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Objective To investigate the epidemiological characteristics of high-risk human papillomavirus(HR-HPV) infection based on vaginal self-collected samples. Study Design and Setting The pooled data of 3045 self-collected samples used for the analysis derived from four previous studies on cervical cancer screening(The Chinese Multi-Center Screening Trial, CHIMUST; The Shenzhen Cervical Cancer Screening Trial-2, SHENCCAST-2; The Chinese Cervical Cancer Prevention Study, CHIPCAPS; Pingshan trial, PINGSHAN)conducted across China by our team since 2011. These cases were evaluated for HR-HPV type prevalence relative to lesion grade and age. The occurrence of cervical intraepithelial neoplasia(CIN) with specific HPV types and the influence of co-infection is explored. Results The top three most common genotypes among the HR-HPV positives were HPV-52(23.4%), HPV-16(18.0%), and HPV-58(15.50%). For women with CIN2+, the most frequent genotypes were HPV-16, 58, 52, and 18 in sequence. HPV-16 accounted for the majority of CIN2/CIN3/Ca with attribution rate of 23.86%, 44.78% and 50.00% respectively. HPV-58 accounted for 19.48%, 16.79% and 13.46% respectively. CIN2+ was found in the following types most frequently: HPV-16(31.23%), HPV-33(24.03%), HPV-58(18.41%), HPV-31(11.76%), HPV-18(7.75%), and HPV-52(7.30%). HPV-16 showed preference for co-infection with HPV-52 and HPV-58. Conclusion The prevalence of HR-HPV infection based on self-sampling among women in China exhibited some unique epidemiologic features.

Objective Organised cervical cancer screening was started in Estonia in 2006, but participation is still low. Human papillomavirus (HPV) self-sampling has proved to increase screening uptake. This study addressed the feasibility of HPV self-sampling and the acceptance of this method among long-term screening non-attenders. Methods A randomised intervention study was conducted in Estonia in 2020. Women born in 1958–1983 without a Pap smear in 2013–2019 were identified in the Estonian Health Insurance Fund database. From them, 12,000 women were randomly allocated to three equal-sized study groups. The opt-out group received a questionnaire and a Qvintip® sampling device by regular mail. Two opt-in groups received a questionnaire and an e-mail invitation to order a self-sampler online; one received Qvintip and the other Evalyn® Brush. Participantś background characteristics were obtained from the Population Register. The effect of covariates on participation rate was estimated with multivariate Poisson regression. Acceptance of self-sampling was analysed according to agreement with statements in the questionnaire. Results The overall participation rate was 16% with significant differences between opt-out (26%) and opt-in (11%) groups. Compared to the opt-out Qvintip group, adjusted relative risks for the Qvintip and Evalyn Brush opt-in groups were 0.41 (95% confidence interval (CI) 0.37–0.45) and 0.44 (95% CI 0.40–0.49), respectively. Participation was associated with living place, citizenship, and education. Self-sampling was well accepted: 98% agreed that it was easy to use, 88% preferred it as a screening method in future. Conclusions The results show the feasibility and good acceptance of HPV self-sampling among long-term screening non-attenders in Estonia.

Background: Nationwide epidemiological surveys of behavioral factors and human papillomavirus (HPV) infection among Japanese women are scarce. This study aimed to determine the prevalence, genotype distribution, and significant predictive factors of HPV infection using self-collected vaginal samples from Japanese female people. Methods: The study population consisted of 1,050 female subjects aged 16–75 years (median 30 years). The participants were asked to provide self-collected samples from the vaginal wall using cotton swabs for genotyping of HPV. We compared the participants’ characteristics and detected HPV genotypes to determine significant predictors of HPV infection. Results: After excluding 47 participants (34 participants of unknown age, 11 virgin participants, 1 participant who engaged in sex with another woman, and 1 participant who did not undergo β-globin detection), 1,003 participants were included in the analysis. Of the 1,003 participants, 426 (42.5%) participants had at least one HPV genotype, 282 (28.1%) participants had high-risk HPV genotypes, 306 (30.5%) had low-risk HPV genotypes, and 162 (16.2%) participants had both HPV genotypes. HPV-16/18 positivity was found in 5.4% (54/1,003) participants. The most frequently detected high-risk HPV genotype was HPV-52 (86/1,003; 8.6% participants). The number of lifetime sex partners (≥6) and a present history of sexually transmitted infection (STI) were significant predictors of high-risk HPV infection. The number of lifetime sex partners (≥6), age of coitarche (≥20 years of age), unmarried status, and a present history of STI were significant predictors of low-risk HPV infection. Conclusions: The prevalence of high-risk and low-risk HPV infection among Japanese female subjects was 28.1% and 30.5%, respectively. The number of lifetime sex partners (≥6) and present history of sexually transmitted infection were the common significant predictors of high-risk and low-risk HPV infection.

Human papillomavirus (HPV) is a primary cause of cervical cancer. Multiple strains of HPV lead to cervical intraepithelial injuries that later progress to cervical cancer. The purpose of this study was to assess attitudes toward and acceptability of self-sampling among Mexican women who have HPV. Methods: The descriptive, cross-sectional design included a convenience sample of Mexican women with a previous diagnosis of cervical dysplasia. Results: Women ( n = 61) were young adults ( M = 27 years, SD = 6.92) reporting single marital status (55%) and sexually active (93%). Mean age at onset of sexual activity was 17 years; a majority of women (78.8%) had more than one sexual partner in their lifetime with 56.6% reporting between two and five partners. All (100%) of the women indicated that they would “choose self-sampling for HPV detection” and would recommend it to other women. Concerning “attitudes toward HPV,” the women responded that it is necessary to comply with HPV treatment and understand that preventative measures can avoid HPV transmission. Conclusion: Women reported high acceptability for self-sampling and positive attitudes toward HPV diagnostic procedures. Women indicated substantial interest in learning more about HPV, its transmission, preventive measures, routine testing, and recommended self-sampling for HPV detection.

Background Self-sampling with proper instruction in 35-37 weeks’ gestation is supplementary to clinician sampling to prevent early-onset invasive group B streptococcal disease of infants. Despite of the accuracy proved in previous studies, disputes were raised on pregnant women’s low preference and adherence to the method of swab collection. We aimed to assess the accuracy of self-sampling and influencing factors for preference on collection method in Chinese women. Methods We compared screening results of self-sampling with clinician collection in a sample of 522 women in late pregnancy. These participants needed to complete a questionnaire on their preference and demographics after self-sampling. A multi-nominal logistic regression model was then used to measure the association between the influencing factors and preference for collection method. Results A good agreement between the two collection methods was found with a Cohen’s Kappa coefficient 0.83 (95%CI 0.71-0.95). The prevalence of GBS infection in the two methods is statistically different. Four factors (maternal age, parity, education attainment and pain difference) were included in the final multi-nominal regression model while gestational age and vaginal suppository use were excluded. Non-elderly parturient women were 2.84 (95% CI 1.19-6.74) times more likely to prefer self-sampling compared to clinician sampling, adjusting for parity, education and pain difference. If these participants experienced more or equal pain during self-sampling compared to clinician collection, they were more likely to prefer clinician sampling controlling the other three factors’ effect. Conclusions Our study suggests high agreement between the two collection methods. Self-sampling presented a higher detection rate than physician-collected samples. Pregnant women are able to collect rectovaginal samples prior to their antenatal visit. Self-sampling is preferable by 1/5 of the participants and it could be an option for those younger than 35 years old, especially for those with low pain threshold.

