Clinical performance of the novel full-genotyping OncoPredict HPV Quantitative Typing assay using the VALGENT framework.

Clinical validation of human papillomavirus (HPV) assays according to international criteria is prerequisite for their implementation in cervical cancer screening. OncoPredict HPV Quantitative Typing (QT) assay (Hiantis Srl, Milan, Italy) is a novel full-genotyping multiplex real-time PCR quantitative assay targeting E6/E7 genes, allowing individual viral load determination of 12 high-risk (HR) HPV types. Quality controls for sample adequacy, efficiency of nucleic acid extraction and PCR inhibition are included in the assay. Clinical performance of OncoPredict HPV QT test was assessed as part of the "Validation of HPV Genotyping Tests" (VALGENT-2) framework, consisting of 1300 cervical liquid-based cytology (LBC) samples of women aged between 20 and 60 years who had originally attended for routine cervical screening in Scotland. The clinical accuracy of the OncoPredict HPV QT (index test) for the detection of CIN2+ was assessed relative to the GP5+/6+ Enzyme ImmunoAssay (GP5+/6+ EIA) (comparator test), using noninferiority criteria. Intra- and interlaboratory reproducibility of the assay was assessed on a subpopulation, comprising 526 samples. The relative sensitivity and specificity for OncoPredict HPV QT vs GP5+/6+-PCR-EIA were 1.01 (95% CI: 0.99-1.03) and 1.03 (95% CI: 1.0-1.06) respectively. The P-values for noninferiority were ≤0.001. The intra- and inter-laboratory reproducibility demonstrated a high concordance (>98.7%) with kappas for individual types ranging from 0.66 to 1.00. OncoPredict HPV QT fulfills the international validation criteria for the use of HPV tests in cervical cancer screening.

Building knowledge using a novel web-based intervention to promote HPV vaccination in a diverse, low-income population.

OBJECTIVES: HPV vaccination rates remain suboptimal despite proven efficacy. Data suggest misconceptions or lack of knowledge are leading barriers. Our study aimed to develop and pilot a novel interactive education resource designed to educate parents and patients about HPV vaccines. METHODS: This is a prospective pilot study conducted in an urban teaching hospital pediatric clinic. The Patient Activated Learning System (PALS) intervention included 3 web-based videos with HPV vaccine-related educational content. Participants were parents of adolescent patients, aged 11-17 years, and young adult patients, aged 18-26 years. Enrolled participants completed an HPV vaccine knowledge survey before and after watching PALS; paired scores were evaluated. Acceptability and participant-reported impact of PALS modules were measured via Likert-scale surveys. RESULTS: 132 individuals were approached; 101 (76%) enrolled and completed the study. Participants self-identified as Hispanic (50%), non-Hispanic Black (23%), non-Hispanic White (7%), Asian (6%), American/Alaskan/Hawaiian Native or Pacific Islander (5%). Half reported earning ≤$40,000 annually; 57% had only a high school education. Post-intervention knowledge scores were increased compared to baseline (9.87/27 points vs 17.53/27 points, p < 0.01). PALS modules were reported as enjoyable to use and understandable (89% and 93%, respectively), and improved participants' understanding of the importance of HPV vaccination (90%). Of the 18 patients unvaccinated at baseline, 39% received 1 shot of the HPV vaccine within one month. CONCLUSION: The PALS HPV vaccine educational intervention was feasible, acceptable, and improved knowledge among a diverse, underserved population. Our intervention may positively influence HPV vaccination rates, with potential to overcome HPV vaccine hesitancy.

Human papillomavirus genotypes and risk of persistence and progression in women undergoing active surveillance for cervical intraepithelial neoplasia grade 2.

