Acceptability and Preference for Human Papilloma Virus Self-Sampling among Thai Women Attending National Cancer Institute

Background: Cervical cancer screening is an important public health strategy to reduce cervical cancer incidence and mortality. Human papillomavirus (HPV) self-sampling is the alternative method that can potentially increase participation in cervical cancer screening. This study aimed to evaluate the acceptability of HPV self-sampling as a primary cervical cancer screening among Thai women. Methods: A cross-sectional study was conducted at National Cancer Institute, Thailand, between March and September 2021. Eligible women were invited to collect their own samples with a vaginal cotton swab for cervical screening. The data on demographics, acceptability, and preference for HPV self-sampling were collected via a self-administered questionnaire. A Likert scale was used to assess the response of self-sampling acceptability. The multivariable logistic regression determined factors that influence preference for HPV self-sampling. Results: A total of 265 participants were recruited. Over 70% agreed that self-sampling was easy, less embarrassing, and not painful. They also felt confident in their ability to self-sample correctly and would recommend this method to a friend or relative. For their next screening round, 66.4% preferred self-sampling whereas 33.6% preferred clinician-collected samples as routine screening. The factors that influence preference for self-sampling were age, marital status, feeling less embarrassed, and confidence in performing the tests. Conclusions: Most of the study participants accepted HPV self-sampling. This suggests that the self-sampling method will be an additional option to increase cervical cancer screening coverage which leads to improving the effectiveness of the national program.     

Primary Study on Providing a Basic System for Uterine Cervical Screening in a Developing Country: Analysis of Acceptability of Self-sampling in Lao PDR

Background: Most developing countries have been unable to implement well-organized health care systems,especially comprehensive Pap smear screening-based programs. One of the reasons for this is regional differencesin medical services, and a low-cost portable cervical screening system is necessary. To improve regionaldiscrepancies in cervical screening systems, we investigated the usefulness and acceptability of cervical selfsamplingby liquid-based cytology (LBC) for 290 volunteers in the Lao PDR. Materials and Methods: Followinghealth education with comprehensive documents, cervical self-sampling kits by LBC were distributed in threeprovincial, district, and village areas to a total of 290 volunteers, who were asked to take cytology samplesby themselves. Subsequently, the acceptability of self-sampling was evaluated using a questionnaire. Results:The documents were well understood in all three regions. Regarding the acceptability of self-sampling, theselections for subsequent screening were 62% self-sampling, 36% gynecologist-sampling, 1% either method,and 1% other methods. The acceptability rates were higher in the district and the village than in the province.For the relationship between acceptability and pregnancy, the self-sampling selection rate was higher in thepregnancy-experienced group (75%) than in the pregnancy-inexperienced group (60%). For the relationshipbetween selection of self-sampling and experience of screening, the self-sampling selection rate was higher inthe screening-inexperienced group (62%) than in the screening-experienced group (52%). Conclusions: Ourdata show that this new way forward, involving a combination of self-sampling and LBC, is highly acceptableregardless of age, educational background, and residence in rural areas in a developing country.     

Acceptability and Concordance of Self- Versus Clinician- Sampling for HPV Testing among Rural South Indian Women

Background: Despite being largely preventable, HPV-related cervical cancers continues to be the second highest cause of cancer deaths among Indian women. HPV testing using self-sampled samples may offer an opportunity to expand cervical cancer screening in India where there is currently a shortage of providers and facilities for cervical cancer screening. The study examines acceptability and concordance of self vs. clinician collected samples for HPV-relted cervical cancer screening among rural South Indian women. Methods: Between May and August 2017, eight mobile screening clinics were conducted among 120 eligible women in rural villages in Mysore District, India. Women over the age of 30 underwent informed consent process and then self-sampled a sample for cervicovaginal HPV DNA testing. Next, the women underwent clinical exam where the clinician collected a cervicovaginal HPV DNA sample. Following the clinical exam, all participants answered an interviewer-administered questionnaire to assess their history of cervical cancer screening and acceptability of self- and clinician-sampling methods. To assess diagnostic accuracy, concordance of self- and clinician-sampled HPV DNA specimens was calculated in addition to five measures of acceptability (feeling of caring, privacy, embarrassment, genital discomfort, and genital pain). Results: Study participants had a median age 39 years, about four-in-ten (41.7%) had a secondary education or above, the vast majority (87.5%) were married and only 3.4% reported having screened for cervical cancer. For all measures of participant acceptability, self-sampling was rated significantly higher than clinician-sampling. Cohen’s kappa was 0.73 (95% CI: 0.34, 1.00), indicating substantial agreement between self- and clinician-sampling. Conclusion: This study demonstrates that HPV self-sampling for cervical cancer screening is feasible and acceptable in a community setting among South Indian rural women. Concordance between self-sampling and clinician-sampling was adequate for screening in community settings.     