Background: Human papillomavirus (HPV)-based screening is rapidly replacing cytology as the cervical screening modality of choice. In addition to being more sensitive than cytology, it can be done on self-collected vaginal or urine samples. This study will compare the high-risk HPV positivity rates and sensitivity of self-collected vaginal samples using four different collection devices and a urine sample. Methods: A total of 620 women referred for colposcopy were invited to provide an initial stream urine sample collected with the Colli-Pee device and take two vaginal self-samples, using either a dry flocked swab (DF) and a wet dacron swab (WD), or a HerSwab (HS) and Qvintip (QT) device. HPV testing was performed by the BD Onclarity HPV Assay. Results: A total of 600 vaginal sample pairs were suitable for analysis, and 505 were accompanied by a urine sample. Similar positivity rates and sensitivities for CIN2+ and CIN3+ were seen for DF, WD, and urine, but lower values were seen for QT and HS. No clear user preferences were seen between devices, but women found urine easiest to collect, and were more confident they had taken the sample correctly. The lowest confidence in collection was reported for HS. Conclusions: Urine, a DF swab, and WD swab all performed well and were well received by the women, whereas the Qvintip and HerSwab devices were less satisfactory. Impact: This is the first study to compare five self-sampling methods in the same women taken at the same time. It supports wider use of urine or vaginal self-sampling for cervical screening.

Background: Human papillomavirus (HPV)-DNA testing combined with self-sampling could increase cervical cancer screening effectiveness, utilizing a sensitive screening modality and an easy sampling method with minimal pain or discomfort. Self-sampling acceptability, though, is pivotal. Materials and Methods: This study is a nested cross-sectional survey within GRECOSELF, a cross-sectional study on HPV-based screening with self-sampling, aiming at investigating self-sampling acceptability among Greek women residing in rural areas, and the factors affecting it. Women between 25 and 60 years old were recruited by midwives participating in a nationwide midwifery network. Participants, after self-sampling, filled out a questionnaire with three sections, one regarding demographic characteristics, a second with questions pertaining to the participants' cervical cancer screening history, and a third with questions regarding the self-sampling process per se. Results: The sample included 13,111 women. Most participants (67.9%), including those screened or not in the past, would prefer self-sampling if assured that the results are not inferior to standard testing. Discomfort or pain during self-sampling was absent or minimal in 97.1% and 96.5% of the cases, respectively, and 74.4% of the women felt adequately confident that they followed the instructions correctly. Women mostly preferred self-sampling at home compared with health care facilities. Pain and discomfort during the procedure, although rare, were significant factors against acceptance. Most of the women reporting a negative impression had a negative experience with conventional sampling in the past. Conclusion: Self-sampling is highly acceptable. Acceptance can be further improved with proper communication of the process and its noninferiority compared with conventional screening.

In France, cervical cancer screening based on cervical smear has a participation rate of around 60%. New screening strategies are encouraged to increase the participation of under-screened women, including vaginal self-sampling with high-risk human papillomavirus (HR-HPV) testing. This study was based on the distribution of an anonymous self-administered questionnaire to assess the acceptability of vaginal self-sampling with HR-HPV testing by women aged 25 to 65 years in two French Departments of the South of France, Aude, and Hérault, showing low participation in cervical cancer screening. Factors influencing this acceptability were also analyzed. From May to July 2017, 349 completed questionnaires were collected. Women declared high acceptability for vaginal self-sampling (81%) preferably at home (82.6%). Acceptability was statistically higher in the Department of Herault (

Background: Self sampled HPV testing is a cervical cancer screening method . However, cytology in self-sampled specimen cannot be used as a triage test. Therefore, other methods for triage should be considered. CyclinA1 (CCNA1) promoter methylation has strong association with cervical precancerous and cancerous lesion. The objective of this study was to compare the diagnostic value of CCNA1 and self-sampled specimen for detecting high-grade cervical intraepithelial lesions or worse (CIN2+). Materials and Methods: A cross sectional study was conducted. Women with abnormal cytology or positive for high risk HPV (hrHPV) indicated for colposcopic examination were enrolled. Self-collected sampling for hrHPV DNA (SS-HPV) and CCNA1 were performed. hrHPV DNA testing was done by Cobas 4800 method. CCNA1 promoter methylation was detected by CCNA1 duplex methylation specific PCR. Histopathologic result as CIN2+ obtaining from colposcopic directed biopsy or excisional procedure was considered as positive a gold standard. The results of hrHPV and CCNA1 were reported as positive or negative. Sensitivity specificity, positive predictive value, and negative predictive value of SS-HPV and CCNA1 were calculated by comparing the results with the gold standard. Results: Two hundreds and eighty women were recruited. High-grade cervical lesions and cervical cancer (CIN2+) were diagnosed in 21.8% (61 cases) of the patients. The most common type of hrHPV was non 16, 18 subtype, followed by HPV16 and 18. CCNA1 was positive in 13 patients out of whom, twelve were CIN2+. Sensitivity of CCNA1 was 19.7 % and its specificity and accuracy were 99.5% and 82.14%, respectively. The sensitivity of SS-HPV was 70.5%, and its specificity and accuracy were 39.2% and 43.3%, respectively. Conclusion: Due to high specificity and positive predictive value of CCNA1, it can be used as alarming sign of having high-grade cervical intraepithelial lesions, especially in patient who has positive hrHPV DNA test based on self-collected sampling.

BACKGROUND/AIM: Cervical cancer is the most common cancer among women in Ethiopia. The objective was to evaluate the participation rate of a free of charge vaginal self-sample (Aptima multitest swab, Hologic) for the detection of human papillomavirus (HPV) in an Ethiopian cohort. PATIENTS AND METHODS: Specimens were collected from women employed by Ethiopian Airlines in Addis Abeba (N=5950). Samples were analysed for the presence of high-risk (HR) HPV mRNA by the Aptima HPV assay (Hologic) and HPV positive women were referred for cytology. Identification of HPV types among HPV positive samples was performed by Modified general primer-PCR and Luminex assay. RESULTS: Participation rate was 3.1% and the prevalence of HPV mRNA was 20.6% (37/180). CONCLUSION: Primary HPV mRNA screening with vaginal self-sampling may be an acceptable approach in Ethiopia. One out of five women harbor HPV in their vaginal self-sample in agreement with other similar studies from the region. (Less)

Objective Cervical cancer screening participation in China remains insufficient, possibly because of embarrassment or discomfort. We assessed knowledge of HPV and its link to cervical cancer, and whether HPV self-sampling might be an acceptable alternative to clinician-based screening, among Sichuan women. Methods A sample of healthy women undergoing routine physical examinations in 2017 at the West China Hospital, Sichuan University, completed a questionnaire. Results From 3000 questionnaires distributed, 1810 were completed and analyzed. Only 29.94% of respondents ( n = 542) had heard of HPV, among whom 65.75% knew that it caused cervical cancer. Among the 766 (42.32%) who considered that HPV self-sampling for cervical cancer screening was an acceptable option, over 90% thought it would be convenient, private, not embarrassing, and not painful. However, 1044 women (57.68%) did not consider self-sampling acceptable, mainly because the result might not be accurate (85.63%), specimens may have gone bad (83.05%), and they may not perform the test correctly (79.98%). Respondents who believed HPV self-sampling was acceptable were more likely than other respondents to be young, and to have completed at least secondary education. Of the 1810 respondents, 1312 (72.49%) reported that they would be willing to be vaccinated against HPV. Conclusion Most women in Chengdu lack basic knowledge about HPV. Over 40% of women believed HPV self-sampling for cervical cancer screening was an acceptable option. To increase screening coverage, public health efforts to educate the public about HPV and HPV self-sampling for cervical cancer screening should be strengthened and expanded.

