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Human papillomavirus (HPV) testing is the recommended primary screening method against cervical cancer. Denmark started implementing HPV testing as a primary screening method in 2021, but no national data are yet available. We report the results of the first and second screening rounds in a large Danish pilot implementation study. The objective was to compare colposcopy referrals, identify high-grade cervical intraepithelial neoplasia (CIN) and cancer, and positive predictive value (PPV) between HPV-based and cytology-based screening. In the HPV SCREEN DENMARK cohort (established May 2017–December 2019), participants were assigned to HPV-based (n = 28,677) or cytology-based screening (n = 43,622) based on the municipality of residence. The first round of screening showed higher colposcopy referrals in the HPV group (6.4 %) compared to cytology (2.3 %), with HPV screening detecting more CIN3+ (n = 306/28,677 (1.1 %)) than cytology (n = 241/43,622 (0.6 %)) (RR = 1.9 (95 %CI 1.6–2.3). In absolute terms, 41 additional colposcopy referrals resulted in the detection of 10 more cases of CIN2+ and five extra CIN3+ cases per 1000 women screened. The PPV for CIN3+ of a colposcopy initiated by routine screening was similar in the HPV group (24.1 %) and cytology group (25.7 %). Within the initial years of screening, the cumulative incidence of CIN3+ and cervical cancer showed a more rapid increase in the HPV group compared to the cytology group. HPV-based cervical screening detects almost twice as many CIN3+ cases but at the expense of a more than two-fold increase in colposcopy referrals. Furthermore, we found that HPV-based screening detects cervical cancer earlier than cytology-based screening. [Display omitted] • Pilot implementation study in Denmark on HPV-based primary cervical screening. • HPV screening detects nearly double the high-grade cervical lesions compared to cytology. • Significant increase in colposcopy referrals observed with HPV screening. • HPV screening shows strong early detection capacity for cervical cancer. • Findings will guide future screening strategies for better disease management and prevention. [ABSTRACT FROM AUTHOR]

Simple Summary: Patients presenting with cystic metastasis in the neck lymph nodes and no obvious primary tumor, neck cancer of unknown primary (NCUP), represent a very complex management challenge, especially today in the Human Papillomavirus (HPV) era. Given the increasing incidence of HPV-related oropharyngeal squamous cell carcinoma (OPSCC), further detection methods other than p16 IHC (immunohistochemistry) for HPV testing are crucial. An HPV-positive status can localize the tumor to the oropharynx, a common site for occult primaries. Furthermore, up to 15% of p16 protein-positive tumors are actually HPV-negative. Failure to perform additional HPV testing can have dangerous prognostic and therapeutic implications such as de-escalation strategies that hesitate in an undertreatment. The other important topic faced in this study is the role of smoking and p53 mutations, especially their significance in HPV-positive cancers and the role of extranodal extension (ENE) in HPV-positive patients. In this paper, biomolecular, diagnostic, prognostic and therapeutical aspects are critically analyzed to make a precise diagnosis and accurately estimate the prognosis of such patients. Background: The incidence of patients showing neck metastasis and no obvious primary tumor at the initial diagnostic evaluation or neck cancer of unknown primary (NCUP) is rising. It is estimated that a relevant part of these tumors arises in the tonsillar crypts or base of the tongue and are p16+-related. However, today, the detection rate of the primary tumor is suboptimal. Identifying the primary tumor and its biomolecular characterization is essential since it influences the treatment administered, possibly reducing radiation fields and providing de-escalation to primary surgical management. However, p16 IHC (immunohistochemistry) might not be sufficient to diagnose HPV-related OPSCC. The other subset of patients discussed are the HPV-positive patients who have a history of tobacco exposure and/or p53 mutations. Possible factors that could negatively influence the outcomes of these patients are investigated and discussed below. So, this paper aims to analyze the diagnostic, bio-molecular, clinico-radiological, morphological, prognostic and therapeutical aspects of p16-positive OPSCC, highlighting the possible bias that can occur during the diagnostic and prognostic process. Methods: A narrative review was conducted to investigate the biases in the diagnostic and therapeutic process of two groups of patients: those who are p16-positive but HPV-negative patients, and those who are p16-positive and HPV-positive with exposure to traditional risk factors and/or p53 mutations. The keywords used for the literature research included the following: NCUP, OPSCC, p16IHC, HPV testing, p16 positive HPV negative OPSCC, p16 positive HPV positive OPSCC, tonsillectomy, tobacco exposure, p53 mutations, cystic neck metastasis, extranodal extension (ENE), radiotherapy, de-escalation and neck neck dissection. Results: HPV-positive OPSCC has specific clinico-radiological features. Bilateral tonsillectomy should be considered for the identification of the primary tumor. P16 IHC alone is not sufficient for diagnosing HPV-related OPSCC; additional detection methods are required. The role of tobacco exposure and p53 mutations should be investigated especially in cases of HPV-positive tumors. Extranodal extension (ENE) must be taken into consideration in the prognostic staging of HPV-positive tumors. Surgical primary treatment involving neck dissection (ND) and bilateral tonsillectomy followed by adjuvant radiation may represent the most appropriate approach for N3 cases. Diagnosis, prognosis and therapeutical implications must be addressed considering clinical, biomolecular and morphological aspects. At least today, the numerous biases that are still present influencing the diagnostic and prognostic process do not permit considering de-escalation protocols. Conclusions: A precise and accurate diagnosis is required in order to adequately stage and manage p16+ OPSCC, particularly with neck metastasis. The role of tobacco exposure and/or p53 mutations must be considered not only in p16+ OPSCC but especially in HPV-positive OPSCC. Until a more accurate diagnosis is possible, ENE should be considered even in p16+HPV+ OPSCC. Primary surgery with unilateral ND and bilateral tonsillectomy might be the treatment of choice given the numerous diagnostic and prognostic pitfalls. Therefore, it is inappropriate and risky to propose de-escalation protocols in routine clinical practice due to the risk of undertreatment. [ABSTRACT FROM AUTHOR]

Objective: This study aims to examine the relationship between human papillomavirus (HPV) testing attitudes and beliefs, knowledge, and vaccination attitudes. Design: This study was a cross‐sectional design. Sample: This study was conducted between March 15, 2024, and June 2, 2024, through social media platforms such as Facebook, Instagram, Twitter, and Telegram, by sharing on forum pages, and involved 674 women who volunteered to participate. Measurements: The research data were collected using the "health belief model scale regarding HPV infection and vaccination (HBMS‐HPVV)" and the "HPV Testing Attitudes and Beliefs Scale (HTABS)," which were developed by the researchers through a literature review. Results: The average age of the women participating in the study was 46.59 ± 11.15 years; 81.5% were married, 57.6% had no knowledge about cervical cancer, and 62.2% had no knowledge about the HPV vaccine, a protective vaccine against cervical cancer. The average scores for the subdimensions of severity, barriers, benefits, and susceptibility of the HBMS‐HPVV were 3.19 ± 0.60, 2.96 ± 1.22, 2.29 ± 1.40, and 3.92 ± 0.49, respectively. The average scores for the subdimensions of personal barriers, social norms, confidence, and worries of the HTABS were 31.14 ± 19.27, 7.57 ± 4.47, 30.03 ± 7.18, and 11.91 ± 2.52, respectively. A statistically significant positive relationship was found between all HBMS‐HPVV subdimensions and the HTABS subdimensions (p < 0.001). Conclusion: The study found that as the perceived severity increases, the perceived benefits, susceptibility, and confidence increase, while the perceived barriers, personal barriers, social norms, and worries decrease. Based on these results, it is recommended that women's health nurses provide education and seminars to raise awareness about cervical cancer, early screening and diagnosis programs, and the HPV vaccine. [ABSTRACT FROM AUTHOR]

Objective The primary objective of this study was to compare the detection rate of high-risk human papillomavirus (HPV) infection between self-sampling to collect vaginal specimens and clinician sampling to collect cervical specimens, as well as the correlation between the two techniques. The secondary objective was to assess satisfaction with self-sampling for HPV testing. Methods From October 2021 to September 2022, women positive for HPV 16/18 and other 12 high-risk HPV genotypes and cytological Ascus were enrolled. All participants were instructed on the method for self-collection of HPV samples. Self-collected vaginal samples and clinician-collected cervical samples were subjected to HPV DNA typing. Results Paired self- and clinician-collected specimens were obtained from 104 women with positive HPV-positive results. The detection rate of high-risk HPV infection was comparable between the two techniques: 79/98 (80.6%) vs. 81/98 (82.7%) for the self-sampling and clinician-sampling techniques, respectively (McNemar’s test; P=0.774). The agreement in detecting HPV infection was substantial, with a kappa coefficient of 0.75. More than 90% of the participants rated self-collection as satisfactory to very satisfactory because of its convenience and safety. Regarding methods of further follow-up, 51% of the participants chose self-sampling, whereas the remaining participants preferred collection by clinicians. No intervention-related complications were observed. Conclusion The self-sampling technique for HPV testing was as effective as the clinician-sampling technique, and both techniques were substantially correlated in detecting high-risk HPV infection. The self-sampling method appears to be highly satisfactory and may provide better compliance for the detection of cervical HPV infection.