BACKGROUND: In recent years, active surveillance has been introduced as an alternative to excisional treatment in younger women with cervical intraepithelial neoplasia grade 2 because regression rates are high and excisional treatment is associated with increased risk of preterm birth. However, early identification of women at increased risk of persistence/progression is important to ensure timely treatment. Evidence is limited on biomarkers that may be used to identify women at increased risk of persistence/progression. OBJECTIVE: This study aimed to describe human papillomavirus HPV type-specific persistence/progression in women undergoing active surveillance for cervical intraepithelial neoplasia grade 2. STUDY DESIGN: We conducted a historical cohort study of women aged 23 to 40 years diagnosed with cervical intraepithelial neoplasia grade 2 at Aarhus University Hospital from 2000 to 2010. Women were identified through the Danish Pathology Data Bank (DPDB) and were considered as undergoing active surveillance if they had a first record of a cervical biopsy within 2 years after index diagnosis and no loop electrosurgical excision procedure before this. Human papillomavirus genotyping was performed on archived tissue samples using the HPV SPF10-DEIA-LiPA25 system (DNA ELISA [enzyme-linked immunosorbent assay] HPV SPF10 kit and RHA HPV SPF10-LiPA25 kit). Persistence/progression was defined as having a record of cervical intraepithelial neoplasia grade ≥2 in the DPDB determined on the last and worst diagnosis on a biopsy or loop electrosurgical excision procedure specimen during follow-up. We estimated the relative risk (95% confidence interval) of persistence/progression using a modified Poisson model. RESULTS: A total of 455 women were included. Two-thirds were aged ≤30 years (73.8%) at index diagnosis, and nearly half had a high-grade index cytology (48.8%). Overall, 52.2% of all women had cervical intraepithelial neoplasia grade ≥2 during follow-up; 70.5% were human papillomavirus-16-positive and 29.5% were positive for other human papillomavirus types. Human papillomavirus-16 was associated with a significantly higher risk of persistence/progression (relative risk, 1.64; 95% confidence interval, 1.37-1.95) compared with non-human papillomavirus-16. The risk of persistence/progression was highest in human papillomavirus-16-positive women with a high-grade index cytology compared with human papillomavirus-16-positive women with a low-grade cytology (relative risk, 1.29; 95% confidence interval, 1.03-1.61), whereas no differences were observed across age groups. CONCLUSION: The highest risk of persistence/progression was observed among human papillomavirus-16-positive women, particularly those with associated high-grade cytology. These findings suggest that early excisional treatment should be considered in this group of women.

Inequities in human papillomavirus vaccination among children aged 9-14 years old under constrained vaccine supply in China.

BACKGROUND: Inequities in access to human papillomavirus (HPV) vaccine are becoming a growing critical issue globally. Few studies investigate the factors determining HPV vaccine uptake disparities when vaccine supply is constrained, especially in low- and middle-income countries. The aim of this study was to investigate inequities of HPV vaccination and related factors under the constrained vaccine supply in China. METHODS: A cross-sectional survey was conducted in a developed eastern coastal province and a developing western one in China between November and December 2022. Employing multistage stratified cluster random sampling, the study collected data from parents of children aged 9-14. Mixed-effects logistic regression models with school units as random effects were used for analysis. RESULTS: From 4,127 eligible parents (as vaccine decision makers for girls), 1,346 (32.6%) intended to vaccinate their daughters against HPV, of which 836 (62.1%) attempted to schedule a vaccination appointment. Only 16.4% succeeded in booking an appointment. More than half of the intended parents expected the imported 9-valent HPV vaccine. There were significant disparities in HPV vaccine awareness, intention, and vaccination behavior across educational, income, geographic, ethnic, gender, and health literacy levels. Vaccine awareness and intentions were higher among parents with higher socioeconomic status; however, girls from lower socioeconomic families were more likely to receive the HPV vaccine and had a higher domestically produced vaccination rate. Significant disparities exist in vaccination intentions and actual vaccination behaviors, primarily due to large supply constraints of the HPV vaccine. CONCLUSIONS: Sustained health education campaigns are needed to raise awareness of the HPV vaccine, improve health literacy, and decrease over-preference for the 9-valent HPV vaccine. A mother's HPV vaccination behavior was positively associated with increased intention and actual vaccination behavior for her daughter. This study advocates for complementary cervical cancer prevention programs targeting both mothers and daughters.

Reproducibility of colposcopy quality indicators-A survey among members of the European Federation for Colposcopy.

INTRODUCTION: Colposcopy is an important part of the diagnostic work-up of women with an abnormal cervical screening test as it is used to guide the collection of biopsies. Although quality assurance has been used in the evaluation of screening programs, not much is known about quality indicators for the diagnostics and treatment of screen-positive women. Therefore, the European Federation for Colposcopy developed quality indicators aiming to support colposcopy practice across Europe. We performed a survey of colposcopy cases to determine if the quality indicators are understandable, relevant, and reproducible. MATERIAL AND METHODS: We conducted a survey among all members of the European Federation for Colposcopy Quality and Standards Group from November 2022 to March 2023. Members were asked to collect information on a total of 17 quality indicators for 50 women who had been newly referred for colposcopy due to an abnormal screening test between January 1, 2020 to December 31, 2021. Results were reported descriptively. RESULTS: We included data on 609 cases from 12 members across Europe. The majority of the quality indicators were either achieved or within reach of the agreed standard, often due to few countries with outlying data. One quality indicator had very low performance, although stratified results indicated that two countries had different clinical management of the patient type thereby skewing the results. In addition, discrepancies between the number of cases included in each quality indicator raised concerns regarding potential misunderstanding of the quality indicator and its objective. CONCLUSIONS: Quality indicators on colposcopy must be understandable to those collecting data, highlighting the importance of validating quality indicators before data collection.