An increasing body of evidence supports the validity of self-sampling as an alternative to clinician collection for primary Human Papillomavirus (HPV) screening. Self-sampling effectively reaches underscreened women and can be a powerful strategy in low- and high-resource settings for all target ages. This work aims to summarize the current use of HPV self-sampling worldwide. It is part of a larger project that describes cervical cancer screening programmes and produces standardized coverage estimates worldwide. A systematic review of the literature and official documents supplemented with a formal World Health Organisation country consultation was conducted. Findings show that the global use of HPV self-sampling is still limited. Only 17 (12%) of countries with identified screening programs recommend its use, nine as the primary collection method, and eight to reach underscreened populations. We identified 10 pilots evaluating the switch to self-sampling in well-established screening programs. The global use of self-sampling is likely to increase in the coming years. COVID-19's pandemic has prompted efforts to accelerate HPV self-sampling introduction globally, and it is now considered a key element in scaling up screening coverage. The information generated by the early experiences can be beneficial for decision-making in both new and existing programs.

Self-sampling provides a powerful means to engage women in cervical screening. In the original Papillomavirus Dumfries and Galloway study (PaVDaG), we demonstrated cross-sectional similarity of high-risk human papillomavirus (Hr-HPV) testing on self-taken vaginal vs clinician-taken samples for the detection of cervical intraepithelial neoplasia 2 or worse (CIN2+). Few data exist on the longitudinal performance of self-sampling; we present longitudinal outcomes of PaVDaG. Routinely screened women provided a self-taken and a clinician-collected sample. Ninety-one percent of 5136 women from the original cohort completed a further screening round. Sensitivity, specificity, positive predictive value and complement of the negative predictive value of the Hr-HPV test on self-samples for detection of CIN2+ and CIN3+ up-to 5 years after testing were determined. Additionally, clinical accuracy of Hr-HPV testing on vaginal and clinician-collected samples was assessed. A total of 183 CIN2+ and 102 CIN3+ lesions were diagnosed during follow-up. Risk of CIN2+ and CIN3+ following an Hr-HPV negative self-sample was 0.6% and 0.2%, respectively, for up to 5 years after testing. The relative sensitivity for CIN3+ and specificity for

Human papillomavirus (HPV) self-sampling (Self-HPV) is a promising strategy to improve cervical cancer screening coverage in low-income countries. However, issues associated with women who prefer conventional HPV clinical-sampling over HPV self-sampling may affect screening participation. To address this issue, our study assessed factors associated with women’s preferences related to Self-HPV. This study was embedded in a large clinical trial recruiting women aged 30–49 years in a primary HPV-based study termed “3T-Approach” (for Test-Triage-Treatment), launched in 2018 at Dschang District Hospital, West Cameroon. Participants were invited to perform a Self-HPV. After the sampling and before receiving the results, participants completed a questionnaire about cervical cancer screening and their preferences and perceptions around Self-HPV. The median age of the 2201 participants was 40.6 (IQR 35–45) years. Most (1693 (76.9%)) preferred HPV self-sampling or had no preference for either method and 508 (23.1%) preferred clinician-sampling. Factors associated with an increased likelihood of reporting a clinician-sampling preference were tertiary educational level (14.4% CI: 12.8–16.1 vs 29.5% CI: 25.6–33.6) and being an employee with higher grade professional or managerial occupations (5.5% CI: 3.8–7.9 vs 2.6% CI: 2.3–2.8). The main reported reason for women preferring clinician-sampling was a lack of “self-expertise”. Most women (>99%) would agree to repeat HPV self-sampling and would recommend it to their relatives. HPV self-sampling in the cultural context of central Africa was well accepted by participants, but some participants would prefer to undergo clinician sampling. Health systems should support well-educated women to increase self-confidence in using HPV self-sampling.

Non-participation in screening is a main risk factor for cervical cancer. Human-papillomavirus (HPV) self-sampling may be an alternative to repeated invitations for non-attenders. Several studies have concluded that participation among non-attenders increases significantly when offering self-sampling kits for HPV. However, participation rates are highly variable between settings, and therefore pilots to determine optimal implementation strategy have been recommended before routine roll out.All women who had not participated in the organized screening program for at least 10 years aged 33-62 in one Swedish county were identified through screening registers. HPV self-sampling kits were sent to all eligible women. Participation was defined as returning a self-sample kit or attending routine screening within 6 months. Women who did not submit the kit within 8 weeks were randomized to receive a written reminder. HPV-positive women were referred directly to colposcopy without prior triage. Biopsies for histopathologic confirmation were used as gold standard.Among eligible women, 150/741 (20.2%) returned the self-sample kit or attended routine screening. A randomized written reminder was sent out to 319/591 non-responders and another 11 women returned the kit. In total, 23/147 (16.3%) of returned kits were HPV positive. Out of the 23 HPV-positive women, 17 (74%) attended colposcopy; 10/17 (59%) had a histopathological high-grade squamous intraepithelial lesions (HSIL) or cervical cancer. The most common HPV type was HPV 52, and 2 out of 3 women with HPV 16 had a histopathologically confirmed cancer.The direct send kit strategy and referral of all HPV-positive women to colposcopy without prior triage appears to be feasible if resources are available and should be prioritized given the high prevalence of HSIL lesions and cancer among non-attenders. A written reminder might further increase attendance.

OBJECTIVES:: Despite the availability of preventive methods for cervical cancer (CC), uptake has been low among African American and Sub-Saharan Immigrant (AA/SAI) women. The purpose of this study was to understand AA/SAI women’s values and beliefs of CC screening and explore willingness, acceptability, and concerns related to the HPV self-sampling method for CC. DESIGN:: Thirty AA/SAI women participated in one of six focus groups, each lasted 60–90 min, and were held over Zoom video conferencing. The sessions were audio-recorded, transcribed verbatim, and checked for accuracy by research staff prior to data analysis. Transcripts were content analyzed by two qualitatively trained research staff. NVivo software was used for data management and analysis. RESULTS:: The average age of participants was 33.67 ± 9.03, more than half were not married (53.3%), and less than half reported having health insurance coverage (46.7%). Participants included 16 AA and 14 SAI. Three main themes emerged from data analysis. (1) Beliefs and values related to CC Screening, (2) perceived barriers to attending CC screening, (3) recommendations to motivate regular CC screening. In addition, three factors emerged in the discussion on the HPV self-sampling method: confidence in ability to self-sample for CC, willingness to use HPV self-sampling kit, and result delivery. CONCLUSIONS:: This study identified a variety of reasons for the disproportionately low utilization of CC prevention services among AA/SAI women. Multidimensional approaches including educational and community engagement programs for this population could improve CC screening uptake and adoption of HPV self-sampling among AA/SAI women.