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. [ABSTRACT FROM AUTHOR]

Cervical cancer is highly preventable through vaccination, early detection, and treatment, yet is the fourth most common cancer globally. HPV testing is superior to cytology for the detection of cervical pre-cancer, and jurisdictions around the world are implementing HPV primary screening, which offers the opportunity for self-screening, an important self-care intervention. Digital health solutions are also increasingly important components of self-care. In this study, we assessed the acceptability and completion of self-screening for cervical cancer offered through a digital platform within a low screening uptake region of British Columbia. The primary objective of this study was to evaluate the acceptability of self-screening for cervical cancer offered through a digital platform as measured by return rates of self-screening kits. Patients due or overdue for cervix screening were invited to participate. Eligible participants registered online to receive a self-screening kit, which included a device for vaginal self-screening, instructions, and a return envelope, sent to their home. After self-screening using the vaginal device, HPV testing was conducted. HPV-negative participants were returned to routine screening, and HPV-positive participants were recommended for cytology or colposcopy. Attendance rates at follow-up were evaluated. Participants were invited to complete an acceptability survey. From April 2019 to December 2023, 283 participants were sent kits, with 207 kits returned for a completion rate of 73%. Of valid samples (n = 202), 15 were HPV positive, and 93% attended follow-up care. Most respondents found the CervixCheck website easy to use, informative, and secure and were satisfied with receiving their results online. CervixCheck had a high completion rate among participants who were sent a self-screening kit. High compliance with recommended follow-up and high acceptability of self-screening for cervical cancer was observed. Most participants indicated they would self-screen again in the future. Innovative approaches to cervical screening, including self-screening and the use of digital health interventions, are ways to enhance equity and improve uptake of cervical screening.

Simple Summary: Anal human papilloma virus (HPV) is the leading etiology of anal and cervical cancer. While cervical HPV screening for women is well established, anal HPV screening is restrained to a limited population and specific indications. Our group performed concomitant anal and cervical screening in 275 women at a single gynecologic appointment and revealed high-risk anal HPV in 91 women (33%). The present follow-up study intended to analyze the outcomes of these women during a specialized follow-up in a dedicated high-resolution anoscopy (HRA) outpatient clinic. Independent risk factors for anal HPV were anal intercourse and the presence of cervical HR-HPV with a three- and fourfold increased risk, respectively. Background: This study represents a follow-up analysis of the AnusGynecology (ANGY) study. Methods: This prospective, cross-sectional, single-center study recruited women for concomitant cervical and anal screening of HPV genotypes and cytology during a single appointment. All women with findings of either HPV or any type of dysplastic lesions on anal smears were offered follow-up in a specialized high-resolution anoscopy (HRA) outpatient clinic, representing the study cohort for this follow-up study. Results: Overall, 275 patients (mean age 42 ± 12) were included. Among them, 102 (37%) had cervical high-risk (HR) HPV. In total, HPV was (incidentally) revealed in 91 patients (33%) on anal smears, while any degree of anal squamous intraepithelial lesion (SIL) was found in 30 patients (11%), 6 if which were high-grade SIL (H-SIL). Furthermore, 10 out of 19 biopsies were positive (3 H-SIL lesions). Only half (48/91, 53%) of the women agreed to undergo the recommended specialized follow-up evaluation. Of them, 18 (38%) were diagnosed with dysplastic lesions (9 low grade (L-SIL) and 9 H-SIL, respectively) on biopsies, while the remaining visits revealed no abnormalities. Multivariable analysis revealed cervical HR-HPV infection (OR 4, 95% CI 2.2–7.5) and anal intercourse (OR 3.1, 95% CI 1.7–5.9) as independent risk factors for anal HR-HPV infection. Conclusions: Close follow-up of these women is hence strongly recommended. [ABSTRACT FROM AUTHOR]

Background: Cervical cancer is a gynecological malignancy that can be prevented, but the utilization of screening is just 2.6%-5% in India. Healthcare providers play a vital role in raising awareness and educating the public about screening and vaccination in a highly populated developing country like India. Material and Methods: 153 third- and final-year MBBS students were tested on their knowledge, attitude, and practice using a prevalidated questionnaire in a Medical College in southern part of Karnataka, India. There were 36 knowledge, 12 attitude and 11 practice related questions. The knowledge and practice levels of the participants were grouped into good, fair, and poor bases on bloom's cut off points. A Likert's scale with 4 points was employed to evaluate the attitude of the participants. Results: Analyses of knowledge showed that majority of students recognized the risk factors and symptoms associated with carcinoma of cervix. A considerable lack of knowledge was observed on the treatment of cervical cancer but a significant portion of students knew about prevention. A positive attitude was observed on all aspects of cervical cancer and its prevention. When practice regarding cervical cancer was assessed, it was noticed that only 27.8% of the participants were given information on HPV vaccine in their schools, and an even smaller portion (10%) have been vaccinated for HPV. Conclusion: This study demonstrates a good knowledge and positive attitude about carcinoma of cervix and its prevention amongst the medical students which plays a key role in the campaign to prevent cervical malignancy. Poor practice seen in this study emphasizes the need to translate the awareness to practice. Easier availability of HPV testing and better distribution of HPV vaccine is paramount to successfully prevent cervical cancer in the future. [ABSTRACT FROM AUTHOR]

Cervical cancer screening is a cornerstone of cervical cancer elimination. Detection of high‐risk human papillomavirus (hrHPV) is recommended as the first step in screening provided that the assay used has been adequately validated. The Sansure® Human Papillomavirus DNA Diagnostic Kit is a new assay designed to detect HPV16, HPV18 and 13 other HPV in aggregate. The study aimed to evaluate the intra‐ and interlaboratory reproducibility of the assay according to international guidelines. Five hundred and fifty cervical residual cell samples from women attending cervical cancer screening were selected from the biobank of the HPV National Reference Centre in Belgium and used in this study. After DNA extraction, HPV was tested using the Sansure® Human Papillomavirus DNA Diagnostic Kit. The lower 95% confidence limit around the general reproducibility of this assay should be greater than or equal to 87%, with κ ≥ 0.50. Five hundred and thirty‐three samples had valid results. The Sansure® Human Papillomavirus DNA Diagnostic Kit demonstrated an excellent intra‐laboratory reproducibility of 93.8% (95% confidence interval [CI]: 91.4–95.7, κ = 0.85). The interlaboratory reproducibility was 93.4 (95% CI: 91.0–95.4, κ = 0.84). Intra and interlaboratory reproducibility were also excellent at the genotype level. Excluding HPV53 single infection samples from the analyses also resulted in excellent agreement. These data show that the Sansure® Human Papillomavirus DNA Diagnostic Kit is highly reproducible. [ABSTRACT FROM AUTHOR]

Introduction: In Denmark, where human papillomavirus (HPV) ‐based cervical cancer screening is being implemented, the aim of this pilot implementation study was to test a specific screening algorithm, assess follow‐up examination attendance, and measure the proportion of precancer lesions found in relation to the number of women referred for colposcopy. Material and Methods: From May 2017 to December 2020, 36 417 women in the uptake area of the Department of Pathology, Vejle Hospital, Region of Southern Denmark, were included in the HPV group. Women positive for HPV16/18 irrespective of cytology and women positive for other high‐risk HPV (hrHPV) types having concomitant abnormal cytology were referred directly to colposcopy. Women positive for other hrHPV types and normal cytology were referred to repeat screening after 12 months, and hrHPV negative to routine screening after three years. We obtained information on screening results and subsequent histological diagnosis from the Danish Pathology Databank through September 2022. Results: 3.6% of the women were referred to colposcopy after primary screening, 5% to repeat screening after 12 months, and 91.4% back to routine screening. High follow‐up rates were observed: 96% attended colposcopy after primary screening, with 91% attending colposcopy after repeat screening. CIN3+ was detected at colposcopy following the primary screening in 28.1% of HPV16/18‐positive women and 18.2% of those positive for other hrHPV types with concomitant abnormal cytology. Of the women with other hrHPV and simultaneous ASCUS/LSIL, 8% had CIN3+. At the repeat screening, 43% had become hrHPV negative, 55% were persistently positive for other hrHPV, and 2% had turned positive for HPV16/18. At the colposcopy following repeat screening, 10.1% of the women positive for other hrHPV were diagnosed with CIN3+, in comparison with 11.1% of the HPV16/18‐positive women. Conclusions: In this pilot implementation study, an algorithm for HPV‐based screening was evaluated in a Danish setting. The results demonstrated high attendance at follow‐up examinations and provided insights into the number of colposcopy referrals and the detection of CIN2 and CIN3+ cases. The results suggest that women testing positive for other hrHPV in combination with ASCUS/LSIL at primary screening could potentially be referred to repeat screening instead of an immediate colposcopy. [ABSTRACT FROM AUTHOR]

