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The Human Papillomavirus FOr CervicAL cancer (HPV FOCAL) trial is a large randomized controlled trial comparing the efficacy of primary HPV testing to cytology among women in the population‐based Cervix Screening Program in British Columbia, Canada. We conducted a cost‐effectiveness analysis based on the HPV FOCAL trial to estimate the incremental cost per detected high‐grade cervical intraepithelial neoplasia of grade 2 or worse lesions (CIN2+). A total of 19,009 women aged 25 to 65 were randomized to one of two study groups. Women in the intervention group received primary HPV testing with reflex liquid‐based cytology (LBC) upon a positive finding with a screening interval of 48 months. Women in the control group received primary LBC testing, and those negative returned at 24 months for LBC and again at 48 months for exit screening. Both groups received HPV and LBC co‐testing at the 48‐month exit. Incremental costs during the course of the trial were comparable between the intervention and control groups. The intervention group had lower overall costs and detected a larger number of CIN2+ lesions, resulting in a lower mean cost per CIN2+ detected ( $7551) than the control group ($ 8325), a difference of ‐ $773 [all costs in 2018 USD]. Cost per detected lesion was sensitive to the costs of sample collection, HPV testing, and LBC testing. The HPV FOCAL Trial results suggest that primary HPV testing every 4 years produces similar outcomes to LBC‐based testing every 2 years for cervical cancer screening at a lower cost. The Human Papillomavirus FOr CervicAL cancer (HPV FOCAL) trial is a large randomized controlled trial comparing primary HPV testing to liquid‐based cytology for cervical cancer screening. We conducted a cost‐effectiveness analysis alongside the HPV FOCAL trial. Results showed the intervention group yielded a higher rate of detected cervical intraepithelial neoplasia of grade 2 or worse lesions (CIN2+) at a lower mean cost per CIN2+ detected ($ 7551) than the control group ( $8325), a difference of −$ 773. Findings suggest that primary HPV testing is cost‐effective compared to liquid‐based cytology.

ObjectiveTo study participant’s acceptability of and attitudes towards human papillomavirus (HPV) testing compared with cytology for cervical cancer screening and what impact having an HPV positive result may have in future acceptability of screening.DesignCross-sectional online survey of clinical trial participants.SettingPrimary care, population-based Cervix Screening Program, British Columbia, Canada.ParticipantsA total of 5532 participants from the HPV FOCAL trial, in which women received HPV and cytology testing at study exit, were included in the analysis. Median age was 54 years. The median time of survey completion was 3 years after trial exit.Outcome measuresAcceptability of HPV testing for primary cervical cancer screening (primary); attitudes and patient perceptions towards HPV testing and receipt of HPV positive screen results (secondary).ResultsMost respondents (63%) were accepting of HPV testing, with the majority (69%) accepting screening to begin at age 30 years with HPV testing. Only half of participants (54%) were accepting of an extended screening interval of 4–5 years. In multivariable logistic regression, women who received an HPV positive screen test result during the trial (OR=1.41 95% CI 1.11 to 1.80) or were older (OR=1.01, 95% CI 1.00 to 1.02) were more likely to report HPV testing as acceptable.ConclusionsIn this evaluation of acceptability and attitudes regarding HPV testing for cervix screening, most are accepting of HPV testing for screening; however, findings indicate heterogeneity in concerns and experiences surrounding HPV testing and receipt of HPV positive results. These findings provide insights for the development of education, information and communication strategies during implementation of HPV-based cervical cancer screening.Trial registration numbersISRCTN79347302 and NCT00461760.

