Primary Human Papillomavirus Testing Research Articles

Risk of high-grade cervical lesions in the second round of primary human papillomavirus testing in CervicalScreen Norway: A population-based cohort study.

As many countries are transitioning from cytology to human papillomavirus (HPV) testing as the primary cervical cancer screening test, we evaluated the impact of cumulative HPV screening during the implementation of HPV screening in the Norwegian cervical cancer screening programme (CervicalScreen Norway). Data from the second HPV screening round was compared with data from the first round. The second-round analyses included only women who returned to routine screening 4-6 years following a negative HPV test in the first round. Associations between screening rounds and HPV positivity, cytology results, and follow-up recommendations were estimated by multinomial logistic regression, and relative risks of cervical intraepithelial neoplasia, grade 3 or worse (CIN3+) by Cox regression. There was a 42% lower risk of being HPV positive in the second screening round compared to the first (age-adjusted relative risk ratio (aRRR) 0.58, 95% confidence interval (CI) 0.53 to 0.65), and a 70% lower risk of having high-grade cytology among HPV16 positive women (0.30, 0.12 to 0.78). There was also a 51% reduction in referrals for immediate colposcopy (0.49, 0.39 to 0.62). The overall risk of CIN3+ was 71% lower in the second round compared to the first (age-adjusted hazard ratio [aHR] 0.29, 95%CI 0.21-0.40), and lower among HPV16 and other high-risk HPV positive women, but not among HPV18 positives. No cervical cancers were diagnosed in the second round (mean follow-up 2.4 years). Our findings indicate that HPV test results from previous screening rounds should be considered when designing optimal screening algorithms.

P16/ki-67 dual stain triage of individuals positive for HPV to detect cervical precancerous lesions.

p16/Ki-67 dual stain is a biomarker-based test that can identify oncogenic transformation in cervical cells with higher sensitivity than cervical cytology, using the same samples taken for human papillomavirus (HPV) testing and liquid-based cytology. Dual stain is approved by the US Food and Drug Administration (FDA) for triage of women with positive results by primary HPV testing or by HPV/cytology co-testing and has recently been incorporated into management guidelines. In this review, we summarize the data showing the utility of dual stain in detecting precancers, reducing the number of unnecessary colposcopies, and reassuring women who test negative. We also discuss the implications of dual stain for future treatment practice and health economics.

Applying Results of Extended Genotyping to Management of Positive Cervicovaginal Human Papillomavirus Test Results: Enduring Guidelines.

The Enduring Consensus Cervical Cancer Screening and Management Guidelines Committee developed recommendations for the use of extended genotyping results in cervical cancer prevention programs. Risks of cervical intraepithelial neoplasia grade 3 or worse were calculated using data obtained with the Onclarity HPV Assay from large cohorts. Management recommendations were based on clinical action thresholds developed for the 2019 American Society for Colposcopy and Cervical Pathology Risk-Based Management Consensus Guidelines. Risk estimates were reviewed in relation to clinical action thresholds and used as the basis for draft recommendations. After an open comment period, recommendations were finalized and ratified through a vote by the Consensus Stakeholder Group. Colposcopy is recommended after positive tests for human papillomavirus (HPV) types 16 and 18. For those positive for HPV 45, 33/58, 31, 52, 35/39/68, or 51 but negative for 16 or 18, triage with cytology or dual stain testing is recommended. When screening with primary HPV testing, for patients who test positive for HPV types 56/59/66 and no other carcinogenic types, repeat HPV testing in 1 year is recommended. When screening with cotesting, for those who test positive for HPV types 56/59/66 and no other carcinogenic types, 1-year return is recommended for negative for intraepithelial lesion or malignancy, atypical squamous cells of undetermined significance, and low-grade squamous intraepithelial lesion, and colposcopy is recommended for atypical squamous cells cannot exclude high-grade squamous intraepithelial lesion (ASC-H), atypical glandular cells, high-grade squamous intraepithelial lesion, or carcinoma. When patients without prior high-grade cytology (atypical squamous cells cannot exclude high-grade squamous intraepithelial lesion, atypical glandular cells, high-grade squamous intraepithelial lesion, or carcinoma) or histology (cervical intraepithelial neoplasia [CIN]2, CIN3, or adenocarcinoma in situ) are being followed, use of extended genotyping results is acceptable. When high-grade cytology or histology results are present, or when patients are being followed after treatment of CIN2+, management using the 2019 guidelines is recommended. Human papillomavirus extended genotyping can guide clinical management in the setting of a positive HPV test result.

