Recurrent cervical cancer detection using DNA methylation markers in self-collected samples from home.

Early detection of recurrent cervical cancer is important to improve survival rates. The aim of this study was to explore the clinical performance of DNA methylation markers and high-risk human papillomavirus (HPV) in cervicovaginal self-samples and urine for the detection of recurrent cervical cancer. Cervical cancer patients without recurrence (n = 47) collected cervicovaginal self-samples and urine pre- and posttreatment. Additionally, 20 patients with recurrent cervical cancer collected cervicovaginal self-samples and urine at time of recurrence. All samples were self-collected at home and tested for DNA methylation and high-risk HPV DNA by PCR. In patients without recurrent cervical cancer, DNA methylation levels decreased 2-years posttreatment compared to pretreatment in cervicovaginal self-samples (p < .0001) and urine (p < .0001). DNA methylation positivity in cervicovaginal self-samples was more frequently observed in patients with recurrence (77.8%) than in patients without recurrence 2-years posttreatment (25.5%; p = .0004). Also in urine, DNA methylation positivity was more frequently observed in patients with recurrence (65%) compared to those without recurrence (35.6%; p = .038). Similarly, high-risk HPV positivity in both cervicovaginal self-samples and urine was more frequent (52.6% and 55%, respectively) in patients with recurrence compared to patients without recurrence (14.9% and 8.5%, respectively) (p = .004 and p = .0001). In conclusion, this study shows the potential of posttreatment monitoring of cervical cancer patients for recurrence by DNA methylation and high-risk HPV testing in cervicovaginal and urine samples collected at home. The highest recurrence detection rate was achieved by DNA methylation testing in cervicovaginal self-samples, detecting 77.8% of all recurrences and, specifically, 100% of the local recurrences.

Sociodemographic characteristics associated with cervical cancer screening participation by send-to-all and opt-in HPV self-sampling: Who benefits? Results from a randomized controlled trial among long-term non-attending women in Norway.

With the objective to investigate associations between sociodemographic characteristics and participation in interventions designed to increase participation in cervical cancer screening among under-screened women, we randomized a random sample of 6000 women in Norway aged 35-69 years who had not attended cervical screening for ≥10 years to receive either (i) a reminder to attend regular screening (control), (ii) an offer to order a self-sampling kit (opt-in), or (iii) a self-sampling kit unsolicited (send-to-all). We analyzed how sociodemographic characteristics were associated with screening participation within and between screening arms. In the send-to-all arm, increased screening participation ranged from 17.1% (95% confidence interval [95% CI] = 10.3% to 23.8%) to 30.0% (95% CI = 21.5% to 38.6%) between sociodemographic groups. In the opt-in arm, we observed smaller, and at times, non-significant increases within the range 0.7% (95% CI = -5.8% to 7.3%) to 19.1% (95% CI = 11.6% to 26.7%). In send-to-all versus control comparisons, there was greater increase in participation for women in the workforce versus not (6.1%, 95% CI = 1.6% to 10.6%), with higher versus lower income (7.6%, 95% CI = 2.2% to 13.1%), and with university versus primary education (8.5%, 95% CI = 2.4% to 14.6%). In opt-in versus control comparisons, there was greater increase in participation for women in the workforce versus not (4.6%, 95% CI = 0.7% to 8.5%), with higher versus lower income (6.3%, 95% CI = 1.5% to 11.1%), but lower increase for Eastern European versus Norwegian background (-12.7%, 95% CI = -19.7% to -5.7%). Self-sampling increased cervical screening participation across all sociodemographic levels, but inequalities in participation should be considered when introducing self-sampling, especially with the goal to reach long-term non-attending women.

HPV self-sampling among women in the United States: preferences for implementation.