Abstract Background Human papillomavirus (HPV) vaccination is safe and efficacious in women without human immunodeficiency virus (HIV). Although good immunogenicity has been observed in women living with HIV (WLWH), efficacy data in this population are needed. Methods We enrolled 420 females aged ≥9 years (range, 9–65) living with HIV. Participants were to receive 3 doses of qHPV vaccine (0/2/6 months). The main endpoint was vaccine failure (ie, incident persistent qHPV infection, cervical intraepithelial neoplasia of grade 2 or higher [CIN2+], or genital warts). We compared these rates to published rates in vaccinated and unvaccinated women without HIV as well as unvaccinated WLWH. Results Among 279 eligible women, median follow-up was 2 years. In the intention-to-treat population, the incidence rate (IR) of persistent qHPV (HPV6/11/16/18) was 2.3 per 100 person-years (/100PY) (95% confidence interval [CI], 1.1–4.1), and IR of genital warts was 2.3/100PY (95% CI, 1.2–4.1). In the per-protocol efficacy population, IR of persistent qHPV was 1.0/100PY (95% CI, 0.3–2.6) and of genital warts was 1.0/100PY (95% CI, 0.3–2.5). No cases of CIN2+ occurred. Reported rates of qHPV-related infection and disease within vaccinated women without HIV, unvaccinated women without HIV, and vaccinated WLWH: 0.1 (95% CI, 0.02–0.03), 1.5 (95% CI, 1.1–2.0), and 1.2 (95% CI, 0.2–3.4) /100PY, respectively. The rate of persistent qHPV among vaccinated WLWH was lower than among unvaccinated WLWH (2.3 vs 6.0/100PY). Conclusions Vaccinated WLWH may be at higher risk for vaccine failure than vaccinated women without HIV. However, overall rates of vaccine failure were low, and rates of persistent qHPV were lower than in unvaccinated WLWH. Vaccinated women living with Human Immunodeficiency Virus (HIV) may be at higher risk for vaccine failure than vaccinated women without HIV. However, overall vaccine failure rates were low and rates of persistent vaccine-type HPV were lower than in unvaccinated women living with HIV.

BackgroundThe role of the cervico-vaginal microbiome in the incidence and persistence of HPV infection is not well understood, particularly in the context of HIV infection. It is critical to understand this relationship in women living with HIV (WLWH) due to much higher rates of HPV-related disease in this population.MethodsWLWH were offered three doses of qHPV vaccine in a multi-centre study. Visits were at months -3, 0, 2, 6, 12, 18, 24, and annually thereafter. Participants provided health data, HPV DNA samples, and cervico-vaginal swabs for microbiota sequencing (cpn60 amplicon). Persistent HPV was defined as the same HPV type in samples detected at ≥2 consecutive visits.Results283 cervico-vaginal microbiota samples from 186 women were sequenced (1–3 samples/woman). Samples were taken between 3–8 years post-vaccination. Participants were predominantly Black (39.2%) and Caucasian (37.1%). At baseline, the median age was 38 years (range: 13–66, IQR: 32–45), median CD4 count was 490 cells/mm3 (IQR: 370–680), and 67.4% had an HIV viral load <50 copies/mL. At the time of microbiota swab collection, median CD4 count was 619 (IQR: 409–794). Samples taken at the time of incident HPV detection (n=44) displayed significantly higher relative abundance of Gardnerella vaginalis A than samples without incident HPV. Samples from women with persistent oncogenic HPV infection (n=41) had greater relative abundances of Porphyromonas uenonis and Prevotella timonensis than samples without persistent HPV.ConclusionThis data supports previous reports of an association between Gardnerella vaginalis subtype A and HPV incidence. Porphyromonas uenonis and Prevotella timonensis should be further explored as potential co-factors in HPV persistence.DisclosureNo significant relationships.

BackgroundIn understanding HPV oncogenesis, several co-factors have been proposed including co-infection with HSV-2. We assessed the relationship between HSV-2 serostatus and HPV-related outcomes in a cohort of quadrivalent HPV-vaccinated women living with HIV (WLWH).MethodsIn this multi-site study of immunogenicity and efficacy of the qHPV vaccine in WLWH, three doses of qHPV vaccine were offered. Visits were at months -3, 0, 2, 6, 12, 18, 24, and annually thereafter. Participants provided clinical data and cervico-vaginal swabs for HPV DNA detection (Linear array assay) at each visit; baseline serum was tested for HSV-2 type-specific serology (Focus EIA). We used non-parametric statistics to compare the HPV-related outcomes (including 37 high and low-risk HPV types) according to HSV-2 serostatus.Results151 women aged ≥16 provided baseline serum samples for HSV-2 testing. The predominant regions of origin were Canada (51%) and Africa (30%). At baseline, median age was 39 years (IQR: 34–45), median CD4 count was 500 cells/mm3 (IQR: 382–692), and 70% had an HIV viral load <50 copies/mL. Baseline seroprevalence of HSV-2 was 76.2%, and median years of follow-up was similar for HSV-2 positive (6, IQR: 5.0–7.8) and negative (6, IQR: 5.2–7.9) participants. HSV-2 positivity was significantly associated with increased age. HSV-2 seropositive and seronegative participants had similar frequencies of HPV persistence (86/115 vs 27/36, p=1), clearance of incident HPV infections (88/115 vs 26/36, p=0.8), number of HPV types detected during the study (4.5 vs 5.7, p=0.1), HSIL cytology during the study (11/115 vs 2/36, p=0.7), and CIN2+ histology ever (15/115 vs 5/36, p=1). Results were similar in sensitivity analyses in which HSV-2 seropositivity was defined as an index value ≥3.5.ConclusionHSV-2 seropositivity was common in this cohort of WLWH in Canada, but was not associated with multiple measures of HPV incidence, persistence, and precancerous lesions.DisclosureNo significant relationships.

