The effect of a self-sampling device for human papillomavirus (HPV) test on the women's participation to cervical cancer screening in Italy

Primary screening based on detection of human papillomavirus (HPV) has proved to be more sensitive than cytology for the detection of high-grade cervical intraepithelial neoplasia (CIN). Self-sampling for specimen collection may also improve the participation rate, especially in the non-responder group. However, HPV is highly prevalent and therefore HPV detection has a lower specificity in cervical cancer screening than cytology. In addition to the clinically validated HPV test, HPV dynamics should be taken into account. It is important to identify women with a chronic productive infection likely to cause, or to already have caused, high-grade CIN or cervical carcinoma, and to limit overtreatment of women with a transient infection. Furthermore, the introduction of the HPV vaccine is likely to lower the incidence of CIN and cervical carcinoma, which will lower the positive predictive value of cervical cancer screening. This potential impact needs to be taken into account when planning for future screening guidelines.

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De-implementation and Substitution of Clinical Care Processes: Stakeholder Perspectives on the Transition to Primary Human Papillomavirus (HPV) Testing for Cervical Cancer Screening

10.21203/rs.3.rs-318847/v1 ◽

2021 ◽

Author(s):

Erin E Hahn ◽

Corrine Munoz-Plaza ◽

Danielle Altman ◽

Chunyi Hsu ◽

Nancy Cannizzaro ◽

...

Keyword(s):

Cervical Cancer ◽

Human Papillomavirus ◽

Clinical Practice ◽

Cancer Screening ◽

Cervical Cancer Screening ◽

Readiness To Change ◽

Barriers And Facilitators ◽

Hpv Testing ◽

Cost Cutting ◽

Hpv Test

Abstract Background: New cervical cancer screening guidelines recommend primary human papillomavirus (HPV) testing for women age 30-65 years. Healthcare organizations are preparing to de-implement the previous recommended strategies of Pap testing or co-testing (Pap plus HPV test) and substitute primary HPV testing. However, there may be significant challenges to replacement of this entrenched clinical practice, even with an evidence-based substitution. We sought to identify stakeholder-perceived barriers and facilitators to this substitution within a large healthcare system, Kaiser Permanente Southern California.Methods: We conducted semi-structured qualitative interviews with clinician, administrative and patient stakeholders regarding: (a) acceptability and feasibility of the planned substitution; (b) perceptions of barriers and facilitators, with an emphasis on those related to the de-implementation/implementation cycle of substitution; and (c) perceived readiness to change. Our interview guide was informed by the Consolidated Framework for Implementation Research (CFIR). Using a team coding approach, we developed an initial coding structure refined during iterative analysis; the data were subsequently organized thematically into domains, key themes, and sub-themes using thematic analysis, followed by framework analysis informed by CFIR.Results: We conducted 23 interviews: 5 patient and 18 clinical/administrative. Clinicians perceived that patients feel more tests equals better care, and clinicians and patients expressed fear of missed cancers (“…it’ll be more challenging convincing the patient that only one test is…good enough to detect cancer.”). Patients perceived practice changes resulting in “less care” are driven by desire to cut costs. In contrast, clinicians/administrators viewed changing from two tests to one as acceptable and a workflow efficiency (“…It’s very easy and half the work.”). Stakeholder-recommended strategies included focusing on the increased efficacy of primary HPV testing and developing clinician talking points incorporating national guidelines to assuage ‘cost-cutting’ fears. Conclusions: Substitution to replace an entrenched clinical practice is complex. Leveraging available facilitators is key to ease the process for clinical and administrative stakeholders—e.g., emphasizing the efficiency of going from two tests to one. Identifying and addressing clinician and patient fears regarding cost-cutting and perceived poorer quality of care is critical for substitution. Multicomponent and multilevel strategies for engagement and education will be required.Trial registration: ClinicalTrials.gov #NCT04371887

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The Role of Human Papillomavirus Genotyping in Cervical Cancer Screening: A Large-Scale Evaluation of the cobas HPV Test

Cancer Epidemiology Biomarkers & Prevention ◽

10.1158/1055-9965.epi-14-1353 ◽

2015 ◽

Vol 24 (9) ◽

pp. 1304-1310 ◽

Cited By ~ 31

Author(s):

Mark Schiffman ◽

Sean Boyle ◽

Tina Raine-Bennett ◽

Hormuzd A. Katki ◽

Julia C. Gage ◽

...

