Primary Cervical Cancer Screening Method Research Articles

OP81 Cost Effectiveness Of Human Papillomavirus Extended Genotyping For Cervical Cancer Screening In Singapore

IntroductionThe World Health Organization recommends the human papillomavirus (HPV) test for cervical cancer screening. HPV partial genotyping (PGT) identifies HPV16 and HPV18 individually and the 12 other high-risk HPV genotypes (hrHPV) collectively. In contrast, HPV extended genotyping (XGT) identifies six hrHPV individually (HPV16,18,31,45,51, and 52) and the other eight in three groups (HPV33/58, HPV56/59/66, and HPV35/39/68). XGT allows better risk stratification for patient management and monitoring of persistent same-genotype infections (PSGI), which convey a higher risk for cervical cancer. This study compared the cost, quality-adjusted life-years (QALYs), and resource use of XGT with PGT when used as the primary cervical cancer screening method in Singapore.MethodsA discretely integrated condition event simulation was developed for screening 500,122 women aged 30 to 69 years over five years from the health system perspective, using a three percent annual discount. For XGT, women with HPV35/39/51/56/59/66/68 and reflex cytology of atypical squamous cells of undetermined significance were recalled for a repeat screening in one year, instead of the immediate colposcopy referral that occurs with PGT. At repeat screening, colposcopy was only provided for women with PSGI on XGT. Published data from Singapore were used for inputs and supplemented with data from international literature. Deterministic and probabilistic uncertainty analyses were conducted. Scenario analysis was conducted to simulate various HPV burdens among women. XGT was cost effective when the incremental cost-effectiveness ratio (ICER) relative to PGT was below SGD100,000 (USD118,906) (gross domestic product per capita in 2021).ResultsXGT was cost effective relative to PGT (ICER SGD16,370 [USD19,465]), with fewer colposcopies (n=7,130; 19%), liquid-based cytology tests (n=6,027; 7%), and clinic consultations (n=9,787; 2%) but more HPV tests (n=2,446; 0.5%). The ICER was most sensitive to the relative cost of XGT and the cost of PGT. XGT remained cost effective in one-way sensitivity analysis in all 1,000 probabilistic uncertainty simulations and in scenario analysis with various HPV burdens.ConclusionsXGT can provide a cost effective, risk-based approach to primary cervical cancer screening, with lower resource utilization than PGT.

Cost-Effectiveness Analysis of HPV Extended versus Partial Genotyping for Cervical Cancer Screening in Singapore.

Human papillomavirus (HPV) partial genotyping (PGT) identifies HPV16 and HPV18 individually, alongside 12 other high-risk HPV genotypes (hrHPV) collectively. HPV extended genotyping (XGT) identifies four additional hrHPV individually (HPV31, 45, 51, and 52), and reports the remaining eight in three groups (HPV33|58; 56|59|66; 35|39|68). Quality-adjusted life years (QALY), health care resource use, and costs of XGT were compared to PGT for cervical cancer screening in Singapore using DICE simulation. Women with one of the three hrHPV identified by XGT (HPV35|39|68; 56|59|66; 51), and atypical squamous cells of undetermined significance (ASCUS) on cytology, are recalled for a repeat screening in one year, instead of undergoing an immediate colposcopy with PGT. At the repeat screening, the colposcopy is performed only for persistent same-genotype infections in XGT, while with PGT, all the women with persistent HPV have a colposcopy. Screening 500,122 women, aged 30-69, with XGT, provided an incremental cost-effectiveness ratio (ICER) versus PGT of SGD 16,370/QALY, with 7130 (19.4%) fewer colposcopies, 6027 (7.0%) fewer cytology tests, 9787 (1.6%) fewer clinic consultations, yet 2446 (0.5%) more HPV tests. The XGT ICER remains well below SGD 100,000 in sensitivity analyses, (-SGD 17,736/QALY to SGD 50,474/QALY). XGT is cost-effective compared to PGT, utilizes fewer resources, and provides a risk-based approach as the primary cervical cancer screening method.