Evaluation of primary HPV-based cervical screening among older women: Long-term follow-up of a randomized healthcare policy trial in Sweden.

Evidence on invasive cervical cancer prevention among older women is limited, especially with the introduction of human papillomavirus (HPV)-based screening and longer interval. We conducted a long-term follow-up of the first phase of a randomized healthcare policy trial in cervical screening, targeting women aged 56 to 61 years old, to investigate the effectiveness of primary HPV-based screening in preventing invasive cervical cancer (ICC) and the safety of extending screening interval. The randomized healthcare policy trial of primary HPV-based cervical screening targeted women residing in Stockholm-Gotland region during 2012 to 2016, aged 30 to 64 years. The trial aimed to investigate the detection rate of cervical intraepithelial neoplasia grade 2 or worse (CIN2+) within 24 months and long-term protection against invasive cervical cancer, comparing primary HPV-based screening to primary cytology-based screening. The initial phase of the trial, which was the focus of this study, targeted women aged 56 to 61 years old in 2012 to 2014 who were randomized to primary cytology arm (n = 7,401) or primary HPV arm (n = 7,318). We used national registries to identify the subsequent cervical tests and all histopathological diagnoses including ICC before December 31, 2022. We calculated cumulative incidence, incidence rate (IR) and IR ratio (IRR) of ICC, by baseline test result. Furthermore, we calculated longitudinal sensitivity and specificity for detecting cervical intraepithelial neoplasia grade 2 or worse (CIN2+) by receipt of primary cytology or primary HPV test for the recommended screening intervals in this age group. We found that the IR of ICC among women in the primary HPV arm was 7.2/100,000 person-years (py) and 3.0 for women who tested HPV negative, compared to 18.4/100,000 py among women in the primary cytology arm and 18.8 for women who tested cytology negative. We further found that the overall point estimate for the risk of ICC over 10 years of follow-up among women in the primary HPV arm was 0.39 compared to women in the primary cytology arm, but this was not statistically significant (IRR: 0.39; 95% confidence interval, CI [0.14, 1.09]; p = 0.0726). However, among women with a negative test result at baseline, women in the primary HPV arm had an 84% lower risk of ICC compared to women in the primary cytology arm (IRR: 0.16; 95% CI [0.04, 0.72]; p = 0.0163). Moreover, primary HPV testing had a higher sensitivity for detecting CIN2+ within a 7-year interval than primary cytology testing within a 5-year interval (89.6% versus 50.9%, p < 0.0001). We were limited by a partial imbalance of invitations during the follow-up between the 2 arms which may have led to an underestimation of the effectiveness of primary HPV-based screening. In this study, we observed that women over 55 years of age who received a primary negative HPV test result had substantially lower risk of CIN2+, and ICC, compared to women who received a primary negative cytology result. This should apply even if the screening interval were prolonged to 7 years. NCT01511328.

Cervical Cancer Screening: Patient Perspectives on Transitioning to Primary High-Risk Human Papillomavirus Testing Alone.

In 2018, the US Preventive Services Task Force updated cervical cancer screening recommendations to allow for screening every 5 years with primary human papillomavirus (HPV) testing in combination with cytology (cotesting) or every 5 years with primary HPV screening alone. Despite these changes, the uptake of primary HPV screening has been lower than expected. The purpose of this study was to evaluate the patient perspective of an integrated health system transition from cotesting to primary HPV testing among a 30- to 65-year-old cohort. Semistructured phone interviews were conducted from July to December 2023 at Kaiser Permanente Colorado with 16 members aged 30-65 years. Interviews asked about reactions to the forthcoming change in cervical cancer screening, personal concern about cervical cancer risk, feedback on patient-facing education materials, and preference on communication timing and modality. Participants reported concerns about cervical cancer screening intervals, primarily the reduction in frequency leading to underdiagnosis of sexually transmitted infections (STIs). Participants recommended defining the rationale for the change to primary HPV testing in the patient education materials. Participants preferred communication about the change in-clinic between practitioner and patient. The interviews identified key themes, including the differentiation between cervical cancer and STI screening methodologies, potential underdiagnosis of STI and cervical cancer, and the rationale supporting primary HPV testing and associated screening intervals. These qualitative findings can inform health systems of potential patient concerns to address when considering the transition from cotesting every 3 years to primary HPV testing every 5 years for cervical cancer screening.

