Clinically validated HPV assays offer comparable long-term safety in primary cervical cancer screening: A 9-year follow-up of a population-based screening cohort.

Molecular testing for human papillomaviruses (HPV) is gradually replacing cytology in cervical cancer screening. In this longitudinal population-based cohort study, 4140 women 20 to 64 years old attending organized screening were tested at baseline by five different screening methods and followed for 9 years. To assess long-term safety, the cumulative risks of CIN2+/CIN3+ were estimated after a negative baseline result obtained by conventional cytology and four clinically validated HPV assays: Hybrid Capture 2 (hc2), RealTime High Risk HPV assay (RealTime), cobas 4800 HPV Test (cobas_4800), and Alinity m HR HPV (Alinity). HPV-negative women at baseline had a substantially lower risk for CIN2+ compared to those with normal baseline cytology: 0.84% (95% CI, 0.46-1.22), 0.90% (95% CI, 0.51-1.29), 0.78% (95% CI, 0.42-1.15), and 0.75% (95% CI, 0.39-1.11) for hc2, RealTime, cobas_4800, and Alinity, respectively, compared to 2.46% (95% CI, 1.88-3.03) for cytology. No differences were observed between HPV assays in longitudinal sensitivity (range: 86.21%-90.36%) and negative predictive values (range: 99.54%-99.70%) for CIN2+ in women ≥30 years, but were significantly different from cytology (p < .05). The 9-year cumulative risk of CIN2+ differed significantly between HPV genotypes, reaching 32.1% (95% CI, 14.5-46.1) for HPV16, 24.9% (95% CI, 4.7-40.8) for HPV18/45, 27.2% (95% CI, 14.6-37.8) for HPV31/33/35/52/58, and 8.1% (95% CI, 0.0-16.7) for HPV39/51/56/59. Four clinically validated HPV assays showed comparable safety and better assurance against precancerous lesions than cytology, but some important differences were identified in the performance characteristics of HPV assays impacting the referral rate. Information about the HPV genotype is valuable for guiding further clinical action in HPV-based screening programs.

[High-grade lesions probability in ASCUS HPV positive patient according to HPV type]. / Probabilité diagnostique d'une lésion de haut grade chez les patientes ASCUS HPV positif en fonction du typage HPV.

OBJECTIVES: The aim of our study was to assess the proportion of high-grade histological lesions, according to HPV type, in patients referred for colposcopy involving a positive HPV-HR test and ASC-US cytology. METHODS: This is a retrospective descriptive study of asymptomatic patients aged 25 to 65 with a positive HPV-HR test and ASC-US cytology. Data were collected at the Nord Franche-Comté Hospital from September 2019 to February 2022. The primary outcome was the proportion of high-grade histological lesions in patients with ASC-US cytology combined to HPV 16 or 18 (associated or not with other HPV type), compared with HPV no 16 no 18. RESULTS: Among the 298 patients included, 67% were HPV no 16 no 18, 22% HPV 16 associated or not with others and 11% HPV 18 associated or not with others. We found significantly fewer high-grade lesions in patients with ASC-US cytology and HPV no 16 no 18 than in patients with HPV 16 or 18 (8.5% versus 22.7%, P<0.01). In patients presenting an ASC-US cytology with HPV no 16, no 18: 53% of the biopsies found no histological lesion compared with 30% for the other HPVs (P<0.01). CONCLUSIONS: We have highlighted the reality of colposcopists: a high ratio of normal coloscopy associated with normal or low-grade biopsies, in patients with a positive HPV-HR test no 16, no 18 and ASC-US cytology.

Review of triage strategies for atypical squamous cells of undetermined significance among young women.