Cervical Cancer: The outcomes of liquid-based cytology vs conventional cytology among HPV/DNA screening test positives of ever married 35 and 45 years old women in Kalutara district and unit cost estimation of colposcopy and biopsy

Background: One major drawback of the present National Cervical Cancer Screening programme is, the suboptimal sensitivity (53%) of the pap smear to detect Cervical Intraepithelial Neoplasia (CIN). HPV/DNA test is highly sensitive (92.9%) for CIN II viral load and the feasibility of HPV/DNA screening with conventional cytology for screen positive follow-up was successfully attempted. The sensitivity of Liquid Based Cytology (LBC) to detect CIN II+ is 79.1%. Objective: To describe the results of LBC vs conventional cytology among HPV/DNA screen positives of 35 and 45 year old ever-married women in MOH areas of Kalutara district. Methods: There are 15 Medical Officer of Health areas in Kalutara district and the Public Health Midwife area (n=413) is taken as a cluster. Three clusters were randomly selected in each MOH area (n=45) by the lot method. Eligible family registers were the sampling frame. Nine subjects in the 35 and 45 age cohort each from all 45 clusters were selected by consecutive sampling technique. The total number of 393 and 390 subjects from 35 and 45 age cohorts were subjected to cervical specimen collection at community Well Woman Clinics (WWC) after applying exclusion criteria at field and clinic setting. HPV/DNA screen positives were subjected to both LBC and pap smear. HPV/DNA screen positive with either conventional cytology or LBC≥ Atypical Squamous Cells of Undetermined Significance (ASCUS) were referred for colposcopy. The incremental cost of the pap smear was calculated. The Scenario-Building technique was used to calculate the per- procedure cost of colposcopy and biopsy. Results: The response rate of 35 and 45 age cohorts women was 97.5% and 96.5% respectively. The number of 25 (6.36%) among 35 and 18 (4.61%) among 45-year- old women were positive for HPV/DNA test. The number of 7 (1.78 %) among 35 year and 5 (1.28%) among 45 year old women had ≥ASCUS in conventional cytology, while the number of 10 (2.54%) among 35 years and 8 (2.05%) among 45 years old women had ≥ASCUS in LBC. Prevalence of CIN by colposcopy among 35 years and 45 years women for LBC vs conventional cytology were 1.53%, 1.28% and 1.53%, 1.03% respectively and there was no significant difference. No invalid results were reported for LBC and the treatment adherence for colposcopy was 86.7%. The incremental cost of pap smear was Rs. 626.18, while the per-procedure cost of colposcopy and biopsy was Rs.1528.15 and Rs.681.16. Conclusions and recommendations: To improve the quality and coverage of the programme HPV/DNA PCR test as a primary cervical cancer screening method with LBC for only screen positive follow-up can be recommended.

Clinician acceptability of self-collected human papillomavirus swabs as a primary cervical cancer screening method.

To determine knowledge and acceptability of and opinions about human papillomavirus (HPV) self-screening as an alternative to Papanicolaou testing among Canadian primary care providers (PCPs: family physicians and nurse practitioners) and obstetrician-gynecologists (OB-GYNs). Descriptive, cross-sectional, anonymous, online pilot survey. Two academic teaching hospitals in downtown Toronto, Ont. Staff physicians and nurse practitioners in the Department of Family and Community Medicine and the Department of Obstetrics and Gynecology at Women's College Hospital and St Michael's Hospital. Recommended patient groups for, potential advantages and disadvantages of, and likelihood of recommending HPV self-sampling for cervical cancer screening. The overall response rate was 30.9%. More than three-quarters of survey respondents were female PCPs. Slightly more than half of clinicians had poor knowledge of HPV self-sampling. However, more than three-quarters would recommend it if there were adequate collection of cervical samples, high patient acceptability, and high sensitivity (almost 100% of respondents), followed by high specificity and cost-effectiveness (more than 80% of respondents). Primary care practitioners were more likely than OB-GYNs to agree that HPV self-sampling made screening easier and less embarrassing for patients. Although not statistically significant, OB-GYNs tended to be more concerned than PCPs were about patients failing to follow up on abnormal HPV results and missed opportunities to address other health issues. Although knowledge of HPV self-sampling for cervical screening was poor, it was generally acceptable to clinicians if certain screening test conditions were met. However, the potential for missed opportunities to visualize pathology and address other health concerns were raised. These and other clinical practice and health systems issues must be addressed before broad implementation of HPV self-sampling in Canada.

