 enrolled; of these, 45% developed iBV. Sequencing was performed on 448 specimens from 14 cases and 8 healthy women. Among healthy women, Lactobacillus crispatus dominated the vaginal microbiota in 75%. In contrast, prior to iBV, the vaginal microbiota in 79% of cases was dominated by Lactobacillus iners and/or Lactobacillus jensenii/Lactobacillus gasseri. The mean relative abundance of Prevotella bivia, Gardnerella vaginalis, Atopobium vaginae, and Megasphaera type I became significantly higher in cases 4 days before (P. bivia), 3 days before (G. vaginalis), and on the day of (A. vaginae and Megasphaera type I) iBV onset. The mean relative abundance of Sneathia sanguinegens, Finegoldia magna, BV-associated bacteria 1-3, and L. iners was not significantly different between groups before onset of iBV. G. vaginalis, P. bivia, A. vaginae, and Megasphaera type I may play significant roles in iBV.