In the present study we reviewed the existing literature regarding management approaches for ASC-US and highlight their pros and cons. The ASC-US entity emerged from Bethesda classification 2001. We conducted this review using search words ASC-US triage, ASC-US management in young women, triage tests for ASC-US, and ASC-US outcome from the English literature. We included different cervical cancer policies (American, European and for WHO) and research articles published on ASC-US in young women from the year 2001. We searched in Google Scholar, PubMed, MEDLINE (NCBI) library, Embase (Elsevier), Wiley online library as well as Cochrane library. We defined young women as aged 30 years and below. We identified 52 articles which focused on management approaches of ASC-US, seven articles focused on young women aged <30 years. Five of these articles combined ASC-US with low-grade squamous intraepithelial lesions (ASC-US/LSIL) while only two addressed ASC-US as a standalone entity. The limited number of articles restricts the evidence base supporting the adoption of triage strategies. There is yet, no consensus in the literature regarding the management of ASC-US, more so in young women below the age of 30 years. Researchers, however, agree on a few aspects, which include the necessity for applying a conservative strategy for managing ASC-US in young women, avoiding direct referral for colposcopy at the initial detection of ASC-US, and avoiding the use of human papillomavirus (HPV) testing on young women (unless living with HIV). Newer techniques such as HPV E6/E7 messenger RNA (mRNA), and dual staining p16/ki-67, may serve as better triage to identify cases of HPV persistence and integration which may subsequently lead to preinvasive or invasive lesions.

PAX1/SOX1 DNA Methylation Versus Cytology and HPV16/18 Genotyping for the Triage of High-Risk HPV-Positive Women in Cervical Cancer Screening: Retrospective Analysis of Archival Samples.

OBJECTIVE: To compare the performance of cytology, HPV16/18 genotyping and PAX1/SOX1 methylation for the triage of high-risk HPV-positive cervical samples. DESIGN: Retrospective analyses of archival samples collected from a large-scale prospective randomised controlled trial. SETTING/SAMPLE: HPV-positive women recruited from the general cervical screening population. METHODS: 403 HPV-positive samples including 113 normal, 173 low-grade cervical intraepithelial neoplasia (LG-CIN), 114 HG-CIN and three cervical cancers. All samples were assessed by liquid-based cytology, HPV genotyping and PAX1/SOX1 methylation. MAIN OUTCOME MEASURES: AUC (area under the curve), sensitivity and specificity for cytology, HPV16/18 genotyping and PAX1/SOX1 methylation for high-grade (HG) premalignant cervical lesions. RESULTS: PAX1 was more sensitive than cytology and HPV16/18 genotyping in detecting a HG lesion (CIN2+). The sensitivity for PAX1, SOX1, cytology and HPV16/18 were 73.5% (95% CI: 65.5-81.5), 41.9% (95% CI: 32.9-50.8), 48.7% (95% CI: 39.7-57.8) and 36.8% (95% CI: 28.0-45.5), respectively, and their respective specificities were 70.3% (95% CI: 65.0-75.6), 83.6% (95% CI: 79.3-87.9), 77.6% (95% CI: 72.8-82.5) and 67.1% (95% CI: 61.7-72.6), respectively. Overall, PAX1 gave the best AUC at 0.72. Adding SOX1 to PAX1 did not improve the AUC (0.68). Three hundred and twenty-two women who did not have a HG lesion at baseline were followed up for two rounds of screening. Fewer women developed a HG lesion with a normal baseline PAX1 compared to women with a normal baseline cytology or negative HPV16/18 (8.4% vs. 14.5% and 17.5%, respectively). CONCLUSION: PAX1 triage for referral to colposcopy in HPV-positive women may be superior to cytology and HPV16/18 genotyping.

Utilising the COM-B model to interpret barriers and facilitators to cervical cancer screening in young women.

As most women now reaching the age for cervical cancer screening (24.5 years old) in the UK will be HPV vaccinated, their current perspectives on screening can inform effective interventions to increase screening uptake (and thus, early detection). Twenty-four interviews were conducted with women aged 24-30 years old to explore their views on cervical cancer screening (n = 12 attendees and n = 12 non-attendees). Reflexive thematic analysis generated six themes that were then mapped onto the COM-B model. Reflective motivations (e.g. reassurance) were key facilitators to screening attendance for both groups. Social opportunities (e.g. open communication) contrasted between the groups, with attendees more likely to have discussed screening with friends. Automatic motivations (e.g. embarrassment) were key barriers to attending screening in both groups. Notably, HPV vaccination did not factor into the decision to attend screening. Interventions to increase screening uptake may target motivational and social factors.