新疆维吾尔族妇女宫颈癌筛查方法横断面比较研究

[目的]探讨适合新疆维吾尔族妇女宫颈癌的筛查方法。[方法]于2006～2007年采用整群抽样方法,选择新疆维吾尔族妇女883名,采用自我采样HPV检测,液基细胞学检查,医生采样HPV检测,肉眼筛查(VIA)进行宫颈癌筛查。分析和比较不同筛查方法的灵敏度、特异度、阳性预测值、阴性预测值。[结果]医师采样HPV检测的灵敏度和特异度均为最高(P<0.01),自我采样的灵敏度与细胞学检查相似(P>0.05),但自我采样HPV检测的特异度高于细胞学检查(P<0.01),与医生采样HPV检测相似(P>0.05)。肉眼筛查的灵敏度和特异度为最低。[结论]新疆维吾尔族妇女的宫颈癌筛查方案应首选医生采样HPV检测,自我采样HPV检测是比较适合于新疆民族地区妇女的方案,在偏远和缺少设备的地区,肉眼筛查也是一种可行的筛查方法。     

Experience with high-risk human papillomavirus testing on vaginal brush-based self-samples of non-attendees of the cervical screening program

We evaluated the effect of offering brush-based vaginal self-sampling for high-risk human papillomavirus (hrHPV) testing to non-attendees of the cervical screening program on response rate, compliance to follow-up and cervical intraepithelial neoplasia grade 2 or 3 (CIN2+/CIN3+) yield. In addition, concordance of hrHPV test results between physician-taken cervical scrapes and vaginal self-samples was determined. A total of 26,409 nonattending women were randomly assigned to receive a vaginal brush device for hrHPV testing by Hybrid Capture-2 method (i.e., self-sampling group, n = 26,145) or a reinvitation for regular cytology-based screening (i.e., recall control group, n = 264). hrHPV-positive self-sampling responders were invited for a physician-taken scrape for cytology and blinded hrHPV testing. If cytology was abnormal, women were referred for colposcopy. Response rate in the self-sampling group was significantly increased compared to the recall control group (30.8% versus 6.5%; p < 0.001). The concordance rate between hrHPV detection in self-samples and corresponding physician-taken cervical scrape samples was 68.8%. Amongst women with CIN3+ and CIN2+, the concordance rates in hrHPV positivity between both samples were 95.5% and 93.8%, respectively. Adherence at baseline to cytology triage of hrHPV-positive self-sampling women (89.1%) and colposcopy referral of those with abnormal cytology (95.8%) was high. The CIN2+/CIN3+/carcinoma yields were 1.5%, 1.0% and 0.1%, respectively, in self-sampling responders. In conclusion, offering hrHPV testing on self-sampled vaginal material with a brush device to non-attendees significantly increases the attendance to the regular screening program, yields hrHPV test results that are in very good concordance with those of physician-taken scrapes in women with CIN2+/CIN3+, and is effective in detecting CIN2+/CIN3+.     