PURPOSE: With the inclusion of primary HPV testing in 2018 U.S. Preventive Services Taskforce guidelines, at-home HPV self-sampling may provide a future option for cervical cancer screening, especially among hard-to-reach populations in the U.S. This study evaluated the association of implementation preferences with the willingness of at-home HPV self-sampling. METHODS: We conducted a cross-sectional study in 2018 among U.S. women ages 30-65 years, without a hysterectomy (n = 812). The outcome was willingness to have at-home HPV self-sampling (yes/no). Primary predictor variables (i.e., information source, methods of payment, methods of sending or receiving self-sampling kits) measured self-sampling implementation preferences. Adjusted logistic regression identified associations with willingness to have at-home HPV self-sampling. RESULTS: Participants who preferred receiving information from healthcare providers (OR = 2.64; 95% CI 1.54,4.52) or from media or other sources (OR = 2.30; 95% CI 1.51,3.48) had higher HPV self-sampling willingness than participants who did not prefer those sources. Participants who did not want to pay for self-sampling (OR = 0.21; 95% CI 0.14,0.32) or did not know if they would pay for self-sampling (OR = 0.35; 95% CI 0.22,0.54) had lower odds of HPV self-sampling willingness compared to participants willing to pay. Participants who did not know which method they preferred for receiving a self-sampling kit (OR = 0.15, 95% CI 0.07,0.31) or preferred delivering the sample to the lab themselves (OR = 0.59; 95% CI 0.36,0.96) had lower odds for self-sampling willingness compared to participants who preferred the mail. CONCLUSION: Understanding the preferences of women regarding the implementation of HPV self-sampling can improve uptake in cervical cancer screening, especially among hard-to-reach populations.

Methylation Analysis to Detect CIN3+ in High-Risk Human Papillomavirus-Positive Self-Samples From the Population-Based Cervical Cancer Screening Program.

Since 2017, a self-sampling device has been introduced to the Dutch population-based screening program to enable higher participation rates. However, routine triage cytology cannot be performed on self-sampling material. Methylation is an alternative triage method that can be performed directly on DNA extracted from self-samples. Recently, we tested a set of 15 published cervical intraepithelial neoplasia grade 3 or worse (CIN3+)-specific methylation markers and found a panel of 3 markers with a sensitivity of 82% and a specificity of 74%. In this study, we determined the sensitivity and specificity of 2 commercial assays using quantitative methylation-specific PCR. DNA from the same cohort of high-risk human papillomavirus-positive self-sampled material obtained through the population-based screening program in the North of the Netherlands from women with CIN2 or less (

The impact of body mass index and physical disability on home-based anal self-sampling.

PURPOSE: Self-sampling is increasingly being used in screening programs, yet no studies to date have examined the impact of bodily characteristics on self-sampling experiences. Our objective was to assess whether body mass index (BMI) and physical disability were associated with anal self-sampling difficulty. METHODS: We recruited sexual minority men (SMM) and trans persons in Milwaukee, Wisconsin to participate in an anal cancer screening study. Between January 2020 and August 2022, 240 participants were randomized to a home (n = 120) or clinic (n = 120) screening arm. Home participants received a mailed at-home anal self-sampling kit and were asked to attend a baseline clinic visit where biometric measurements were collected. Participants were asked to complete a survey about their experience with the kit. This research utilized data from participants who used the at-home kit and completed a baseline clinic visit and post-swab survey (n = 82). We assessed the impact of BMI and physical disability on reported body or swab positioning difficulty. RESULTS: Most participants reported no or little difficulty with body positioning (90.3%) or swab positioning (82.9%). Higher BMI was significantly associated with greater reported difficulty with body positioning (aOR = 1.10, 95% CI 1.003-1.20, p = 0.04) and swab positioning (aOR = 1.11, 95% CI 1.02-1.20, p = 0.01). Although not significant, participants who said body positioning was difficult had 2.79 higher odds of having a physical disability. Specimen adequacy did not differ by BMI category (p = 0.76) or physical disability (p = 0.88). CONCLUSION: Anal self-sampling may be a viable option to reach obese persons who may be more likely to avoid screening due to weight-related barriers.

Consistency in human papillomavirus type detection between self-collected vaginal specimens and physician-sampled cervical specimens.