Clinical validation of the Roche cobas HPV test on the Roche cobas 5800 system for the purpose of cervical screening.

This study assessed the relative clinical sensitivity and specificity, as well as reproducibility, for high-risk HPV types of the Roche cobas HPV test when processed using the Roche cobas 5800 system. The results from this study demonstrate that the cobas HPV test using the cobas 5800 system fulfils the Meijer criteria for use in population-based cervical screening. This clinical validation study also examines the clinical sensitivity and specificity based on partial genotyping, with separate detection of HPV16 and HPV18, compared with the Roche cobas 4800 HPV test, a second-generation standard comparator assay. The cobas HPV test has a relative clinical sensitivity of 1.000, when compared with the cobas 4800 HPV test to detect histologically confirmed CIN2+ lesions in woman aged 30 years or older, with a relative clinical specificity of 0.995. The general intra- and inter-laboratory agreement for the cobas HPV test on the cobas 5800 system for finding a HPV positive result were 99.1% and 99.6%, respectively.IMPORTANCEThis study demonstrates, for the first time, the clinical performance of the Roche cobas HPV test when processed using the new cobas 5800 system [cobas (5800)]. This study shows that the cobas (5800) demonstrates relative clinical sensitivity and specificity, when compared with a standard comparator HPV test, which meets the international HPV test validation requirements. Intra- and inter-laboratory reproducibility also fulfills these criteria. The current study demonstrates that the cobas (5800) can be used for primary HPV-based cervical screening on cervical specimens.

Age-specific performance of human papillomavirus E6/E7 mRNA assay versus cytology for primary cervical cancer screening and triage: community-based screening in China.

Background: In the general population, primary human papillomavirus (HPV) testing is advocated for cervical cancer (CC) screening. HPV E6/E7 mRNA (Aptima HPV, AHPV) assays have garnered considerable traction due to their higher specificity when compared with HPV DNA assays. Here, we investigated age-specific primary AHPV screening assays and different triage strategies versus cytology to identify the best approach. Methods: Between April 2018 and December 2021, we recruited female participants from 34 communities across Liaoning province and Qingdao City, China. Primary cervical screening protocols included liquid-based cytology (LBC) and AHPV assays, with females positive for any assays undergoing colposcopy. Genotyping (AHPV-GT) was conducted on all HPV-positive samples. Our primary outcomes were the identification of age-specific detection rates, colposcopy referral rates, and sensitivity and specificity values for high-grade squamous intraepithelial lesions or worse (HSIL+). AHPV and different triage strategy performances were also examined across different age cohorts. Results: Our investigation included 9911 eligible females. Age-specific abnormal cytology rates were in the 6.1%-8.0% range, and were highest in 45-54-year olds. When compared with 35-44-or 45-54-year olds, HPV prevalence was highest in 55-64-year olds (12.2% or 11.6% vs.14.1%, P = 0.048 and P = 0.002, respectively). In 35-44-year olds, AHPV sensitivity for detecting HSIL+ was 96.6 (95% confidence interval [CI]: 89.7-100) - significantly higher than LBC sensitivity (65.5 [95% CI: 48.3-82.8], P < 0.001). When compared with LBC, HSIL+ detection rates by AHPV-GT using reflex LBC triage increased by 31.5% (9.6‰ vs. 7.3‰), and colposcopy referral rates decreased by 16.4% (5.1% vs. 6.1%). In 45-54-year olds, HSIL+ detection rates for AHPV-GT using reflex LBC triage were lower than LBC rates (6.2‰ vs. 6.6‰). In 55-64-year olds, AHPV sensitivity (97.2 [95% CI: 91.7-100.0]) was higher than LBC sensitivity (66.7 [95% CI: 50.0-80.6], P = 0.003). The area under the curve (AUC) value was not significantly different between AHPV-GT with reflex LBC triage and LBC (0.845 [95% CI: 0.771-0.920] vs. 0.812 [95% CI: 0.734-0.891], P = 0.236). Conclusions: Primary AHPV screening using different triage strategies were different across different age cohorts. Thus, AHPV may be an appropriate primary screening method for 35-44 and 55-64 year old females, while AHPV-GT with reflex LBC triage may be more apt for 35-44 year old females.

