Cytology-based Screening Research Articles

An Interprofessional Approach to Training in Cervical Cancer Screening in a Low Resource Setting of Rural Haiti [12H

INTRODUCTION: Cervical cancer continues to be a public health concern mostly affecting low-resource countries and has a high prevalence in Haiti, where no national prevention program exists. To address this gap, Hospital Albert Schweitzer (HAS) launched a cervical cancer screening and treatment program. The first step consisted of a two-week workshop providing didactic and supervised clinical training to healthcare professionals. METHODS: A US-based interprofessional team developed a comprehensive curriculum focusing on visual inspection with acetic acid, cytology-based screening, colposcopy, cryotherapy and loop electrosurgical excisional procedure. 3 Ob/Gyns, 2 general practitioners, 3 nurse-midwives and 2 nurses were trained. The course consisted of half-day didactic sessions and half-day supervised clinical practice sessions during the first week. The second week involved high-volume practice of skills. Pre-and post-tests were utilized during didactics, and clinical competency assessment were utilized at the end of each week. These tools will also be used during the 6-month follow-up evaluation. RESULTS: All trainees attended all didactic and clinical training sessions. They screened a total of 988 women. Based on the pre- and post-tests, trainees demonstrated an average increase of knowledge of cervical cancer screening by 9.5%. They all demonstrated satisfactory clinical competency by the end of the second week. CONCLUSION: Implementation of an interprofessional training event in a low-resource setting proved to be effective in teaching healthcare professionals to perform cervical cancer screening and treatment services on a clinically competent level. Results of the 6-month.

Reduction of cervical cancer incidence within a primary HPV screening pilot project (WOLPHSCREEN) in Wolfsburg, Germany

BackgroundRandomised controlled trials showed human papillomavirus (HPV)-based screening leads to a significant reduction in cervical cancer incidence compared with cytology-based screening only.MethodsNon-hysterectomised participants ≥30 years underwent co-testing with Papanicolaou (Pap) smear and HR-HPV testing (Hybrid Capture 2; HC2). Women with normal findings had their next screening round after 5 years, and HC2+ and Pap abnormal cases were immediately referred for colposcopy, while cases with discordant findings had repeat testing after 12 months with referral to colposcopy in cases with persistent positive findings.ResultsTwenty-six thousand six hundred and twenty-four women were recruited between February 2006 and December 2016. Two hundred and seventy-four CIN3+ cases were diagnosed (270 HPV+, 4 HPV−), including 31 invasive cervical cancers (29 HPV+, 2 HPV−). No CIN3+ was detected in HPV− women with abnormal cytology. We observed a significant decline in the 5-year incidence of CIN3+ (from 0.96% [95% CI 0.85–1.09%] to 0.16% [95% CI 0.10–0.25%]; p < 0.0001) and cervical cancer (from 0.10% [95% CI 0.07%–0.15%] to 0.025% [95% CI 0.01–0.08%]; p = 0.01) between the first and subsequent rounds. Approximately 90% (246/274) of CIN3+ cases were diagnosed at first colposcopy.ConclusionsThe decline in disease rates with 5-yearly co-testing seems mainly attributable to HPV testing since no CIN3+ occurred in HPV−/Pap+ women.

Cervical cancer awareness and presence of abnormal cytology among HIV-infected women on antiretroviral therapy in rural Andhra Pradesh, India.

Cervical cancer is a leading cause of death among women in low- and middle-income countries, and women living with HIV are at high risk for cervical cancer. The objective of this study was to estimate the prevalence and correlates of cervical cancer and pre-cancer lesions and to examine cervical cancer knowledge among women living with HIV receiving antiretroviral therapy in rural Andhra Pradesh, India. We conducted cytology-based screening and administered a standardized questionnaire among 598 HIV-infected women. We found 5 (0.8%), 39 (6.5%), 29 (4.9%), and 4 (0.7%) had atypical squamous cells of undetermined significance (ASCUS), low-grade squamous intraepithelial lesion (LSIL), high-grade squamous intraepithelial lesion (HSIL), and squamous cervical carcinoma (SCC), respectively. In multivariable logistic regression analysis, ASCUS/LSIL was independently associated with age >16 years old at first sexual encounter and smokeless tobacco use. We found no factors associated with HSIL/SCC. In total, 101 women (16.9%) had heard of cervical cancer and 28 (27.7%) of them correctly identified HIV infection as a risk factor. In light of the high prevalence of pre-cancer lesions and low level of cervical cancer knowledge in our study population, focused interventions are needed to improve cervical cancer literacy and prevention among rural women living with HIV.