Keyword(s):

Cervical Cancer ◽

Human Papillomavirus ◽

Cancer Screening ◽

Cervical Cancer Screening ◽

Large Scale ◽

Scale Evaluation ◽

Hpv Test

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Point-Counterpoint: Cervical Cancer Screening Should Be Done by Primary Human Papillomavirus Testing with Genotyping and Reflex Cytology for Women over the Age of 25 Years

Journal of Clinical Microbiology ◽

10.1128/jcm.01087-15 ◽

2015 ◽

Vol 53 (9) ◽

pp. 2798-2804 ◽

Cited By ~ 23

Author(s):

Mark H. Stoler ◽

R. Marshall Austin ◽

Chengquan Zhao

Keyword(s):

Cervical Cancer ◽

Human Papillomavirus ◽

Cancer Screening ◽

Cervical Cancer Screening ◽

Positive Likelihood Ratio ◽

Pap Test ◽

The United States ◽

Primary Screening ◽

Screening Algorithm ◽

Hpv Test

Screening for cervical cancer with cytology testing has been very effective in reducing cervical cancer in the United States. For decades, the approach was an annual Pap test. In 2000, the Hybrid Capture 2 human papillomavirus (HPV) test was approved by the U.S. Food and Drug Administration (FDA) for screening women who have atypical squamous cells of underdetermined significance (ASCUS) detected by Pap test to determine the need for colposcopy. In 2003, the FDA approved expanding the use of the test to include screening performed in conjunction with a Pap test for women over the age of 30 years, referred to as “cotesting.” Cotesting allows women to extend the testing interval to 3 years if both tests have negative results. In April of 2014, the FDA approved the use of an HPV test (the cobas HPV test) for primary cervical cancer screening for women over the age of 25 years, without the need for a concomitant Pap test. The approval recommended either colposcopy or a Pap test for patients with specific high-risk HPV types detected by the HPV test. This was based on the results of the ATHENA trial, which included more than 40,000 women. Reaction to this decision has been mixed. Supporters point to the fact that the primary-screening algorithm found more disease (cervical intraepithelial neoplasia 3 or worse [CIN3+]) and also found it earlier than did cytology or cotesting. Moreover, the positive predictive value and positive-likelihood ratio of the primary-screening algorithm were higher than those of cytology. Opponents of the decision prefer cotesting, as this approach detects more disease than the HPV test alone. In addition, the performance of this new algorithm has not been assessed in routine clinical use. Professional organizations will need to develop guidelines that incorporate this testing algorithm. In this Point-Counterpoint, Dr. Stoler explains why he favors the primary-screening algorithm, while Drs. Austin and Zhao explain why they prefer the cotesting approach to screening for cervical cancer.

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High Acceptability of Human Papillomavirus Self-Sampling Among Nonattenders of a Public Cervical Cancer Screening Program in El Salvador

Journal of Global Oncology ◽

10.1200/jgo.18.50000 ◽

2018 ◽

Vol 4 (Supplement 1) ◽

pp. 13s-13s

Author(s):

Mauricio Maza ◽

Mario Melendez ◽

Miriam Cremer ◽

Rachel Masch ◽

Todd Alonzo ◽

...

Keyword(s):

Cervical Cancer ◽

Human Papillomavirus ◽

Cancer Screening ◽

El Salvador ◽

Cancer Prevention ◽

Cervical Cancer Screening ◽

Rural Women ◽

Cervical Cancer Prevention ◽

Middle Income ◽

Hpv Test

Abstract 29 Purpose In high-income countries, human papillomavirus (HPV) self-sampling has been demonstrated to increase adherence to cervical cancer prevention initiatives in underscreened women. El Salvador recently completed the Cervical Cancer Prevention in El Salvador (CAPE) program using a high-risk HPV test as the screening method. Although successful, 12% of targeted women did not attend their screening appointments. HPV self-sampling may offer the opportunity to reach these nonattending women. In the current study, we evaluated HPV self-sampling as a way to increase screening among CAPE nonattenders and to report factors that impact self-sampling acceptability in a low- to middle-income country. Methods Nonattending and underscreened women age 30 to 59 years from the Paracentral region of El Salvador were invited to participate (N = 2,019). Women were visited at home and offered self-sampling with an HPV test. Women who provided consent also received a series of questionnaires to collect demographic and test acceptability data. After tests were analyzed, women were provided with results during another home visit. HPV-positive women were asked to make an appointment at a local clinic to undergo colposcopy, biopsy, and, if eligible, cryotherapy treatment. Women with contraindications for cryotherapy were referred to appropriate treatment or follow-up. Results Of 1,989 eligible women, 94% accepted the HPV self-sampled test. Of these, 11.8% (n = 221) tested positive. All but 13 women attended the colposcopy appointment, and 190 women received cryotherapy. Biopsy results revealed low-grade precancer in 6.3% of women, whereas 12.6% received diagnoses of high-grade precancer. Reasons for not attending the original CAPE appointment included logistic concerns, but also discomfort with male providers, confidentiality fears, and misconceptions regarding HPV, cervical cancer, and the screening procedure. Conclusion HPV self-sampling was shown to be overwhelmingly acceptable to nonattending and underscreened rural women in El Salvador. This method may be a feasible alternative that circumvents barriers to cervical cancer screening in low- to middle-income countries. AUTHORS' DISCLOSURES OF POTENTIAL CONFLICTS OF INTEREST No COIs from the authors