Cervical screening participation and access facilitators and barriers for people with intellectual disability: a systematic review and meta-analysis.

Background: The World Health Organisation's vision of eliminating cervical cancer as a public health problem is achievable, but elimination must be achieved equitably, including for people with intellectual disability. A better understanding of cervical screening within the context of the lives of people with intellectual disability is needed. This study systematically reviewed research on the rates of cervical screening participation among people with intellectual disability, and facilitators and barriers that affect participation. Method: Six electronic databases were systematically searched: MEDLINE, CINAHL, Scopus, PsycINFO, Embase and Pro-Quest Central Social Sciences Collection. Empirical studies published between 1986 and 2023, in English language peer-reviewed journals were eligible for inclusion. Further articles were identified through forward and backward citation tracking, and hand-searching the index lists of two key journals. Two authors screened the studies, extracted the data and collated study outcomes using a standardised software program. A meta-analysis was performed using the DerSimonian and Laird method to estimate pooled effect sizes in prevalence rates and odds ratios (ORs). The socio-ecological model (SEM) was used as a framework to thematically analyse facilitators and barriers impacting participation in cervical screening. Results: Sixty-three articles met the inclusion criteria. Of these, 42 reported on rates of cervical screening participation and 24 reported on facilitators or barriers to cervical screening for people with intellectual disability. Overall, the studies reported a screening prevalence of 35% (95% CI: 26% to 45%), indicating that just over a third of people with intellectual disability have had cervical screening. The pooled odds ratio of 0.30 (95% CI: 0.23 to 0.41) indicated that people with intellectual disability are significantly less likely to have a cervical screening test compared with people without intellectual disability. Most studies examined individual and interpersonal factors impacting cervical screening. These included: (i) fear and anxiety among people with intellectual disability, (ii) misassumptions preventing screening participation, (iii) the role of support people, (iv) the need for education, (v) accessible information, and time to prepare for screening, (vi) patient-provider communication including challenges obtaining informed consent, and (vii) healthcare provider lack of confidence. Conclusion: Future research, policy and practice efforts must address barriers to cervical screening participation among people with intellectual disability and ensure these efforts are co-produced and community-led. This is critical to ensuring equity in global and local efforts to eliminate cervical cancer.

Nationwide registry-based trial of risk-stratified cervical screening.

In well-screened populations, most cervical cancers arise from small groups of women with inadequate screening. The present study aims to assess whether registry-based cancer risk assessment could be used to increase screening intensity among high-risk women. The National Cervical Screening Registry identified the 28,689 women residents in Sweden who had either no previous cervical screening or a screening history indicating high risk. We invited these women by SMS and/or physical letter to order a free human papillomavirus (HPV) self-sampling kit. The Swedish national HPV reference laboratory performed extended HPV genotyping and referred high-risk HPV-positive women to their regional gynecologist. A total of 3691/28,689 (12.9%) women ordered a self-sampling kit and 10.0% (2853/28,689) returned a sample for testing. Participation among women who had never attended screening was low, albeit improved. Up to 22.5% of women in other high-risk groups attended. High-risk HPV types were detected in 8.3% of samples. High-risk HPV-positive women (238/2853) were referred without further triaging and severe cervical precancer or cancer (HSIL+) in histopathology were detected in 36/158 (23%) of biopsied women. Repeat invitations gave modest additional participation. Nationwide contacting of women with high risk for cervical cancer with personal invitations to order HPV self-sampling kits resulted in high yield of detected CIN2+. Further efforts to improve risk-stratified screening strategies should be directed to improving (i) the precision of the risk-stratification algorithm, (ii) the convenience for the women to participate and, (iii) ensuring that screen-positive women are followed-up.

AICyte-alone capabilities as an independent screener for triaging cervical cytology using a 50% negative cutoff value.