With the rising need for accessible cervical cancer screening, self-sampling methods offer a promising alternative to traditional physician-led sampling. This study aims to evaluate the efficacy of the HygeiaTouch Self Sampling Kit for Women in detecting human papillomavirus (HPV) types and predicting cervical lesions. We studied the concordance in identifying high-risk HPV (hrHPV) types between samples collected by physicians and those self-collected by women using a self-sampling kit for validation. Women aged 21-65, fitting into specific categories based on their cervical health history were eligible. Cohen's kappa coefficient to gauge concordance between the two specimen types and relative accuracy metrics in identifying cervical intraepithelial neoplasia (CIN) were also calculated, with physician-sampled specimens serving as a reference. A total of 1210 participants from three institutes were involved. The self-sampling kit closely matched the physician-led method in terms of collecting valid specimens (100% vs. 100%), identifying hrHPV types (kappa: 0.75, 95% confidence interval [95% CI]: 0.72-0.79; agreement: 87.7%, 95% CI: 85.8-89.6) and predicting CIN grade 2 or worse (CIN2+) (relative sensitivity: 0.949, relative accuracy: 0.959). Kappa values varied between 0.71 and 0.83 for different hrHPV types and combinations, with an overall value 0.75 (95% CI: 0.72-0.79) signifying robust compatibility between the two methods. Our study underscores the potential of the HygeiaTouch Self Sampling Kit as a reliable, efficient, and user-friendly alternative to traditional sampling methods. This suggests that self-sampling could be pivotal in expanding cervical cancer screening accessibility and enhancing detection rates.

A health decision analytical model to evaluate the cost-effectiveness of female genital schistosomiasis screening strategies: The female genital schistosomiasis SCREEN framework.

Female genital schistosomiasis is a chronic gynaecological disease caused by the waterborne parasite Schistosoma (S.) haematobium. It affects an estimated 30-56 million girls and women globally, mostly in sub-Saharan Africa where it is endemic, and negatively impacts their sexual and reproductive life. Recent studies found evidence of an association between female genital schistosomiasis and increased prevalence of HIV and cervical precancer lesions. Despite the large population at risk, the burden and impact of female genital schistosomiasis are scarcely documented, resulting in neglect and insufficient resource allocation. There is currently no standardised method for individual or population-based female genital schistosomiasis screening and diagnosis which hinders accurate assessment of disease burden in endemic countries. To optimise financial allocations for female genital schistosomiasis screening, it is necessary to explore the cost-effectiveness of different strategies by combining cost and impact estimates. Yet, no economic evaluation has explored the value for money of alternative screening methods. This paper describes a novel application of health decision analytical modelling to evaluate the cost-effectiveness of different female genital schistosomiasis screening strategies across endemic settings. The model combines a decision tree for female genital schistosomiasis screening strategies, and a Markov model for the natural history of cervical cancer to estimate the cost per disability-adjusted life-years averted for different screening strategies, stratified by HIV status. It is a starting point for discussion and for supporting priority setting in a data-sparse environment.

Cervical cancer screening activity in the Capital Region of Denmark before, during and after the COVID-19 pandemic.

OBJECTIVE: Denmark went through various COVID-19 pandemic restrictions including periodic lockdowns from March 2020 to January 2022. All cancer screening programs were kept operational, yet access to clinicians for cervical screening was at times limited. We assessed the impact of the pandemic on cervical cancer screening activity in the Capital Region of Denmark. METHODS: Cervical screening activity was defined as regular screening by invitation, opportunistic screening, and screening participation by HPV self-sampling. Activity was monitored during and post-pandemic and compared relatively to a 3-year pre-pandemic reference. RESULTS AND CONCLUSIONS: The activity of cervical cancer screening was initially affected by the pandemic lockdowns, but increased activity during summer 2020 partly compensated this effect. Regular screening activity decreased 8.4% in 2020 and returned to pre-pandemic levels in 2021. During 2022 restrictions were removed and the decrease in activity was recorded to be 2.3%. Opportunistic screening activity was reduced by 14.3% in 2020 and 12.6% in 2021. A continued post-pandemic opportunistic screening activity reduction of 18.5% was observed, possibly related to changed patterns of primary health care use introduced during the pandemic. Screening by HPV self-sampling increased from 17.1% in the pre-pandemic period to 21.2% during the pandemic. Significantly more acceptance was recorded amongst older women (p < 0.0001). This increase mirrors the decrease in total clinician collected sample activity during the pandemic, where an increased reduction by age was observed. Post-pandemic HPV self-sampling participation decreased to 12.8%, possible reflecting a temporarily changed composition and motivation in the group of women invited for self-sampling.