An Assessment of the Acceptability of Cervical Cancer Education Intervention Materials Among Healthcare Providers in Ghana.

Cervical cancer is currently the second leading cause of cancer death among women in Ghana. Previous studies have identified lack of awareness, lack of perceived susceptibility, and stigmatizing beliefs as significant sociocultural barriers to cervical cancer screening among Ghanaian women. The purpose of this study was to assess the acceptability of evidence and theory-based, culturally relevant cervical cancer education intervention materials among Ghanaian healthcare providers. Central-location intercept questionnaires were completed by providers (n = 60) in the Greater Accra region of Ghana. Providers reviewed a poster, an audio message, and a brief educational video. The variables assessed included the reaction to the materials, the ability of the materials to attract the attention of the intended audience, the ability of the materials to communicate the main point of the cancer education message, and the reaction to cultural characteristics of the materials. The mean age of the providers (n = 60) was 30.6 years, and the majority (70.8%) were females. Most of the providers had a positive general reaction to the poster, audio message, and video. The majority found the materials to be motivating. Most of the providers found the information in the materials to be attention-getting, interesting, useful, direct/to the point, and related to someone like them. Very few providers (5%) indicated that they were confused by the images or messages used in the materials. The culturally relevant cervical cancer education materials were acceptable to Ghanaian healthcare providers. These materials may be effective in shared decision-making for cervical cancer screening.

A Systematic Review of the Effectiveness of Health Education Programs for Cervical Cancer Prevention in Rural Communities: Implications for Promoting Health Equity.

Rural women face an increased risk of cervical cancer diagnosis in comparison to women living in metropolitan areas. This review synthesized and critically evaluated cervical cancer screening interventions that target women living in rural communities in the USA. EBSCO, JSTOR, Medline, PsychINFO, Psychology and Behavioral Sciences Collection, PubMed, and Cochrane Library were searched using keywords related to cervical cancer screening, rural communities, and prevention interventions. Study eligibility included randomized controlled trials or quasi-experimental designs, a psychosocial or educational intervention targeting cervical cancer prevention, and implementation in a rural setting. Eleven articles met criteria for the systematic review and 6 of those included information sufficient for meta-analysis. Cochrane guidelines, CONSORT-Equity 2017, and PROGRESS-Plus were used to assess included studies. The systematic review encompassed 9720 participants who were involved in a variety of intervention types: social media campaigns, faith-based, and patient navigation with lay health advisors. None of the studies met all criteria for the health equity assessment. The meta-analysis found that women in the intervention groups were more likely to participate in cervical cancer screening than women in control groups (OR: 2.43, 95% CI: 1.49 to 3.97). The type of intervention mattered in increasing cervical cancer screening participation for women living in rural communities. Educational interventions in combination with patient navigation saw the most success in promoting cervical cancer screening. Further, health inequities focus is lacking robust consideration. Our results highlight a continued need to develop multicomponent interventions with a health equity focus to address barriers to screening and prevention.

Impact of HPV testing in opportunistic cervical screening: Support for primary HPV screening in the United States.