BACKGROUND: AICyte has previously demonstrated a potential role in cervical cytology screening for reducing the workload by using a 50% negative cutoff value. The aim of the current study is to evaluate this hypothesis. METHODS: The authors used the Ruiqian WSI-2400 (with the registered trademark AICyte) to evaluate a collection of 163,848 original cervical cytology cases from 2018 to 2023 that were collected from four different hospital systems in China. A breakdown of cases included 46,060 from Shenzhen, 67,472 from Zhengzhou, 25,667 from Shijiazhuang, and 24,649 from Jinan. These collected cases were evaluated using the AICyte system, and the data collected were statistically compared with the original interpretative results. RESULTS: In 98.80% of all artificial intelligence cases that were designated as not needing further review, the corresponding original diagnosis was also determined to be negative. For any cases that were designated atypical squamous cells, cannot exclude high-grade squamous intraepithelial lesion or higher, the sensitivity and negative predictive value were 90.77% and 98.80%, respectively. The sensitivity and negative predictive value were greater in cases designated as low-grade squamous intraepithelial lesion or higher at 98.92% and 99.94%, respectively. Of the 49 low-grade squamous intraepithelial lesion or higher that were designed by AICyte as not needing further review, the cytohistologic correlation revealed eight cases of cervical intraepithelial neoplasia 1 and 18 negative cases; and the remaining cases were without histologic follow-up. In practice, AICyte used at a 50% negative cutoff value could reduce the anticipated workload if a protocol were implemented to label cases that qualified within the negative cutoff value as not needing further review, thereby finalizing the case as negative for intraepithelial lesions and malignancy. CONCLUSIONS: For pathologic practices that do not have cytotechnologists or in which the workflow is sought to be optimized, the artificial intelligence system AICyte alone to be an independent screening tool by using a 50% negative cutoff value, which is a potential assistive method for cervical cancer screening.

Corrigendum: Actions speak louder than words; pediatricians, gynecologists, nurses, and other mothers' perspectives on the human papillomavirus vaccine: an Istanbul multicenter study.

[This corrects the article DOI: 10.3389/fpubh.2024.1361509.].

Identifying optimum implementation for human papillomavirus self-sampling in underserved communities: A systematic review.

OBJECTIVE: To review the existing evidence to identify the optimum methods for implementing human papillomavirus self-sampling to increase screening uptake for underserved groups. SETTING: Specific groups are less likely to participate in cervical screening. These include individuals from low socioeconomic status groups, ethnic minority groups, younger age groups (25-29), older age groups (≥50), with a physical disability, with a learning disability and with an LGBTQ+ identity. The advent of human papillomavirus self-sampling for cervical screening presents an opportunity to promote equitable access to screening. Implementation for human papillomavirus self-sampling can vary, for example, opt-out or opt-in approaches. However, it is unclear which of these is the best method of offering human papillomavirus self-sampling to underserved groups. METHODS: Six databases were searched through May 2023. Studies comparing cervico-vaginal human papillomavirus self-sampling provision using different implementation strategies with the standard screening pathway in underserved groups were identified. A narrative synthesis was conducted. RESULTS: In total, 4574 studies were identified; 25 studies were included, of which 22 were from high-income countries. Greater uptake was found for offering human papillomavirus self-sampling compared to standard clinician-based sampling. Directly mailing human papillomavirus self-sampling kits to participants resulted in higher uptake of screening than using an 'opt-in' approach or standard recall in low socioeconomic status and ethnic minority groups, and older women. Strategies that used community health workers or educational materials increased uptake in ethnic minority and low socioeconomic status groups. CONCLUSIONS: Directly mailing human papillomavirus self-sampling kits to low socioeconomic status groups, ethnic minority groups and older women has the potential to increase uptake of human papillomavirus self-sampling. Using community health workers to offer human papillomavirus self-sampling should be considered for ethnic minority and low socioeconomic status groups. Further research exploring the preferences of younger women is needed.

The acceptability of, and informational needs related to, self-collection cervical screening among women of Indian descent living in Victoria, Australia: A qualitative study.