Self-sampled multi-anatomic site testing for uncovering the community burden of undiagnosed Chlamydia trachomatis and Neisseria gonorrhoeae infection in men who have sex with men.

PURPOSE: To detect otherwise undiagnosed asymptomatic sexually transmitted infection (STI), and for estimating prevalence among men who have sex with men (MSM). METHODS: In this community-based study in Hong Kong, adult MSM were recruited. After completion of an online survey, free multi-anatomic sites self-sampling kits (urine specimens, pharyngeal and rectal swabs) for Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (NG) tests were delivered to requesting participants. Factors associated with STI positivity were analyzed in logistic regression. RESULTS: From September 2021 to October 2022, 712 MSM were recruited, with 86% aged 18-39, and 16% reported history of chemsex engagement. A majority (81%) had previously undergone HIV testing, 68% had ever tested for STI, and 35% previously diagnosed with STI. Totally 428 (60%) had requested self-sampling kits, and 276 (39%) returned collected samples. Among participants who returned the samples, about half had never been tested in the past and had no history of STI. Overall 21% tested positive for CT and/or NG (CT/NG)-CT positive 16% and NG positive 7%. By anatomic site, 16% of rectal swabs, 7% of pharyngeal swabs, but just 3% of urine specimens were CT/NG positive. The prevalence of CT/NG was not significantly different by history of STI diagnosis and testing. CONCLUSION: Self-sampled STI testing is a potentially useful means for enhancing uptake of screening in MSM in the community, which could uncover otherwise undiagnosed asymptomatic infections. Internet-based self-sampling for STI testing could complement the current clinic-based STI testing for supporting epidemiologic evaluation of STI control in the community.

Prevalence of high-risk human papillomavirus genotypes in outpatient Malian women living with HIV: a pilot study.

INTRODUCTION: Long-term exposure to high-risk human papillomavirus (Hr-HPV) is a well-known necessary condition for development of cervical cancer. The aim of this study is to screen for Hr-HPV using vaginal self-sampling, which is a more effective approach to improve women's adherence and increase screening rates. METHODS: This pilot study included a total of 100 Women living with HIV (WLWHIV), recruited from the Center for Listening, Care, Animation, and Counseling of People Living with HIV in Bamako. Hr-HPV genotyping was performed on Self-collected samples using the Cepheid GeneXpert instrument. RESULTS: The median age of WLWHIV was 44 (interquartile range [IQR], 37-50) years. Approximately 92% of the study participants preferred self-sampling at the clinic, and 90% opted to receive result notifications via mobile phone contact. The overall prevalence of Hr-HPV among study participants was 42.6%, and the most frequent Hr-HPV sub-types observed were HPV18/45 (19.1%), HPV31/35/33/52/58 (13.8%), and HPV39/68/56/66 (12.8%), followed by HPV16 (5.3%), and HPV51/59 (5.3%). WLWHIV under 35 years of age had a higher frequency of Hr-HPV compared to their older counterparts, with rates of 30% versus 11.1% (p = 0.03). The duration of antiretroviral treatment showed an inverse association with Hr-HPV negativity, with patients on treatment for 15 (IQR, 10-18) years versus 12 (IQR = 7-14) years for Hr-HPV positive patients (95% CI [1.2-5.8], t = 3.04, p = 0.003). WLWHIV with baseline CD4 T-Cell counts below 200 exhibited a higher frequency of Hr-HPV compared to those with baseline CD4 T-Cell counts above 200 (17.9% versus 1.9%, p = 0.009). However, other demographics and clinical factors, such as marital status, age of sexual debut, parity, education, history of abortion, history of preeclampsia, and cesarean delivery, did not influence the distribution of Hr-HPV genotypes. CONCLUSION: Our findings indicate that WLWHIV under the age of 35 years old exhibited the highest prevalence of Hr-HPV infection, with HPV18/45 being the most prevalent subtype. Additionally, WLWHIV with baseline CD4 T-Cell counts below 200 showed the highest infection rates.