Cost-effectiveness evaluation of HPV self-testing offered to non-attendees in cervical cancer screening in Switzerland

ObjectiveAbout 30% of women who are eligible for cervical cancer (CC) screening remain un-screened or under-screened in Switzerland. HPV testing on self-collected vaginal samples (Self-HPV) has shown to be more sensitive than cytology while also reaching non-attendees. The objective of this study was to explore the cost-effectiveness of offering Self-HPV to non-attendees in Switzerland. MethodsA recursive decision-tree with one-year cycles was used to model the life-long natural HPV history. Markov cohort simulations were used to assess the expected outcomes from the model. The outcomes of three strategies were compared with the absence of screening: Self-HPV and triage with colposcopy (Self-HPV/colpo), Self-HPV and triage with Pap cytology (Self-HPV/PAP), cytological screening and triage with HPV (PAP/HPV). Sensitivity analyses for the key parameters of the model were conducted to check the robustness of findings. ResultsOffering a Self-HPV screening to non-attendees could prevent 90% of CC and 94% of CC-related deaths in the study population. The current cytology-based program could reduce by 83% the number of CC cases and by 88% the number of CC-related deaths over the population's lifetime. Compared to the absence of screening, incremental cost-effectiveness ratios (ICER) were estimated to be, per saved Quality Adjusted Life Year (QALY), 12413US$ for the strategy Self-HPV/colpo, 11138US$ for the strategy Self-HPV/Pap and 22488US$ for the strategy PAP/HPV. ConclusionsOffering Self-HPV as a CC screening strategy to non-attendees in Switzerland is a cost-effective solution that is associated with a reduction of CC cases and related deaths. Self-HPV is more cost-effective than the currently used cytology-based screening.

Prospective cohort study examining cervical cancer screening methods in HIV-positive and HIV-negative Cambodian Women: a comparison of human papilloma virus testing, visualization with acetic acid and digital colposcopy

ObjectivesLogistical and economic issues make traditional cytology-based cervical cancer screening challenging in developing countries. Alternative, cost-effective, screening strategies must be developed to screen millions of women in resource-poor countries such...

Prevention of Cervical Cancer: Guideline of the DGGG and the DKG (S3 Level, AWMF Register Number 015/027OL, December 2017) - Part 1 with Introduction, Screening and the Pathology of Cervical Dysplasia.

Aims Annual opportunistic screening for cervical carcinoma has been carried out in Germany since 1971. The creation of this S3 guideline meets an important need, outlined in the National Cancer Plan, with regard to screening for cervical cancer, as the guideline aims to provide important information and support for planned organized screening for cervical cancer in Germany. Methods With the financial support of German Cancer Aid, 21 professional societies developed evidence-based statements and recommendations (classified using the GRADE system) for the screening, management and treatment of precancerous conditions of the cervix. Two independent scientific institutes compiled systematic reviews for this guideline. Recommendations The first part of this short summary presents the pathological basis and considers various questions related to screening for cervical cancer. As also reported in earlier reviews, the meta-analysis by Kleijnen Systematic Reviews showed that HPV-based screening offers better protection against invasive cervical cancer compared to cytology-based screening. The authors of this guideline therefore recommend – in accordance with the guideline of the Joint National Committee of Germany (Gemeinsamer Bundesauschuss, G-BA) – that women aged 35 and above should be examined at regular intervals (at least every 3 years) and undergo HPV-based screening. Co-testing can also be carried out. Women between the ages of 20 and 35 should have cytological screening every 2 years.

Lessons from the renewal of the National Cervical Screening Program in Australia.