Effectiveness and feasibility of HPV self-sampling for coverage of cervical cancer screening on internet-based

Objectives: To assess self-sampling HPV testing combining with the internet may serve as a primary cervical cancer screening method in low-resource settings, and to establish an internet self-sampling cervical cancer screening-management model. Methods: 20,136 women aged 30~59 years with vaginal self-sampling HPV testing as primary screening on internet-based was performed in 13 provinces, municipalities of China. The women who participated in the screening registered on the screening website. A questionnaire was investigated the acceptance of self-sampling after self-sampling. Results: Among 20103 women with qualified samples, 35.81% of them was remote areas, 37.69% of them was never-screened, 59.96% of them under-screened, 18.54% with a primary school education or below and overall high-risk HPV prevalence was 13.86%. In 8136 respondents, 95.97% of women felt self-collection was easy to operate, 84.61% had no discomfort when using a self-sampling brush, 62. 37% women were more likely to choose self-sampling for cervical cancer screening in the future, 92. 53% were willing to introduce to others around them. Multivariate analysis showed that the reliability of self-sampling and the easy degree of sampling were the independent influencing factors of selecting self-sampling (p<0.05), while no statistical significance was found in different age, education, occupation, gravidity, medical insurance, age of sexual initiation (p>0.05). Conclusions: The Internet-facilitated self-HPV-testing screening and management model for cervical cancer prevention with large sample study is feasible and effective and can be used as a supplement to the traditional screening, especially in marginal areas with few medical resources, finally the coverage of cervical cancer screening will be significantly improved.

The feasibility of new HPV/DNA test as a primary cervical cancer screening method among 35- years- old ever-married women in Kalutara district; a cross-sectional study

BackgroundCervical cancer is the second commonest female cancer in Sri Lanka. Two major drawbacks of the present cervical cancer screening programme are the suboptimal sensitivity of the pap smear and the low coverage. The objective of the study is to determine the feasibility of a new HPV/DNA test among 35 -years -old ever-married women in a district of Sri Lanka.MethodA community based descriptive cross-sectional study was conducted from 1stof July 2018 to 30th November 2018 in the public health divisions called Medical Officer of Health (MOH) areas of Kalutara district. The study population is comprised of ever-married women 35 years of age. Three women from each cluster (n = 413) were selected by consecutive sampling. A total of 918 women were recruited. HPV/DNA cervical specimen collection (n = 822) was carried out. Cervical specimens were tested by two cytoscreeners with the cobas 4800 PCR based screening machine. Clients’ perceptions and prevalence were assessed. The follow-up of women with positive HPV/DNA screening results was carried out. The operational and technical feasibility of the screening test were assessed. Data entry was done by using the statistical package IBM SPSS version 20.ResultsOverall response rate was 91.1% (n = 836). Clients’ perception was highly positive for HPV/DNA screening test procedure (99.9%, n = 821) and 99.6% (n = 819) of clients had mentioned that the HPV/DNA screening test is worthwhile to be incorporated into the National Cervical Cancer Screening program. The prevalence of HPV was 6.2% (95%CI: 6.18–6.22%). The coverage of the HPV/DNA screening was 89.5%(n = 822). Invalid results reported were 0.12% (n = 1). The percentage of HPV/DNA test positive women who underwent pap test within 3 months of the initial screening was 100% (n = 51), while the percentage of women who attempted to get a colposcopy within the 1 month of referral was 86.7% (n = 13).ConclusionsHPV/DNA test implementation as a primary cervical cancer screening method is feasible among the 35- year age cohort of ever- married women in Kalutara district. It is necessary to further attempt alternative methods of cobas 4800 HPV/DNA test, which would be much suitable for resource-limited settings.