Human papillomavirus (HPV) testing for cervical screening increases diagnosis of precancer and reduces the incidence of cervical cancer more than cytology alone. However, real-world evidence from diverse practice settings is lacking for the United States (U.S.) to support clinician adoption of primary HPV screening. Using a population-based registry, which captures all cervical cytology (with or without HPV testing) and all cervical biopsies, we conducted a real-world evidence study of screening in women aged 30 to 64 years across the entire state of New Mexico. Negative cytology was used to distinguish cotests from reflex HPV tests. A total of 264 198 cervical screening tests (with exclusions based on clinical history) were recorded as the first screening test between 2014 and 2017. Diagnoses of cervical intraepithelial neoplasia grades 2 or 3 or greater (CIN2+, CIN3+) from 2014 to 2019 were the main outcomes. Of cytology-negative screens, 165 595 (67.1%) were cotests and 4.8% of these led to biopsy within 2 years vs 3.2% in the cytology-only group. Among cytology-negative, HPV tested women, 347 of 398 (87.2%) CIN2+ cases were diagnosed in HPV-positive women, as were 147 of 164 (89.6%) CIN3+ cases. Only 29/921 (3.2%) CIN3+ and 67/1964 (3.4%) CIN2+ cases were diagnosed in HPV-negative, cytology-positive women with biopsies. Under U.S. opportunistic screening, across a diversity of health care delivery practices, and in a population suffering multiple disparities, we show adding HPV testing to cytology substantially increased the yield of CIN2+ and CIN3+. CIN3+ was rarely diagnosed in HPV-negative women with abnormal cytology, supporting U.S. primary HPV-only screening.

High prevalence of HPV16 and high-grade cytology in women undergoing active surveillance for cervical intraepithelial neoplasia grade 2.

INTRODUCTION: Many countries have adopted active surveillance in women with cervical intraepithelial neoplasia grade 2 (CIN2), leaving the lesion untreated. However, there is a lack of consensus on the eligibility criteria for active surveillance across countries, with some abstaining from active surveillance in women with human papilloma virus 16 (HPV16) or a high-grade cytology. Here, we aimed to describe the distribution of HPV genotypes, age, and cytology in women undergoing active surveillance for CIN2. MATERIAL AND METHODS: We conducted a single-center cross-sectional study on women aged 23-40 undergoing active surveillance for CIN2 during 2000-2010. Women were identified through the Danish Pathology Data Bank (DPDB) at Aarhus University Hospital, Denmark. We collected information on basic characteristics and results of histopathological examinations via DPDB. Women were deemed eligible for inclusion if they had a subsequent biopsy after index CIN2, and had no prior record of CIN2+, hysterectomy, or cone biopsy. Archived biopsies underwent HPV genotyping using the HPV SPF10 - DEIA-LiPA25 system, and the diagnosis was re-evaluated by three expert pathologists. We used the Chi squared-test (p-value) for comparison across groups. RESULTS: We identified 3623 women with CIN2 of whom 455 (12.6%) were included. Most women were 30 years or younger (73.8%), and half (48.8%) had a high-grade index cytology. The prevalence of any high-risk HPV was 87.0%, with HPV16 being the most prevalent genotype (35.6%). The prevalence of HPV16 was significantly higher in women aged 30 or younger (39.3%) compared to women older than 30 years (25.2%) (p = 0.006). Upon expert review, 261 (57.4%) had CIN2 confirmed, whereas 56 (12.3%) were upgraded to CIN3 and 121 (26.6%) were downgraded to CIN1/normal. While the HPV16 prevalence was similar between community and expert confirmed CIN2, the prevalence of HPV16 was significantly higher in women with expert CIN3 compared to women with expert CIN1/normal (64.3% vs. 19.0%, p = 0.001). CONCLUSIONS: The high prevalence of HPV16 and high-grade cytology imply that these women may be perceived as a high-risk population and non-eligible for active surveillance in countries outside Denmark. Future studies should investigate the importance of HPV, age, cytology, and expert review on risk of progression to help refine criteria for active surveillance.

Cervical cancer screening among English- and Spanish-speaking Hispanic women in an urban safety net health system, 2015-2020.

BACKGROUND: The Hispanic population is heterogeneous with differences in health behaviors across subgroups by nativity and preferred language. We evaluated cervical cancer screening adherence among English- and Spanish-speaking Hispanic patients receiving care at a safety net health system. METHODS: Electronic health records were used to identify 46,094 women aged 30-65. Up to date (UTD) screening was defined based on date of last Pap test, human papillomavirus (HPV) test, or Pap/HPV co-test. RESULTS: Overall, 81.5% of 31,297 Hispanic women were UTD. English-speaking Hispanic women had a lower prevalence of being UTD when compared to Spanish-speaking Hispanic women (aPR: 0.94, 95% CI: 0.93 - 0.96). Further, those with indigent healthcare plans had a higher prevalence of being UTD when compared to those with private insurance (aPR: 1.10, 95% CI: 1.09 - 1.12), while all other health insurance plans were associated with lower UTD screening when compared to private insurance. CONCLUSIONS: These findings suggest screening differences within the Hispanic population, highlighting the need for disaggregated research assessing heterogeneity within racial/ethnic groups, specifically among Hispanic populations.