Australia was one of the first countries to make the transition from cytology-based to HPV-based cervical screening.This analysis of the national program's transition to a new model looks at the lessons learnt that can provide valuable insights to other settings. Type of program: Australia's National Cervical Screening Program (NCSP). Following an extensive policy review, in December 2017 the NCSP transitioned from 2-yearly cytology-based screening in women from age 18, to 5-yearly primary HPV screening from age 25. Some changes were more complex than initially anticipated. Building and implementing the National Cancer Screening Register was a more demanding and specialised project than expected. Regulatory requirements for self-collection were unexpectedly onerous, because self-collection was not formally included as an intended use by HPV test manufacturers. This delayed the rollout of a key measure to improve participation and equity. Colposcopy demand was expected to increase substantially but exceeded expectations. Uncertainty about appropriate clinical management or testing outside guideline recommendations may have contributed to the excess demand, highlighting the importance of training providers in the rationale for guidelines as well as the content. Although the changes were evidence based, there were nevertheless some concerns among women and healthcare providers, especially about the longer interval and later starting age for screening. These could have been reduced through earlier and more extensively delivered information to healthcare providers, who play a key role in addressing community concerns. Improved coordination of stakeholder support between government and nongovernment organisations may also have extended both the reach and credibility of communication about the program changes. Transitioning a well-established program is challenging, not only because of the changes required, but also because the existing program must continue to function until the transition. Delays may be hard to avoid, but early communication will enable better forward planning, especially by service providers. Since delays can reduce wider confidence in the changes, proactive communication is critical. Achieving high and equitable screening coverage is a key element if Australia and other countries are to succeed in eliminating cervical cancer as a public health problem. Improving screening program confidence and participation remain important ongoing work. Lessons from Australia will provide valuable insights for other countries making similar changes.

Use of HPV testing in cervical cancer screening services in Mexico, 2008-2018: a nationwide database study.

To describe the methods of a study aimed at evaluating high risk-HPV (hrHPV)-based screening and cervical cytology as triage compared to conventional cervical cytology as primary screening in the detection of grade 2+ cervical intraepithelial neoplasia in the National Cancer Screening Program (NCSP) of Mexico. We will use information originated from the Womens Cancer Information System of Mexico regarding cervical cancer from 2008 to 2018. The database includes cytology results, diagnostic confirmation by histopathology and/or treatment colposcopy. We will then carry out statistical analyses on approximately 15 million hrHPV. We will evaluate the overall performance of hrHPV-based screening as part of the NCSP and compare hrHPV-based to cytology-based screening under real-life conditions. To guarantee an unbiased comparison between hrHPV with cytology triage and conventional cytology we will use propensity score matching. ytology we will use propensity score matching. Conclusion. Decision makers may use our results to identify areas of opportunity for improvement in NCSP processe.

DNA methylation markers as a triage test for identification of cervical lesions in a high risk human papillomavirus positive screening cohort.

Objective triage strategies are required to prevent unnecessary referrals for colposcopy in population‐based screening programs using primary high‐risk human papillomavirus (hrHPV) testing. We have identified several DNA methylation markers with high sensitivity and specificity for detection of high‐grade cervical intraepithelial neoplasia or worse (CIN2+) in women referred for colposcopy. Our study assessed diagnostic potential of these methylation markers in a hrHPV‐positive screening cohort. All six markers (JAM3, EPB41L3, C13orf18, ANKRD18CP, ZSCAN1 and SOX1) showed similar association across histology in the hrHPV‐positive cohort when compared to the Dutch cohort (each p > 0.15). Sensitivity for CIN2+ was higher using methylation panel C13orf18/EPB41L3/JAM3 compared to the other 2 panels (80% vs. 60% (ANKRD18CP/C13orf18/JAM3) and 63% (SOX1/ZSCAN1), p = 0.01). For CIN3+ all three methylation panels showed comparable sensitivity ranging from 68% (13/19) to 95% (18/19). Specificity of SOX1/ZSCAN1 panel (84%, 167/200) was considerably higher compared to ANKRD18CP/C13orf18/JAM3 (68%, 136/200, p = 2 × 10−5) and C13orf18/EPB41L3/JAM3 (66%, 132/200, p = 2 × 10−7). High negative predictive value (NPV) (91–95% and 96–99%) was observed for CIN2+ and CIN3+, for all three methylation panels, while positive predictive value (PPV) varied from 25 to 40% for CIN2+ and 15–27% for CIN3+. Interestingly, 118/235 samples were negative for all six markers (including 106 controls (89.8%), 6 CIN1 (5.1%), 5 CIN2 (4.2%) and 1 CIN3 (0.8%)). Methylation results from both independent cohorts were comparable as well as high sensitivity for detection of cervical cancer and its high‐grade precursors in hrHPV‐positive population. Our study therefore validates these methylation marker panels as triage test either in hrHPV‐based or abnormal cytology‐based screening programs.