Cervical cancer is highly preventable through vaccination, early detection, and treatment, yet is the fourth most common cancer globally. HPV testing is superior to cytology for the detection of cervical pre-cancer, and jurisdictions around the world are implementing HPV primary screening, which offers the opportunity for self-screening, an important self-care intervention. Digital health solutions are also increasingly important components of self-care. In this study, we assessed the acceptability and completion of self-screening for cervical cancer offered through a digital platform within a low screening uptake region of British Columbia. The primary objective of this study was to evaluate the acceptability of self-screening for cervical cancer offered through a digital platform as measured by return rates of self-screening kits. Patients due or overdue for cervix screening were invited to participate. Eligible participants registered online to receive a self-screening kit, which included a device for vaginal self-screening, instructions, and a return envelope, sent to their home. After self-screening using the vaginal device, HPV testing was conducted. HPV-negative participants were returned to routine screening, and HPV-positive participants were recommended for cytology or colposcopy. Attendance rates at follow-up were evaluated. Participants were invited to complete an acceptability survey. From April 2019 to December 2023, 283 participants were sent kits, with 207 kits returned for a completion rate of 73%. Of valid samples (n = 202), 15 were HPV positive, and 93% attended follow-up care. Most respondents found the CervixCheck website easy to use, informative, and secure and were satisfied with receiving their results online. CervixCheck had a high completion rate among participants who were sent a self-screening kit. High compliance with recommended follow-up and high acceptability of self-screening for cervical cancer was observed. Most participants indicated they would self-screen again in the future. Innovative approaches to cervical screening, including self-screening and the use of digital health interventions, are ways to enhance equity and improve uptake of cervical screening. [ABSTRACT FROM AUTHOR]

Summary: Background: HPV test-based primary cervical screening is replacing cytology in Canada. In other countries, women's unpreparedness and concerns hindered the transition and post-implementation screening uptake. We investigated psychosocial correlates of intentions of screening in eligible individuals to participate in HPV-based primary cervical screening. Methods: We conducted a nationwide web-based survey of individuals aged 21–70 years in 2022 and oversampled under-screened individuals. We used five Canadian-validated scales to measure HPV test-based screening knowledge, attitudes, and beliefs. Using the multistage Precaution Adoption Process Model, we assessed women's stage of intentions to participate in HPV testing and self-sampling. We estimated associations of psychosocial factors with intentions' stage using multinomial logistic regression. Findings: In both groups (adequately screened n = 1778; under-screened n = 1570), higher HPV knowledge was associated with intention for HPV testing and more personal barriers to the HPV test were associated with lower intentions to participate in HPV testing or use of self-sampling. In both groups, higher self-sampling concerns were associated with lower intentions for self-sampling and higher women's need for autonomy was associated with increased intentions for self-sampling. In the under-screened group, increased age was associated with lower intentions for HPV testing and self-sampling, while living in Canada for

Background: Cervical cancer screening remains an essential preventive tool worldwide. First line high-risk Human Papillomavirus (HrHPV) genotyping became gold standard for cervical cancer screening, and has been adopted by several countries, including Portugal. Herein, we aimed to assess the early outcomes of the regional Cervical Cancer Screening Program of Northern Portugal. Methods: The analysis of a representative set of cases evaluated during a one-month period (January 2020), with adequate follow-up was performed. Descriptive analysis was performed. Results: Overall, 7278 samples were received, of which 15.2% were HrHPV positive, most of these disclosing a negative result in subsequent liquid-based cytology. Nearly half of the HrHPV-positive women were referred to colposcopy. Within this group, HPV16/18+ cases depicted the higher frequency of high-grade squamous intraepithelial lesion (HSIL) or worse, compared with abnormal cytology or persistent HrHPV infection. Among women with non-HPV16/18 HrHPV infection and negative cytology, which are eligible for repeat sampling in one year, 65% were re-tested. Importantly, nearly half of these cleared HrHPV infection. Furthermore, referral to colposcopy due to HPV16/18 infection and/or abnormal cytology results were associated with > 40% risk for HSIL or worse lesion. Conclusions: Our study confirmed the reliability and effectiveness of first line HrHPV genotyping in the Cervical Cancer Screening Program of Northern Portugal. Nonetheless, it also raised concerns about excessive referral to colposcopy, with the inherent human and financial costs. Thus, further improvement and optimization are key to ensure the sustainability of the program.

Introduction: The rates of cervical cancer screening in Cameroon are unknown and HPV vaccination coverage for age-appropriate youths is reported at 5%. Objectives: To implement the mother–child approach to cervical cancer prevention (cervical screening by HPV testing for mothers and HPV vaccination for daughters) in Meskine, Far North, Cameroon. Methods: After the sensitization of the Meskine–Maroua region using education and a press-release by the Minister of Public Health, a 5-day mother–child campaign took place at Meskine Baptist Hospital. The Ampfire HPV Testing was free for 500 women and vaccination was free for age-appropriate children through the EPI program. Nurses trained in cervical cancer education conducted group teaching sessions prior to having each woman retrieve a personal sample. Self-collected samples were analyzed for HPV the same day. All women with positive tests were assessed using VIA–VILI and treated as appropriate for precancers. Results: 505 women were screened, and 92 children vaccinated (34 boys and 58 girls). Of those screened, 401 (79.4%) were aged 30–49 years old; 415 (82%) married; 348 (69%) no education. Of the HPV positive cases (101): 9 (5.9%) were HPV 16, 11 (10.1%) HPV 18, 74 (73%) HPV of 13 other types. Those who were both HPV and VIA–VILI positive were treated by thermal ablation (63%) or LEEP (25%). Conclusion: The mother–child approach is an excellent method to maximize primary and secondary prevention against cervical cancer.

The U.S.-affiliated Pacific Islands (USAPI) have higher cervical cancer incidence and mortality rates and lower screening coverage compared with the United States. This is likely because of economic, geographical, health care delivery, and cultural barriers for women living in these resource‐constrained, isolated regions. The most recent U.S. and World Health Organization cervical cancer screening guidelines recommended primary human papillomavirus (HPV) testing as one screening option or the preferred screening modality. Primary HPV screening-based strategies offer several advantages over current screening methods in the USAPI. However, adoption of this newer screening modality has been slow in the United States and not yet incorporated into USAPI screening programs. The U.S. Centers for Disease Control and Prevention and partners initiated the Pacific Against Cervical Cancer (PACe) project in 2019 to evaluate the feasibility, acceptability, and cost‐effectiveness of primary HPV testing-based strategies in Guam and in Yap, Federated States of Micronesia. This report provides an overview of the PACe project and outlines the approaches we took in implementing primary HPV testing as a new cervical cancer screening strategy (including the option of self-sampling in Yap), encompassing four core components: (1) community engagement and education, (2) medical and laboratory capacity building, (3) health information and system improvement, and (4) modeling and cost-effectiveness analysis. The PACe project provides examples of systematic implementation and resource appropriate technologies to the USAPI, with broader implications for never screened and under-screened populations in the United States and Pacific as they face similar barriers to accessing cervical cancer screening services. [ABSTRACT FROM AUTHOR]

Cervical cancer is a significant public health concern, particularly in low‐ and middle‐income countries where resources for prevention and treatment are limited. Routine screening, such as the Papanicolaou test (Pap smears) and human papillomavirus (HPV) testing, plays a crucial role in the early detection and prevention of cervical cancer. However, the participation rate in cervical cancer screening programs remains below optimal levels due to various factors. This study aimed to evaluate the reliability and acceptability of the HygeiaTouch Self Sampling Kit for Women in collecting vaginal samples for HPV typing, comparing the results with samples collected by physicians. The study included 1210 women aged 21–65 from three medical centers in Taiwan. The findings indicated that the self‐sampling kit was as effective as physician‐collected specimens in terms of obtaining valid samples and identifying HPV. The agreement between the two methods was 88%, with a κ value of 0.75. Furthermore, the study assessed the mechanical characteristics of the self‐sampling applicator through tensile, bending, and torque tests, and determined that it was safe for intravaginal use. Additionally, the study evaluated the safety and satisfaction of self‐sampling and found a low rate of adverse events (0.7%) and high levels of satisfaction (over 90%) among participants. Overall, we demonstrated that the HygeiaTouch Self Sampling Kit for Women is a reliable and acceptable device for HPV testing and cervical screening, providing a convenient, safe, and effective alternative for women. [ABSTRACT FROM AUTHOR]

High‐risk human papillomavirus (hrHPV) is the cause of virtually all cervical cancers, most vaginal and anal cancers, and some vulvar cancer cases. With HPV testing becoming the primary screening method for cervical cancer, understanding the link between cervical hrHPV infection and the risk of other anogenital cancers is crucial. We assessed the risk of vulvar, vaginal and anal cancer and precancer (VIN2+, VaIN2+ and AIN2+) in a prospective cohort study including 455,349 women who underwent cervical hrHPV testing in Denmark from 2005 to 2020. We employed Cox proportional hazard models, adjusting for age, calendar year and HPV vaccination status, and estimated hazard ratios (HRs) and 95% confidence intervals (CI). We used the Aalen Johansen estimator to calculate the absolute risks of VIN2+, VaIN2+ and AIN2+. In total, 15% of the women were hrHPV positive at baseline. A positive cervical hrHPV test was associated with increased incidence of vulvar, vaginal and anal squamous cell carcinoma (SCC). Five‐year risk estimates of VIN2+, VaIN2+ and AIN2+ among hrHPV‐positive women (0.45%, 0.14% and 0.12%) were higher than among hrHPV‐negative women (0.14%, 0.01% and 0.05%). Particularly high risk was observed among the hrHPV‐positive women of the oldest age, with a history of anogenital precancer and those not HPV vaccinated. In conclusion, our study confirms the association between cervical hrHPV infection and non‐cervical anogenital precancers and cancers. Currently, no established risk threshold or guidelines for follow‐up. As HPV testing becomes the primary method for cervical cancer screening, future data will help define high‐risk groups and acceptable risk thresholds. [ABSTRACT FROM AUTHOR]