Cervical cancer is a common cancer among women caused by infections with certain types of human papillomavirus (HPV). Nearly four in five people are infected with HPV during their lifetime, making it the most common sexually transmitted infection worldwide. Vaccination against the virus can prevent infections and routine screening for precancerous lesions can enable early diagnosis and treatment, improving outcomes. However, the COVID-19 pandemic has disrupted routine cervical cancer screening programs in several countries. This has caused delays in screening, which could result in more women being diagnosed with advanced-stage cancers. El-Zein et al. showed that despite the interrupted screening programmes, about half of practices in Canada were able to catch up on delayed screening by February 2021. Between November 2020 and February 2021, El-Zein et al. surveyed 510 Canadian healthcare professionals involved in cervical cancer screening and treatment. About 64%-75% of the respondents reported canceled or postponed screening appointments. Most appointment delays were less than four months. Fewer than one in ten delays were longer than six months. Most survey respondents said their practices pivoted to using telemedicine for some patient visits, such as cervical cancer screening follow-ups. About 40% of respondents suggested that the pandemic provided support to alternative screening options, such as HPV self-sampling at home. The survey results may help healthcare professionals and policymakers to develop plans that mitigate disruptions to cervical cancer screening during future emergencies.

BackgroundWomen who do not regularly attend cervical cancer screening are at increased risk for cervical cancer. In British Columbia (BC), approximately 30% of women aged 21–69 years are under-screened. As cervical cancer screening in BC moves towards the use of primary HPV testing, there is an opportunity to address screening barriers women face through self-collected, rather than clinician collected specimens. CervixCheck is an internet-based program for HPV self-collection being piloted in communities across BC with low screening rates. To inform the implementation of CervixCheck, we investigated digital health literacy (DHL) in South Asian women.MethodsA cross-sectional anonymous survey was administered July-August 2018 through collaborating primary care clinics in predominantly South Asian communities in the Fraser Health Region of BC. The study population was a convenience sample of women 30–65 years of age, presenting at a primary care clinic. Women were administered the survey on a tablet, which collected demographic, screening history, and internet use information. DHL was measured using the validated eHEALS and Digital Health Literacy Instruments.Results51 women participated from four family practices where 30% of women were 50 years or older. 29.4% of women self-reported not having had a Pap test in the last 3 years. English (86%) and Punjabi (58%) were the most common languages participants reported reading and speaking. Majority of women reported using the internet daily (82.4%), with mobile phones being the most common device (72.6%). DHL was higher in under-screened women. Over 80% of women responded that they would be likely to very likely to participate in self-collected screening using CervixCheck.ConclusionThe survey revealed CervixCheck is a promising digital health platform to increase cervical cancer screening uptake among under-screened South Asian women. Findings were used to inform CervixCheck website design and program resources in preparation for its launch.DisclosureNo significant relationships.

BackgroundIn 2008 British Columbia (BC), Canada, implemented a voluntary school-based HPV vaccination program for girls, born 1994 or later, with an average uptake of 63%. Given the long time-lead between infection and malignant disease, effects on cancer incidence will take decades to assess. To evaluate the early impact of the HPV vaccine in BC, ecological trends in cervical intraepithelial neoplasia (CIN) rates were assessed in young women before and after the implementation of the HPV vaccination program.MethodsFrom the population-based cervical cancer screening program database in BC, information on all Pap smears and histopathological abnormalities, in calendar years 2004–2017 in women under age 28 were obtained. Rates of cervical intraepithelial neoplasia (CIN) were calculated as the number of cases divided by the number of cytology specimens for that period. Incidence rate ratios (IRR) comparing pre- and post-vaccination years, adjusted for age and screening year, were calculated by piece-wise Poisson regression analysis. We performed a sensitivity analysis including only women eligible for routine screening.ResultsThe total number of screens in the unvaccinated cohort was 1,417,512 and in the vaccinated cohort 73,343. After the introduction of the HPV vaccination program in BC, a decrease in the incidence of CIN was observed in vaccine-eligible birth cohorts. The adjusted IRR for CIN1, 2 and 3 were respectively 0.60 (95%CI 0.53–0.67), 0.49 (95%CI 0.41–0.57) and 0.39 (95%CI 0.32–0.47). Sensitivity analysis confirmed these findings, also indicating a significant decline in CIN rates in birth cohorts eligible for the HPV vaccination program.ConclusionThis study illustrates the population impact of the provincial school-based HPV vaccination program, by an observed decline in rates of CIN since introduction of the program. Further evaluation of the population-based impact includes a linkage between vaccination and screening registry.DisclosureNo significant relationships.