Validation of intra- and inter-laboratory reproducibility of the Xpert HPV assay according to the international guidelines for cervical cancer screening

BackgroundCervical cancer screening with assays detecting DNA of high-risk human papillomavirus (hrHPV) types is more effective than cytology-based screening. This study completes the diagnostic accuracy assessment conducted previously within the framework of VALGENT-2 (Validation of HPV genotyping Tests) and aims to determine whether the reproducibility of Xpert HPV is in line with international validation criteria.MethodsValidation of new hrHPV DNA assays requires demonstration of good reproducibility and non-inferior clinical accuracy for cervical precancer compared to a standard comparator assay. The international reproducibility criteria are: lower bound of 95% confidence interval of the intra- and inter-laboratory agreement regarding detection of high-risk HPV DNA exceeding 87% with kappa ≥0.5.ResultsThe Xpert HPV assay showed high intra-laboratory reproducibility with an overall positivity/negativity agreement of 96.9% and a kappa of 0.925. Inter-laboratory testing showed an agreement of 97.8% with a kappa of 0.948.ConclusionsThe Xpert HPV assay fulfills the HPV test reproducibility criterion requirement for use in cervical cancer screening.

The projected timeframe until cervical cancer elimination in Australia: a modelling study

In 2007, Australia was one of the first countries to introduce a national human papillomavirus (HPV) vaccination programme, and it has since achieved high vaccination coverage across both sexes. In December, 2017, organised cervical screening in Australia transitioned from cytology-based screening every 2 years for women aged from 18-20 years to 69 years, to primary HPV testing every 5 years for women aged 25-69 years and exit testing for women aged 70-74 years. We aimed to identify the earliest years in which the annual age-standardised incidence of cervical cancer in Australia (which is currently seven cases per 100 000 women) could decrease below two annual thresholds that could be considered to be potential elimination thresholds: a rare cancer threshold (six new cases per 100 000 women) or a lower threshold (four new cases per 100 000 women), since Australia is likely to be one of the first countries to reach these benchmarks. In this modelling study, we used Policy1-Cervix-an extensively validated dynamic model of HPV vaccination, natural history, and cervical screening-to estimate the age-standardised incidence of cervical cancer in Australia from 2015 to 2100. We incorporated age-specific coverage of the Australian National HPV Vaccination Program in girls, including the catch-up programme, and the inclusion of boys into the vaccine programme from 2013, and a change from the quadrivalent to the nonavalent vaccine from 2018. We also modelled the effects of the transition to primary HPV screening. We considered two scenarios for future screening recommendations regarding the cohorts who will be and who have been offered the nonavalent vaccine: either that HPV screening every 5 years continues, or that no screening would be offered to these women. We estimate that, in Australia, the age-standardised annual incidence of cervical cancer will decrease to fewer than six new cases per 100 000 women by 2020 (range 2018-22), and to fewer than four new cases per 100 000 women by 2028 (2021-35). The precise year of attaining these rates is dependent on the population used for age-standardisation, HPV screening behaviour and test characteristics, the incremental effects of vaccination of men on herd immunity in women, and assumptions about the future frequency of benign hysterectomies. By 2066 (2054-77), the annual incidence of cervical cancer will decrease and remain at fewer than one case per 100 000 women if screening for HPV every 5 years continues for cohorts who have been offered the nonavalent vaccine, or fewer than three cases per 100 000 women if these cohorts are not screened. Cervical cancer mortality is estimated to decrease to less than an age-standardised annual rate of one death per 100 000 women by 2034 (2025-47), even if future screening is only offered to older cohorts that were not offered the nonavalent vaccine. If high-coverage vaccination and screening is maintained, at an elimination threshold of four new cases per 100 000 women annually, cervical cancer could be considered to be eliminated as a public health problem in Australia within the next 20 years. However, screening and vaccination initiatives would need to be maintained thereafter to maintain very low cervical cancer incidence and mortality rates. National Health and Medical Research Council (Australia).