The Acceptance of Human Papillomavirus Self-Sampling Test among Muslim Women:A Systematic Review

Introduction: Human Papillomavirus (HPV) self-sampling test has the potential to increase cervical cancer screening rate. Although every screening test has its own advantages and disadvantages, culture and religion can be significant predictors for the acceptability of screening tests among patients, including the HPV self-sampling test. This systematic review intends to identify and review published literature on the acceptance of HPV self-sampling test among Muslim women globally. Methods: The Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) review protocol was utilised to guide this systematic review. We also used the Mixed Method Appraisal Tool (MMAT) for the evaluation of articles, and data from selected papers were retrieved and analysed using thematic analysis. Results: This systematic review includes seven publications that discussed on Muslim women’s perceptions of HPV self-sampling test. This comprises articles that revealed Muslim women’s acceptance of the HPV self-sampling test, including considerable positive factors that influenced their approval. On the other hand, the test’s disadvantages were mentioned, which served as barriers for these women’s participation. Convenience, cultural sensitivity, and availability were positive features, whereas religious taboo, low self-confidence, and perceived cost were some of the negative factors that were discussed. Conclusion: This review emphasises the positive and negative aspects that have an impact on the acceptance of HPV self-sampling test among Muslim women. Identifying the elements that influence HPV self-sampling test acceptance will help policymakers to better understand cervical cancer screening programmes and further guide future plans in reducing the incidence of cervical cancer.     

Human papillomavirus testing on self-sampled cervicovaginal brushes: an effective alternative to protect nonresponders in cervical screening programs

Women not attending cervical screening programs are at increased risk of cervical cancer. We investigated in these nonresponders to what extent offering self-sampling devices for cervicovaginal brushes for high-risk human papillomavirus (hrHPV) testing would induce participation and, if so, what the yield of precursor (i.e. CIN2 or worse) lesions following self-sampling would be. In addition, we assessed screening history of participants and costs per detected high-grade CIN2 or worse ("CIN2+") lesion in comparison to the regular program in the Netherlands. Nonresponders received a device for hrHPV testing (self-sampling group, n=2,546) or an extra recall for conventional cytology (control group, n=284). The percentage of self-sampling responders were compared with responders in the recall group. hrHPV positive self-sampling responders were invited for cytology and colposcopy. CIN2+ yield and costs per detected CIN2+ were evaluated. Active response was higher in the self-sampling than in the control group (34.2 vs. 17.6%; p<0.001). hrHPV positive self-sampling responders were less likely to have a prior screening history than screening participants (p<0.001), indicating that they are regular nonresponders. hrHPV prevalence was similar (8.0 vs. 6.8%; p=0.11), but CIN2+ yield was higher in self-sampling responders compared to screening participants (1.67 vs. 0.97%; OR=2.93, 95% CI 1.48-5.80; p=0.0013). Costs per CIN2+ lesion detected via self-sampling were in the same range as those calculated for conventional cytological screening (euro 8,836 vs. euro 7,599). Offering self-sampling for hrHPV testing in nonresponders is an attractive adjunct to effectively increase population coverage of screening without the adverse effect of markedly increased costs per detected CIN2+ lesion.     

Effective cervical cytology screening programmes in middle-income countries: the Chilean experience

OBJECTIVE: To demonstrate that an effective cervical cancer screening programme based on the Papanicolaou (Pap) smear can be organized in a middle-income country, such as Chile. METHODS: The cervical cytology screening programme in Chile is evaluated by comparing process measures and cervical cancer mortality before and after its reorganization in 1987. FINDINGS: Two decades of opportunistic annual screening for cervical cancer from the mid-1960s to the mid-1980s did not reduce cervical cancer mortality in Chile. In 1987, a public health oriented program was launched, based on screening women aged 25-64 every 3 years, rather than the annual screening of low risk women attending family planning clinics that gathered mainly women less than 25 years of age. The reoriented program emphasized the optimization of existing resources, the timeliness of diagnosis and treatment, reliability of the Pap smear and low cost screening promotion strategies at the community level. More than 80% of women with abnormal Pap smears received prompt medical attention and 100% of the public laboratories were subject to external quality control. According to biannual national surveys, coverage by Pap smear screening in the target group rose from 40% in 1990 to 66% in 1996. The age adjusted cervical cancer mortality rate decreased from 12.8 in 1980 to 6.8 per 100,000 women in 2001. CONCLUSIONS: Improved organization of the national cervical cancer screening programme in Chile and more efficient use of existing resources resulted in a decrease of cervical cancer mortality.     