Modeling HPV self-sampling impact on cervical cancer in East African immigrants

IntroductionCervical cancer screening uptake among East African immigrants (EAI) in the US is low. Offering self-collected samples for human papillomavirus (HPV) testing increases screening coverage among underserved populations, but the potential impact on cervical cancer incidence and mortality is understudied. MethodsA Markov cohort state-transition model was used to predict the impact of primary HPV screening with self-sampling on cervical cancer incidence and mortality among EAI women in Washington state. The model estimated cervical cancer cases and deaths for a hypothetical cohort from ages 25-80 years under alternative screening, diagnostic colposcopy and treatment scenarios. Base case scenarios compared primary HPV testing by clinician-sampling exclusively (standard-of-care, SOC) with self-sampling exclusively, assuming higher screening coverage (70% vs. 63%) but lower colposcopy adherence with self-sampling (67% vs. 83%) with equal treatment coverage of 85%, based on Washington state patient data. Sensitivity analyses with varied coverages, and also the combinations of the two strategies were evaluated. The model was developed and fitted between 2022 and 2024 ResultsIn the base case scenario, an exclusive self-sampling strategy results in 4% higher cervical cancer incidence and mortality compared to the SOC. Self-sampling results in lower cancer incidence and mortality if colposcopy adherence is raised to the level of the SOC and/or if coverage is increased beyond 90%. In scenarios combining clinician- with self-sampling, the benefits of reaching more women with self-sampling are attenuated if more than 34% of screening is done by self-sampling. ConclusionsSelf-sampling has the potential to improve cervical cancer prevention for underserved populations. The impact of the strategy can be enhanced with stronger linkage to follow-up care.

Self-Collection for Primary HPV Testing: Acceptability in a Large Urban Emergency Department

Overdue cervical cancer screening increases the risk of invasive cervical cancer. It is important to identify settings where self-collection for primary human papillomavirus (HPV) testing can be implemented to have high effect on cervical cancer screening among hard-to-reach women with overdue screening. Herein, we examined the acceptability of HPV self-collection, including completion rates, attitudes, and experiences among women seeking noncritical care at a high-volume urban safety-net hospital emergency department (ED) in Houston, Texas, United States. In this single-arm intervention pilot study, we recruited women overdue for cervical cancer screening in the waiting areas of a safety-net hospital ED, seeking noncritical care from November 2023 to April 2024. Participants completed a preintervention survey and were offered an HPV self-collection kit. A postintervention survey followed immediately after HPV self-collection. Nearly 30% (119 of 401) screened for eligibility were overdue for cervical cancer screening. Of these, 93% were enrolled and were predominantly Hispanic, non-US born, and uninsured, with a median age of 45 years (IQR: 37 to 53). HPV self-collection completion rate was 90% (95% CI 82.9% to 94.9%). More than a quarter (27%) of these women had never been screened, and 14% had a screening >10 years prior. Most women who completed the HPV self-collection had positive attitudes and experiences and reported that the kit was easy to use (97%) and would be very willing to use HPV self-collection for regular screening (88%). HPV self-collection for primary cervical cancer screening during noncritical ED visits is possible and highly acceptable among women overdue for cervical cancer screening.

Sensitivity, Specificity, and Cost-Benefit Effect Between Primary Human Papillomavirus Testing, Primary Liquid-Based Cytology, and Co-Testing Algorithms for Cervical Lesions.