Screen and Triage by Community Extension Workers to Facilitate Screen and Treat: Task-Sharing Strategy to Achieve Universal Coverage for Cervical Cancer Screening in Nigeria.

PurposeUniversal coverage of cervical cancer screening remains elusive in most low- and middle-income countries (LMICs), home to the greatest burden of this preventable disease. Implementation of a cytology-based screening strategy in these countries is challenging. Also, there is shortage of health care workers (HCWs) to implement the low-technology, cheaper, but equally effective, methods like visual inspection with acetic acid. However, the implementation of HIV programs in LMICs has introduced the innovation of task shifting and task sharing, using the community health extension workers (CHEWs) and community health officers (CHOs) to complement clinical HCWs, especially at the primary health care, level with good outcome. Hence, this study leveraged this strategy.MethodsWe piloted a study to improve knowledge and practice skills of CHEWs and CHOs in a rural community of Oyo state, Nigeria, through training and participatory supervision to screen for cervical cancer using visual inspection with acetic acid and link positive cases for treatment with cryotherapy.ResultsA total of 51 HCWs, including doctors, nurses, CHEWs, and CHOs, were trained during the study to provide cervical cancer screening services. After the training, cervical cancer and its prevention knowledge improved from 52.4% before training to 91.5% immediate after training. Over 12 months, 950 eligible women were screened, of whom 848 (89.3%) were screened by CHEWs and CHOs. Of the 63 rescreened by CHEWs and CHOs (data grouped), and nurses, 88.1% and 92.3%, respectively, agreed with expert team review, with κ statistics of 0.76 and 0.84, respectively.ConclusionThis pilot project showed the ability of CHEWs and CHOs to identify cervical dysplasia was good and that of nurses was very good with appropriate competency training to achieve universal coverage of cervical cancer screening in LMICs.

Abstract 2202: Long term risk prediction of p16/Ki-67 dual stain in triage of HPV-positive women

Abstract Background: Human papillomavirus (HPV) testing has been approved as a primary strategy for cervical cancer screening, either alone or in combination with cytology (co-testing), based on its high sensitivity and long-term reassurance against cervical precancer following a negative test result. However, nearly twice as many women will screen positive for HPV compared with cytology-based screening. Thus, effective management of HPV-positive women requires triage markers to distinguish those at high-risk who should be referred to colposcopy from those with benign infections who can safely return to routine screening. p16/Ki-67 dual stain cytology has previously shown good risk stratification for triage of HPV-positive women; however, studies with follow-up extending beyond 3 years are lacking. We evaluated the long-term risk prediction of p16/Ki-67 for detection of cervical precancer (cervical intraepithelial neoplasia grade 3 or worse, CIN3+) in a large population of HPV-positive women. Methods: 1,588 HPV-positive women screened with HPV/cytology co-testing were enrolled in 2012 at Kaiser Permanente Northern California. p16/Ki-67 cytology was performed on residual Surepath material and slides were evaluated for p16/Ki-67 positivity. Cervical histology endpoints were ascertained from the clinical database with follow-up through 2017. We conducted a Kaplan Meier analysis to estimate risk of CIN3+ by p16/Ki-67 and cytology (atypical squamous cells of undetermined significance or worse, ASC-US+, versus normal cytology). Risks were compared to internal benchmarks for colposcopy referral and for a one year return interval. Results: In women testing p16/Ki-67 positive at baseline, the 2-year risk of CIN3+ was 14.3%, compared with 2.2% in p16/Ki-67-negative women. For ASC-US+, the risk was 12.6% and 2.9% for normal cytology. The 5-year risk of CIN3+ in p16/Ki-67-positive women was 21.6% and 5.0% in p16/Ki-67-negatives. The 5-year risk of ASC-US+ was 17.1% compared to 8.2% for normal cytology. Among p16/Ki-67-negatives, the risk remained below the colposcopy referral threshold for 5 years while in women with normal cytology, the colposcopy referral threshold was crossed after year 3. Conclusion: In the first study evaluating long-term risk stratification of p16/Ki-67 dual staining, p16/Ki-67- negativity provided strong reassurance against CIN3+ for at least five years. In contrast, the risk in women with normal cytology crossed the colposcopy referral threshold after three years. These data support use of p16/Ki-67 for triage of HPV-positive women with the possibility of extending surveillance intervals in p16/Ki-67-negative women. Citation Format: Megan A. Clarke, Barbara Fetterman, Mark Schiffman, Philip E. Castle, Eric Stiemerling, Diane Tokugawa, Nancy Poitras, Walter Kinney, Thomas Lorey, Nicolas Wentzensen. Long term risk prediction of p16/Ki-67 dual stain in triage of HPV-positive women [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2018; 2018 Apr 14-18; Chicago, IL. Philadelphia (PA): AACR; Cancer Res 2018;78(13 Suppl):Abstract nr 2202.