Cervical Cancer Prevention and High-Risk HPV Self-Sampling Awareness and Acceptability among Women Living with HIV: A Qualitative Investigation from the Patients’ and Providers’ Perspectives

Routine cervical cancer screening is important for women living with HIV (WLH) due to the greater incidence and persistence of high-risk HPV (HR-HPV) infection. HR-HPV self-sampling has been proposed to overcome barriers to in-office cervical cancer screening in underserved populations. However, little is known about baseline knowledge of HR-HPV and the acceptability of HR-HPV self-sampling among WLH. This paper describes WLH’s experiences and needs regarding cervical cancer screening, specifically HR-HPV self-sampling, and seeks to reconcile their experiences with the views of their providers. In total, 10 providers and 39 WLH participated in semi-structured interviews and group discussions, respectively. Knowledge of cervical cancer and HR-HPV was generally limited among WLH; when present, it was often due to personal experience of or proximity to someone affected by cervical cancer. Most WLH were not familiar with HR-HPV self-sampling but, despite some of the providers’ skepticism, expressed their willingness to participate in a mail-based HR-HPV self-sampling intervention and highlighted convenience, ease of use, and affordability as facilitators to the uptake of HR-HPV self-sampling. The experiences identified can be used to guide patient-centered communication aimed at improving cervical cancer knowledge and to inform interventions, such as HR-HPV self-sampling, designed to increase cervical cancer screening among under-screened WLH.     

HPV self-sampling as an alternative strategy in non-attenders for cervical screening - a randomised controlled trial

Background:

A randomised trial to ascertain whether women who do not attend for cervical screening are more likely to respond to the opportunity to collect a self-sample for human papillomavirus (HPV) testing, or to a further invitation to attend for cervical screening.

Methods:

The study was carried out in a Primary Care Trust (PCT) in London between June 2009 and December 2009. In total, 3000 women were randomly selected from persistent non-responders (i.e., who had not responded to at least two invitations to attend for screening). The women were randomised on a 1 : 1 basis to either receive an HPV self-sampling kit or a further invitation to attend for cervical cytology. The main outcome measures were (1) percentage of women attending for cervical cytology compared with those returning a self-sample HPV test or attending for cytology subsequent to receiving the kit and (2) percentage of those testing positive for HPV who attended further investigation.

Results:

The total response in the self-sampling group for screening was 10.2%. Of the 1500 women in the control group sent a further invitation for cervical screening, 4.5% attended for cytology screening. This difference is highly statistically significant (P<0.0001). Of the 8 women who tested positive for HPV, 7 attended for a cervical smear and had a concurrent colposcopy. Three of these (43%) had high-grade disease (defined as CIN 2+), with one found to have an invasive cancer (stage 1b) and one CIN 3.

Conclusions:

The value of this intervention relies on the detection of high-grade CIN and early stage cancer with a good prognosis. The relatively high yield of abnormalities found is consistent with that expected among a hard to reach and relatively high-risk group of women. Our study suggests that self-sampling could increase participation among non-responders in England, but further work is needed to ascertain whether the low response rate seen here is likely to be representative of the rest of the country. Other studies are needed to investigate the response to self-sampling in different demographic and geographic settings.     

Acceptability of Self-Sampling HPV Testing Among Thai Women for Cervical Cancer Screening

Background: Acceptability of self-sampling HPV testing is confirmed worldwide. However, some cultural differences may affect this question. Therefore, this study was conducted to evaluate the acceptability of selfsampling HPV testing in Thai women. Materials and Methods: One hundred women aged 30-65 years with anintact cervix were included in this study. The participants were asked to do the Pap test by physicians and then brush type self-sampling instruments were assigned for self-collection and finally completed a questionnaire for acceptability evaluation. The questionnaire contains 2 parts. Part one covered general information of the participants and part two is the acceptability questions. Results: Mean age was 40.6 years. The incidence of high risk HPV detection in this study was 16%. The most common reason for doing Pap smear was for annualcheckup. On the topic of ease of use, 85 % of the subjects agreed. Most of the participants (82%) reported that they felt less pain. However, reliability of the result was not satisfactory because 37% of the participants hesitated to rely on the results of the test. According to the price, if the price is less than 1,000 Baht (32.59 Baht = 1USD), 82% of the subjects would use it for their next screening. Conclusions: The acceptability of self-sampling device in this study is quite good but the reliability of the test was questioned by some of the participants. Moreover, the price of the test in Thailand may also influence the acceptability of the test.     