A comparison of the carbon footprint of alternative sampling approaches for cervical screening in the UK: A descriptive study.

OBJECTIVE: To understand whether self-sampling can reduce carbon emissions (CO2 e) from the NHS cervical screening programme (NHSCSP) by comparing the carbon footprint of three sampling strategies: routine cervical sampling, vaginal self-sampling and first-void (FV) urine collection. DESIGN: Descriptive study. SETTING: National Health Service (NHS), United Kingdom (UK). POPULATION OR SAMPLE: Patients aged 25-64 years eligible for cervical screening in the UK. METHODS: A carbon footprint analysis was undertaken for three cervical screening sampling approaches, from point of invitation to screening through to preparation for transport to the laboratory for HPV testing. A combination of primary and secondary data were used, with a bottom-up approach applied to collection of primary data. MAIN OUTCOME MEASURES: We report CO2 e per sampling approach, which is the unit used to express carbon footprint and harmonise the contributions of greenhouse gases with different global warming potentials. RESULTS: The total carbon footprint of routine cervical sampling is 3670 g CO2 e. By comparison, vaginal self-sampling had a total carbon footprint of 423 g CO2 e, and FV urine sampling 570 g CO2 e. The largest share of emissions for routine sampling was attributable to the carbon footprint associated with an appointment in a primary care setting, which totalled 2768 g CO2 e. CONCLUSIONS: Routine cervical sampling is up to 8.7-fold more carbon-intensive than self-sampling approaches with equivalent effectiveness. We found negligible differences in the carbon footprint of alternative self-sampling methods, supporting the need for an informed choice of screening options for participants, which includes sharing information on their environmental impacts.

Urine high-risk human papillomavirus testing as an alternative to routine cervical screening: A comparative diagnostic accuracy study of two urine collection devices using a randomised study design trial.

OBJECTIVE: To evaluate the sensitivity of human papillomavirus (HPV) tested urine to detect high-grade cervical precancer (cervical intraepithelial neoplasia grade 2+ [CIN2+]) using two urine collection devices. DESIGN: Randomised controlled trial. SETTING: St Mary's Hospital, Manchester, UK. POPULATION: Colposcopy attendees with abnormal cervical screening; a total of 480 participants were randomised. Matched urine and cervical samples were available for 235 and 230 participants using a first-void urine (FVU)-collection device and standard pot, respectively. METHODS: Urine was self-collected and mixed with preservative - randomised 1:1 to FVU-collection device (Novosanis Colli-pee® 10 mL with urine conservation medium [UCM]) or standard pot. Matched clinician-collected cervical samples were taken before colposcopy. HPV testing used Roche cobas® 8800. A questionnaire evaluated urine self-sampling acceptability. MAIN OUTCOME MEASURES: The primary outcome measured sensitivity of HPV-tested urine (FVU-collection device and standard pot) for CIN2+ detection. Secondary outcomes compared HPV-tested cervical and urine samples for CIN2+ and evaluated the acceptability of urine self-sampling. RESULTS: Urine HPV test sensitivity for CIN2+ was higher with the FVU-collection device (90.3%, 95% CI 83.7%-94.9%, 112/124) than the standard pot (73.4%, 95% CI 64.7%-80.9%, 91/124, p = 0.0005). The relative sensitivity of FVU-device-collected urine was 0.92 (95% CI 0.87-0.97, pMcN = 0.004) compared with cervical, considering that all women were referred after a positive cervical HPV test. Urine-based sampling was acceptable to colposcopy attendees. CONCLUSIONS: Testing of FVU-device-collected urine for HPV was superior to standard-pot-collected urine in colposcopy attendees and has promising sensitivity for CIN2+ detection. General population HPV testing of FVU-device-collected urine will establish its clinical performance and acceptability as an alternative to routine cervical screening.