BACKGROUND: Human Papilloma Virus (HPV), the causative agent for cervical cancer, can be tested for using self-collected vaginal samples. Self-collection is promising for HPV screening in hard-to-reach populations. To assess the relationship between willingness to self-collect and subsequent uptake of self-collection, we conducted a longitudinal study of reproductive-age women in rural Malawi. METHODS: At baseline, we asked women if they would be willing to self-collect a vaginal sample for HPV testing. At follow-up (12–18 months later), we offered the same women the opportunity to self-collect a sample for HPV testing. We examined unadjusted and adjusted associations between baseline willingness to self-collect a sample for HPV testing and uptake of self-collection at follow-up using log-binomial models. RESULTS: Among 122 women who, at baseline, indicated willingness to self-collect, n=65 (53%) agreed to self-collect a sample at follow-up. Of 64 women who stated unwillingness at baseline to self-collect, n=30 (47%) self-collected a sample for testing at follow-up. We observed no association between women’s willingness at baseline and their observed self-collection decision at follow-up (unadjusted prevalence ratio: 1.14, 95% confidence interval: 0.83–1.55). The association remained non-significant after adjustment for age, awareness of cervical cancer, and perceived behavioral control. CONCLUSIONS: Our results suggest that evaluation of acceptability of self-collection should go beyond simply asking women if they would be willing to self-collect a vaginal sample. Given that half of this study’s participants agreed to self-collect a sample when the opportunity was offered, regardless of their previously stated preferences, self-collection should be offered to everyone.

Background Rates of sexually transmitted infection (STI) screening are suboptimal among college women. Self-sampling methods (SSMs) may improve STI screening rates, but critical gaps remain regarding the influential characteristics of SSM to prioritize in intervention development. The purpose of this study was to explore intervention characteristics influencing the decision to adopt SSM among college women. Methods In-depth interviews (n = 24) were conducted with sexually active college women aged 18-24 years to explore preferred intervention characteristics of SSM. Interviews were stratified by screening status (screened or not screened). The instrument was guided by constructs from the Diffusion of Innovation theory and included characteristics of SSM, such as relative advantage, compatibility, complexity, adaptability, and risk and uncertainty. Results Overall, women felt that the SSM was not complex and that the instructions were straightforward. Participants discussed their strong preference for receiving their results via text or e-mail rather than via telephone. In addition, women described their concerns about mailing their sample and described their concern about potential contamination and tampering. The most salient advantage to use of SSM was avoiding an interaction with a health care provider. Conclusions This study contributes to an understanding of the salient intervention characteristics influencing the use of SSM for STI screening, which can be leveraged to improve the health of students and improve rates of screening. Findings can be used to inform the development of a future innovative, theory-based intervention that promotes the use of SSM to improve STI screening rates, and ultimately decrease the burden of STI-related disease.

This study aims to investigate acceptance of vaginal self-sampling for high-risk human papilloma virus (HPV) among long-term screening non-attenders at increased cervical cancer risk and to identify leverage points to promote screening adherence among these women. Forty-three long-term screening non-attenders performed home vaginal self-sampling for HPV, had positive HPV results, and subsequently attended gynecologic examination. Sixteen (37.2%) had high-grade cervical intraepithelial neoplasia (CIN2 or 3), and two had invasive cervical cancer. Forty-one of these women completed a questionnaire concerning Specific Knowledge about HPV, CIN, and cervical cancer, potential barriers to screening and views about self-sampling. Results were compared with 479 women treated for CIN2+ who attended gynecologic follow-up and also performed self-sampling. Significant multivariate predictors of long-term non-attender status compared with referents were low Specific Knowledge, high confidence in self-sampling, and potential barriers—refraining from activity to attend gynecologic examination, needing another's help to attend, and long travel time. Non-attenders citing fear/refraining from gynecologic examination as why they preferred self-sampling significantly more often had lowest Specific Knowledge compared with other non-attenders. All non-attenders could envision themselves doing self-sampling again while only 74% of referents endorsed this statement (p = 0.0003). We conclude that HPV self-sampling is an acceptable option for women at increased cervical cancer risk who have been long-term screening non-attenders. Educational outreach to enhance Specific Knowledge about HPV, CIN and cervical cancer is critical. Those non-attenders who explicitly avoid gynecologic examinations need special attention. Trial Registry: Clinicaltrials.gov NCT02750124

International audience; Vaginal self-sampling and human papillomavirus (HPV) DNA testing can be useful tools for women with limited access to health care living in sub-Saharan Africa. To assess the feasibility and acceptability of vaginal self-sampling and high-risk HPV prevalence in two villages of central Senegal, women were asked to self-sample vaginal swabs for HPV detection in May, 2016. Vaginal swabs were collected from 133 women and were tested for HPV genotyping. The acceptability rate of vaginal self-sampling was 98.5%, and 99.2% of the women (133/134) used the device correctly. The quality of self-sampling was satisfactory in 100% of the samples; 10.5% of the samples were positive for HPV, including 6% with high-risk HPV types and 4% with low-risk HPV types. This preliminary study indicates that vaginal self-sampling is a valuable strategy for high-risk HPV detection and cervical cancer screening in a population of women not attending gynecologic screening in rural areas of Senegal.

PURPOSE To obtain insight into the feasibility of, and the patients' perspective on, dried blood spot (DBS) self-sampling by patients with chronic myeloid leukemia (CML) using nilotinib. METHODS Sixty-eight patients with CML using nilotinib participated in this multicenter observational study. Patients were asked to perform blood sampling by means of the DBS method at home just before drug intake (trough level) and to complete a questionnaire including demographics and five questions on their experience with DBS self-sampling. RESULTS Sixty-one patients (57.5 ± 15.0 years, 49% female) provided 178 DBS samples of which 137 (77%) proved useful in clinical practice. Twenty percent of the samples were rejected because the spot size was too small for analysis. A further 3% were taken at the wrong time. Unsuitable DBS samples were provided by 23 patients. Their educational level was significantly lower than that of patients whose samples were all suitable (p = 0.041). Patients considered DBS self-sampling easy and not painful, and three quarters of the patients performed DBS sampling without additional assistance. Patients' belief in the reliability of DBS self-sampling was moderate to high. It was preferred over venous sampling by 37% of the patients, whereas 39% had no preference. CONCLUSION DBS self-sampling by CML patients is feasible in clinical practice provided that patients, particularly those with a lower educational level, are adequately instructed about sample collection with emphasis on timing and volume of sample collection.

Several countries offer HPV self-sampling for screening non-attendees. It is assumed that screening attendees also prefer self-sampling to clinician-based sampling, however, little research has been conducted with respect to this. Women participating in the IMPROVE-study were randomised (1:1) to self- or clinician-collected HPV testing, and HPV-positive women were retested using the other collection method. Three different questionnaires were sent out among a subset of participating women: Q1) HPV-positive women from both study groups were asked about their experiences with self-sampling and clinician-based sampling (n = 497); Q2) HPV-negative women from the self-sampling group were asked about their experiences with self-sampling (n = 2366); and Q3) HPV-negative women in the clinician-collection group were asked about their experiences with clinician-based sampling (n = 2092). Response rates ranged from 71.6 to 79.4%. Women reported significantly lower levels of shame, nervousness, discomfort and pain during self-sampling compared to clinician-based sampling. However, trust in correct sampling was significantly higher during clinician-based sampling. The majority of women in group Q1 preferred self-sampling (76.5%) to clinician-based sampling (11.9%) in future screening, while 11.6% of women reported to have no preference for either method. To conclude, women from a regular screening population have a positive attitude towards self-sampling but express some concerns with respect to accuracy. The majority prefers self-sampling to clinician-based sampling in future screening. Based on these results, a screening approach where women can choose for either self-sampling or clinician-based sampling seems highly justifiable.