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Persistent Disparities in Cervical Cancer Screening Uptake: Knowledge and Sociodemographic Determinants of Papanicolaou and Human Papillomavirus Testing Among Women in the United States

Public Health Reports ◽

10.1177/0033354920925094 ◽

2020 ◽

Vol 135 (4) ◽

pp. 483-491

Author(s):

Nicole L. Johnson ◽

Katharine J. Head ◽

Susanna Foxworthy Scott ◽

Gregory D. Zimet

Keyword(s):

United States ◽

Cervical Cancer ◽

Health Insurance ◽

Human Papillomavirus ◽

Cancer Screening ◽

Cervical Cancer Screening ◽

Pap Test ◽

The United States ◽

Populations At Risk ◽

Hpv Test

Objectives Cervical cancer is the second-most common type of cancer among women aged 15-44, and racial, ethnic, and economic disparities exist in survival rates despite widely available screening tests and early treatment options. The objective of this study was to describe the association among knowledge, sociodemographic characteristics, and cervical cancer screening, with the goal of developing interventions to prevent cervical cancer in populations at risk of the disease. Methods In 2017, we conducted a nationwide survey of women in the United States aged ≥18 who had ever received a Papanicolaou (Pap) test (N = 630). We conducted t tests and one-way analysis of variance to determine sociodemographic differences (age, education, race, ethnicity, income, type of health insurance) in knowledge about cervical cancer screening (Pap test and human papillomavirus [HPV] test). We used logistic regressions to define significant determinants of cervical cancer screening behaviors in the previous 5 years. Results Of 629 respondents, 407 (64.7%) had an annual household income <$30 000, and 322 of 536 (60.1%) respondents had government-provided health insurance. Of 630 women who had ever had a Pap test, 425 (67.5%) had an HPV test. Hispanic and non-Hispanic white women were more likely than Hispanic and non-Hispanic black women (odds ratio [OR] = 2.49; 95% CI, 1.12-4.54; P = .02) and women with government-provided health insurance (OR = 1.91; 95% CI, 1.08-3.37; P = .03) were more likely than women with private health insurance to have received a Pap test in the previous 5 years. Knowledge of HPV was a significant predictor of having received an HPV test in the previous 5 years (OR = 1.37; 95% CI, 1.22-1.54; P < .001). Conclusion Disparities in cervical cancer screening among sociodemographic groups of women suggest the need for targeted interventions to improve knowledge about Pap and HPV tests.

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De-implementation and substitution of clinical care processes: stakeholder perspectives on the transition to primary human papillomavirus (HPV) testing for cervical cancer screening

Implementation Science Communications ◽

10.1186/s43058-021-00211-z ◽

2021 ◽

Vol 2 (1) ◽

Author(s):

Erin E. Hahn ◽

Corrine Munoz-Plaza ◽

Danielle E. Altman ◽

Chunyi Hsu ◽

Nancy T. Cannizzaro ◽

...

Keyword(s):

Cervical Cancer ◽

Human Papillomavirus ◽

Clinical Practice ◽

Cancer Screening ◽

Cervical Cancer Screening ◽

Readiness To Change ◽

Barriers And Facilitators ◽

Hpv Testing ◽

Cost Cutting ◽

Hpv Test

Abstract Background New cervical cancer screening guidelines recommend primary human papillomavirus (HPV) testing for women age 30–65 years. Healthcare organizations are preparing to de-implement the previous recommended strategies of Pap testing or co-testing (Pap plus HPV test) and substitute primary HPV testing. However, there may be significant challenges to the replacement of this entrenched clinical practice, even with an evidence-based substitution. We sought to identify stakeholder-perceived barriers and facilitators to this substitution within a large healthcare system, Kaiser Permanente Southern California. Methods We conducted semi-structured qualitative interviews with clinician, administrative, and patient stakeholders regarding (a) acceptability and feasibility of the planned substitution; (b) perceptions of barriers and facilitators, with an emphasis on those related to the de-implementation/implementation cycle of substitution; and (c) perceived readiness to change. Our interview guide was informed by the Consolidated Framework for Implementation Research (CFIR). Using a team coding approach, we developed an initial coding structure refined during iterative analysis; the data were subsequently organized thematically into domains, key themes, and sub-themes using thematic analysis, followed by framework analysis informed by CFIR. Results We conducted 23 interviews: 5 patient and 18 clinical/administrative. Clinicians perceived that patients feel more tests equals better care, and clinicians and patients expressed fear of missed cancers (“…it’ll be more challenging convincing the patient that only one test is…good enough to detect cancer.”). Patients perceived practice changes resulting in “less care” are driven by the desire to cut costs. In contrast, clinicians/administrators viewed changing from two tests to one as acceptable and a workflow efficiency (“…It’s very easy and half the work.”). Stakeholder-recommended strategies included focusing on the increased efficacy of primary HPV testing and developing clinician talking points incorporating national guidelines to assuage “cost-cutting” fears. Conclusions Substitution to replace an entrenched clinical practice is complex. Leveraging available facilitators is key to ease the process for clinical and administrative stakeholders—e.g., emphasizing the efficiency of going from two tests to one. Identifying and addressing clinician and patient fears regarding cost-cutting and perceived poorer quality of care is critical for substitution. Multicomponent and multilevel strategies for engagement and education will be required. Trial registration ClinicalTrials.gov, #NCT04371887