Simple Summary: Our purpose was to assess the impact of urine-sample HPV (human papillomavirus) testing on the effectiveness of screening for cervical cancer. We also assessed the acceptability of the self-collection of urine samples for HPV screening tests. Our analysis took into account research results published in systematic reviews of the available literature on the topic under study. Of the 1869 articles found in this area, we included 5 studies that met the criteria we assessed. We discovered that the sensitivity and specificity for the detection of any HPV in first-void urine samples were 87% [95% CI: (0.74; 0.94)] and 89% [95% CI: (0.81; 0.93)]. Moreover, participants in the analyzed studies had indicated that they felt comfortable with urine testing. We therefore conclude that the detection of HPV infection in first-void urine samples may have great diagnostic significance. The use of this method in commonly available screening tests could significantly increase patients' willingness to participate in research. Background: The aim of the study was to evaluate the impact of urine-sample HPV (human papillomavirus) testing on the effectiveness of screening for cervical cancer. Methods: The analysis was based on the results of a systematic review. Secondary studies were searched in the following medical databases: Medline, Embase, and the Cochrane Library. The results of the statistical tests presented in the article originate from research conducted by the authors of the included articles. Results: From a total of 1869 citations, 5 studies were included in this review. Sensitivity and specificity for the detection of any HPV from first-void urine samples were 87% [95% CI: (0.74; 0.94)] and 89% [95% CI: (0.81; 0.93)], respectively. Moreover, participants in the analyzed studies had indicated that they felt comfortable with urine testing. Conclusions: The development of methods to detect HPV infection in first-void urine samples and the application of this sampling method in widely available screening tests could significantly increase patients' willingness to participate in testing. [ABSTRACT FROM AUTHOR]

Cervical cancer screening remains an essential preventive tool worldwide. First line high-risk Human Papillomavirus (HrHPV) genotyping became gold standard for cervical cancer screening, and has been adopted by several countries, including Portugal. Herein, we aimed to assess the early outcomes of the regional Cervical Cancer Screening Program of Northern Portugal. The analysis of a representative set of cases evaluated during a one-month period (January 2020), with adequate follow-up was performed. Descriptive analysis was performed. Overall, 7278 samples were received, of which 15.2% were HrHPV positive, most of these disclosing a negative result in subsequent liquid-based cytology. Nearly half of the HrHPV-positive women were referred to colposcopy. Within this group, HPV16/18+ cases depicted the higher frequency of high-grade squamous intraepithelial lesion (HSIL) or worse, compared with abnormal cytology or persistent HrHPV infection. Among women with non-HPV16/18 HrHPV infection and negative cytology, which are eligible for repeat sampling in one year, 65% were re-tested. Importantly, nearly half of these cleared HrHPV infection. Furthermore, referral to colposcopy due to HPV16/18 infection and/or abnormal cytology results were associated with > 40% risk for HSIL or worse lesion. Our study confirmed the reliability and effectiveness of first line HrHPV genotyping in the Cervical Cancer Screening Program of Northern Portugal. Nonetheless, it also raised concerns about excessive referral to colposcopy, with the inherent human and financial costs. Thus, further improvement and optimization are key to ensure the sustainability of the program. • First-line HrHPV genotyping with cytology triage is a reliable screening strategy but increases colposcopy referral. • HPV16/18, abnormal cytology and persistent HrHPV associate with HSIL or worse. • First-line HrHPV testing enables detection of women carrying significant cervical lesion but with NILM cytology. [ABSTRACT FROM AUTHOR]

This study aimed to provide comprehensive clinical screening data for anal intraepithelial neoplasia (AIN). This study included 312 patients who underwent high‐resolution anoscopy (HRA) examinations between January 1, 2020 and April 15, 2024. Clinical data, including demographic information, clinical history, cytology/high‐risk human papilloma virus (hrHPV) results, and HRA records, were analyzed. The median age of all patients was 42 years (interquartile range: 33–52 years). Approximately 26.3% reported a history of VIN2/3+, 13.5% had a history of VaIN2/3+, 29.8% had a history of CIN2/3+, 44.6% had persistent cervical HPV16 infection, and 12.5% had immune suppression. Among the 312 patients, 14.4% were diagnosed with AIN2/3, 25.0% with AIN1 and 60.6% were normal. Anal cytological abnormalities were found in 41.3% of all patients, with a significantly higher rate in AIN2/3 patients than in ≤AIN1, 71.1% versus 36.3%, p < 0.001. The hrHPV positivity rate was 89.7%, with HPV16 being the most prevalent. The complete agreement rate for HRA impressions was 79.5%. Multi‐variable analysis revealed immune suppression (odds ratio [OR]: 3.47, 95% confidence interval [CI]: 1.42–8.5) and VIN2/3+ (OR: 2.82, 95% CI: 1.27–6.28) were independent risk factors for AIN2/3. Abnormal cytology results (OR: 3.3, 95% CI: 1.52–7.17) and anal HPV16 infection (OR: 3.2, 95% CI: 1.26–8.12) demonstrated similar ORs for AIN2/3. Early screening for AIN2/3+ is crucial in Chinese women with lower genital tract precancerous and cancerous lesions, particularly in those with VIN2/3+ and immune suppression. [ABSTRACT FROM AUTHOR]

Introduction: The rates of cervical cancer screening in Cameroon are unknown and HPV vaccination coverage for age-appropriate youths is reported at 5%. Objectives: To implement the mother–child approach to cervical cancer prevention (cervical screening by HPV testing for mothers and HPV vaccination for daughters) in Meskine, Far North, Cameroon. Methods: After the sensitization of the Meskine–Maroua region using education and a press-release by the Minister of Public Health, a 5-day mother–child campaign took place at Meskine Baptist Hospital. The Ampfire HPV Testing was free for 500 women and vaccination was free for age-appropriate children through the EPI program. Nurses trained in cervical cancer education conducted group teaching sessions prior to having each woman retrieve a personal sample. Self-collected samples were analyzed for HPV the same day. All women with positive tests were assessed using VIA–VILI and treated as appropriate for precancers. Results: 505 women were screened, and 92 children vaccinated (34 boys and 58 girls). Of those screened, 401 (79.4%) were aged 30–49 years old; 415 (82%) married; 348 (69%) no education. Of the HPV positive cases (101): 9 (5.9%) were HPV 16, 11 (10.1%) HPV 18, 74 (73%) HPV of 13 other types. Those who were both HPV and VIA–VILI positive were treated by thermal ablation (63%) or LEEP (25%). Conclusion: The mother–child approach is an excellent method to maximize primary and secondary prevention against cervical cancer. [ABSTRACT FROM AUTHOR]

Abstract Objective This study aims to evaluate the feasibility and applicability of an online cervical cancer screening program using a website as the public platform and self-collected HPV testing as the primary screening method. Methods A website (mcareu.com) was developed to facilitate the online cervical cancer screening program by Peking University Shenzhen Hospital (PUSH). Women in Shenzhen could register for participation on the website by providing essential demographic data. Sampling kits and specimens were delivered through regular logistics. Eligible women collected vaginal samples by themselves using the provided kits and in referring of the graphic guidance. The specimens were tested for HPV at PUSH or a reference lab, and the results were accessible on the website through participants' personal accounts. Participants who tested positive for high-risk HPV were scheduled for colposcopy and biopsies. The demographic and social background data of the eligible participants were analyzed to evaluate the feasibility and applicability of the online screening approach. Results A total of 1712 applicants registered for participation, with 99.9% (1710/1712) completing registration with full data. The analysis included 1560 applicants aged 30–59, with an average age of 41.1 (± 7.6) years. Among them, 83.3% (1299/1560) provided self-collected samples for testing. Age-group analysis revealed an overall sample provision rate (SPR) exceeded 80% in all age groups. A significant difference in SPR was observed only between the 30–34 and 45–49 age groups (p

Objective: This study aims to evaluate the feasibility and applicability of an online cervical cancer screening program using a website as the public platform and self-collected HPV testing as the primary screening method. Methods: A website (mcareu.com) was developed to facilitate the online cervical cancer screening program by Peking University Shenzhen Hospital (PUSH). Women in Shenzhen could register for participation on the website by providing essential demographic data. Sampling kits and specimens were delivered through regular logistics. Eligible women collected vaginal samples by themselves using the provided kits and in referring of the graphic guidance. The specimens were tested for HPV at PUSH or a reference lab, and the results were accessible on the website through participants' personal accounts. Participants who tested positive for high-risk HPV were scheduled for colposcopy and biopsies. The demographic and social background data of the eligible participants were analyzed to evaluate the feasibility and applicability of the online screening approach. Results: A total of 1712 applicants registered for participation, with 99.9% (1710/1712) completing registration with full data. The analysis included 1560 applicants aged 30–59, with an average age of 41.1 (± 7.6) years. Among them, 83.3% (1299/1560) provided self-collected samples for testing. Age-group analysis revealed an overall sample provision rate (SPR) exceeded 80% in all age groups. A significant difference in SPR was observed only between the 30–34 and 45–49 age groups (p < 0.05), while no significant differences were found among other age groups. 99.7% of the samples were tested qualified, and there was no significant difference in sampling failure rate among age groups. Analysis of demographic and social elements showed no significant impact on the rates of sample provision among groups in most of the social elements but the medical insurance and the monthly family-incomes. Conclusion: The findings demonstrate that online cervical cancer screening is reliable for self-registration, self-sampling, and self-ordering for specimen transportation. It is suitable for women of all ages needing to be screened, irrespective of social elements, and effectively facilitates screening for women with limited access to medical resources. Therefore, online screening holds promise as an effective approach to increase screening coverage. [ABSTRACT FROM AUTHOR]