BACKGROUND: In July 2022, self-collection became universally available as part of Australia's National Cervical Screening Program. This change aims to address screening inequities experienced among underscreened populations, including women of Indian descent. This study explored experiences of cervical screening, alongside the acceptability of self-collection, among women of Indian descent living in Victoria, Australia. We also aimed to articulate the informational needs to promote self-collection among this population. METHODS: Five focus group discussions with 39 women living in Victoria were conducted in English (n = 3) and Punjabi (n = 2). Transcripts were thematically analysed, as informed by the Theoretical Framework of Acceptability. RESULTS: Women were motivated by the choice to self-collect, perceiving the ability to maintain modesty and greater autonomy as key enablers. Healthcare practitioners were seen as central in supporting patient-centred models of care. Perceived barriers to self-collection included concerns around its accuracy and women's confidence in collecting their own sample. Widespread dissemination of culturally tailored promotion strategies communicating concepts such as 'privacy' and 'accuracy' were suggested by women to promote self-collection. CONCLUSION: Self-collection was highly acceptable among women of Indian descent, particularly when assured of its accuracy, and sociocultural norms and previous screening experiences are considered. This study highlights the huge potential that self-collection can play in increasing equity in Australia's cervical screening programme. PATIENT OR PUBLIC CONTRIBUTION: Members of the public were involved in focus group discussions. Findings were summarised and disseminated via a poster. A bicultural worker was involved in all stages of the research.

Improving the effectiveness of cervical cancer screening: Managing positive high-risk human papillomavirus results.

Introduction: Good compliance of the management of abnormal results is important for effective cervical screening. This study investigated the rate of surveillance and follow-up outcomes for human papillomavirus (HPV)-positive women in cervical screening. Method: Women on surveillance by repeat HPV testing were identified in a prospectively managed database. Data retrieved included women's age, country residence status, history of colposcopy, HPV-DNA status on the first and repeat tests, dates of follow-up during the 5 years since the initial screening, and histological diagnosis of cervical lesions. The main outcome measures were compliance rate for repeat HPV testing, regression and persistence rates of HPV subtypes, and detection rate of high-grade lesions (CIN2+). Results: This analysis included 680 residents in the community, mean age 44.8 (95% confidence interval 20.1-69.5) years. The compliance rate of repeat testing was 28.2% at 12 months and, cumulatively, 42.8% for the entire 5-year follow-up period. The rates were unaffected by age (P=0.5829) nor prior colposcopy (P=0.1607). There were 5 (1.7%) cases of CIN2+ detected. Of 391 women on longitudi-nal follow-up, 194 (60.8%) cleared their HPV infection. Some women with multiple HPV infection cleared 1 but not the other subtype(s). Thus, the regression rate was 90.3% for HPV-16, 87.0% for HPV-18 and 65.2% for HPV-12-others (P=0.001). The annualised HPV regression rates were similar for HPV subtypes and for each follow-up year. Conclusion: Surveillance of HPV positivity is clinically important for detecting high-grade lesions. Despite a high regression rate of HPV, surveillance hesitancy is a serious weakness in routine cervical screening.

Cervical Cancer Screening Uptake and Experiences of Black African Immigrant Women in Canada.

Cervical cancer is one of the leading causes of cancer-related death among African women. Unfortunately, in most sub-Saharan African nations, women are vulnerable if they are unaware that cervical cancer is preventable with frequent screening and early treatment. The aim of this study was to examine Black African immigrant women's perceptions and experiences of cervical screening in British Columbia, Canada. Twenty Black African immigrant women were interviewed using the qualitative research method Interpretive Description. Data collection approaches included indepth interviews and analytic memos. Data were analyzed using a constant comparative technique guided by a socioecologic framework to capture subjective experiences and perceptions. Four key themes were identified, including confusing conceptualizations about cancer and cancer screening, competing priorities, concerns for modesty, and commitment to culture. The study findings point to the need for more active approaches to promoting cervical screening for this population.

Important and Feasible Actions to Address Cervical Screening Participation amongst South Asian Women in Ontario: A Concept Mapping Study with Service Users and Service Providers.