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Cost-Effectiveness of Human Papillomavirus DNA Testing for Cervical Cancer Screening in Women Aged 30 Years or More

Obstetrics and Gynecology ◽

10.1097/01.aog.0000120143.50098.c7 ◽

2004 ◽

Vol 103 (4) ◽

pp. 619-631 ◽

Cited By ~ 139

Author(s):

Sue J. Goldie ◽

Jane J. Kim ◽

Thomas C. Wright

Keyword(s):

Cervical Cancer ◽

Human Papillomavirus ◽

Cost Effectiveness ◽

Cancer Screening ◽

Cervical Cancer Screening ◽

Dna Testing ◽

Papillomavirus Dna

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Effect of introducing human papillomavirus genotyping into real-world screening on cervical cancer screening in China: a retrospective population-based cohort study

Therapeutic Advances in Medical Oncology ◽

10.1177/17588359211010939 ◽

2021 ◽

Vol 13 ◽

pp. 175883592110109

Author(s):

Binhua Dong ◽

Huachun Zou ◽

Xiaodan Mao ◽

Yingying Su ◽

Hangjing Gao ◽

...

Keyword(s):

Cervical Cancer ◽

Cohort Study ◽

Human Papillomavirus ◽

Cancer Screening ◽

Cervical Cancer Screening ◽

Cox Regression ◽

Intraepithelial Neoplasia ◽

Population Based ◽

Hpv Genotyping ◽

Cytology Screening

Background: China’s Fujian Cervical Pilot Project (FCPP) transitioned cervical cancer screening from high-risk human papillomavirus (HR-HPV) nongenotyping to genotyping. We investigated the clinical impact of this introduction, comparing performance indicators between HR-HPV genotyping combined with cytology screening (HR-HPV genotyping period) and the previous HR-HPV nongenotyping combined with cytology screening (HR-HPV nongenotyping period). Methods: A retrospective population-based cohort study was performed using data from the FCPP for China. We obtained data for the HR-HPV nongenotyping period from 1 January 2012 to 31 December 2013, and for the HR-HPV genotyping period from 1 January 2014 to 31 December 2016. Propensity score matching was used to match women from the two periods. Multivariable Cox regression was used to assess factors associated with cervical intraepithelial neoplasia of grade 2 or worse (CIN2+). The primary outcome was the incidence of CIN2+ in women aged ⩾25 years. Performance was assessed and included consistency, reach, effectiveness, adoption, implementation and cost. Results: Compared with HR-HPV nongenotyping period, in the HR-HPV genotyping period, more CIN2+ cases were identified at the initial screening (3.06% versus 2.32%; p < 0.001); the rate of colposcopy referral was higher (10.87% versus 6.64%; p < 0.001); and the hazard ratio of CIN2+ diagnosis was 1.64 (95% confidence interval, 1.43–1.88; p < 0.001) after controlling for health insurance status and age. The total costs of the first round of screening (US$66,609 versus US$65,226; p = 0.293) were similar during the two periods. Higher screening coverage (25.95% versus 25.19%; p = 0.007), higher compliance with age recommendations (92.70% versus 91.69%; p = 0.001), lower over-screening (4.92% versus 10.15%; p < 0.001), and reduced unqualified samples (cytology: 1.48% versus 1.73%, p = 0.099; HR-HPV: 0.57% versus 1.34%, p < 0.001) were observed in the HR-HPV genotyping period. Conclusions: Introduction of an HR-HPV genotyping assay in China could detect more CIN2+ lesions at earlier stages and improve programmatic indicators. Evidence suggests that the introduction of HR-HPV genotyping is likely to accelerate the elimination of cervical cancer in China.

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