BackgroundThe purpose of this study was to compare cervical cancer screening by pap smear (PS) versus preliminary HPV testing based on self-collected samples (SC-HPV).MethodsInterventional study among underprivileged women from 25 to 65 years old in four French cities. The control group (CG) was referred for a PS. The experimental group (EG) conducted a SC-HPV test followed by a PS in case of positivity. Differences on screening completion and cytological abnormalities were analysed by logistic and Cox regression.Results383 women were assigned to the EG and 304 to the CG. The screening completion proportion was 39.5% in the CG compared to 71.3% in the EG (HR = 2.48 (CI 95% [1.99–3.08];p p = 0.18).ConclusionProviding an SC-HPV-test increased the participation of underprivileged women in CCS. Nevertheless, the significant number of lost to follow-up in both groups can undermine the initial benefits of the strategy for HPV positive women.Registration: Clinicaltrials.gov: NCT03118258.

Serological testing is emerging as a powerful tool to progress our understanding of COVID-19 exposure, transmission and immune response. Large-scale testing is limited by the need for in-person blood collection by staff trained in venepuncture, and the limited sensitivity of lateral flow tests. Capillary blood self-sampling and postage to laboratories for analysis could provide a reliable alternative. Two-hundred and nine matched venous and capillary blood samples were obtained from thirty nine participants and analysed using a COVID-19 IgG ELISA to detect antibodies against SARS-CoV-2. Thirty eight out of thirty nine participants were able to self-collect an adequate sample of capillary blood (≥ 50 µl). Using plasma from venous blood collected in lithium heparin as the reference standard, matched capillary blood samples, collected in lithium heparin-treated tubes and on filter paper as dried blood spots, achieved a Cohen’s kappa coefficient of > 0.88 (near-perfect agreement, 95% CI 0.738–1.000). Storage of capillary blood at room temperature for up to 7 days post sampling did not affect concordance. Our results indicate that capillary blood self-sampling is a reliable and feasible alternative to venepuncture for serological assessment in COVID-19.

Introduction Urine self-sampling for human papillomavirus (HPV)-based cervical cancer screening is a non-invasive method that offers several logistical advantages and high acceptability, reducing barriers related to low screening coverage. This study developed and evaluated the performance of a low-cost urine self-sampling method for HPV-testing and explored the acceptability and feasibility of potential implementation of this alternative in routine screening. Methods A series of sequential laboratory assays examined the impact of several pre-analytical conditions for obtaining DNA from urine and subsequent HPV detection. Initially, we assessed the effect of ethylaminediaminetetraacetic acid (EDTA) as a DNA preservative examining several variables including EDTA concentration, specimen storage temperature, time between urine collection and DNA extraction, and first-morning micturition versus convenience sample collection. We further evaluated the agreement of HPV-testing between urine and clinician-collected cervical samples among 95 women. Finally, we explored the costs of self-sampling supplies as well as the acceptability and feasibility of urine self-sampling among women and healthcare workers. Results Our results revealed higher DNA concentrations were obtained when using a 40mM EDTA solution, storing specimens at 25°C and extracting DNA within 72 hrs. of urine collection, regardless of using first-morning micturition or a convenience sampling. We observed good agreement (Kappa = 0.72) between urine and clinician-collected cervical samples for HPV detection. Furthermore, urine self-sampling was an affordable method (USD 1.10), well accepted among cervical cancer screening users, healthcare workers, and decision-makers. Conclusion These results suggest urine self-sampling is feasible and appropriate alternative for HPV-testing in HPV-based screening programs in lower-resource contexts.

Primary screening with human papillomavirus (HPV) test is more effective in reducing cervical cancer incidence than cytology and it also offers the opportunity to self-sample. We conducted a randomized study to compare vaginal self-sampling with cervical sampling by medical professionals for HPV testing concerning prevalence of HPV and detection of cervical intraepithelial neoplasia (CIN) of grade 2 or worse (CIN2+) or grade 3 or worse (CIN3+) in primary screening. In total, 11 951 women aged 30-60 years were randomized into two groups, 5961 for self-sampling (SS arm) and 5990 for sampling by medical professionals (SMP arm). Sampling was performed with a RoversViba-brush in the SS arm and a cytobrush in the SMP arm. All samples were applied to an indicating FTA elute card and analyzed for HPV using a clinically validated real-time PCR test (hpVIR). All HPV-positive women performed repeated sampling about 6 months later using the same procedure as used initially. All HPV-positive women in the second sampling were referred to colposcopy. The prevalence of HPV in the first test did not differ between the SS arm (6.8%, 167/2466) and the SMP arm (7.8%, 118/1519) (P = .255). The prevalence of CIN2+ per 1000 screened women was 17 (43/2466 × 1000) (95%CI 13-24) in the SS arm and 21 (32/1519 × 1000) (95%CI 15-30) in the SMP arm. For CIN3+, the prevalence per 1000 screened women was 14 (35/2466 × 1000) (95%CI 10-20) in the SS arm and 15 (23/1519 × 1000) (95%CI 10-23) in the SMP arm. In conclusion, self-sampling and sampling by medical professionals showed the same prevalence of HPV and detection rate of CIN2+ and CIN3+ in histology.

Objective To assess the feasibility and acceptability of HPV self-sampling in Arusha region, northern Tanzania, because the ability for women to self-collect HPV samples can help reduce the number of health facility visits and improve cervical cancer screening coverage rates. Methods We conducted a facility- and community-based cross-sectional study among 350 women aged 25-55 years in Arumeru district, Arusha region, northern Tanzania. Women were trained to self-collect an HPV sample, and follow-up visits were used to provide results after laboratory testing. Data were analyzed using Stata version 15.1 and summarized using mean and standard deviation for numeric variables and frequencies and percentages for categorical variables. Results Among 350 women, 65 (18.6%) ever screened for cervical cancer, all provided self-collected samples, and 349 (99.4%) would advise their female friends to undergo the same procedure. The prevalence of positive HPV results was 31 (8.9%), of which 26 (83.9%) were further examined. Two women found with lesions were treated following the national guidelines. Conclusion This study has demonstrated that the HPV self-sampling intervention for cervical cancer screening is a feasible and acceptable intervention, especially in resource-limited countries like Tanzania. Scaling-up policies should consider addressing the potential barriers to the uptake of this intervention.

Internet-based testing for Chlamydia trachomatis and Neisseria gonorrhoeae is a public health service in Sweden. However, knowledge about users of the service is limited. This study examined experiences of using the C. trachomatis/N. gonorrhoeae self-sampling service. Individuals ordering a free-of-charge C. trachomatis/N. gonorrhoeae self-sampling test from an eHealth website in 2018/2019 were invited to complete a questionnaire. Of the 1,785 participants 69.4% were women. The majority of participants (77.1%) were single and heterosexual (88.2%) and 5.3% of samples tested positive. The self-sampling service was appreciated, with > 90% considering it good/very good. The main reason subjects gave for testing was to check their health after unprotected sex (72.9%). Almost half (44.7%) had regretted having sex after alcohol intake. Differences in attitudes were seen between categories: born vs not born in Sweden, employed vs student, single vs married/having a partner. Participants were happy with the self-sampling test service, and sexual risk behaviours motivated use of the test.