Regular cervical screening can largely prevent the development of cervical cancer and innovative methods are needed to better engage people in screening. In Ontario, Canada, South Asian women have some of the lowest rates of screening in the province. In this study, we used concept mapping to engage two stakeholder groups-South Asian service users and service providers-to identify and prioritize points of intervention to encourage the uptake of cervical screening. After participants brainstormed a master list of statements, 45 participants rated the statements based off 'importance' and 'ease to address' in relation to encouraging cervical screening. A bivariate plot (X-Y graph) that shows the average rating values for each statement across the two rating variables (a 'go-zone' display) was produced to display priorities for implementation. Statements that were considered high priority to address reflected issues around education and awareness including understanding and communication related to cervical screening and preventative care, as well as the need for trusted sources of information. Statements that were considered high priority but challenging to implement were centered around fear, stigma, discomfort, family and personal priorities. This study highlighted that stigma, norms and social relations that impact the uptake of screening must be addressed in order for education and awareness raising to be effective and to move people from conviction around screening to action.

Is there a need for screening of cervical HPV infections and carcinoma?

Antenatal cervical screening aims to detect cervical intraepithelial neoplasms as precancerous lesions and invasive cervical cancer. Whether this screening is performed routinely during pregnancy varies depending on each country's screening participation rates, guidelines, and the risks to the pregnant woman. In some countries with the high rate of routinely implemented cervical screening among the target women, women are recommended to defer cervical screening intentionally to post-delivery, though having screening in consultation with physicians may be possible if routine screening overlaps. However, when cervical screening rate in fertile women is low and the incidence of cervical cancer is high, cervical screening during pregnancy may play an important role in the early detection of cervical cancer. Cervical screening using high-risk human papillomavirus (HPV) testing is accepted worldwide as a highly sensitive and objective test method, and it should replace traditional primary cervical cytology in the future. However, the benefits and disadvantages of using HPV testing in pregnant women is unclear because a false positive rate may be increased due to pregnant women being generally under an immunosuppressed condition.

Experiences of Self-Sampling and Future Screening Preferences in Non-Attenders Who Returned an HPV Vaginal Self-Sample in the YouScreen Study: Findings From a Cross-Sectional Questionnaire.

BACKGROUND: We assessed experiences of human papillomavirus (HPV) vaginal self-sampling and future screening preferences in an ethnically and socio-economically diverse group of women overdue for cervical screening. SETTING AND PARTICIPANTS: A postal questionnaire was embedded in the YouScreen self-sampling trial in England: 32.5% (2712/8338) of kit completers returned the survey. Kit non-completers were encouraged to return a questionnaire, but no responses were received. Participants were ethnically diverse (40.3% came from ethnic minority backgrounds), and 59.1% came from the two most deprived quintiles. Differences in confidence in kit completion, trust in the test results and intention to attend a follow-up test if HPV-positive were evaluated using Pearson's χ2 analyses. Binary logistic regression models explored predictors of a future screening choice and preferences for urine versus vaginal self-sampling. RESULTS: Most kit-completers reported high confidence in self-sampling (82.6%) and high trust in the results (79.9%), but experiences varied by ethnicity and screening status. Most free-text comments were positive but some reported difficulties using the device, pain or discomfort. Most women would opt for self-sampling in the future (71.3% vs. 10.4% for a clinician-taken test) and it was more often preferred by ethnic minority groups, overdue screeners and never attenders. Urine self-tests were preferred to vaginal tests (41.9% vs. 15.4%), especially among women from Asian, Black or Other Ethnic backgrounds. CONCLUSIONS: Kit-completers were confident, found the test easy to complete, and trusted the self-sample results. However, experiences varied by ethnic group and some women highlighted difficulties with the kit. Most women would prefer self-sampling in the future, but it was not a universal preference, so offering a choice will be important. PATIENT OR PUBLIC CONTRIBUTION: We did not have direct patient and public involvement and engagement (PPIE) in the questionnaire design. However, patients and public representatives did input into the design of the YouScreen trial and reviewed the wider study materials (e.g. participant information sheet). TRIAL REGISTRATION: This questionnaire study was embedded in the YouScreen trial. The protocol for the YouScreen trial is available at https://www.isrctn.com/ISRCTN12759467. The National Institute for Health Research 43 Clinical Research Network (NIHR CRN) Central Portfolio Management System (CPMS) ID is 4441934.