Despite the successes achieved in implementing screening programs and treating diseases caused by human papillomavirus (HPV) infection, the frequency of cervical intraepithelial neoplasia (CIN) of moderate and high grades associated with high-risk human papillomavirus (HR-HPV) remains between 9% to 21%. Vaginal dysbiosis and the development of immunodeficient states due to persistent HR-HPV infection require effective immunomodulatory and antiviral therapy before cervical surgery in perimenopausal women with recurrent CIN II. The objective: to evaluate the effectiveness of antiviral and immunomodulatory therapy by determining the state of vaginal biocenosis, immunological status and papillomavirus load of the cervical mucosa before surgical treatment in perimenopausal women with recurrent CIN II. Materials and methods. A prospective study was conducted on 98 women aged 40 to 55 years old, including 60 patients with morphologically verified recurrent CIN II associated with high-risk HPV, forming the main group. The control group comprised 38 women with negative HPV test results and without significant gynecological or somatic pathology. In the main group, a complex consisting of a blend of plant extracts of sod pike grass (Deschampsia caespitosa), ground cinquefoil grass (Calamagrostis epigeios), and echinacea purpurea grass (Echinaceae purpureae) was administered orally. Vaginal microbiota was assessed using Hey-Іson criteria, and immunological status was examined in patients using solid-phase enzymelinked immunosorbent assay to determine IgG, IgM, IgA antibodies in serum and cervical mucus, levels of interleukin-1β (IL-1β), interferons alpha (IFN-α), gamma (IFN-γ), tumor necrosis factor alpha (TNF-α). Additionally, the DNA of high-risk HPV in cervical mucosa was quantitatively assessed using real-time PCR. The investigations were conducted before and after the applied therapy. Results. The investigation of vaginal content revealed the presence of bacterial vaginosis in 65.0% of patients in the main group, the frequency of which decreased by 2 times after treatment, with the number of women with an intermediate type of vaginal content increasing by 2.8 times (51.7%) and those with normal microbiota increasing by 2.5 times. Disruptions in cellular and humoral immunity systems were identified. After treatment, there was an increase in viral load in the significant «threshold» category (3–5 lg) by 1.25 times and in the «above threshold for progression» category (>5 lg) by 2.3 times, reflecting natural HPV clearance. No direct correlation was found between viral load activity and the degree of CIN or positive morphological changes regarding regression of cervical intraepithelial lesions. Conclusions. The use of a complex containing a blend of plant extracts of sod pike grass (Deschampsia caespitosa), ground cinquefoil grass (Calamagrostis epigeios), and echinacea purpurea grass (Echinacea purpureae) improves the state of vaginal biocenosis, indicators of cellular and humoral immunity, and promotes HPV elimination, it has adequate safety and tolerability, which determines the feasibility of its use in the complex treatment of cervical intraepithelial neoplasia at the preparatory stage before surgery and in the postoperative period to prevent complications and relapses. [ABSTRACT FROM AUTHOR]

Cervical cancer, primarily caused by high-risk human papillomavirus (HR-HPV) types 16 and 18, is a major global health concern. Persistent HR-HPV infection can progress from reversible precancerous lesions to invasive cervical cancer, which is driven by the oncogenic activity of human papillomavirus (HPV) genes, particularly E6 and E7. Traditional screening methods, including cytology and HPV testing, have limited sensitivity and specificity. This review explores the application of p16/Ki-67 dual-staining cytology for cervical cancer screening. This advanced immunocytochemical method allows for simultaneously detecting p16 and Ki-67 proteins within cervical epithelial cells, offering a more specific approach for triaging HPV-positive women. Dual staining and traditional methods are compared, demonstrating their high sensitivity and negative predictive value but low specificity. The increased sensitivity of dual staining results in higher detection rates of CIN2+ lesions, which is crucial for preventing cervical cancer progression. However, its low specificity may lead to increased false-positive results and unnecessary biopsies. The implications of integrating dual staining into contemporary screening strategies, particularly considering the evolving landscape of HPV vaccination and changes in HPV genotype prevalence, are also discussed. New guidelines and further research are necessary to elucidate the long-term effects of integrating dual staining into screening protocols. [ABSTRACT FROM AUTHOR]

The positive clinical threshold of human papillomavirus (HPV) tests validated for primary cervical cancer screening (CCS) is designed to offer an optimal balance between clinical sensitivity and specificity. However, there may be a gap between the analytical sensitivity of the test and the positive clinical threshold, referred to here as the "gray‐zone." This study aims to determine the prevalence and significance of HPV results obtained in the gray‐zone in routine practice. Cervical samples obtained in our institution for CCS over a 22‐month‐period were tested with the Alinity m HR‐HPV Assay (Abbott). Clinical and biological data, including cytological results and patients' HPV history were collected. Of the 6101 samples collected, 1.7% had an HPV result in the gray‐zone (102 patients). The proportion of gray‐zone results varied according to HPV genotype, reaching 11.8% of samples with detectable HPV DNA in the case of HPV31/33/52/58 genotypes. Reflex cytologies showed no abnormalities or Atypical Squamous Cells of Undetermined Significance results in 74.6% and 17.9% of cases, respectively. A previous or subsequent HPV‐positive result with a (possibly) identical genotype was observed in 58% and 38% of cases, respectively. Two women with a history of persistent HPV detection had a CIN2+ lesion 1 year after the gray‐zone result. In conclusion, the proportion of HPV results in the gray‐zone varies according to genotype. No cytological abnormality is observed in the majority of cases, but a few rare patients with a history of persistent HPV infection should be closely monitored even if the HPV result is transiently located in the gray‐zone. [ABSTRACT FROM AUTHOR]

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

Abstract Objective To evaluate the feasibility of an internet-facilitated community model for cervical cancer screening using self-collected HPV testing as primary screening. Method A population-based cervical cancer screening program was conducted in the suburb of Shenzhen, China, from September 2014 to July 2017. Women with 25–60 years of age and no pregnancy were eligible for participation. Participants could register for screening by logging in a website by themselves or with the aids of local community workers. A unique barcode was issued to each applicant upon successful registration. After registration, women could get sampling kits from community screening site/study clinic, collect vaginal samples privately or in group, and provide their sample for Hr-HPV tests on Cobas4800 and SeqHPV assays. Testing reports were checkable through personal account for all participant and phone calls were given to all women positive of Hr-HPV. Participants positive of both or either the 2 assays were identified as the positives. The positives could return the study clinic for triage or search medical care in other clinics. Colposcopy directed or ramdom biopsies were performed on all positives who returned to the study clinics. Results A total of 10,792 community women registered for screening, among whom, 10,010 provided their vaginal samples for tests. 99.5% of the participants were confirmed to have correct personal identifiable information and samples, and 98.9% of them got HPV testing results from both or either assays. No adverse event was reported. Conclusion When self-collected HPV testing is used as the primary testing, the internet-based data platform facilitates the screening in registration, data collection, and data tracking, and increases the screening coverage. Internet-facilitated community model is promising to cervical cancer control and applicable in regions with variety of resources.

Yun Zhao,1,&ast; Lijun Zhao,1,&ast; Zhaohuang Wang,1 Shuhui Cui,1 Chenchen Ren,2 Li Yang,2 Yang Bai,2 Yuanhang Zhu,2 Jingyan Xie,3 Yujuan Li,3 Xiaoqing Wu,3 Jing Feng,3 Shanqing Man,4 Longmei Huang,4 Xiaoqi Li,4 Xiaotian Yu,4 Jianliu Wang1 1Department of Obstetrics and Gynecology, Peking University People’s Hospital, Beijing, People’s Republic of China; 2Department of Obstetrics and Gynecology, The Third Affiliated Hospital of Zhengzhou University, National Clinical Research Center for Obstetrics and Gynecology, Zhengzhou Key Laboratory of Cervical Disease, Zhengzhou Key Laboratory of Endometrial Disease Prevention and Treatment, Zhengzhou, Henan, People’s Republic of China; 3Department of Obstetrics and Gynecology, Nanjing First Hospital, Nanjing Medical University, Nanjing, Jiangsu, People’s Republic of China; 4Hangzhou New Horizon Health Technology Co. Ltd, Hangzhou, Zhejiang, People’s Republic of China&ast;These authors contributed equally to this workCorrespondence: Jianliu Wang, Department of Obstetrics and Gynecology, Peking University People’s Hospital, 11 Xizhimen South Street, Xicheng District, Beijing, 100044, People’s Republic of China, Tel +8618901086568, Email wangjianliu1203@163.comObjective: The objective of this study is to assess the clinical performance of a urine-based high-risk human papillomavirus (hrHPV) test for the detection of cervical intraepithelial neoplasia grade 2 or higher (CIN2+).Methods: Between September and December 2021, women aged 20 to 65 years referred to colposcopy clinic were prospectively recruited at three clinical centers in China. Paired urine and cervical specimens from all enrolled women were obtained for hrHPV DNA fluorescence quantitative PCR test. The results of liquid-based cytology (LBC), colposcopy and diagnostic biopsies were collected. We evaluated the sensitivity and specificity for CIN and assessed the agreement/kappa value.Results: A total of 732 women (median age, 40 years) with valid results were included in the study, and 130 (17.8%) women were histologically confirmed as CIN2+. The sensitivity of urine and cervical test for CIN2+ and CIN3+ were 87.69% and 85.45%, respectively. The specificity of urine test performed better than cervical test in women with

In response to the incidence of cervical intraepithelial neoplasia and cervical cancer in China and global screening strategies, a collaborative effort was undertaken by seven Chinese medical associations to develop this guideline for cervical cancer screening. The guideline recommends high-risk human papillomavirus (hr-HPV) testing as the preferred method for primary screening, which should have been approved by authoritative institutions and clinically validated for primary screening. In areas without access to HPV testing, cytology can be used as an alternative. However, it is recommended to replace cytology with HPV-based screening as conditions permit. Cotesting (HPV testing in combination with cytology) is recommended for areas with sufficient medical resources, opportunistic screening populations, and partial special populations. The guideline recommends that individuals with a cervix initiate cervical cancer screening at the age 25 years and undergo HPV testing alone or cotesting every five years, or cytology alone every three years. Women over the age of 65 who have had documented adequate negative prior screening in the past may terminate screening. Corresponding screening programs are proposed for different special populations. The development of these guidelines is an important step in the effort to eliminate cervical cancer in China.