Detection of Human Papillomavirus in Male and Female Urine by Electrochemical DNA Chip and PCR Sequencing

Background: Cervical cancer is the second most common cancer in Thai women after breast cancer. Currently,the Papanicolaou (Pap) smear is the recommended procedure for cervical cancer screening in Thailand, butonly a relatively small percentage of women follow this screening program. An alternative method to detectHPV genotypes associated with cervical cancer is self-sampling of urine, which is a more widely acceptedmethod. Our study aimed to evaluate the prevalence of HPV in Thai women using urine and cervical swabsand prevalence of HPV in Thai men using urine samples. Materials and Methods: Tumorigenic HPV detectionwas accomplished by electrochemical DNA chip and PCR/direct sequencing. In addition to HPV prevalence,we report the concordance between different methods and sample types. One-hundred and sixteen women and100 men were recruited. Histological examination revealed normal cytology in 52 women, atypical squamouscells of undetermined significance (ASCUS) in 9, low-grade squamous intraepithelial lesions (LSIL) in 24, andhigh-grade squamous intraepithelial lesions (HSIL) in 31. One-hundred men were classified as heterosexuals(n=45) and homosexuals (n=55). Results: The most prevalent HPV genotype in our study was HPV16. The HPVdetection rate was generally lower in urine samples compared with cervical samples. Overall, there was goodagreement for the detection of carcinogenic HPV from female cervical samples between the DNA chip and PCR/sequencing, with 88.8% total agreement and a kappa value of 0.76. In male urine samples, the level of agreementwas higher in heterosexuals compared with homosexuals. Conclusions: Further improvement is required toincrease an overall yield of HPV DNA detection in urine samples before clinical application of a urine-basedHPV screening program. The electrochemical DNA chip test is a promising technique for carcinogenic HPVdetection.     

Comparative Assessment of a Self-sampling Device and Gynecologist Sampling for Cytology and HPV DNA Detection in a Rural and Low Resource Setting: Malaysian Experience

Purpose: This study was conducted to assess the agreement and differences between cervical self-sampling with a Kato device (KSSD) and gynecologist sampling for Pap cytology and human papillomavirus DNA (HPV DNA) detection. Materials and Methods: Women underwent self-sampling followed by gynecologist sampling during screening at two primary health clinics. Pap cytology of cervical specimens was evaluated for specimen adequacy, presence of endocervical cells or transformation zone cells and cytological interpretation for cells abnormalities. Cervical specimens were also extracted and tested for HPV DNA detection. Positive HPV smears underwent gene sequencing and HPV genotyping by referring to the online NCBI gene bank. Results were compared between samplings by Kappa agreement and McNemar test. Results: For Pap specimen adequacy, KSSD showed 100% agreement with gynecologist sampling but had only 32.3% agreement for presence of endocervical cells. Both sampling showed 100% agreement with only 1 case detected HSIL favouring CIN2 for cytology result. HPV DNA detection showed 86.2%agreement (K=0.64, 95% CI 0.524-0.756, p=0.001) between samplings. KSSD and gynaecologist sampling identified high risk HPV in 17.3% and 23.9% respectively (p= 0.014). Conclusion: The self-sampling using Kato device can serve as a tool in Pap cytology and HPV DNA detection in low resource settings in Malaysia. Self-sampling devices such as KSSD can be used as an alternative technique to gynaecologist sampling for cervical cancer screening among rural populations in Malaysia.     