Cytology has long been a major screening method for cervical cancer prevention. Human papillomavirus (HPV) testing has recently been introduced for cervical cancer screening, and HPV tests become a major screening method in some countries. To seek the optimal strategy considering the cost-effectiveness for cervical cancer screening, we compared the performance of primary LBC, primary HPV test, and LBC plus HPV co-test in real practice. From March 2016 to June 2018, 3742 patients were included in this study. Liquid-based cytology (LBC), HPV test, and histopathological assessment were performed in 3727, 1063, and 508 cases, respectively. The sensitivity, specificity, and cost-benefit effects of primary HPV, primary LBC, and co-test algorithms were simulated for 317 cases with LBC, HPV, and histopathological results. On the LBC, 13.0% of the cases were diagnosed with atypical squamous cells of undetermined significance or higher grade lesions. In the HPV test, high-risk HPV was found in 43.5%, and 11.9% was positive for HPV type 16 or 18. Among the three simulated algorithms, the co-test demonstrated the best sensitivity (97.5%) and the lowest specificity (50.3%). The primary LBC demonstrated the best specificity (53.5%) and a slightly better sensitivity, compare with the primary HPV (95.1% vs. 93.8%). Using the primary LBC algorithm, 82.0% can be determined without additional HPV test, whereas 50.1% could be determined without additional LBC using the primary HPV algorithm. The primary LBC algorithm for uterine cervical cancer (UCC) screening is comparable to the primary HPV algorithm and has the best cost-benefit effect among the three algorithms.

Promise and Perils of Primary HPV Testing.

Cervical cancer screening has reduced morbidity and mortality in many countries, but efforts to optimize screening modalities and schedules are ongoing. Using data from a randomized trial conducted in British Columbia, Canada, in conjunction with a provincial screening registry, Gottschlich and colleagues demonstrated that the estimated risk for precancerous disease (cervical intraepithelial neoplasia grades 2 or worse) at 8 years following a negative human papillomavirus (HPV) test was similar to the current standard of care (Pap testing after 3 years). The study supports extending screening intervals for those with a negative HPV test beyond currently recommended 5-year intervals. In an ideal world, the resources saved through less frequent routine cervical screening could be redirected to increasing screening uptake and follow-up of abnormalities to improve equity in cervical cancer prevention. However, implementation of extending screening intervals remains less than straightforward in settings with fragmented healthcare systems that lack information systems to support patient call/recall, such as the United States. To achieve the full promise of primary HPV testing, stakeholders at every level must commit to identifying and addressing the diverse spectrum of barriers that undergird existing inequities in care access, appropriately resource implementation strategies, and improve health information systems. See related article by Gottschlich et al., p. 904.

Primary human papillomavirus testing by clinician- versus self-collection: Awareness and acceptance among cervical cancer screening-eligible women.

Primary human papillomavirus (HPV) testing by clinician-collection is endorsed by U.S. guideline organizations for cervical cancer screening, but uptake remains low and insights into patients' understanding are limited. This study aims to primarily address patient awareness of primary HPV screening by clinician-collection and acceptance of primary HPV screening by clinician- and self-collection, and secondarily assess factors associated with awareness and acceptance. Primary care practices affiliated with an academic medical center. A cross-sectional survey study of screening-eligible women aged 30-65 years was conducted to assess awareness and acceptability of primary HPV screening. We analyzed bivariate associations of respondent characteristics with awareness of primary HPV screening by clinician-collection, willingness to have clinician- or self-collected primary HPV testing, and reasons for self-collection preference. Respondents (n = 351; response rate = 23.4%) reported cervical cancer screening adherence of 82.8% but awareness of clinician-collected primary HPV as an option was low (18.9%) and only associated with HPV testing with recent screening (p = 0.003). After reviewing a description of primary HPV screening, willingness for clinician-collected (81.8%) or home self-collected (76.1%) HPV testing was high, if recommended by a provider. Acceptability of clinician-collected HPV testing was associated with higher income (p = 0.009) and for self-collection was associated with higher income (p = 0.002) and higher education (p = 0.02). Higher education was associated with reporting self-collection as easier than clinic-collection (p = 0.02). Women expected self-collection to be more convenient (94%), less embarrassing (85%), easier (85%), and less painful (81%) than clinician-collection. Educational interventions are needed to address low awareness about the current clinician-collected primary HPV screening option and to prepare for anticipated federal licensure of self-collection kits. Informing women about self-collection allows them to recognize benefits which could address screening barriers.

Building Capacity for Cervical Cancer Prevention in U.S.-Affiliated Pacific Islands: The Pacific Against Cervical Cancer Project.

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.

Primary human papillomavirus testing vs cotesting: clinical outcomes in populations with different disease prevalence.