Stability of steroid hormones in dried blood spots (DBS).

OBJECTIVES: Steroid hormone levels of patients may be monitored via dried blood spot (DBS) sampling at home. Stability of steroid hormones in DBS samples, however, needs to be established. METHODS: DBS samples from healthy volunteers were collected and stored at various temperatures. Steroid hormone concentrations in DBS were measured directly, at day 2, day 7 and day 14 following storage at 37 °C and after 7 days, 14 days, 3 months and 6 months following storage at -20 °C, 4 °C and room temperature (RT). Cortisol, cortisone, corticosterone, testosterone, androstenedione, and 17-hydroxyprogesterone (17-OHP) were assessed using LC-MS/MS. RESULTS: All steroids were stable (±15 %) up to 14 days when stored at 37 °C, except for cortisone (only stable until 2 days). All steroids were stable up to 6 months when stored at -20 °C, 4 °C and RT. However, there were some exceptions, for androstenedione at RT (only stable until 7 days), for 17-OHP when stored at -20 °C (only stable until 3 months), for cortisone at RT and 4 °C (only stable until 14 days), and cortisol at RT (only stable until 3 months). CONCLUSIONS: Overall, we demonstrated stability of steroid hormone concentrations in DBS under various conditions which may be encountered during shipping to the diagnostic laboratory and during long-term storage before analysis.

Blood self-sampling devices: innovation, interpretation and implementation in total lab automation.

The introduction of the vacuum tube in 1949 revolutionized blood collection, significantly improving sample quality and patient comfort. Over the past 75 years, laboratory diagnostics have evolved drastically, from manual to automated processes, reducing required test volumes by over 1,000 times. Despite these advancements, venous blood collection presents logistical challenges, including centralized scheduling and a large volume of biological waste due to the imbalance between the needed blood volume (often very little) and the collected volume (often in excess). The COVID-19 pandemic further emphasized the need for decentralized healthcare solutions and patient empowerment. Capillary blood collection, widely used in point-of-care testing, offers a promising alternative, particularly for patients facing frequently, or difficulties with, venous sampling. The Leiden University Medical Center in the Netherlands experienced a 15 % reduction in volume of laboratory tests during and after the pandemic, attributed to patient preference for local blood collection and testing. To address these challenges, self-sampling devices are emerging, empowering patients and streamlining sample logistics. However, challenges such as cost, transportation regulations, and sample volume adequacy persists. Robust devices tailored for total lab automation and sustainable practices are crucial for widespread adoption. Despite hurdles, the integration of self-sampling into diagnostic processes is inevitable, heralding a shift towards patient-centered, proactive healthcare. Practical recommendations include robust device design, ease of use, affordability, sustainability, sufficient quality and acceptability by seamless integration into laboratory workflows. Although obstacles remain, self-sampling represents the future of laboratory diagnostics, offering convenience, cost-effectiveness, interoperability and patient empowerment.

The levels of women's awareness, experience, acceptability and preference for Vaginal Human Papillomavirus (HPV) self-sampling in three provinces of China: a cross-sectional study.

BACKGROUND: The primary screening technique for precancerous lesions and cervical cancer is human papillomavirus (HPV) testing, and HPV self-sampling has been shown to be consistent with clinician sampling in terms of the accuracy of the results and may improve cervical cancer screening rates. The aim of this study was to understand the level of awareness, experience, acceptability, and preference for vaginal HPV self-sampling among women in Jiangsu, Zhejiang, and Shanghai, China, and to analyze the possible influencing factors to determine the feasibility of implementing self-sampling. METHODS: Overall, 1793 women were included in the data analysis. A self-administered questionnaire was utilized. In addition to descriptive analysis, univariate and multivariate analyses were used to explore the associations between sociodemographic features, history of cervical cancer screening, and the level of awareness, experience, acceptability, and preference for HPV self-samples. RESULTS: The participants' level of awareness of and experience with HPV self-sampling were moderate. A total of 88.8% of participants rated the acceptability as "high", and self-sampling was preferred by 64.2% of them for cervical cancer screening. People aged 45 to 54 years showed a preference for both clinician sampling(OR = 1.762 (1.116-2.163)) and self-sampling (OR = 1.823 (1.233-2.697)). Those who had graduated from high school or above (OR = 2.305 (1.517-3.503), OR = 2.432 (1.570-3.768), OR = 3.258 (2.024-5.244)) preferred clinician-sampling, and those with a bachelor's degree or above (OR = 1.664 (1.042-2.657)) preferred self-sampling. Middle- and high-income individuals showed no preference for either sampling method (OR < 1). CONCLUSIONS: HPV self-sampling is widely accepted, but awareness, experience and preferences need to be improved. These results may help to adjust public health strategies for the early inclusion of HPV self-sampling as a screening method in national initiatives to prevent cervical cancer.