The World Health Organization recommends human papillomavirus (HPV) testing for cervical screening. Extended genotyping can identify the highest‐risk HPV‐positive women. An inexpensive, rapid, mobile isothermal amplification assay (ScreenFire HPV RS test) was recently redesigned to yield four channels ordered by cancer risk (ie, hierarchical approach): HPV16, HPV18/45, HPV31/33/35/52/58 and HPV39/51/56/59/68. Stored specimens from 2076 women (mean age 30.9) enrolled in a colposcopy clinic, with high HPV prevalence, were tested with ScreenFire. We calculated hierarchical channel positivity and non‐hierarchical channel and type positivity, according to histologic diagnosis (256 cancer, 350 cervical intraepithelial neoplasia [CIN]3, 409 CIN2, 1020 < CIN2) and known virologic reference results (Linear Array and TypeSeq). Additionally, we analyzed ScreenFire time‐to‐positive up to 60 min by channel and histology. Overall clinical sensitivity for CIN3+ was 94.7% (95% confidence interval 92.6‐96.4), similar to Linear Array (92.3, 89.7‐94.3) and TypeSeq (96.0, 93.9‐97.6). Sensitivity was high for all types and channels. The hierarchical approach was well in line with HPV typing and histologic diagnosis, prioritizing higher risk women having HPV16 and precancer. For HPV16, time‐to‐positive was shorter in women with precancer. ScreenFire showed excellent agreement with research reference typing tests and detection of CIN2+. Risk‐based type results could help guide clinical management of HPV‐positive women. Time‐to‐positive combined with genotyping might be useful. ScreenFire is rapid, mobile, relatively inexpensive and designed for implementation of HPV‐based screening and management, including in lower‐resource settings. Further validation in screening by self‐sampling and practical effectiveness merit evaluation. [ABSTRACT FROM AUTHOR]

Objective: To evaluate the feasibility of an internet-facilitated community model for cervical cancer screening using self-collected HPV testing as primary screening. Method: A population-based cervical cancer screening program was conducted in the suburb of Shenzhen, China, from September 2014 to July 2017. Women with 25–60 years of age and no pregnancy were eligible for participation. Participants could register for screening by logging in a website by themselves or with the aids of local community workers. A unique barcode was issued to each applicant upon successful registration. After registration, women could get sampling kits from community screening site/study clinic, collect vaginal samples privately or in group, and provide their sample for Hr-HPV tests on Cobas4800 and SeqHPV assays. Testing reports were checkable through personal account for all participant and phone calls were given to all women positive of Hr-HPV. Participants positive of both or either the 2 assays were identified as the positives. The positives could return the study clinic for triage or search medical care in other clinics. Colposcopy directed or ramdom biopsies were performed on all positives who returned to the study clinics. Results: A total of 10,792 community women registered for screening, among whom, 10,010 provided their vaginal samples for tests. 99.5% of the participants were confirmed to have correct personal identifiable information and samples, and 98.9% of them got HPV testing results from both or either assays. No adverse event was reported. Conclusion: When self-collected HPV testing is used as the primary testing, the internet-based data platform facilitates the screening in registration, data collection, and data tracking, and increases the screening coverage. Internet-facilitated community model is promising to cervical cancer control and applicable in regions with variety of resources. [ABSTRACT FROM AUTHOR]

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As Canadian provinces and territories prepare to transition to HPV-based primary screening for cervical cancer, failure to identify and address potential barriers to screening could hinder program implementation. We examined screening-eligible Canadians’ attitudes towards and knowledge of cervical screening. A nationally representative sample of screening-eligible Canadians (N = 3724) completed a web-based survey in the summer of 2022. Oversampling ensured that half of the sample were underscreened for cervical cancer (>3 years since previous screening or never screened). The participants completed validated scales of cervical cancer, HPV, and HPV test knowledge and HPV test and self-sampling attitudes and beliefs. Between-group differences (underscreened vs. adequately screened) were calculated for scales and items using independent sample t-tests or chi-square tests. The underscreened participants (n = 1871) demonstrated significantly lower knowledge of cervical cancer, HPV, and the HPV test. The adequately screened participants (n = 1853) scored higher on the Confidence and Worries subscales of the HPV Test Attitudes and Beliefs Scale. The underscreened participants scored higher on the Personal Barriers and Social Norms subscales. The underscreened participants also endorsed greater Autonomy conferred by self-sampling. Our findings suggest important differential patterns of knowledge, attitudes, and beliefs between the underscreened and adequately screened Canadians. These findings highlight the need to develop targeted communication strategies and promote patient-centered, tailored approaches in cervical screening programs.

Abstract Background: Cervical cancer screening rates in the USA fall behind national targets, requiring innovation to circumvent screening barriers. Cervical cancer screening where human papillomavirus (HPV) testing is performed on vaginal samples collected by the patients themselves (self-sampling) are effective and acceptable, and patient-operated rapid HPV tests (self-testing) are currently under development. It is unclear why there is ambivalence toward HPV self-sampling and self-testing among clinicians, an important stakeholder group. We conducted a mixed convergent quantitative and qualitative study to identify the factors influencing clinicians’ attitudes toward self-sampling and self-testing. Methods: A survey of Midwest clinicians distributed by professional group media and a market research firm between May and November 2021 was analyzed (n = 248) alongside in-depth interviews with Midwest clinicians from professional groups (n = 23). Logistic regression models examined willingness to support self-sampling and self-testing across respondent characteristics. Results: We report that family practice physicians and those in rural areas were more willing to adopt HPV self-sampling (adjusted OR (aOR) = 3.16 [1.43–6.99]; aOR = 2.17 [1.01–4.68]). Clinician willingness to support self-testing was positively associated with current use of self-testing for other conditions and negatively associated with performing 10 or more monthly cervical cancer screenings (aOR = 2.02 [1.03–3.95], aOR = 0.42 [0.23–0.78]). Qualitative data contextualize how clinical specialty and experience with self-sampling and self-testing for other conditions inform clinician perspectives. Conclusion: These data suggest clinician populations most accepting of initiatives to implement self-sampling and self-testing for cervical cancer screening and highlight that experience with other forms of self-testing could facilitate more widespread adoption for cervical cancer.

In the context of cervical cancer prevention, where human papillomavirus (HPV) infection is pivotal, HPV testing is replacing Pap Smear in primary screening. This transition offers an opportunity for integrating self-sampling to enhance coverage. We evaluated the accuracy of HPV testing using self-collected urine and vaginal samples, comparing them to physician-collected cervical swabs. From a cohort of 245 women with abnormal cytology, we collected self-sampled vaginal, urine, and clinician-administered cervical specimens. Employing Anyplex™II HPV28 assay, outcomes revealed HPV positivity rates of 75.1% (cervical), 78.4% (vaginal), and 77.1% (urine). Significant, hr-HPV detection concordance was observed between self-taken cervical samples and clinical counterparts (k = 0.898 for vaginal; k = 0.715 for urine). This study extends beyond accuracy, highlighting self-collected sample efficacy in detecting high-grade cervical lesions. The insight underscores self-sampling's role in bolstering participation and aligns with WHO's goal to eliminate cervical cancer by 2030. [ABSTRACT FROM AUTHOR]

The recognition that persistent infection with carcinogenic human papillomavirus (HPV) is a necessary cause of cervical precancer and cancer has led to the introduction of HPV testing into cervical cancer screening, either as a primary screening test or in conjunction with cervical cytology (i.e., co-testing). HPV testing has much higher sensitivity for detection of cervical precancer and provides greater long-term reassurance if negative compared to cytology. However, most HPV infections are transient, and do not progress to invasive cancer, thus triage tests are required to identify individuals who should be referred to colposcopy for diagnostic evaluation. This chapter begins with a description of the biology, natural history, and epidemiology of HPV as a foundation for understanding the role of HPV in cervical carcinogenesis. This section is followed by a detailed discussion regarding the introduction of HPV-based testing and triage into cervical cancer screening and management. Summarized triage tests include cervical cytology, HPV genotyping, p16/Ki-67 dual stain, and HPV and cellular methylation markers. The final section of this chapter includes an important discussion on cervical cancer disparities, particularly within the United States, followed by concluding remarks. [ABSTRACT FROM AUTHOR]

The 2019 ASCCP Risk Based Management Consensus Guidelines for prevention of cervical cancer promote clinical management recommendations aligned with our increased understanding of HPV biology and cervical carcinogenesis. They employ HPV-based testing as the basis for risk estimation, allow for personalized risk-based management by incorporating knowledge of current results with prior results, and streamline incorporation of new test methods as they are validated. They continue to support the principles of "equal management for equal risk" and "balancing harms and benefits" adopted in the 2012 version of the guidelines. These updated guidelines will be able to adjust for decreasing CIN3+ risks as more patients who received HPV vaccination reach screening age. Pathology organizations were closely involved in the development of these guidelines. Herein the pathologists who served as representatives to the 2019 ASCCP guidelines steering committee and workgroups, summarize the changes that are relevant to laboratories, pathologists, and cytotechnologists. Prior relevant screening and reporting recommendations that have not been widely and/or inconsistently adopted by laboratories are also discussed and considerations for modification of laboratory practices offered.