Implementation of an mHealth intervention to increase adherence to triage among HPV positive women with HPV-self-collection (ATICA study): post-implementation evaluation from the women's perspective.

BACKGROUND: Low adherence to triage after positive screening is a widespread problem for cervical cancer screening programs in Low- and Middle-income Countries. Adherence to cytology-based triage can be challenging, especially among women with self-collected tests. SMS-based interventions are accepted by women and can increase screening uptake. The ATICA study was an effectiveness-implementation hybrid type I trial, combining a cluster randomized controlled trial (RCT) with a mixed-methods implementation evaluation involving quantitative and qualitative methods. Although the RCT provided evidence regarding the effectiveness of the SMS-based intervention, less is known about its acceptability, relevance, and usefulness from the women´s perspective. METHODS: We carried out a cross-sectional study based on a structured questionnaire among HPV-positive women who were enrolled in ATICA's intervention group. We measured acceptability, appropriateness, and message content comprehension. Also, we evaluated if the SMS message was considered a cue to encourage women to pick up their HPV test results and promote the triage. RESULTS: We interviewed 370 HPV-positive women. Acceptability of SMS messages among women who had received at least one message was high (97%). We found high levels of agreement in all appropriateness dimensions. More than 77% of women showed high comprehension of the content. Among women who received at least one SMS message, 76% went to the health center to pick up their results. Among those who got their results, 90% reported that the SMS message had influenced them to go. We found no significant differences in acceptability, appropriateness or message comprehension between women who adhered to triage and those who did not adhere after receiving the SMS messages. CONCLUSION: The intervention was highly acceptable, and women reported SMS was an appropriate channel to be informed about HPV test results availability. SMS was also a useful cue to go to the health center to pick up results. The implementation did not encounter barriers associated with the SMS message itself, suggesting the existence of other obstacles to triage adherence. Our results support the RCT findings that scaling up SMS is a highly acceptable intervention to promote cervical screening triage adherence.

Exploring engagement in cervical cancer prevention services among Haitian women in Haiti and in the United States: a scoping review.

PROBLEM IDENTIFICATION: Haitian women in Haiti and in the United States experience a disproportionate burden of cervical cancer, however their uptake of cervical cancer prevention services remains concerningly low. LITERATURE SEARCH: A comprehensive search on bibliographic databases coupled with a grey literature search was conducted. A total of 401 studies were identified, with 28 studies retained after following Arksey and O'Malley's Scoping Review Guidelines. DATA EVALUATION/SYNTHESIS: Knowledge levels of HPV and cervical cancer, along with preventative measures was alarmingly low. Traditional health practices, cultural worldviews, and social networks had an influence on the uptake of cervical cancer prevention. Health systems barriers were found to be a prevalent barrier among Haitian women in the U.S. CONCLUSIONS: Future health promotion interventions developed for Haitian women must address personal, cultural, social, and structural factors with an emphasis on modifying knowledge and beliefs to improve engagement in cervical cancer prevention behaviors.

Human papilloma virus (HPV) vaccine and cervical cancer prevention in Africa.

Cervical cancer remains a critical challenge in reproductive health worldwide, with especially high burden in Africa. A recent publication in the Lancet reported 604,127 cases of cervical cancer worldwide in 20201, of which 117,316 cases (19.4%) were in the five African regions. East Africa had the highest incidence rate followed by West Africa, while north and South Africa had the lowest rates. Similarly, the highest cervical cancer mortality rate worldwide, 28.6 deaths per 100,000 women years, was reported from East Africa, and was followed by South Africa.

Le cancer du col de l'utérus reste un défi majeur en matière de santé reproductive dans le monde, avec un fardeau particulièrement élevé en Afrique. Une publication récente du Lancet a fait état de 604 127 cas de cancer du col de l'utérus dans le monde en 20201, dont 117 316 cas (19,4 %) dans les cinq régions africaines. L'Afrique de l'Est avait le taux d'incidence le plus élevé, suivie de l'Afrique de l'Ouest, tandis que l'Afrique du Nord et l'Afrique du Sud avaient les taux les plus bas. De même, le taux de mortalité par cancer du col de l'utérus le plus élevé au monde, soit 28,6 décès pour 100 000 femmes-années, a été signalé en Afrique de l'Est, suivi par l'Afrique du Sud.

Exploring Factors Influencing Cervical Cancer Prevention Behaviors: Unveiling Perspectives of Conservative Muslim American Women in Virginia.