ObjectivesTo establish temporal links between vaginal microbiota (VMB) data and incident clinical events, frequent longitudinal vaginal sampling is required. Self-collection of swabs at the participant’s home may be useful to avoid overburdening research clinics and participants. One-off vaginal self-sampling for STI or cervical cancer screening programmes has been shown to be feasible and acceptable to women in multiple studies, including in sub-Saharan Africa, but the feasibility and acceptability of frequent longitudinal vaginal sampling in the context of VMB sequencing studies is unknown.MethodsTwelve participants of a randomised clinical trial in Kigali, Rwanda, self-collected vaginal swabs three times a week for a month. We studied feasibility by comparing DNA concentrations, proportions of samples with >1000 16S rRNA amplicon sequencing reads and VMB composition outcomes of self-collected swabs with clinician-collected swabs. We evaluated the acceptability of self-collection using structured face-to-face interviews and a focus group discussion.ResultsThe participants collected vaginal swabs at 131 different time points. One woman stopped self-sampling after one try due to a social harm. All self-sampled swabs generated >1000 rRNA amplicon sequencing reads, and the DNA concentration of self-sampled swabs and clinician-sampled swabs did not differ significantly (Kruskal-Wallis p=0.484). Self-sampled and clinician-sampled swabs generated similar VMB composition data. Participants reported feeling very comfortable during self-sampling (11/12; 91.7%) and that self-sampling had become easier over time (12/12; 100%). They mentioned reduced travel time and travel costs as advantages of self-sampling at home.ConclusionsFrequent longitudinal vaginal sampling at home is feasible and acceptable to participants, even in the context of a low-resource setting, as long as adequate counselling is provided.Trial registration numberNCT02459665.

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&ndash, 35 and aged &ge, 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 &ge, 45 than those aged 25&ndash, 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.

Willingness to self-collect vaginal swabs at a pharmacy clinic is of interest as a venue to increase sexually transmissible infections (STIs) screening for chlamydia, gonorrhoea and trichomonas. Women self-collected vaginal swabs at the pharmacy, completed questionnaires and received STI results within 2 h. Women with STIs were offered free treatment. A total of 313 of 777 (40.3%) women consented and prevalence for any STI was 3.9%. Questionnaires demonstrated acceptability for self-collection at the pharmacy, with 63% (95% CI 57.3–68) and 32.3% (95% CI 27.4–37.8) indicating they ‘strongly agreed’ or ‘agreed’ that they felt comfortable with pharmacy collection, respectively. Self-collected vaginal swabs for STI testing for women who were at a pharmacy were feasible and acceptable to women.

Background Haitian and Hispanic immigrant women experience substantial disparities in cervical cancer screening. Recently, our team completed two randomized trials of human papillomavirus (HPV) self-sampling as a cervical cancer screening strategy among Haitian and Hispanic women, using a community-based participatory research (CBPR) approach. Objective To reflect on lessons learned in the process of completing two large randomized cancer screening trials within underserved communities. Methods Haitian and Hispanic women were randomized to HPV self-sampling versus navigation to Pap smear versus standard cervical cancer screening education in the first trial, and HPV self-sampling delivered in-person versus via mail in the second trial. Lessons learned During the two trials, our team encountered several challenges. The lessons learned from these challenges allowed for the strengthening of our community partnerships, study procedures, and our ability to conduct CBPR within an academic setting. Conclusions Lessons learned from our trials may be useful to other researchers engaging in CBPR within underserved communities.

ObjectiveImplementation of a novel, rapid, high-volume, see-and-treat cervical cancer screening programme using self-swab human papillomavirus (HPV) testing and digital colposcopy in underserved regions of Yunnan China.Design480–980 women per day self-swabbed for high-risk HPV (hrHPV+). Four careHPV machines (Qiagen) were run simultaneously to test the specimens. All hrHPV+ patients were contacted the same day and digital colposcopy was performed with the enhanced visual assessment system (MobileODT). Digital images were obtained, and all suspected lesions were biopsied and then treated.SettingRural and underserved areas of the Yunnan province, Kunming municipality.Participants3600 women, mean age 50.2 years, who had never been screened for cervical cancer. The women were of the Yi, Hui, Dai and Han ethnicities.InterventionsCryotherapy was performed on all lesions suspicious for cervical intraepithelial neoplasia (CIN) 1 and loop electrosurgical excision procedure was performed on all lesions suspicious for ≥CIN2. Endocervical curettage was performed if the transformation zone was not fully visualised.Results216 women (6%) were hrHPV+. 168 underwent same-day colposcopy (23 CIN1, 17≥CIN2). Digital colposcopy was able to identify 15 of 16 (93.8%)≥CIN2 lesions.ConclusionsThis study illustrates a high-volume, rapid and practical strategy that can be used to screen and treat an ethnically diverse group of Chinese women. First, HPV self-sampling allows large numbers of women to be screened rapidly and relatively inexpensively. Only hrHPV+ women will then require further evaluation. Digital colposcopy is then performed on hrHPV+ women with a portable digital colposcope. The high-resolution images obtained can facilitate appropriate same-day treatment as they are able to accurately distinguish between CIN1 and ≥CIN2 lesions.

Molecular detection of high-risk human papillomavirus (HPV) in genital cells is being widely endorsed as a preferred tool for cervical cancer screening globally. In low- and middle-income countries (LMICs) where cervical cancer remains a leading killer, HPV testing is an appealing, accessible alternative to traditional cytology (ie, Pap smear) screening that enables women to self-collect specimens. This article examines self-sampling and its suitability as a strategy for cervical cancer prevention in LMICs that would promote equitable access to cervical cancer screening.

BACKGROUND/AIM: Cervical cancer is associated with poorer diagnosis among the elderly and pap-smear screening has a lower sensitivity. Self-sampling for detection of high-risk human papillomavirus (hr-HPV) may be an alternative screening method. The aim of this study was to analyze the response rate to vaginal HPV self-sampling and the HPV mRNA prevalence among women 69-70 years. MATERIALS AND METHODS: An HPV self-sampling kit was sent to 1,000 women 69-70 years whom had not taken a cervical smear in ≥5 years. The samples were analyzed by the Aptima HPV mRNA assay. HPV-positive women were recalled for a follow-up examination. RESULTS: The self-sample response rate was 43.3%. The HPV mRNA prevalence was 6.2%. All HPV-positive women attended follow-up. CONCLUSION: HPV self-sampling was accepted among older women. Although the HPV mRNA prevalence was 6.2%, no high-grade cytological abnormalities were found. Larger studies are needed to elucidate hr-HPV self-sampling as a tool to identify older women at risk of cervical cancer. (Less)

Background To overcome obstacles within the Slovenian organised cervical cancer screening programme, a randomised pilot study of human papillomavirus (HPV) self-sampling among non-attenders was performed, aiming to assess three different screening approaches. Participants and methods Non-attenders aged 30–64 years from two Slovenian regions were randomised to two HPV self-sampling groups–the opt-in (I1, n = 14.400) and the opt-out (I2, n = 9.556), with a control group (P, n = 2.600). Self-collected samples were analysed using the Hybrid Capture 2 assay. HPV-positive women were invited to a colposcopy. The overall and type-specific intention-to-screen response rates and histological outcomes with a positive predictive value (PPV) according to the women’s age, the screening approach, the level of protection resulting from previous screening history, and the region of residence were assessed. Results Of the 26.556 women enrolled, 8.972 (33.8%) responded with self-sample for HPV testing and/or traditional cytology within one year of enrolment. Response rates were 37.7%, 34.0% and 18.4% (p < 0.050) for opt-out, opt-in and control groups. Cervical intraepithelial neoplasia (CIN)2+ was diagnosed in 3.9/1.000, 3.4/1.000, and 3.1/1.000 women (p > 0.050), respectively. PPV of the HPV self-sampling was 12.0% and 9.6% for CIN2+ and CIN3+. The highest PPV was obtained in non-attenders in screening programme for more than 10-years and concordant results of HPV testing with 40.8% for CIN2+ and 38.8% for CIN3+. Conclusions The results of our study show that a high response to HPV self-sampling can be achieved also in an opt-in approach, if women are encouraged to choose between self-sampling at home and screening with gynaecologist. In addition, clinically important risk difference for a high-grade cervical lesion exists in the case of a positive result of HPV testing on self-collected samples, depending on the length of the interval since last screening. Stratified management of these women should be strongly considered. Women who were not screened with cytology for at least 10 years should be referred to immediate colposcopy for histology verification instead to delayed re-testing.