Evaluating the Performance of Hybrid Capture 2 Test as a Primary Screening Test from Studies Conducted in Low and Middle-Income Country Settings- Special Focus India

Among the screening tests for cervical cancer, advantages of screening with second generation molecular Hybrid Capture 2 (HC2) test is the high sensitivity and negative predictive value that makes it easy to implement as a cervical cancer screening policy necessitating less screening rounds. High income countries are now implementing HC2 test in their national cervical cancer screening program. Since the acceptance of any screening test depends on the sensitivity of the test, the current study was carried out to evaluate the sensitivity of HC2 test reported from Low- and Middle-income countries (LMIC) which share major burden of cervical cancer globally and to establish if HC2 test could be used as a primary screening test in India. Materials and methods: The population based cross sectional studies from LMICs which evaluated HC2 test as a primary screening modality to diagnose Cervical intraepithelial neoplasm grade 2 and above (CIN2+) lesions were included. Results: A total of 18 studies from LMIC involving 1,13,086 women were reviewed for sensitivity of HC2 as a primary screening test. The overall average sensitivity and specificity to diagnose CIN2+ lesions were 79.84% (95% CI-71.01,86.73) and 85.63% (95% CI- 84.37,86.92) respectively. India demonstrated an average sensitivity and specificity of 65% (95% CI 57,77) and 93% (95% CI- 92,94) respectively. Conclusion: Results from LMIC demonstrate a comparably low sensitivity of HC2 test to diagnose CIN2+ lesions as compared to that reported from High income countries. Sensitivity of HC2 was substantially low for India. The current study discusses issues of HC2 assay and the role of untreated Reproductive tract infections as probable causes for low sensitivity of the test. This needs further research in an attempt to improve the sensitivity of the test in an era of self-sampling and low-cost HPV test on horizon to improve the coverage for cervical cancer.     

The Korean guideline for cervical cancer screening

The incidence rate of cervical cancer in Korea is still higher than in other developed countries, notwithstanding the national mass-screening program. Furthermore, a new method has been introduced in cervical cancer screening. Therefore, the committee for cervical cancer screening in Korea updated the recommendation statement established in 2002. The new version of the guideline was developed by the committee using evidence-based methods. The committee reviewed the evidence for the benefits and harms of the Papanicolaou test, liquid-based cytology, and human papillomavirus (HPV) testing, and reached conclusions after deliberation. The committee recommends screening for cervical cancer with cytology (Papanicolaou test or liquid-based cytology) every three years in women older than 20 years of age (recommendation A). The cervical cytology combined with HPV test is optionally recommended after taking into consideration individual risk or preference (recommendation C). The current evidence for primary HPV screening is insufficient to assess the benefits and harms of cervical cancer screening (recommendation I). Cervical cancer screening can be terminated at the age of 74 years if more than three consecutive negative cytology reports have been confirmed within 10 years (recommendation D).     

重庆市宫颈癌机会性筛查方法研究

[目的]分析重庆市宫颈癌机会性筛查的基本现状,探索适合重庆市宫颈癌机会性筛查方法。[方法]收集分析2009年重庆市8家医院机会性筛查资料,筛查方法包括液基细胞学、巴氏涂片、HPVDNA检测,以及专家推荐的三种筛查方案,Ⅰ方案：HPV检测和液基细胞学组合;Ⅱ方案：传统巴氏涂片和HPV检测;Ⅲ方案：仅用肉眼观察（醋酸或碘染色法,VIA/VILI）。病理确诊宫颈病变及宫颈癌,并对受检妇女进行流行病学调查。[结果]筛查过程中医生实际使用液基细胞学2390例（64.26%）,Ⅲ方案2300例（61.84%）,巴氏涂片194例（5.22%）,Ⅰ方案103例（2.77%）,Ⅱ方案52例（1.40%）,HPVDNA检测17例（0.46%）,最普遍采用的方法是液基细胞学、肉眼观察。检出CIN217例,检出率为9.68%;宫颈癌22例,检出率为0.98%。对受检妇女进行流行病学调查显示,愿意选择液基细胞学所占比例（69.69%）最高,其次分别为阴道镜（47.26%）、VIA/VILI（40.04%）、巴氏涂片（4.35%）,所占比例最低为HPVDNA（3.54%）,而经济欠发达、文化程度低、年长者、家人未患有肿瘤者更愿意选择传统筛查方法。[结论]不管是筛查过程中医生实际使用,还是受检妇女的选择,均是以细胞学为重庆市宫颈癌的主要检测手段,液基细胞学正逐步被广泛使用;而肉眼观察仍为重庆市经济欠发达地区宫颈癌筛查的另一主要检测手段。     