Barriers to Cervical Cancer Screening and the Cervical Cancer Care Continuum in Rural Guatemala: A Mixed-Method Analysis.

PurposeCervical cancer is an important cause of mortality in low- and middle-income countries. Although screening technologies continue to improve, systems of care remain fragmented. It is important to better understand factors that affect use of screening services and loss to follow-up along the care continuum.MethodsWe conducted a mixed-methods study of a cytology-based screening program in rural Guatemala. A retrospective electronic chart review was performed on data from all patients from 2013 to 2014. We analyzed progression through care and calculated loss–to–follow-up rates. We also analyzed the prior experiences of patients with cervical cancer screening on the basis of self-reported historical data available in the chart review. Structured interviews with a subset of individuals to explore social supports and barriers to screening and engagement in care were conducted at the time of screening.ResultsThe analysis included 515 women (median age, 36 years). Cytologic screening showed concern for neoplastic changes in 0.83%; half resulted in biopsy-proven cervical intraepithelial neoplasia. An additional 9.9% showed severe inflammation. The rate of loss to follow–up was 11.3%. All losses to follow-up occurred for severe inflammation, not for cervical intraepithelial neoplasia. Historical data showed that 73% of the cohort had previously been screened and had high levels of loss to follow-up (57.4%). Qualitative interviews revealed factors that promoted loss to follow-up; these included cost, lack of social supports, transportation, distrust in public facilities, long turn-around times, and failure to return test results or offer follow-up treatments.ConclusionsTaken together, these quantitative and qualitative results highlight the need for cervical cancer screening programs in Guatemala to improve uptake of screening services by eligible women and to improve follow-up after a first abnormal screen.

Screen and Triage to Facilitate Screen and Treat by Community Health Extension Workers: Task-Sharing Strategy to Achieve Universal Cervical Cancer Screening in Nigeria

Abstract 31 Purpose Universal access to cervical cancer screening remains elusive in most low- to middle-income countries, which shoulder the greatest burden of this preventable disease. Whereas a cytology-based screening strategy is logistically impossible, the shortage of health care workers (HCWs) and appropriate training limit the implementation of cheaper and equally effective methods, such as visual inspection after application of acetic acid (VIA); however, effective use of task shifting and sharing to involve community health extension workers (CHEWs) in HIV program delivery in low- to middle-income countries has brought innovation to bear in overcoming the HCW shortage. Hence, this study leveraged this novel strategy to pilot the provision of cervical cancer screening by CHEWs in Nigeria. The current study aimed to train and support the available health care workforce in rural communities to achieve population coverage for cervical cancer screening and reduce the cervical cancer burden in Nigeria. Methods We piloted improving the knowledge and practice skills of CHEWs/CHOs in a rural local government area of Oyo state, Nigeria, to provide community-level cervical cancer screening service. Improvement in knowledge and skills was accomplished through training, technical and infrastructural support, and participatory supervision for HCWs in the PHCs and general hospital in the local government area using the VIA method and by linking VIA-positive cases to the general hospital to screen and treat. Results Fifty-one HCWs, including physicians, nurses, and CHEWs/CHOs, were trained with five PHCs, and the general hospital was provided with materials with which to administer cervical cancer screening services. Participants’ knowledge improved from an average of 50.5% at pretraining to 88.8% immediately post-training. Of the 950 eligible women who were screened in 1 year, 848 (89.3%) were screened by CHEWs/CHOs. Of the 66 who were screened as VIA positive by CHEWs/CHOs, 58 (88.1%) agreed with the supervisory team review compared with 18 (92.3%) of 19 who were screened by nurses (κ statistics, 0.84 and 0.76, respectively). Three cases of invasive cervical cancer were diagnosed during this period, two of which were by CHEWs/CHOs. Conclusion This pilot project demonstrated that, with appropriate competency training and necessary support, CHEWs/CHOs can successfully identify cervical dysplasia. These HCWs are important resources to leverage to achieve universal coverage of cervical cancer screening services in Nigeria. We plan to expand this program to involve the seven health zones in Oyo state, Nigeria, in a hub and spoke manner to establish its wider feasibility. AUTHORS' DISCLOSURES OF POTENTIAL CONFLICTS OF INTEREST No COIs from the authors.