Implementation of primary human papillomavirus (HPV) testing has been slow in the United States perhaps because of concerns of decreased sensitivity compared with concurrent HPV and cytology testing ("cotesting"). We used the National Breast and Cervical Cancer Early Detection Program and the Kaiser Permanente of Northern California cohort to quantify potential trade-offs with primary HPV compared with cotesting in 4 US populations with differing precancer or cancer prevalence. In all settings, cotesting required more lab tests and more colposcopies compared with primary HPV testing. Additional cervical intraepithelial neoplasia grade 3 or cancer immediately detected from cotesting vs primary HPV decreased with decreasing population-average cervical intraepithelial neoplasia grade 3 or cancer prevalence from 71 per 100 000 screened among never or rarely screened individuals in the National Breast and Cervical Cancer Early Detection Program (prevalence = 1212 per 100 000) to 4 per 100 000 screened among individuals with prior HPV-negative results in Kaiser Permanente of Northern California (prevalence = 86 per 100 000). These data suggest that cotesting confer an unfavorable benefit-to-harm ratio over primary HPV testing.

2024 Updates to Cervical Cancer Screening in Canada

The landscape of cervical cancer screening in Canada is about to undergo a major shift from cytology-based screening to testing directly for the presence of high-risk strains of the human papilloma virus (HPV), the persistence of which is known to be a prerequisite for the development of almost all cases of cervical cancer. In 2018, the World Health Organization declared a call to action for the worldwide elimination of cervical cancer by 2040. Subsequently the Canadian Partnership Against Cancer (CPAC) released an action plan outlining the necessary steps for Canada to reach this goal. One of the 3 major priorities identified in the action plan is the transition to primary HPV testing. This transition from screening to testing represents a major shift in infrastructure and also a shift in mindset for clinicians, policymakers, and the public. To help guide this transition, CPAC has collaborated with the Gynecologic Oncology Society of Canada (GOC) and the Society of Canadian Colposcopists (SCC) to release two open-access, evidence‑based guidelines in June 2023. These guidelines address how to manage a positive HPV screening test, and colposcopy in the context of primary HPV‑screening. This paper will outline the evolution of cervical cancer screening in Canada along with the rationale behind the transition to HPV testing. Also included is a discussion on the broad recommendations from the 2023 CPAC/GOC/SCC guidelines, as well as recommendations for age and interval of screening and special populations. Readers of this article in e-journal format can access the Canadian Guideline on the Management of a Positive Human Papillomavirus Test and Guidance for Specific Populations here. Readers may also access the 2023 Canadian Colposcopy Guideline: A Risk-Based Approach to Management and Surveillance of Cervical Dysplasia here.

Attitudes toward the American Cancer Society's 2020 cervical cancer screening guidelines: A qualitative study of a national sample of US clinicians.

The 2020 American Cancer Society (ACS) guidelines are the most recent national guidelines for cervical cancer screening. These guidelines propose two major changes from current practice: initiating screening at age 25 years and using primary human papillomavirus (HPV) testing. Adoption of guidelines often occurs slowly, and therefore understanding clinician attitudes is important to facilitate practice change. Interviews with a national sample of clinicians who perform cervical cancer screening in a variety of settings explored attitudes toward the two major changes from the 2020 ACS cervical cancer screening guidelines. Clinicians participated in 30- to 60-min interviews exploring their attitudes toward various aspects of cervical cancer screening. Qualitative analysis was performed. Seventy clinicians participated from across the United States. Few respondents were initiating screening at age 25 years, and none were using primary HPV testing. However, over half would be willing to adopt these practices if supported by scientific evidence and recommended by professional medical organizations. Barriers to adoption included the lack of endorsement by professional societies, lack of laboratory availability and insurance coverage, limited autonomy within large health care systems, and concerns related to missed disease. Few clinicians have adopted screening initiation or primary HPV testing, as recommended by the 2020 ACS guidelines, but over half were open to adopting these changes. Implementation may be facilitated via professional organization endorsement, clinician education, and laboratory, health care system, and insurance support. In 2020, the American Cancer Society (ACS) released updated guidelines for cervical cancer screening. The main changes to current practices were to initiate screening at age 25 years instead of age 21 years and to screen using primary human papillomavirus (HPV) testing rather than cytology alone or in combination with HPV testing. We performed in-depth interviews with 70 obstetrics and gynecology, family medicine, and internal medicine physicians and advanced practice providers about their attitudes toward these guidelines. Few clinicians are following the 2020 ACS guidelines, but over half were open to changing practice if the changes were supported by evidence and recommended by professional medicalorganizations. Barriers to adoption included the lack of endorsement by professional medical organizations, logistical issues, and concerns about missed disease.