Acceptability and Feasibility of HPV Self-Sampling as an Alternative Primary Cervical Cancer Screening in Under-Screened Population Groups: A Cross-Sectional Study

Background: Cervical cancer is one of the most common cancers in women and about 90% of cervical cancer can be reduced by regular screening. The Pap smear has been well in place as a primary cervical screening method since 1950s; however, coverage is still not optimal. This study explored the feasibility of HPV self-sampling in two under-screened population groups in Hong Kong (HK): never screened and not regularly screened females, to estimate the uptake rate and preference rate in the future. Materials and Methods: This was a cross-sectional study to explore the acceptability and feasibility of HPV self-sampling in two age groups: aged 25–35 and aged ≥45, which were reported as the highest proportion of the under-screened population in HK between 2017 and 2018. The study invited eligible women from an HPV study cohort to perform HPV self-sampling at home by themselves. The number of specimens returned from participants was recorded and used to determine the feasibility of HPV self-sampling in the community. The participants were asked to fill in the questionnaires before and after HPV self-sampling to indicate their attitudes, acceptability, and future preference for HPV self-sampling as an acceptable alternative primary cervical cancer screening method. Results: A total of 177 subjects participated in the present study and have achieved a good overall uptake rate of 73% (129/177) who returned the self-collected cervicovaginal sample for HPV testing. Among the under-screened population, there was a higher response rate in aged ≥45 than those aged 25–35. The findings also revealed that women who were under-screened, including those who have never been screened, were more likely to prefer HPV self-sampling than those who had regular screening. This study found that the acceptability of HPV self-sampling was fairly positive among the respondents. The findings also indicated that HPV self-sampling was not only beneficial to enhance their health awareness but also to promote the cervical cancer screening uptake rate, especially among the under-screened or never screened populations. Conclusions: HPV self-sampling would be a solution to overcome the perceived barriers in clinician-based screening. The findings also indicated that it could be feasible to use as an alternative primary cervical cancer screening.

Economic evaluation of HPV DNA test as primary screening method for cervical cancer: A health policy discussion in Greece.

BackgroundHPV test appears to be more effective in cervical cancer (CC) screening. However, the decision of its adoption as a primary screening method by substituting the established cytology lies in the evaluation of multiple criteria. Aim of this study is to evaluate the economic and clinical impact of HPV test as primary screening method for CC.MethodsA decision tree and a Markov model were developed to simulate the screening algorithm and the natural history of CC. Fourteen different screening strategies were evaluated, for women 25–65 years old. Clinical inputs were drawn from the HERMES study and cost inputs from the official price lists. In the absence of CC treatment cost data, the respective Spanish costs were used after being converted to 2017 Greek values. One-way and probabilistic sensitivity analyses were conducted.ResultsAll screening strategies, that offer as primary screening method triennial HPV genotyping (simultaneous or reflex) alone or as co-testing with cytology appear to be more effective than all other strategies, with regards to both annual CC mortality, due to missed disease (-10.1), and CC incidence(-7.5) versus annual cytology (current practice). Of those, the strategy with HPV test with simultaneous 16/18 genotyping is the strategy that provides savings of 1.050 million euros annually. However, when the above strategy is offered quinquennially despite the fact that outcomes are decreased it remains more effective than current practice (-7.7 deaths and -1.3 incidence) and more savings per death averted (1.323 million) or incidence reduced (7.837 million) are realized.ConclusionsHPV 16/18 genotyping as a primary screening method for CC appears to be one of the most effective strategies and dominates current practice in respect to both cost and outcomes. Even when compared with all other strategies, the outcomes that it generates justify the cost that it requires, representing a good value for money alternative.