An overview of cervical cancer epidemiology and prevention in Scandinavia.

New technologies such as human papillomavirus (HPV) testing and vaccination necessitate comprehensive policy analyses to optimize cervical cancer prevention. To inform future Scandinavian-specific policy analyses, we aimed to provide an overview of cervical cancer epidemiology and existing prevention efforts in Denmark, Norway and Sweden. We compiled and summarized data on current prevention strategies, population demography and epidemiology (for example, age-specific HPV prevalence and cervical cancer incidence over time) for each Scandinavian country by reviewing published literature and official guidelines, performing registry-based analyses using primary data and having discussions with experts in each country. In Scandinavia, opportunistic screening occurred as early as the 1950s and by 1996, all countries had implemented nationwide organized cytology-based screening. Prior to implementation of widespread screening and during 1960-66, cervical cancer incidence was considerably higher in Denmark than in Norway and Sweden. Decades of cytology-based screening later (i.e. 2010-2014), cervical cancer incidence has been considerably reduced and has converged across the countries since the 1960s, although it still remains lowest in Sweden. Generally, Scandinavian countries face similar cervical cancer burdens and utilize similar prevention approaches; however, important differences remain. Future policy analyses will need to evaluate whether these differences warrant differential prevention policies or whether efforts can be streamlined across Scandinavia.

Impact of replacing cytology with human papillomavirus testing for cervical cancer screening on the prevalence of Trichomonas vaginalis: a modelling study

ObjectivesTrichomonas vaginalis (TV) is the most common curable STI worldwide and is associated with increased risk of HIV acquisition and serious reproductive morbidities. The prevalence of TV infection is very...

Assessment of the Roche Linear Array HPV Genotyping Test within the VALGENT framework

BackgroundCervical cancer screening programs are switching from cytology-based screening to high-risk (hr) HPV testing. Only clinically validated tests should be used in clinical practice. ObjectivesTo assess the clinical performance of the Roche Linear Array HPV genotyping test (Linear Array) within the VALGENT-3 framework. Study designThe VALGENT framework is designed for comprehensive comparison and clinical validation of HPV tests that have limited to extended genotyping capacity. The Linear Array enables type-specific detection of 37 HPV types. For the purpose of this study, Linear Array results were designated as positive only if one of the 13 hrHPV types also included in the Hybrid Capture 2 (HC2) was detected. The VALGENT-3 framework comprised 1600 samples obtained from Slovenian women (1300 sequential cases from routine cervical cancer screening enriched with 300 cytological abnormal samples). Sensitivity for cervical intraepithelial neoplasia of grade 2 or worse (CIN2+) (n=127) and specificity for <CIN2 (n=1216) were assessed for Linear Array and for HC2 and non-inferiority of Linear Array relative to HC2 was checked. In addition, the prevalence of separate hrHPV types in the screening population, as well as the concordance for presence of HPV16, HPV18 and other hrHPV types between Linear Array and the Abbott RealTime High Risk HPV test (RealTime) were assessed. ResultsThe clinical sensitivity and specificity for CIN2+ of the Linear Array in the total study population was 97.6% (95% CI, 93.3–99.5%) and 91.7% (95% CI, 90.0–93.2%), respectively. The relative sensitivity and specificity of Linear Array vs HC2 was 1.02 [95% CI, 0.98–1.05, (p<0.001)] and 1.02 [95% CI, 1.01–1.03, (p<0.001)], respectively The overall prevalence of hrHPV using the Linear Array in the screening population was 10.5% (95% CI, 8.9–12.3%) with HPV16 and HPV18 detected in 2.3% and 0.9% of the samples, respectively. Excellent agreement for presence or absence of HPV16, HPV18 and other hrHPV between Linear Array and RealTime was observed. ConclusionsLinear Array showed similar sensitivity with higher specificity to detect CIN2+ compared to HC2. Detection of 13 hrHPV types with Linear Array fulfils the clinical accuracy requirements for primary cervical cancer screening.