Perceived barriers to self-collected HPV testing for cervical cancer screening, and knowledge of HPV: a survey of primary healthcare smear-takers across Aotearoa New Zealand.

Cervical cancer remains a burden within Aotearoa New Zealand, with 2022 screening rates sitting 12.7% below target. The National Cervical Screening Programme has changed to primary human papillomavirus (HPV) testing for all screen-eligible people, with the aim for home self-testing. Little is known about the readiness of primary care for the change to self-testing and its associated challenges. A pilot HPV cervical cancer screening programme is being conducted in 17 practice centres. The aim of this study is to explore smear-taker knowledge at these centres about the use of primary HPV testing for cervical cancer screening. This is an ethically approved questionnaire study, with data from a structured web-based questionnaire sent to all smear-takers at the pilot centres. We achieved a total completion rate of 57.8%. The average score for "Knowledge of HPV" was 56.5% (range=20-100%). The challenges to patient home HPV self-testing were felt to be overall "not at all" to "mildly challenging". Up to 73.3% of participants identified ongoing needs for further education. The findings indicate knowledge deficits regarding HPV testing for cervical cancer screening and a desire for the provision of further education. Overall, respondents felt that no major barriers to implementing HPV self-testing would occur.

Integrating HPV self-collect into primary care to address cervical cancer screening disparities

Human papillomavirus (HPV) self-collect shows promise to increase cervical cancer screening rates in underscreened populations, such as Somali patients, but little is known about how to integrate such an approach in primary care. In this study, primary care providers and staff who provide primary care services to Somali women were asked for their views on integrating HPV self-collect into routine care to address cervical cancer screening disparities. Thirty primary care providers and staff participated in semi-structured interviews exploring their views on HPV self-collect and their anticipated needs or barriers to implementing this approach into the clinic generally and with specific patient populations, such as Somali women. A thematic analysis using the constructivist version of grounded theory was undertaken. Providers and staff anticipate positive patient reaction to the option of HPV self-collect, and were interested in using this approach both for Somali patients and for all patients in general. HPV self-collect was viewed as straightforward to integrate into existing clinic workflows. Providers largely lacked awareness of the evidence supporting primary HPV testing and HPV self-collect specifically, sharing concerns about effectiveness of self-collect and the lack of a physical exam. Providers felt clinic-wide staff education and patient education, along with strategies to address disparities, such as cultural and linguistic tailoring would be needed for successful implementation. Integrating HPV self-collect as an option in the cervical cancer screening process in a primary care clinical encounter offers considerable opportunity to address health disparities and may benefit all patients.

Cost-utility analysis of primary HPV testing through home-based self-sampling in comparison to visual inspection using acetic acid for cervical cancer screening in East district, Sikkim, India, 2023.

Primary Human Papilloma Virus (HPV) testing offers higher sensitivity and specificity over Visual Inspection using Acetic acid (VIA) in cervical cancer screening. Self-sampling is a promising strategy to boost participation and reduce disparities. However, concerns about the initial costs hinder HPV testing adoption in low and middle-income countries. This study assesses the cost-utility of home-based HPV self-sampling versus VIA for cervical cancer screening in India. A cross-sectional study was conducted in East district, Sikkim, India, comparing the costs and utility outcomes of population-based cervical cancer screening through VIA and primary HPV screening through self-sampling. Cost-related data were collected from April 2021 to March 2022 using the bottom-up micro-costing method, while utility measures were collected prospectively using the EuroQoL-5D-5L questionnaire. The utility values were converted into quality-adjusted life days (QALDs) for an 8-day period. The willingness to pay threshold (WTP) was based on per capita GDP for 2022. If the calculated Incremental Cost-Effectiveness Ratio (ICER) value is lower than the WTP threshold, it signifies that the intervention is cost-effective. The study included 95 women in each group of cervical cancer screening with VIA & HPV self-sampling. For eight days, the QALD was found to be 7.977 for the VIA group and 8.0 for the HPV group. The unit cost per woman screened by VIA and HPV self-testing was ₹1,597 (US$ 19.2) and ₹1,271(US$ 15.3), respectively. The ICER was ₹-14,459 (US$ -173.6), which was much below the WTP threshold for eight QALDs, i.e. ₹ 4,193 (US$ 50.4). The findings support HPV self-sampling as a cost-effective alternative to VIA. This informs policymakers and healthcare providers for better resource allocation in cervical cancer screening in Sikkim.