Major clinical research advances in gynecologic cancer in 2018.

Nineteen topics were selected as major clinical research advances in gynecologic oncology in 2018. For cervical cancer, the importance of human papillomavirus (HPV) testing alone as primary cervical cancer screening method and negative survival impact of minimally invasive surgery in early-stage cervical cancer were addressed. For ovarian cancer, cost-effectiveness of genetic testing to prevent cancer, use of analgesics and oral pill to reduce cancer risk, efficacy of secondary cytoreductive surgery and hyperthermic intraperitoneal chemotherapy, update in the use of poly (ADP-ribose) polymerase inhibitor, and efficacy of anti-angiogenic targeted treatments, including bevacizumab and tyrosine kinase inhibitors, were reviewed. For corpus cancer, sentinel lymph node mapping technique, adjuvant therapy in high-risk endometrial cancer (PORTEC-3), and targeted therapy in recurrent disease were covered. For the field of radiation oncology, survival outcomes of chemoradiation compared with chemotherapy alone in metastatic cervical cancer and new findings regarding the use of neoadjuvant chemotherapy in locally advanced cervical cancer were introduced. Lastly, for breast cancer, the use of talazoparib in patients with germline BRCA1/2 mutation, ovarian suppression for premenopausal patients, adjuvant chemotherapy guided by 21-gene assay, and combination therapy of atezolizumab and nab-paclitaxel for triple-negative cancer as well as promising overall survival results of palbociclib and fulvestrant in advanced breast cancer were briefly mentioned.

Comparing self- and provider-collected swabbing for HPV DNA testing in female-to-male transgender adult patients: a mixed-methods biobehavioral study protocol

BackgroundCervical cancer, nearly all cases of which are caused by one of several high-risk strains of the human papillomavirus (hr-HPV), leads to significant morbidity and mortality in individuals with a cervix. Trans masculine (TM) individuals were born with female reproductive organs and identify as male, man, transgender man, or another diverse gender identity different from their female assigned sex at birth. Routine preventive sexual health screening of TM patients is recommended, including screening for cervical cancer and other sexually transmitted infections (STIs); however, as many as one in three TM patients are not up-to-date per recommended U.S. guidelines. Among cisgender (non-transgender) women, self-swab hr.-HPV DNA testing as a primary cervical cancer screening method and self-swab specimen collection for other STIs have high levels of acceptability. No study has yet been conducted to compare the performance and acceptability of self- and provider-collected swabs for hr.-HPV DNA testing and other STIs in TM patients.MethodsThis article describes the study protocol for a mixed-methods biobehavioral investigation enrolling 150 sexually active TM to (1) assess the clinical performance and acceptability of a vaginal self-swab for hr.-HPV DNA testing compared to provider cervical swab and cervical cytology, and (2) gather acceptability data on self-collected specimens for other STIs. Study participation entails a one-time clinical visit at Fenway Health in Boston, MA comprised of informed consent, quantitative assessment, venipuncture for syphilis testing and HIV (Rapid OraQuick) testing, randomization, collection of biological specimens/biomarkers, participant and provider satisfaction survey, and qualitative exit interview. Participants are compensated $100. The primary study outcomes are concordance (kappa statistic) and performance (sensitivity and specificity) of self-collected vaginal HPV DNA specimens vs provider-collected cervical HPV swabs as a gold standard.DiscussionThis study addresses critical gaps in current clinical knowledge of sexual health in TM patients, including comparing alternative strategies for screening and diagnosis of cervical cancer, hr.-HPV, and other STIs. Findings have implications for improving the delivery of sexual health screening to this often overlooked and underserved patient population. Less-invasive patient-centered strategies may also generalize to other at-risk cisgender female populations that face barriers to timely and needed STI and cervical cancer screening.Trial registrationClinicalTrials.gov ID: NCT02401867

Impact of an educational intervention on women's knowledge and acceptability of human papillomavirus self-sampling: a randomized controlled trial in Cameroon.