Understanding the complexities surrounding cervical cancer prevention methods and hesitancy among conservative Muslim American women is crucial in addressing health disparities. This qualitative study aimed to delve into the religious, behavioral, and socio-cultural factors influencing Muslim women's decisions regarding cervical cancer screening (CC-S) and HPV vaccination (HPV-V) in Virginia, USA. Through interviews with 10 Muslim women residing in Virginia, qualitative data were collected as part of a mixed-method cross-sectional study conducted between August and September 2021. Findings revealed that participants had limited knowledge about cervical cancer, CC-S, and HPV-V, with notable themes emerging, such as cultural influences, misconceptions, language barriers, and challenges posed by the intricate US healthcare system. Future research should focus on exploring these barriers to mitigate the impact of cervical cancer within the Muslim population.

Comparison of accuracy and reproducibility of colposcopic impression based on a single image versus a two-minute time series of colposcopic images.

OBJECTIVE: Colposcopy is an important part of cervical screening/management programs. Colposcopic appearance is often classified, for teaching and telemedicine, based on static images that do not reveal the dynamics of acetowhitening. We compared the accuracy and reproducibility of colposcopic impression based on a single image at one minute after application of acetic acid versus a time-series of 17 sequential images over two minutes. METHODS: Approximately 5000 colposcopic examinations conducted with the DYSIS colposcopic system were divided into 10 random sets, each assigned to a separate expert colposcopist. Colposcopists first classified single two-dimensional images at one minute and then a time-series of 17 sequential images as 'normal,' 'indeterminate,' 'high grade,' or 'cancer'. Ratings were compared to histologic diagnoses. Additionally, 5 colposcopists reviewed a subset of 200 single images and 200 time series to estimate intra- and inter-rater reliability. RESULTS: Of 4640 patients with adequate images, only 24.4% were correctly categorized by single image visual assessment (11% of 64 cancers; 31% of 605 CIN3; 22.4% of 558 CIN2; 23.9% of 3412 < CIN2). Individual colposcopist accuracy was low; Youden indices (sensitivity plus specificity minus one) ranged from 0.07 to 0.24. Use of the time-series increased the proportion of images classified as normal, regardless of histology. Intra-rater reliability was substantial (weighted kappa = 0.64); inter-rater reliability was fair ( weighted kappa = 0.26). CONCLUSION: Substantial variation exists in visual assessment of colposcopic images, even when a 17-image time series showing the two-minute process of acetowhitening is presented. We are currently evaluating whether deep-learning image evaluation can assist classification.

Overtreatment rate after immediate local excision of suspected cervical intraepithelial neoplasia: A prospective cohort study.

OBJECTIVE: The gold standard of cervical intraepithelial neoplasia (CIN) treatment is large loop excision of the transformation zone (LLETZ) after histopathological diagnosis from punch biopsies. In addition, treatment may be appropriate at initial colposcopy. Our objective was to study the applicability of immediate treatment strategy according to clinical parameters. METHODS: We conducted a prospective cohort study among patients referred to colposcopy at Helsinki University Hospital, Finland, between January 2014, and September 2018 (ISRCTN10933736). Patients treated with LLETZ, either after biopsies or immediately at initial colposcopy, were included. The main outcome measure was overtreatment (OT) rate defined as normal or low-grade histopathological findings in LLETZ specimen within both treatment groups. RESULTS: A total of 572 patients treated with LLETZ were included: 360 treated after biopsies and 212 treated immediately at initial colposcopy. When LLETZ was performed immediately after high-grade referral cytology and with colposcopic impression of high-grade disease, the overtreatment (OT) rate was 10.0% (95% CI 9.10 to 17.2), whereas when LLETZ was done after biopsy-confirmed high-grade lesions, the OT rate was 18.9% (95% CI 14.7 to 23.7), resulting in risk difference (RD) -8.91% (95% CI -16.0 to -1.82). Among HPV16/18 positive patients the OT rate was 8.22% (95% CI 3.08 to 17.0) for immediate treatment, resulting in RD of -10.7% (95% CI -18.3 to -3.04) compared to LLETZ after biopsies. CONCLUSIONS: Immediate LLETZ does not result in overtreatment when applied on selected cases, especially after high-grade referral cytology and when high-grade lesion is also colposcopically suspected.

Colposcopic performance in a birth cohort previously eligible for human papillomavirus vaccination.