How do young women approaching screening age interpret the NHS cervical screening leaflet? A mixed methods study of identifying interpretation difficulties, barriers, facilitators, and leaflet interpretation, engagement and future screening behaviour.

BACKGROUND: Cervical cancer is a common cancer among young women aged 25-29 in England, and the NHS cervical screening leaflet is the first point of contact for those being invited for their first screening. This study aimed to explore how young women (18-24) understand and engage with the leaflet, as well as the barriers and facilitators associated with its interpretation, engagement, and screening intentions. METHODS: The study used a mixed-methods approach, including a survey (n = 120) to identify interpretation difficulties and how they were affected by different characteristics, and a follow-up interview (n = 10) to assess the utility of the leaflet, identify issues with its practicality, and determine the factors that influence screening intentions. RESULTS: The survey results showed that interpretation difficulties were common, particularly regarding HPV assessment, screening results, additional tests/treatment, and screening risks. Lower interpretation accuracy was associated with lower numeracy scores and non-white ethnicity. Despite these difficulties, participants had high confidence and motivation to engage with the leaflet. The interviews revealed knowledge gaps, issues with the leaflet's practicality, and a preference for digital information. Factors that were identified as barriers and facilitators of leaflet interpretation, engagement, and screening intentions included knowledge, social influence, beliefs about consequences, environmental context and resources, social role and identity, emotions and intentions. CONCLUSION: The current leaflet does not provide enough information for young women to make an informed decision about screening attendance. Implementing a digital invitation featuring simplified gist representation, targeted behaviour change techniques (BCTs), videos, and interactive tools can enhance education and promote screening behaviour. Future research should consider using digital tools and strategies to address existing barriers related to interpretation and engagement.

Working together with people with intellectual disability to make a difference: a protocol for a mixed-method co-production study to address inequities in cervical screening participation.

Introduction: Cervical cancer is one of the most preventable cancers yet remains a disease of inequity for people with intellectual disability, in part due to low screening rates. The ScreenEQUAL project will use an integrated knowledge translation (iKT) model to co-produce and evaluate accessible cervical screening resources with and for this group. Methods: Stage 1 will qualitatively explore facilitators and barriers to screening participation for people with intellectual disability, families and support people, healthcare providers and disability sector stakeholders (n ≈ 20 in each group). An accessible multimodal screening resource, accompanying supporting materials for families and support people, and trauma-informed healthcare provider training materials will then be co-produced through a series of workshops. Stage 2 will recruit people with intellectual disability aged 25 to 74 who are due or overdue for screening into a single-arm trial (n = 48). Trained support people will provide them with the co-produced resource in accessible workshops (intervention) and support them in completing pre-post questions to assess informed decision-making. A subset will participate in qualitative post-intervention interviews including optional body-mapping (n ≈ 20). Screening uptake in the 9-months following the intervention will be measured through data linkage. Family members and support people (n = 48) and healthcare providers (n = 433) will be recruited into single-arm sub-studies. Over a 4-month period they will, respectively, receive the accompanying supporting materials, and the trauma-informed training materials. Both groups will complete pre-post online surveys. A subset of each group (n ≈ 20) will be invited to participate in post-intervention semi-structured interviews. Outcomes and analysis: Our primary outcome is a change in informed decision-making by people with intellectual disability across the domains of knowledge, attitudes, and screening intention. Secondary outcomes include: (i) uptake of screening in the 9-months following the intervention workshops, (ii) changes in health literacy, attitudes and self-efficacy of family members and support people, and (iii) changes in knowledge, attitudes, self-efficacy and preparedness of screening providers. Each participant group will evaluate acceptability, feasibility and usability of the resources. Discussion: If found to be effective and acceptable, the co-produced cervical screening resources and training materials will be made freely available through the ScreenEQUAL website to support national, and potentially international, scale-up.