ObjectiveHuman papillomavirus (HPV) self-sampling (Self-HPV) may be used as a primary cervical cancer screening method in a low resource setting. Our aim was to evaluate whether an educational intervention would improve women's knowledge and confidence in the Self-HPV method.MethodWomen aged between 25 and 65 years old, eligible for cervical cancer screening, were randomly chosen to receive standard information (control group) or standard information followed by educational intervention (interventional group). Standard information included explanations about what the test detects (HPV), the link between HPV and cervical cancer and how to perform HPV self-sampling. The educational intervention consisted of a culturally tailored video about HPV, cervical cancer, Self-HPV and its relevancy as a screening test. All participants completed a questionnaire that assessed sociodemographic data, women's knowledge about cervical cancer and acceptability of Self-HPV.ResultsA total of 302 women were enrolled in 4 health care centers in Yaoundé and the surrounding countryside. 301 women (149 in the “control group” and 152 in the “intervention group”) completed the full process and were included into the analysis. Participants who received the educational intervention had a significantly higher knowledge about HPV and cervical cancer than the control group (p<0.05), but no significant difference on Self-HPV acceptability and confidence in the method was noticed between the two groups.ConclusionEducational intervention promotes an increase in knowledge about HPV and cervical cancer. Further investigation should be conducted to determine if this intervention can be sustained beyond the short term and influences screening behavior.Trials RegistrationInternational Standard Randomised Controlled Trial Number (ISRCTN) Register ISRCTN78123709

HPV self-sampling as primary screening test in sub-Saharan Africa: Implication for a triaging strategy

Our objective was (i) to assess if a self-collected test for human papillomavirus (HPV) may serve as a primary cervical cancer screening method in a low-resource setting, (ii) to evaluate its implication in a screen and treat approach and (iii) to identify the most eligible age group in a screening program. Women were recruited through a cervical cancer screening campaign conducted in Cameroon. Written and oral instructions were given to participants by a health-care professional to carry out an unsupervised self-collected HPV-test (Self-HPV), followed by a physician-collected cervical sample for HPV testing (Physician-HPV) and cytology. Differences in performance between Self-HPV versus Physician-HPV and their ability to detect abnormal cytology results (ASC-US+) were evaluated. Descriptive analyses were used to examine the correlation between HPV positivity and cervical abnormalities by age. A sample of 789 women was prospectively enrolled. HPV prevalence was 14.6% and 12.7% for Self-HPV and Physician-HPV, respectively (Cohen's kappa = 0.74). HPV positivity by cytological diagnosis for ASC-US+ was similar with the two tests. positive predictive value of the Self-HPV for ASC-US+ was 20.4; odds ratio and number needed to treat were 6.5 (3.2-13.4) and 6 (4.2-10.9), respectively. We observed a trend of increasing cytological abnormalities in 30-49 year-old women and a concomitant trend of decreasing HPV prevalence supporting that this age group might be the most eligible group for screening. In conclusion, Self-HPV can be used as a primary screening test but needs to be followed by a triaging test that would identify the subset of women affected by clinically significant precancer or cancer.

Evaluation of visual inspection as the primary screening method in a four-year cervical (pre-) cancer screening program in rural China

The aim of the study is to evaluate the feasibility of visual inspection with acetic acid/Lugol's iodine (VIA/VILI) as a primary screening method for cervical lesions in low-resource settings in China. Participants underwent VIA/VILI, and, if positive, received colposcopy and direct biopsy of visible lesions. Women who were negative for VIA/VILI or who were diagnosed with cervical intraepithelial neoplasia (CIN) 1 were re-screened the following year with the same procedure. In total, 10,269 women received VIA/VILI (of whom 8263, twice). Overall test positivity was 8.07% (1495/18532) for VIA/VILI, 33.44% (500/1495) for colposcopy, and the incidence of pathology-confirmed CIN1, CIN2/3 and cervical cancer was 0.85% (87/10,269), 0.53% (54/10,269) and 0.02% (2/10,269), respectively. Women aged 30-39 years at screening had higher rates of CIN2+ (include CIN2, CIN3 and cervical cancer). Our study indicates that VIA/VILI is a simple, feasible, and effective primary cervical cancer screening method in an impoverished, rural community that lacks access to standard medical care.