Clinical Evaluation of Human Papillomavirus Detection by careHPVTM Test on Physician-Samples and Self-Samples using The Indicating FTA Elute® Card

Objective: To make the clinical evaluation of a solid-state human papillomavirus (HPV) sampling medium in combination with an economical HPV testing method (careHPVTM) for cervical cancer screening. Methods: 396 women aged 25-65 years were enrolled for cervical cancer screening, and four samples were collected. Two samples were collected by woman themselves, among which one was stored in DCM preservative solution (called “liquid sample”) and the other was applied on the Whatman Indicating FTA Elute® card (FTA card). Another two samples were collected by physician and stored in DCM preservative solution and FTA card, respectively. All the samples were detected by careHPVTM test. All the women were administered a colposcopy examination, and biopsies were taken for pathological confirmation if necessary. Results: FTA card demonstrated a comparable sensitivity of detecting high grade Cervical Intraepithelial Neoplasia (CIN) with the liquid sample carrier for self and physician-sampling, but showed a higher specificity than that of liquid sample carrier for self-sampling (FTA vs Liquid: 79.0% vs 71.6%, p=0.02). Generally, the FTA card had a comparable accuracy with that of Liquid-based medium by different sampling operators, with an area under the curve of 0.807 for physician&FTA, 0.781 for physician &Liquid, 0.728 for self & FTA, and 0.733 for self &Liquid (p>0.05). Conclusions: FTA card is a promising sample carrier for cervical cancer screening. With appropriate education programmes and further optimization of the experimental workflow, FTA card based self-collection in combination withcentralized careHPVTM testing can help expand the coverage of cervical cancer screening in low-resource areas.     

Cervical cancer screening and management practices among providers in the National Breast and Cervical Cancer Early Detection Program (NBCCEDP)

BACKGROUND: This study was conducted to describe clinicians serving women in the National Breast and Cervical Cancer Early Detection Program (NBCCEDP) with regard to demographic and practice characteristics and their usual practices in cervical cancer screening and abnormal cytology management, as well as human papillomavirus (HPV) test use. METHODS: The authors analyzed data from a nationally representative survey conducted in 2004 of providers practicing 7 specialties that commonly offer cervical cancer screening. The program providers were compared with nonprogram providers. RESULTS: Program providers were found to be significantly more likely than nonprogram providers to be midlevel providers and to serve low-income, racial/ethnic minorities who are insured by Medicaid. In addition, they had significantly more patients with abnormal Papanicolaou tests and were more likely to offer onsite colposcopy (57% vs 40%). Program providers were less likely to use liquid-based cytology (LBC) as their sole method for cytology. Approximately 20% of program and nonprogram providers used HPV DNA testing as an adjunct to screening cytology and two-thirds used HPV tests to manage patients with abnormal cytology results. However, many also used HPV testing for reasons not approved by the U.S. Food and Drug Administration (FDA), such as for screening women age <30 years. CONCLUSIONS: As of mid-2004, program providers served racially and ethnically diverse, low-income patients who are at high risk for cervical cancer compared with nonprogram providers, as intended by this program. Because many providers offered on-site colposcopy, used LBC, and used HPV tests for patients with abnormal cytology results, they are well equipped to reduce the risk of cervical cancer. Many program providers used the HPV test for reasons that were not approved of by the FDA or reimbursed by the NBCCEDP. The results of this survey have informed training materials for program providers, reimbursement policies for LBC and HPV tests, and interventions to discourage inappropriate HPV testing.     

How will transitioning from cytology to HPV testing change the balance between the benefits and harms of cervical cancer screening? Estimates of the impact on cervical cancer,treatment rates and adverse obstetric outcomes in Australia,a high vaccination coverage country