BACKGROUND: Sweden started subsidized quadrivalent human papillomavirus vaccination for girls aged 13 to 17 in 2007. Since 2012, vaccination has been offered to all girls aged 10 to 12 within a school-based vaccination program, with a coverage of 80% or more. In addition, the vaccine has been offered on-demand as catch-up vaccination for girls aged 13 to 18, with a cumulative coverage of 55% to 60%. Since the first women in Sweden eligible for human papillomavirus vaccination entered the cervical screening program, questions on how to evaluate colposcopic findings among vaccinated women have arisen. Evidence is inconsistent on whether colposcopic features for the detection of cervical lesions are influenced by specific human papillomavirus genotypes and what role they can play in the prevention of invasive cervical cancer in vaccinated women. OBJECTIVE: The primary objective of the study was to compare colposcopic evaluation in vaccinated and unvaccinated women entering the organized cervical screening program. STUDY DESIGN: Women in the 1994 and 1995 birth cohorts who entered the cervical screening program at age 23 in 1 region in Sweden were identified. Colposcopy was performed within 2 to 4 months after a positive screening result in accordance with national guidelines. Colposcopic performance was evaluated according to national guidelines with the Swede score and colposcopic impression. Punch biopsies were taken from colposcopic lesions and as "random biopsies" in the absence of lesions. These biopsies were used as the gold standard for the analysis. An endocervical sample was analyzed for cytologic findings and detection of 14 high-risk human papillomavirus genotypes. All colposcopic imaging was saved digitally for re-review. Vaccination status was obtained through linkage to national vaccination registries. Results were compared between vaccinated and unvaccinated women. RESULTS: In 2018 and 2019, 160 out of 165 (98%) women with a positive screening result attended colposcopy, of which 90 (56%) were vaccinated and 70 (44%) were unvaccinated. Only 7 out of 90 (5%) women in the vaccinated group were human papillomavirus 16/18-positive, compared with 23 out of 70 (33%) in the unvaccinated group (P<.001). There was a total of 61 out of 160 (38%) women with high-grade lesions-33 out of 90 (37%) in the vaccinated group and 28 out of 70 (40%) in the unvaccinated group (P=.697). There was 64% (21/33) of vaccinated women and 75% (21/28) of unvaccinated women with high-grade squamous intraepithelial lesions who had a Swede score of 6 to 10 (indicating high-grade squamous intraepithelial lesions) (P=.124). The sensitivity was slightly higher for the detection of high-grade squamous intraepithelial lesions in unvaccinated women using both colposcopic tests (Swede score, 0.67 vs 0.75; colposcopic impression, 0.67 vs 0.68), but the difference was not statistically significant. CONCLUSION: We found no statistically significant difference between the colposcopic evaluation of vaccinated and unvaccinated women, although human papillomavirus vaccination reduced the prevalence of human papillomavirus 16/18 infection in human papillomavirus-vaccinated women. Our results indicate that colposcopic examination is still a useful tool in vaccinated women entering the organized cervical screening program.

Knowledge, Attitudes and Practices Towards Human Papillomavirus Vaccination Among Medical Doctors at a Tertiary Hospital: A Cross Sectional Study.

BACKGROUND: Human papillomavirus (HPV) infection is a common sexually transmitted disease, characterised by persistent infection with high-risk strains leading to malignant conditions such as cervical cancer. The HPV vaccine is a well-known primary preventive measure for HPV infections. Previous studies have shown that medical doctors' vaccine recommendation is one of the key strategies in improving HPV vaccine uptake. In 2019, Zambia rolled out the free national HPV vaccination program targeting 14-year-old girls. However, the annual coverage for HPV vaccination is variable, with rates as low as 33% for 2021. MATERIALS AND METHODS: We conducted a cross-sectional study between September and December 2020 at the University Teaching Hospitals in Lusaka, Zambia. We used analysis of variance to assess the mean differences in the overall scores for knowledge, attitude and practices towards the HPV vaccine. In addition, we used structural equation modelling (SEM) to test the traditional education theory as medical doctors' HPV vaccine knowledge, attitude, and practices cover several facets, and SEM can model latent variables. RESULTS: We enrolled 121 medical doctors, of whom 67 (44.6%) were male. The majority, 76 (62.8%), were registrars and 79 (65.3%) had more than ten years of clinical experience. The overall mean knowledge, attitude, and practice score of the HPV vaccine mean (SD) were 70.2 (15.1), 72.1 (18.5) and 77.1 (28.9), respectively. More than half of the medical doctors would advise anyone eligible to take the HPV vaccine 66 (54.6%). There was a positive correlation between attitude and practice towards the HPV vaccine (ß = .03, P = .017). Conversely, there was no evidence of a correlation between overall HPV knowledge and attitude (ß = .01, P = .670) and rank of the medical doctors (ß = -7.87, P = .355). CONCLUSION: Knowledge was high with good attitudes and practices among medical doctors, which are vital in vaccine recommendation and subsequent uptake.