In a cross-sectional study carried out in El Salvador between February 2016 and July 2017, self-sampling and human papillomavirus (HPV) testing was found to be highly acceptable among 2019 women who had not attended a cervical cancer screening in at least 3 years. Within this population, HPV positivity rates differed according to age, marital status, number of children, and lifetime sexual partners. The proportion of women who tested HPV positive or who were diagnosed with cervical intraepithelial neoplasia grade 2 (CIN2) or more severe diagnoses (CIN2+) was similar to the general population of the area. Among the reasons for failing to participate in previous screening programs, non-attending women described logistic concerns, but also erroneous beliefs regarding HPV and cervical cancer, misconceptions regarding the screening procedure, discomfort with male providers, and confidentiality fears. The aim of this study was to identify opportunities and challenges that emerged from the use of self-sampling and HPV testing as part of a public cervical cancer control effort in a low-resource setting.

Objective To investigate whether self-sampling is as reliable as professional sampling for HPV testing and genotype detection among postmenopausal women. Methods In the present prospective cross-sectional study, women in Orebro County, Sweden, who had high-risk HPV (hrHPV) and normal cytology results in exit screening tests conducted in between January 1, 2012, and December 31, 2014, were invited to follow-up screenings between February 24, 2015 and May 15, 2015, that included professional sampling and self-sampling. HPV genotypes were identified by a DNA-based assay that could detect 35 HPV genotypes. Findings between the different sampling methods were compared. Results Of 143 women who participated, 119 returned a self-sample. Completely concordant results were observed in 67 of these samples when both hrHPV and low-risk HPV genotypes were analyzed. Overall, 99 (83.2%) women had the same clinically relevant finding from both sampling methods. Twenty women had discordant hrHPV results (hrHPV detected in 10 self-samples vs 10 professionally collected samples; Cohen κ 0.66, 95% confidence interval 0.53-0.80). There was no significant difference between the two sampling methods for clinically significant infections (P>0.99) or extended genotyping (P=0.827). Conclusion Postmenopausal women could be offered self-sampling devices to increase screening-program coverage while maintaining test quality.

As a new initiative, HPV self-sampling to non-attenders using the dry Evalyn self-sampling brush is offered in the Capital Region of Denmark. The use of a dry brush is largely uncharted territory in terms of analytical stability. In this study we aim to provide evidence on the analytical quality of dry HPV self-sampling brushes as a function of time and temperature. We assessed the analytical stability of dry stored Evalyn brushes at three different temperatures, (4 °C, room temperature, 30 °C) and five different storage time points; T = 0 (baseline), 2, 4, 8, 16, and 32 weeks prior to HPV analysis using the BD Onclarity HPV assay. Mean Ct value of the Onclarity internal control was used as comparator of cellularity across time and temperatures, with no or only borderline statistical differences observed. HPV detection was stable throughout the five time points. In addition, analytically amplifiable DNA copy numbers and DNA fragmentation was assessed using the Agena iPLEX Exome QC assay, with no or only borderline statistical differences observed. In conclusion, the Evalyn brush is analytically stable with respect to human genomic material and HPV detection for up to 32 weeks at temperatures ranging from 4 °C to 30 °C., Highlights • The Capital Region of Denmark is implementing HPV self-sampling using a dry brush. • But how analytically stable is a dry collected self-sampling device? • Stability was established for both human DNA (all, N = 637) and HPV (positives, N = 41). • We found the Evalyn Self-sampling brush stable up to 6 month. • Neither 4 °C nor 30 °C changed the analytical stability of the dry brush.

High-risk human papillomavirus (hr-HPV) infection of the cervicovaginal tract is known to be the major cause of cervical cancer. Similar to various other countries, Germany introduced an organized combined screening including cytology and HPV testing in 2020. The participation rate was around 70% in the past. Self-testing for hr-HPV infections could be an option to increase the participation rate. Two dry vaginal self-sampling devices and a device for the self-collection of first-void urine were evaluated in combination with a PCR-based hr-HPV test regarding their clinical performance (sensitivity for high-grade cervical intraepithelial neoplasia, CIN 2+). A cervical smear taken by a clinician during colposcopy was used as reference. This open prospective multicenter trial recruited patients referred to the two participating colposcopy clinics (Hannover Medical School and IZD Hannover, Germany) with abnormal results from cervical cancer screening from 05/2020 to 11/2020. All patients received three CE-certified self-sampling devices (FLOQSwabs, COPAN, Italy, Evalyn Brush, Rovers Medical Devices, the Netherlands, Colli-Pee FV-5000, Novosanis, Wijnegem, Belgium) with instructions to read and apply at home in a pre-specified alternating order without medical assistance. HPV testing was performed after adequate preservation and DNA extraction. Histological results from colposcopy or cervical excisional surgery after self-sampling were used as the gold-standard. The data of 65 patients were analyzed. All invasive cancer cases and over 90% of the CIN 3 lesions were found to be hr-HPV positive with all three self-collection devices. All devices were considered easy to use without any difficulties following the written instructions. Hr-HPV testing of self-collected first-void urine and dry vaginal self-samples showed a high sensitivity for CIN 3+ comparable to that of a clinician-taken smear. Self-sampling was well accepted as it is convenient and easy to use.

Contains fulltext : 177357.pdf (Publisher’s version ) (Open Access) In 2017 the cervical cancer screening program in The Netherlands will be revised. Cervical smears will primarily be tested for the presence of high-risk human papillomavirus (hrHPV) instead of cytology, and vaginal self-sampling will be offered to non-responders. This includes a potential risk that part of the women who would otherwise opt for a cervical smear will wait for self-sampling. However, self-sampling for hrHPV in a responder population has never been studied yet. The aim of this study was to investigate the applicability and accuracy of self-sampling in detecting hrHPV in a screening responder population. A total of 2049 women, aged 30-60years, participating in the screening program in The Netherlands were included from April 2013 to May 2015. After they had their cervical smear taken, women self-collected a cervicovaginal sample with a brush-based device, the Evalyn Brush. Both the cervical smear and self-sample specimen were tested with the COBAS 4800 HPV platform. The hrHPV prevalence was 8.0% (95% CI 6.9-9.2) among the physician-taken samples, and 10.0% (95% CI 8.7-11.3) among the self-samples. There was 96.8% (95% CI 96.0-97.5) concordance of hrHPV prevalence between self-samples and physician-taken samples. Women in our study evaluated self-sampling as convenient (97.1%), user-friendly (98.5%), and 62.8% preferred self-sampling over a physician-taken sampling for the next screening round. In conclusion, self-sampling showed high concordance with physician-taken sampling for hrHPV detection in a responder screening population and highly acceptable to women. Implementation of HPV-self-sampling for the responder population as a primary screening tool may be considered.