Primary Human Papillomavirus Testing and Other New Technologies for Cervical Cancer Screening

(Abstracted from Obstet Gynecol 2023;142(5):1036–1043) Cervical cancer screening has saved millions of lives over the past 7 decades. Never-screened or underscreened women currently account for more than half of all cervical cancer cases in the United States.

Primary Human Papillomavirus Test Uptake and Cervical Cancer Screening Trends in the Midwest, United States.

Despite U.S. Preventive Services Task Force and American Cancer Society endorsement of primary HPV screening, limited published data shows low uptake. Assess cervical cancer screening rates over time, particularly primary HPV test uptake, among patients in a midwestern practice. Evaluate associations between sociodemographics and screening adherence. Cross-sectional study. Qualifying subjects and type of screening test used were identified by applying ICD-9, ICD-10, lab test, and CPT codes to the Unified Data Platform. Sociodemographics were found through the electronic health record. Primary HPV uptake represented <1% of annual screening from 1/2017 to 1/2022. On 1/1/2022, only 55% of 21 to 29 year old and 63% of 30 to 65 year old were up to date with screening among the studied population. For 21 to 29 year old, compared with White women, Black women were 28% less likely to be screened [RR = 0.72 (0.66-0.79)]. Compared with never-smokers, current smokers were 9% less likely to be screened [RR = 0.91 (0.87-0.96)], past smokers were 14% more likely [RR = 1.14 (1.09-1.2)]. Among 30 to 65 year old, compared with White women, Black women were 14% less likely to be screened [RR = 0.86 (0.81-0.9)]. Compared with never-smokers, current smokers were 21% less likely to be screened [RR = 0.79 (0.77-0.81)], past smokers were 6% less likely [RR = 0.94 (0.92-0.95)]. Jointly considering race, ethnicity, smoking status, Charlson score, and rurality, findings were similar for 21 to 29 year old; Black women were screened less than White women [RR = 0.73 (0.67-0.79)]; current smokers [RR = 0.9 (0.85-0.94)] and past smokers [RR = 1.12 (1.06-1.17)] were screened less than never smokers. For 30 to 65 year old, Black women were screened less than White women [RR = 0.83 (0.79-0.88)]; current smokers [RR = 0.8 (0.78-0.81)] and past smokers [RR = 0.95 (0.93-0.96)] were screened less than never smokers. Screening rates remained below the Healthy People 2030 goal of 79.2% over time, particularly for younger Black women and current smokers, with minimal use of primary HPV screening.

Cost-effectiveness of primary human papillomavirus triage approaches among vaccinated women in Norway: A model-based analysis.

As Norway considers revising triage approaches following their first adolescent cohort with human papillomavirus (HPV) vaccination entering the cervical cancer screening program, we analyzed the health impact and cost-effectiveness of alternative primary HPV triage approaches for women initiating cervical cancer screening in 2023. We used a multimodeling approach that captured HPV transmission and cervical carcinogenesis to evaluate the health benefits, harms and cost-effectiveness of alternative extended genotyping and age-based triage strategies under five-yearly primary HPV testing (including the status-quo screening strategy in Norway) for women born in 1998 (ie, age 25 in 2023). We examined 35 strategies that varied alternative groupings of high-risk HPV genotypes ("high-risk" genotypes; "medium-risk" genotypes or "intermediate-risk" genotypes), number and types of HPV included in each group, management of HPV-positive women to direct colposcopy or active surveillance, wait time for re-testing and age at which the HPV triage algorithm switched from less to more intensive strategies. Given the range of benchmarks for severity-specific cost-effectiveness thresholds in Norway, we found that the preferred strategy for vaccinated women aged 25 years in 2023 involved an age-based switch from a less to more intensive follow-up algorithm at age 30 or 35 years with HPV-16/18 genotypes in the "high-risk" group. The two potentially cost-effective strategies could reduce the number of colposcopies compared to current guidelines and simultaneously improve health benefits. Using age to guide primary HPV triage, paired with selective HPV genotype and follow-up time for re-testing, could improve both the cervical cancer program effectiveness and efficiency.