Empowering Low-Income Asian American Women to Conduct Human Papillomavirus Self-Sampling Test: A Community-Engaged and Culturally Tailored Intervention.

BACKGROUND: Asian American women face disproportionate burden of cervical cancer (CC) than non-Hispanic white women in the U.S. The goal of this study was to assess the feasibility and impact of a culturally tailored intervention to promote Human papillomavirus (HPV) self-sampling test among hard-to-reach Asian American women. METHODS: We adopted the community-based participatory research (CBPR) approach to conduct this efficacy study. A total of 156 female participants (56 Chinese, 50 Korean, and 50 Vietnamese) were recruited from community-based organizations (CBOs) in the greater Philadelphia metropolitan area. The intervention components included HPV-related education, HPV self-sampling test kit and instructions, group discussions, and patient navigations, all available in Asian languages. We examined several outcomes, including the completion of HPV self-sampling, HPV-related knowledge, perceived social support, self-efficacy, and comfort with the self-sampling test at post-intervention assessment. RESULTS: The majority of Asian American women had low annual household income (62.3% earned less than $20,000) and low educational attainment (61.3% without a college degree). We found significant increase in participants' knowledge on HPV (baseline: 2.83, post: 4.89, P <.001), social support (baseline: 3.91, post: 4.09, P < .001), self-efficacy (baseline: 3.05, post: 3.59, P < .001), and comfortable with HPV self-sample test (baseline: 3.62, post: 4.06, P < .001). CONCLUSION: To the best of our knowledge, this is the first intervention study that promoted HPV self-sampling test among Asian American women. Our findings showed that CBPR culturally tailored intervention of self-sampling was highly effective in empowering low-income Asian American women to conduct HPV self-sampling tests.

Human papillomavirus vaccination in women undergoing excisional treatment for cervical intraepithelial neoplasia and subsequent risk of recurrence: A systematic review and meta-analysis.

INTRODUCTION: In this review and meta-analysis we aimed to investigate whether human papilloma virus (HPV) vaccination administered after excisional treatment of cervical intraepithelial neoplasia (CIN) is associated with a reduced risk of recurrence of CIN grade 2 or worse (CIN2+). MATERIAL AND METHODS: We performed a systematic literature search in three online databases through June 2021. Observational studies and randomized controlled trials (RCTs) were eligible for inclusion if the prophylactic HPV vaccine was administered after excisional treatment for histologically verified CIN. Only English language literature was included. The primary outcome measure was recurrence of CIN2+ after treatment. A meta-analysis was performed using fixed and random-effects models, and results were reported as pooled odds ratios (OR) with 95% confidence intervals (95% CI). Quality assessment was performed using ROB2-tool for RCTs and ROBINS-I for observational studies. The protocol was registered in PROSPERO (CRD42021238257). RESULTS: A total of 1561 studies were identified, of which nine, including 19 971 women, were included. Two studies were RCTs and seven were observational studies. Using the fixed-effect model on the two RCTs, the OR for recurrence of CIN2+ was 0.29 (95% CI 0.16-0.53). Due to considerable heterogeneity in observational studies, the random-effects model was used to estimate pooled OR for CIN2+ recurrence in these studies. Thus, using unadjusted data from observational studies, the OR for CIN2+ recurrence was 0.35 (95% CI 0.18-0.67), whereas when using adjusted data, the OR for CIN2+ recurrence was 0.54 (95% CI 0.21-1.35). However, quality assessment revealed a serious risk of bias for the majority of the studies included. CONCLUSIONS: HPV vaccination post-treatment was associated with a significantly reduced risk of CIN2+ recurrence when using unadjusted estimates from observational studies and RCTs. We found no significant effect of HPV vaccination on risk of CIN2+ recurrence when using the outcome measure from observational studies with the least risk of bias. Large, well-designed randomized placebo-controlled trials are needed to determine whether post-treatment HPV vaccination should be recommended to all women undergoing excisional treatment for CIN.