BackgroundHPV self-collection is a promising approach to improve uptake of cervical screening in under-screened women. The aim of this feasibility study was to measure uptake of HPV self-collection, HPV positivity, and screening history of street entrenched women in a rural region centre.MethodsWomen 30–69 years of age, attending drop-in community-based primary care and integrative reproductive health clinics in Northern British Columbia (BC), Canada and self-reported not having received cervix screening in the last 3 years, were offered self-collection for HPV testing. A convenience sample of all comers was administered a questionnaire and underwent a medical chart review, including the provincial cervix screening registry. Demographics, HIV status, and cervix screening history were collected. All women who tested HPV16/18 positive were referred for colposcopy.ResultsA total of 66 eligible women were analyzed (mean age 43.3 years), with population saturation reached after 3 months recruitment. An additional 11 women were deemed ineligible due to age or prior hysterectomy. 83% self-reported as Indigenous. Based on the provincial cervix screening registry, 48% of women were up-to-date on cervix screening based on triennial screening guidelines. All women undertook self-collection and the majority of women reported high perceived acceptability, safety, and accuracy of HPV self-collection. HPV 16/18 positivity was 7.6%, with 40% co-infected with HIV. Overall HIV prevalence was 16.4%, however, over 25% of women had unknown HIV status based on medical chart review.ConclusionHPV self-collection was highly acceptable as part of community-based integrative reproductive health services. Despite being a traditionally underserved population, and women self-reporting being overdue for screening, over half the women were up to date on cervix screening, albeit regular screening was lacking for many. The findings from this feasibility study will inform future implementation of HPV self-collection to improve and maintain regular cervix screening services in street entrenched women.DisclosureNo significant relationships.

BackgroundGlobally, cervical screening is moving from cytology (Pap) to HPV-based testing. Cytology-based screening has occurred for decades; therefore, engaging the screened population is critical to success of this significant paradigm shift. HPV FOCAL, a large clinical trial, compared primary HPV testing every 4 years to liquid-based cytology (LBC) every 2 years. Participants were surveyed to assess experiences surrounding HPV screening.MethodsWomen aged 25–65 (n=19,009) from two urban centres were randomized to control (LBC) or intervention (HPV) arms, and 16,374 women attended 48 month exit with HPV/LBC co-testing. At trial entry, women were provided information about HPV, cervical cancer, HPV testing and results. Women completing exit screening were invited to complete a survey assessing attitudes to HPV vs. Pap testing, screening intervals, and receipt of HPV results.ResultsOf 14,535 invites sent, 5,532(38%) responders completed some or all of the survey with 63% reporting that HPV vs. Pap testing was acceptable; and 54% willing to have HPV testing every 4–5 yrs vs. a Pap every 3 yrs. Concerns regarding HPV positive results differed by age. More women >50 yrs reported it important for them to know who gave them HPV than younger women (25–34 yrs: 68%; 35–49 yrs: 69%; 50+yrs: 76%). More women 25–34 yrs than >35 yrs would feel judged for having HPV (25–34 yrs: 44%; 35–49 yrs: 36%; 50+yrs: 34%). More women >50 yrs reported being HPV positive would affect the relationship with a sexual partner (25–34 yrs: 36%; 35–49 yrs: 41%; 50+: 45%). Response differences by education will also be presented.ConclusionIn this large HPV screening trial, the majority of women reported that HPV vs. Pap testing was acceptable and over half would be willing to have HPV testing every 4–5 yrs. Women had varied concerns regarding HPV positive results and responses varied by age. These findings illustrate the importance of comprehensive, targeted communication strategies prior to implementation of primary HPV screening.DisclosureNo significant relationships.