Experiences of Self-Sampling and Future Screening Preferences in Non-Attenders Who Returned an HPV Vaginal Self-Sample in the YouScreen Study: Findings From a Cross-Sectional Questionnaire.

BACKGROUND: We assessed experiences of human papillomavirus (HPV) vaginal self-sampling and future screening preferences in an ethnically and socio-economically diverse group of women overdue for cervical screening. SETTING AND PARTICIPANTS: A postal questionnaire was embedded in the YouScreen self-sampling trial in England: 32.5% (2712/8338) of kit completers returned the survey. Kit non-completers were encouraged to return a questionnaire, but no responses were received. Participants were ethnically diverse (40.3% came from ethnic minority backgrounds), and 59.1% came from the two most deprived quintiles. Differences in confidence in kit completion, trust in the test results and intention to attend a follow-up test if HPV-positive were evaluated using Pearson's χ2 analyses. Binary logistic regression models explored predictors of a future screening choice and preferences for urine versus vaginal self-sampling. RESULTS: Most kit-completers reported high confidence in self-sampling (82.6%) and high trust in the results (79.9%), but experiences varied by ethnicity and screening status. Most free-text comments were positive but some reported difficulties using the device, pain or discomfort. Most women would opt for self-sampling in the future (71.3% vs. 10.4% for a clinician-taken test) and it was more often preferred by ethnic minority groups, overdue screeners and never attenders. Urine self-tests were preferred to vaginal tests (41.9% vs. 15.4%), especially among women from Asian, Black or Other Ethnic backgrounds. CONCLUSIONS: Kit-completers were confident, found the test easy to complete, and trusted the self-sample results. However, experiences varied by ethnic group and some women highlighted difficulties with the kit. Most women would prefer self-sampling in the future, but it was not a universal preference, so offering a choice will be important. PATIENT OR PUBLIC CONTRIBUTION: We did not have direct patient and public involvement and engagement (PPIE) in the questionnaire design. However, patients and public representatives did input into the design of the YouScreen trial and reviewed the wider study materials (e.g. participant information sheet). TRIAL REGISTRATION: This questionnaire study was embedded in the YouScreen trial. The protocol for the YouScreen trial is available at https://www.isrctn.com/ISRCTN12759467. The National Institute for Health Research 43 Clinical Research Network (NIHR CRN) Central Portfolio Management System (CPMS) ID is 4441934.

The acceptability of, and informational needs related to, self-collection cervical screening among women of Indian descent living in Victoria, Australia: A qualitative study.