The disrupted introduction of the HPV-based cervical screening program in several jurisdictions has demonstrated that the attitudes and beliefs of screening-eligible persons are critically implicated in the success of program implementation (including the use of self-sampling). As no up-to-date and validated measures exist measuring attitudes and beliefs towards HPV testing and self-sampling, this study aimed to develop and validate two scales measuring these factors. In October-November 2021, cervical screening-eligible Canadians participated in a web-based survey. In total, 44 items related to HPV testing and 13 items related to HPV self-sampling attitudes and beliefs were included in the survey. For both scales, the optimal number of factors was identified using Exploratory Factor Analysis (EFA) and parallel analysis. Item Response Theory (IRT) was applied within each factor to select items. Confirmatory Factor Analysis (CFA) was used to assess model fit. After data cleaning, 1027 responses were analyzed. The HPV Testing Attitudes and Beliefs Scale (HTABS) had four factors, and twenty items were retained after item reduction. The HPV Self-sampling Attitudes and Beliefs Scale (HSABS) had two factors and seven items were retained. CFA showed a good model fit for both final scales. The developed scales will be a valuable resource to examine attitudes and beliefs in anticipation of, and to evaluate, HPV test-based cervical screening.

Abstract Background A field trial to evaluate a self-collect point-of-care HPV screen-and-treat (HPV S&T) program was implemented in two Well Women Clinics in Papua New Guinea (Papua New Guinea). Assessing the acceptability of a health intervention is a core element of evaluation. In this study, we examined women’s acceptability of both self-collection and HPV S&T intervention in Papua New Guinea. Methods Sixty-two semi-structured interviews were conducted with women who had undergone cervical screening in the same-day self-collected HPV screen-and-treat program in Madang and Western Highlands Provinces, Papua New Guinea. Data were thematically analysed using the Theoretical Framework of Acceptability (TFA) and managed using NVivo 12.5. Results Most women agreed that self-collection was transformative: it helped circumvent the culturally embarrassing pelvic examination and increased their self-efficacy, especially due to the provision of health education, instructions, and pictorial aids. The availability of same-day results, and treatment if indicated, was particularly valued by the women because it reduced the financial and temporal burden to return to the clinic for results. It also meant they did not need to wait anxiously for long periods of time for their results. Women also appreciated the support from, and expertise of, health care workers throughout the process and spoke of trust in the HPV-DNA testing technology. Most women were willing to pay for the service to ensure its sustainability and timely scale-up throughout Papua New Guinea to support access for women in harder to reach areas. Conclusion This study reported very high levels of acceptability from a field trial of self-collection and HPV same-day screen-and-treat. The program was deemed culturally congruent and time efficient. This innovative cervical screening modality could be the ‘solution’ needed to see wider and more immediate impact and improved outcomes for women in Papua New Guinea and other high-burden, low-resource settings.

Summary: Background: Cervical cytology remains widely used as the initial tool in cervical cancer screening worldwide. WHO guidelines recommend replacing cytology with primary HPV testing to reach cervical cancer elimination goals. We assessed the performance of cytology and high-risk HPV testing to detect cervical precancer, cervical intraepithelial neoplasia (CIN) grade 3 or worse (CIN3+) among women aged 30–64 years participating in the ESTAMPA study. Methods: Women were screened with cytology and HPV across ESTAMPA study centres in Latin America. Screen-positives were referred to colposcopy with biopsy collection and treatment as needed. Those with no evident precancer were recalled at 18-months for a second HPV test to complete disease ascertainment. Performance indicators for cytology and HPV to detect CIN3+ were estimated. Findings: 30,606 participants with available cytology and HPV results were included in the analysis. A total of 440 histologically confirmed CIN3s and 30 cancers were diagnosed. Cytology sensitivity for CIN3+ was 48.5% (95% CI: 44.0–53.0), whereas HPV testing had a sensitivity of 98.1% (95% CI: 96.3–96.7). Specificity was 96.5% (95% CI: 96.3–96.7) using cytology and 88.7% (95% CI: 88.3–89.0) with HPV. Performance estimates varied substantially by study centre for cytology (ranging from 32.1% to 87.5% for sensitivity and from 89.2% to 99.5% for specificity) while for HPV results were more consistent across sites (96.7%–100% and 83.6–90.8%, respectively). Interpretation: The limited and highly variable sensitivity of cytology strongly supports transition to the more robust and reproducible HPV-based cervical screening to ensure progress towards global cervical cancer elimination targets in Latin America. Funding: IARC/WHO, UNDP, HRP/WHO, NCI and local funders.

In the past 2 decades, cervical cancer screening guidelines in the United States have undergone numerous revisions with recent greater emphasis on primary high-risk human papillomavirus (hrHPV) testing. We examine the trends of Papanicolaou test and hrHPV testing at our large academic center across 4 years (2006, 2011, 2016, and 2021) over a 15-year period. The number of ThinPrep Papanicolaou and hrHPV tests, as well as the triggers for HPV testing, were retrospectively analyzed. A total of 308,355 Papanicolaou tests and 117,477 hrHPV tests were reported across the 4 years. The number of Papanicolaou tests performed decreased nearly 3-fold over the study period, with only 43,230 Papanicolaou tests performed in 2021. The HPV test to Papanicolaou test ratio increased: 17% of Papanicolaou tests had an associated HPV test in 2006, whereas 72% of Papanicolaou tests ordered in 2021 had a companion hrHPV. The use of co-testing also increased. Overall, 73% were co-tests and 27% were reflexively ordered in the 4 one-year time periods. Co-tests constituted only 46% of HPV tests in 2006, but this increased to 93% in 2021. The percentage of positive hrHPV results decreased; in 2006, 18.3% of cases were positive, dropping to 8.6% in 2021 due to the marked increase in co-testing. Stratifying by diagnostic category, hrHPV results have remained relatively constant. With the numerous recent revisions of cervical screening guidelines, screening strategies at our institution reflected these changes in clinical practice. Papanicolaou and HPV co-testing became the most common screening method for women 30 to 65 years of age in our cohort. • The numbers of Papanicolaou test decreased and the numbers of HPV testing increased. • Papanicolaou cytology and HPV co-testing is a most common screening method for women aged 30 years and older. • No primary HPV testing in our clinical practice. • hrHPV positive rates are relatively constant among diagnostic categories of Papanicolaou cytology. [ABSTRACT FROM AUTHOR]

Background and objectives: Cervical cancer is the fourth leading cause of cancer-related deaths in women. Human papilloma virus (HPV) is known to cause cervical cancer. The incidence and mortality of cervical cancer has drastically reduced due to effective vaccination against HPV in developed countries. The projected rise in cervical cancer cases in Latin American and Caribbean countries necessitates a study to evaluate awareness about HPV, cervical cancer, the HPV vaccine, and prevention among women in Antigua and Barbuda. Materials and methods: This was an observational, cross-sectional study. The participants were women aged between 18 and 65 years, residing in Antigua and Barbuda. The study was conducted over the period of February to April 2023. After taking informed consent electronically, sociodemographic and behavioral data was collected through questionnaires sent out as links and QR-codes and were analyzed by QualtricsXM. The association between the demographic groups and awareness about HPV, cervical cancer, the HPV vaccine, and prevention was analyzed by a Chi-square test. Results: In total, 467 women were included in the study. The percentage of participants aware of HPV was 91.6% (n = 412). A total of 70.7% (n = 318) and 56.7% (n = 255) women were aware that cervical cancer is caused by HPV and is sexually transmitted, respectively. Although 70.6% (n = 315) of participants were aware that the vaccine protects against HPV, only 12.8% (n = 57) were vaccinated. Of the participants, 49.7% (n = 192) were willing to get vaccinated. The percentage of participants aware of the Papanicolaou (Pap) smear procedure was 98.9% (n = 435) and 87.8% (n = 382) had a Pap smear within the last 10 years while 12.2% (n = 53) never had a Pap smear screening. The willingness to know more information about HPV and the HPV vaccine among the participants was 77% (n = 335). Conclusions: The overall awareness among women in Antigua and Barbuda about HPV, cervical cancer, the HPV vaccine, and prevention was high. We recommend a national health education program and vaccine drive to complement our findings. [ABSTRACT FROM AUTHOR]