High-grade cervical intraepithelial neoplasia in human papillomavirus self-sampling of screening non-attenders

Background:Self-sampling for human papillomavirus (HPV) offered to women who do not participate in cervical cancer screening is an increasingly popular method to increase screening coverage. The rationale behind self-sampling is that unscreened women harbour a high proportion of undetected precancer lesions. Here, we compare the cervical intraepithelial neoplasia grade 2 or worse (⩾CIN2) detection rate between non-attenders who participated in self-sampling and women attending routine screening.Methods:A total of 23 632 women who were qualified as non-attenders in the Copenhagen Region were invited for HPV-based self-sampling. Of these, 4824 women returned a self-sample, and HPV-positive women were referred for cytology and HPV co-testing as follow-up. The entire cohort and a reference cohort (3347 routinely screened women) were followed for histopathology confirmed ⩾CIN2. Odds ratio (OR) and the relative positive predictive value of ⩾CIN2 detection between the two populations were estimated.Results:Women participating in self-sampling had a higher ⩾CIN2 detection than women undergoing routine cytology-based screening (OR=1.83, 95% CI: 1.21–2.77) and a similar detection as routinely screened women tested with cytology and HPV testing (OR=1.03, 95% CI: 0.75–1.40). The positive predictive value for ⩾CIN2 was higher in screening non-attenders than in routinely HPV- and cytology-screened screened women (36.5% vs 25.6%, respectively).Conclusions:Self-sampling offered to non-attenders showed higher detection rates for ⩾CIN2 than routine cytology-based screening, and similar detection rates as HPV and cytology co-testing. This reinforces the importance of self-sampling for screening non-attenders in organised cervical cancer screening.

Barriers to HPV self-sampling and cytology among low-income indigenous women in rural areas of a middle-income setting: a qualitative study

BackgroundData is needed about barriers to self-collection of Human Papillomavirus (HPV) samples and cytology among low-income, disadvantaged women living in rural areas of lower-income countries as these women are at increased risk of cervical cancer mortality.MethodsIndividual interviews (n = 29), focus groups (n = 7, 5–11 participants) and discussion groups (n = 2, 18–25 participants) were organized with women from three indigenous ethnic groups residing in rural areas in Mexico, after they were provided with free, self-sampled HPV tests. These groups are low-income, underserved by healthcare and have historically been on the receiving end of racism and social exclusion. Descriptive, qualitative content analysis was done, including two cycles of coding.ResultsInterview and focus/discussion group data indicate women had limited understanding of HPV’s role in cervical cancer etiology. They identified HPV’s existence, that cytology detects cervical cancer, the need for regular testing and that cervical cancer is sexually transmitted. Organizational barriers to clinic-based cytology included irregular supplies of disposable speculums, distance to clinics and lack of clear communication by healthcare personnel. Women considered self-collected HPV-testing easy, less embarrassing and less painful than cytology, an opportunity for self-care and most felt they understood how to take a self-sample after a 20-min explanation. Some women feared hurting themselves when taking the self-sample or that they would take the sample incorrectly, which they worried would make the test useless. Attending HPV-testing in groups facilitated use by allowing women to discuss their doubts and fears before doing self-collection of the sample or to ask other women who were the first to do the self-sampling what the experience had been like (whether it hurt and how easy it was). Lack of indoor bathrooms was a barrier to doing HPV self-sampling at home, when those homes were resource-poor (one-room dwellings).ConclusionsLow-income, indigenous Mexican women residing in rural, underserved areas identified their need for cervical cancer screening but encountered multiple barriers to cytology-based screening. They found a number of advantages of HPV self-sampled tests. Employing self-collected HPV-testing instead of cytology could resolve some but not all gender-related, organizational or technical quality-of-care issues within cervical cancer detection and control programs.