Molecular biomarkers in cervical cancer diagnosis: a critical appraisal

It is expected that in the near future high-risk human papillomavirus (hr-HPV) testing will be implemented as the primary cervical cancer screening method in some countries. However, only a fraction of hr-HPV positive women will have a clinically relevant lesion. As a result, there is an urgent need for additional biomarkers that can detect these lesions and that can at the same time be applied to cytological specimens. This overview evaluates the most promising cytological biomarkers. Cytological biomarkers that can be used are being discussed in view of their molecular background. The most promising biomarkers are p16(INK4a)/Ki-67 dual immunostaining; methylation of the promoter region of the cell adhesion molecule 1 (CADM1) gene and the T-lymphocyte maturation associated protein (MAL) gene and viral integration. Their sensitivity, specificity and limitations are discussed in detail and their diagnostic accuracy is evaluated. The most promising cytological biomarkers for cervical cancer screening are p16(INK4a)/Ki-67 dual immunostaining, methylation of CADM1 and MAL and viral integration. Although some of the biomarkers are very promising for this purpose, no studies have evaluated how accurately these biomarkers classify or predict the outcome. Additional clinical trials are needed to determine the true clinical value of these promising cytological biomarkers.

Pooled Analysis of a Self-Sampling HPV DNA Test as a Cervical Cancer Primary Screening Method

BackgroundWorldwide, one-seventh of cervical cancers occur in China, which lacks a national screening program. By evaluating the diagnostic accuracy of self-collected cervicovaginal specimens tested for human papillomavirus (HPV) DNA (Self-HPV testing) in China, we sought to determine whether Self-HPV testing may serve as a primary cervical cancer screening method in low-resource settings.MethodsWe compiled individual patient data from five population-based cervical cancer–screening studies in China. Participants (n = 13 140) received Self-HPV testing, physician-collected cervical specimens for HPV testing (Physician-HPV testing), liquid-based cytology (LBC), and visual inspection with acetic acid (VIA). Screen-positive women underwent colposcopy and confirmatory biopsy. We analyzed the accuracies of pooled Self-HPV testing, Physician-HPV testing, VIA, and LBC to detect biopsy-confirmed cervical intraepithelial neoplasia grade 2 or more severe (CIN2+) and CIN3+. All statistical tests were two-sided.ResultsOf 13 004 women included in the analysis, 507 (3.9%) were diagnosed as CIN2+, 273 (2.1%) as CIN3+, and 37 (0.3%) with cervical cancer. Self-HPV testing had 86.2% sensitivity and 80.7% specificity for detecting CIN2+ and 86.1% sensitivity and 79.5% specificity for detecting CIN3+. VIA had statistically significantly lower sensitivity for detecting CIN2+ (50.3%) and CIN3+ (55.7%) and higher specificity for detecting CIN2+ (87.4%) and CIN3+ (86.9%) (all P values < .001) than Self-HPV testing, LBC had lower sensitivity for detecting CIN2+ (80.7%, P = .015), similar sensitivity for detecting CIN3+ (89.0%, P = .341), and higher specificity for detecting CIN2+ (94.0%, P < .001) and CIN3+ (92.8%, P < .001) than Self-HPV testing. Physician-HPV testing was more sensitive for detecting CIN2+ (97.0%) and CIN3+ (97.8%) but similarly specific for detecting CIN2+ (82.7%) and CIN3+ (81.3%) (all P values <.001) than Self-HPV testing.ConclusionsThe sensitivity of Self-HPV testing compared favorably with that of LBC and was superior to the sensitivity of VIA. Self-HPV testing may complement current screening programs by increasing population coverage in settings that do not have easy access to comprehensive cytology-based screening.