Primary HPV screening enables earlier diagnosis of cervical lesions compared to cytology, however, its effect on the risk of treatment and adverse obstetric outcomes has not been extensively investigated. We estimated the cumulative lifetime risk (CLR) of cervical cancer and excisional treatment, and change in adverse obstetric outcomes in HPV unvaccinated women and cohorts offered vaccination (>70% coverage in 12–13 years) for the Australian cervical screening program. Two‐yearly cytology screening (ages 18–69 years) was compared to 5‐yearly primary HPV screening with partial genotyping for HPV16/18 (ages 25–74 years). A dynamic model of HPV transmission, vaccination, cervical screening and treatment for precancerous lesions was coupled with an individual‐based simulation of obstetric complications. For cytology screening, the CLR of cervical cancer diagnosis, death and treatment was estimated to be 0.649%, 0.198% and 13.4% without vaccination and 0.182%, 0.056% and 6.8%, in vaccinated women, respectively. For HPV screening, relative reductions of 33% and 22% in cancer risk for unvaccinated and vaccinated women are predicted, respectively, compared to cytology. Without the implementation of vaccination, a 4% increase in treatment risk for HPV versus cytology screening would have been expected, implying a possible increase in pre‐term delivery (PTD) and low birth weight (LBW) events of 19 to 35 and 14 to 37, respectively, per 100,000 unvaccinated women. However, in vaccinated women, treatment risk will decrease by 13%, potentially leading to 4 to 41 fewer PTD events and from 2 more to 52 fewer LBW events per 100,000 vaccinated women. In unvaccinated women in cohorts offered vaccination as 12–13 year olds, no change to lifetime treatment risk is expected with HPV screening. In unvaccinated women in cohorts offered vaccination as 12–13 year olds, no change to lifetime treatment risk is expected with HPV screening. HPV screening starting at age 25 in populations with high vaccination coverage, is therefore expected to both improve the benefits (further decrease risk of cervical cancer) and reduce the harms (reduce treatments and possible obstetric complications) associated with cervical cancer screening.     

Long Term Results of Follow-up After HPV Self-sampling with Devices Qvintip and HerSwab in Women Non-attending Cervical Screening Programme

BackgroundWe are presenting the results of the Slovenian human papillomaviruses (HPV) self-sampling pilot study in colposcopy population of National Cervical Cancer Screening Programme ZORA for the first time. One-year and four-year follow-up results are presented for two different self-sampling devices.Participants and methodsA total of 209 women were enrolled in the study at colposcopy clinic. Prior to the gynaecological examination, all women performed self-collected vaginal swab at the clinic; 111 using Qvintip and 98 using HerSwab self-sampling device. After self-sampling, two cervical smears were taken by a clinician; first for conventional cytology and second for HPV test. After that, all women underwent colposcopy and a cervical biopsy if needed. We compared sensitivity, specificity, and predictive values of cytology (at the cut-off atypical squamous cells of undetermined significance or more [ASC-US+]) and HPV test (on self- and clinician-taken samples) for the detection of cervical intraepithelial neoplasia grade 2 or more (CIN2+) after one and four years of follow-up. Hybrid Capture 2 (HC2) assay was used for all HPV testing.ResultsThe mean age of 209 women was 37.6 years and HPV positivity rate 67.0% (140/209), 36.9 years and 70.3% (78/111) in the Qvintip group and 38.4 years and 63.3% (62/98) in the HerSwab group, respectively. Overall, percent agreement between self and clinician-taken samples was 81.8% (kappa 0.534) in the Qvintip and 77.1% (kappa 0.456) in the HerSwab group. In the Qvintip group, the longitudinal sensitivity, specificity, positive and negative predictive values were 71.8%, 75.0%, 83.6%, 60.0% for cytology; 83.1%, 51.3%, 75.6% and 62.5% for HPV test of self-taken samples and 94.4%, 57.5%, 79.8% and 85.2% for HPV test on clinician-taken samples. In the HerSwab group, the corresponding results were 71.7%, 46.7%, 61.3%, 58.3% for cytology; 75.0%, 47.7%, 62.9% and 61.8% for HPV test on self-taken samples and 94.3%, 44.4%, 66.7% and 87.0% for clinician-taken samples, respectively.ConclusionsThe results confirm that HPV self-sampling is not as accurate as clinician sampling when HC2 is used. All HPV tests showed a higher sensitivity in detecting CIN2+ compared to cytology. Due to non-inferior longitudinal sensitivity of HPV self-sampling compared to cytology, HPV self-sampling might be an option for non-attenders to the National Cancer Screening Programme.Key words: HPV self-sampling, cytology, high-grade intraepithelial lesion