Background: The aim of this study is to evaluate whether self-sampling can increase screening attendance of women who do not attend regular screening in Switzerland. Methods: Participants were proactively recruited in Geneva between September 2011 and November 2015. Women (25–69 years) who had not undergone CC screening in the last 3 years were considered eligible. Through a 1 : 1 ratio randomisation, enrolled participants were invited to either undergo liquid-based cytology, which was performed by a health-care provider (control group, CG) or to take a self-sample for HPV-testing, which was mailed to their home (intervention group, IG). Results: A total of 331 and 336 women were randomised in the CG and in the IG, respectively. Overall, 7.3% (95% CI: 4.9–10.6) women in the CG and 5.7% (95% CI: 3.6–8.7) women in the IG did not undergo the initial screening (P=0.400). There were 1.95% (95% CI: 0.8–4.3) women in the CG and 5.05% (95% CI: 3.1–8.1) women in the IG with a positive screen who did not attend triage and colposcopy (P=0.036). Conclusions: The participation in CC screening in women offered self-sampling was not higher than among those offered specimen collection by a clinician. Compliance with further follow-up for women with a positive HPV test on the self-sample requires further attention.

We conducted an online survey to examine the preferences for receiving a text message with results of a test for sexually transmitted infections (STIs) as part of online self-sampling service at Solent NHS Trust. Findings showed that if all tests were negative, participants would prefer to receive one text message. However, in the event of a positive result, a large majority (86%) would prefer to receive a separate text with the name of the STI for which the test was positive. Similarly, three-quarters (74%) of participants would prefer to receive multiple texts indicating which test was inconclusive and required an additional sample. The results of this survey support a change of practice to sending multiple text messages with the results of online self-sampling that include the names of STIs.

In Ethiopia, the standard method of cervical cancer screening is using Visual Inspection with Acetic Acid (VIA). Self-collection–based human papillomavirus (HPV) testing is assumed to improve the uptake of screening, especially for hard to reach populations. We investigated whether HPV DNA testing with the self-collection of cervical samples would be associated with increased uptake and adherence to procedures at the population level compared with VIA within defined rural population in Ethiopia. A total of 22 clusters (comprising 2,356 women ages 30–49 years) were randomized in two arms. Following the community mobilization, women of the clusters were invited to go either to the local health post for a self-collection–based HPV DNA testing (arm A) or Butajira Hospital for VIA screening (arm B). In the HPV arm, of the 1,213 sensitized women, 1,020 (84.1%) accessed the health post for self-sampling compared with the VIA arm, where 575 of 1,143 (50.5%) visited the hospital for VIA (P < 0.0001). Of those women who attended the VIA and HPV arms, 40% and 65.4% adhered to all procedures expected after screening, respectively. Out of women positive for high risk HPV, 122 (85%) attended VIA as a follow-up test. The trial demonstrated significantly higher levels of population-based uptake and adherence for self-collection HPV testing. Women were more receptive for VIA after their HPV testing result was positive. Self-collection HPV testing can be done at the local health facility and may significantly improve the uptake of cervical cancer screening in Ethiopia.

Dried blood spot (DBS) is an attractive matrix alternative to plasma for the measurement of antiepileptic drug concentrations with the possibility of self-sampling at home. The aim of this study was to evaluate whether DBS concentrations from a children population could be used as an alternative to plasma concentrations in a clinical routine laboratory.Children with epilepsy using carbamazepine (CBZ), lamotrigine (LTG), levetiracetam (LEV), or valproic acid (VPA) had capillary blood collected for routine plasma analysis. DBS samples were collected by guardians or nurses, and the quality of sampling was compared between the groups. DBS samples were analyzed with liquid chromatography-tandem mass spectrometry methods and plasma samples with immunochemical methods. In the comparison between DBS and plasma concentrations, previously analyzed sample data were pooled with data in this study and resulted in 190 comparison pairs. A bioanalytical cross-validation according to European Medicines Agency was performed. Clinicians evaluated the results to understand if a DBS concentration was linked to a different clinical dose recommendation for the patient in comparison with plasma concentrations.Comparison of DBS sample quality showed that 2.3% of the capillary DBS collected by guardians were rejected and 8.0% of the capillary DBS collected by nurses. For DBS, a conversion factor of 0.85 for CBZ and 1.65 for VPA was applied for the comparison with plasma. LTG and LEV results were directly comparable. In the cross-validation, 88% of CBZ, 75% of LTG, 74% of LEV, and 94% of VPA comparisons were within 20% of the difference of the mean, although LEV had a few major differences (+31% to -40%). In 4 of the 190 comparisons, the clinical evaluation indicated a risk of conflicting decisions regarding the need for dose adjustment when using DBS concentrations. However, the risk of negative patient outcomes was considered negligible.Our study demonstrates that a combination of bioanalytical cross-validation and clinical evaluation is an effective way to describe the applicability of DBS as an alternative to plasma, taking into account how therapeutic drug monitoring is used in specific patient groups. For LTG, converted CBZ and VPA, DBS is a feasible alternative for self-sampling at home. DBS for LEV can only be recommended for nonadherence queries due to the high variability of the plasma/DBS concentration ratios.

At the recent BASHH Annual Conference, there were numerous presentations referring to home-sampling or testing, oftentimes interchangeably and inconsistently, despite these being distinct methodologies. Furthermore, by specifying ‘home’ as opposed to ‘self’, the sampling or testing is constrained to the home environment. With diagnostic advances enabling modified care pathways, we urge that these terms be used consistently. The WHO defines HIV self-testing as ‘a process whereby a person who …

Objectives Cervical cancer incidence and mortality is increasing in Japanese women under age 50. Screening uptake is low and proactive recommendations for human papillomavirus vaccination have been suspended. Other cervical cancer prevention initiatives are urgently needed. We assessed whether human papillomavirus self-sampling might be an acceptable alternative to physician-led screening, particularly in women with limited experience of tampon use. We also sought to identify any practical, logistical, or safety issues in women already attending for screening, before carrying out further large-scale studies in non-responders. Methods In total, 203 women aged 20–49 attending their annual workplace healthcheck in Sapporo, northern Japan, performed unsupervised human papillomavirus self-sampling before undergoing a physician-led cervical smear and human papillomavirus test, and completing a measure of acceptability for both tests. Results Ninety per cent of participants stated they would use self-sampling again. They found instructions easy to follow and reported no issues with the usability of the self-sampling device. Compared with physician-led testing, women found self-sampling significantly less painful, less embarrassing and could relax more (p Conclusions Self-sampling was highly acceptable in this population of women. They could perform the test safely unsupervised, but lacked confidence the test has been carried out correctly. Japanese women need to be educated about the accuracy of human papillomavirus self-sampling and further large-scale studies are necessary in non-responders.

Women living with HIV experience higher risk of cervical cancer, but screening rates in the United States are lower than recommended. The purpose of this study was to examine whether an intervention using self-sampling of cervicovaginal cells for human papillomavirus (HPV) with results counseling would increase cervical cytology ("Pap") testing among women with HIV.This was a randomized controlled trial to test the effectiveness of an intervention of self-sampling for HPV and results counseling. Participants were 94 women older than 18 years, with HIV infection, attending an HIV clinic for a primary care visit, whose last cervical cancer screening was 18 months or more before baseline. Women were assigned to the intervention or information-only group. The primary outcome was completion of cervical cytology testing within 6 months of baseline. The secondary outcome was the women's perceived threat of developing cervical cancer.A total of 94 women were enrolled and analyzed in the study. The cytology completion rate overall was 35% by 6 months from baseline. There were no differences in comparing HPV-positive with HPV-negative women nor comparing them with the information-only group. In the intervention group, a positive HPV test increased perceived threat of cervical cancer.The intervention did not improve cytology test attendance, although education about HPV and cervical cancer risk as part of study procedures was associated with testing for 35% of this group of women whose previous cytology occurred an average of 3.6 years before the baseline appointment. Self-sampling for HPV testing was feasible.