As Canadian provinces and territories prepare to transition to HPV-based primary screening for cervical cancer, failure to identify and address potential barriers to screening could hinder program implementation. We examined screening-eligible Canadians' attitudes towards and knowledge of cervical screening. A nationally representative sample of screening-eligible Canadians (N = 3724) completed a web-based survey in the summer of 2022. Oversampling ensured that half of the sample were underscreened for cervical cancer (>3 years since previous screening or never screened). The participants completed validated scales of cervical cancer, HPV, and HPV test knowledge and HPV test and self-sampling attitudes and beliefs. Between-group differences (underscreened vs. adequately screened) were calculated for scales and items using independent sample t-tests or chi-square tests. The underscreened participants (n = 1871) demonstrated significantly lower knowledge of cervical cancer, HPV, and the HPV test. The adequately screened participants (n = 1853) scored higher on the Confidence and Worries subscales of the HPV Test Attitudes and Beliefs Scale. The underscreened participants scored higher on the Personal Barriers and Social Norms subscales. The underscreened participants also endorsed greater Autonomy conferred by self-sampling. Our findings suggest important differential patterns of knowledge, attitudes, and beliefs between the underscreened and adequately screened Canadians. These findings highlight the need to develop targeted communication strategies and promote patient-centered, tailored approaches in cervical screening programs. [ABSTRACT FROM AUTHOR]

Objective: To triage low-grade cervical smears (ASCUS/LSIL) by HPV 16/18 genotyping and dual staining with p16/Ki67 and to compare the sensitivity and specificity of these two triage methods for detection of high-grade cervical intraepithelial neoplasia (HGCIN). Methods: In this prospective cross-sectional study, we evaluated a total of 89 women with low-grade smears (54 ASCUS, 35 LSIL) recruited from a tertiary care hospital. All patients underwent colposcopy guided cervical biopsy. Histopathology was used as gold standard. All samples were subjected to HPV 16/18 genotyping (excluding 9) using DNA PCR and p16/Ki67 dual staining (excluding 4) using Roche® kit. We then compared the two triage methods to detect high-grade cervical lesions. Results: Overall, in all low-grade smears sensitivity, specificity and accuracy of HPV 16/18 genotyping, was found to be 66.7%, 77.1% and 76.2% respectively (p = 0.03). In low-grade smears sensitivity, specificity and accuracy of dual staining, was found to be 66.7%, 84.8% and 83.5% respectively (p = 0.01). Conclusions: Overall, in all low-grade smears the sensitivity of the two tests was comparable. However, dual staining had a higher specificity and accuracy than HPV 16/18 genotyping. It was concluded that both are effective triage methods but dual staining had a better performance than HPV 16/18 genotyping. [ABSTRACT FROM AUTHOR]

We compared 2 human papillomavirus (HPV) assays to detect the 14 high-risk HPV (hrHPV) genotypes in self-collected anal samples. We found a good agreement and similar performance to detect HPV-16, HPV-18, and the 12 other hrHPV genotypes. The global performance to detect the 14 hrHPV genotypes was not significantly different between the 2 assays. [ABSTRACT FROM AUTHOR]

Program ROSE (removing obstacles to cervical screening) is a primary HPV-based cervical screening program that incorporates self-sampling and digital technology, ensuring that women are linked to care. It was developed based on the principles of design thinking in the context of Malaysia. The program illustrates the importance of collaborative partnerships and addressing the multi-faceted barriers from policy changes, and infrastructure readiness to the implementation of a radically new cervical screening program in communities. The paradigm shift in cervical cancer requires a monumental and concerted effort in educating both the healthcare providers and the general public. In this short review, we highlight how Pilot Project ROSE incorporated evidence-based tools that rapidly scaled up to Program ROSE. These ideas and solutions can be adapted and adopted by other countries. Notwithstanding the impact of COVID-19, it is incumbent on countries to pave the road towards the elimination of cervical cancer with pre-existing footpaths.

Aim: Self‐sampling human papillomavirus (HPV) testing has been introduced for cervical cancer screening worldwide. In Japan, there are two types (brush and sponge) of HPV self‐sampling devices. However, the recommended type for cervical cancer screening remains unclear. This study aimed to evaluate the feasibility of the HPV self‐sampling device–sponge type (HSD‐ST). Additionally, we aimed to examine the positive rate (sensitivity) for cervical intraepithelial neoplasia (CIN) 2 or worse using the HSD‐ST. Finally, we aimed to perform a questionnaire survey regarding the usability of the HSD‐ST. Methods: We included 165 women who underwent HPV testing at one of three gynecologic clinics. First, the women used the HSD‐ST and completed a questionnaire regarding its usability. Subsequently, they underwent physician‐sampling HPV testing and cytology. We examined the agreement rate of HPV positivity between self‐ and physician‐sampling HPV testing. Results: The HPV‐positive rates of self‐ and physician‐collected samples were 59.4% and 62.4%, respectively, with an overall concordance rate of 88.5% and a calculated kappa coefficient of 0.76, indicating high concordance. Moreover, the positive (sensitivity) rates for CIN2 or worse were 81.4% and 89.8% in the self‐ and physician‐collected samples, respectively. Conclusions: Our findings demonstrated the feasibility and usability of the HSD‐ST. [ABSTRACT FROM AUTHOR]

The prevalence and distribution of oncogenic human papillomavirus (HPV) genotypes in women who underwent screening for cervical cancer in the Wielkopolska region, Poland, were assessed, and the correlation of genotypes with the histological results was evaluated. Cervical samples were collected from 2969 women for cervical cancer screening. Participants were screened by liquid-based cytology and HPV genotyping (n = 1654) and referred to colposcopy and punch biopsy (n = 616) if recommended. HPV genotypes 16, 31, 52, 66, 53, and 51 are the most frequent types in the studied population. Genotypes 16 and 31 account for nearly one-fifth of the infections of diagnosed HPV infections. HPV 16, 31, and 52 are found in nearly 80% of premalignant HSIL lesions (CIN 2 and CIN 3). That leads to the conclusion that vaccination programs should cover as many types of HPV as possible and shows the urgent need to vaccinate the Polish population with a 9-valent vaccine. [ABSTRACT FROM AUTHOR]

Brhanu Teka,1,2 Muluken Gizaw,2– 4 Ededia Firdawoke,1 Adamu Addissie,3 Tesfamichael Awoke Sisay,3 Carola Schreckenberger,5 Anna Sophie Skof,5 Sarah Thies,5 Adane Mihret,1,6 Eva Johanna Kantelhardt,2,4 Tamrat Abebe,1 Andreas M Kaufmann5 1Department of Microbiology, Immunology and Parasitology, School of Medicine, College of Health Sciences, Addis Ababa University, Addis Ababa, Ethiopia; 2Department of Gynaecology Martin-Luther-University, Halle-Wittenberg, Germany; 3School of Public Health, College of Health Sciences, Addis Ababa University, Addis Ababa, Ethiopia; 4Institute for Medical Epidemiology, Biometrics and Informatics, Martin-Luther-University, Halle-Wittenberg, Germany; 5Department of Gynecology, Charité – Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin and Humboldt-Universität zu Berlin, Berlin, 13353, Germany; 6Armauer Hansen Research Institute (AHRI), Addis Ababa, EthiopiaCorrespondence: Andreas M Kaufmann, Tel +49 30 450516499, Fax +4930 450-7 564958, Email Andreas.Kaufmann@charite.dePurpose: High-risk Human Papillomavirus (HPV) is the most important cause of cervical cancer. The highest burden of disease is seen in Low- and Low-Middle-Income Countries (LMIC). Several new HPV screening assays have been developed for high-risk HPV (hr-HPV) testing. We compared the performance and adequacy of three HPV genotyping assays on samples from a population of rural women in south-central Ethiopia.Patients and Methods: One hundred and ten cervical swabs from rural women screened for HPV were assayed. HPV DNA was tested using MPG-Luminex Assay, Anyplex II HPV HR Detection, and EUROArray HPV. MPG-Luminex Assay was used as a reference method to compute the sensitivity and specificity of the two commercial assays in detecting hr-HPV infections.Results: Of the 110 samples, MPG-Luminex Assay found 18.2% positive for the 14 hr-HPV and 7.3% for the probable hr-HPV genotypes. Anyplex™ II HPV HR Detection assay and EUROArray HPV Assay identified 21.82% and 12.7% samples, respectively, for the 14 hr-HPVs and both 7.3% for the probable hr-HPV genotypes (κ=0.734). Among the 14 hr-HPV genotypes, the genotype-specific agreement of the three HPV genotyping assays was moderate or better for HPV16, 31, 35, 39, 52, 56, 66 and 68. The aggregated sensitivity in detecting the 14 hr-HPV infections of Anyplex™ II HPV HR Detection and EUROArray HPV assays was high, 100% and 70%, respectively. The specificities of Anyplex™ II HPV HR Detection and EUROArray HPV were 95.6% and 100%, respectively.Conclusion: The three evaluated assays showed similar analytical performance in the detection of hr-HPV infections and moderate or better concordance in HPV genotyping. This study is part of the ongoing cluster-randomized trial that has been registered in clinicaltrials.gov (NCT03281135) on September 13, 2017.Keywords: analytical performance, HPV PCR test accuracy, HPV test complexity, HPV testing, LMIC