BACKGROUND: In July 2022, self-collection became universally available as part of Australia's National Cervical Screening Program. This change aims to address screening inequities experienced among underscreened populations, including women of Indian descent. This study explored experiences of cervical screening, alongside the acceptability of self-collection, among women of Indian descent living in Victoria, Australia. We also aimed to articulate the informational needs to promote self-collection among this population. METHODS: Five focus group discussions with 39 women living in Victoria were conducted in English (n = 3) and Punjabi (n = 2). Transcripts were thematically analysed, as informed by the Theoretical Framework of Acceptability. RESULTS: Women were motivated by the choice to self-collect, perceiving the ability to maintain modesty and greater autonomy as key enablers. Healthcare practitioners were seen as central in supporting patient-centred models of care. Perceived barriers to self-collection included concerns around its accuracy and women's confidence in collecting their own sample. Widespread dissemination of culturally tailored promotion strategies communicating concepts such as 'privacy' and 'accuracy' were suggested by women to promote self-collection. CONCLUSION: Self-collection was highly acceptable among women of Indian descent, particularly when assured of its accuracy, and sociocultural norms and previous screening experiences are considered. This study highlights the huge potential that self-collection can play in increasing equity in Australia's cervical screening programme. PATIENT OR PUBLIC CONTRIBUTION: Members of the public were involved in focus group discussions. Findings were summarised and disseminated via a poster. A bicultural worker was involved in all stages of the research.

Pre-assessment of patients with suspected axial spondyloarthritis combining student-led clinics and telemedicine: a qualitative study.

OBJECTIVE: Patients referred to rheumatologists are currently facing months of inefficient waiting time due to the increasing demand and rising workforce shortage. We piloted a pre-assessment of patients with suspected axial spondyloarthritis (axSpA) combining student-led clinics and telemedicine (symptom assessment, symptom monitoring and at-home capillary self-sampling) to improve access to rheumatology care. The aim of this study was to explore (1) current challenges accessing axSpA care and (2) patients' first-hand experiences. METHODS: Embedded within a clinical trial, this study was based on qualitative interviews with patients with suspected axSpA (n = 20). Data was analysed via qualitative content analysis. RESULTS: Student-led clinics were perceived as high-quality care, comparable to conventional rheumatologist-led visits. Patients expressed that their interactions with the students instilled a sense of trust. History-taking and examinations were perceived as comprehensive and meticulous. Telehealth tools were seen as empowering, offering immediate and continuous access to symptom assessment at home. Patients reported a lack of specificity of the electronic questionnaires, impeding accurate responses. Patients requested a comments area to supplement questionnaire responses. Some patients reported receiving help to complete the blood collection. CONCLUSION: Patients' access to rheumatology care is becoming increasingly burdensome. Pre-assessment including student-led clinics and telemedicine was highly accepted by patients. Patient interviews provided valuable in-depth feedback to improve the piloted patient pathway.

Older women's perceptions of HPV self-sampling and HPV-sampling performed by a midwife - a phenomenographic study.

BACKGROUND: Cervical cancer is a global disease and it is well established that cervical cancer is caused by human papillomavirus (HPV). In Sweden self-sampling for HPV is now used as a complement to sampling performed by a midwife. However, there is a lack of knowledge on how older women perceive the self-sampling compared to the sampling performed by a midwife. Therefore, the aim of the study was to describe how women, aged 64 years and older, perceived the process of self-sampling and sampling performed by a midwife for HPV-testing. METHODS: Eighteen women were included in a qualitative interview study, and a phenomenographic approach was used for the analysis of the interviews. RESULTS: Three descriptive categories emerged: Confidence in sampling, Facilitating participation and Being informed. Within the categories, eight conceptions emerged describing the variation relating to how the women perceived the process of self-sampling and sampling performed by a midwife. CONCLUSIONS: Women in this study describe confidence in self-sampling for HPV-testing and that the self-sampling was saving time and money, both for themselves and for society. Information in relation to an HPV-positive test result is of importance and it must be kept in mind that women affected by HPV may feel guilt and shame, which health care professionals should pay attention to. This knowledge can be used in education of health care staff. TRIAL REGISTRATION: https://researchweb.org/is/fourol/project/228071 . Reg. no 228,071.

Invitation strategy of vaginal HPV self-sampling to improve participation in cervical cancer screening: a systematic review and meta-analysis of randomized trials.

BACKGROUND: Human papillomavirus (HPV) self-sampling is recognized as a feasible option for enhancing screening for cervical cancer, particularly among hard-to-reach women. The magnitude of the effectiveness of screening participation under different invitation strategies was reported. This review seeks to compare the effectiveness of invitation strategies in increasing screening participation of HPV self-sampling across diverse study settings. METHODS: A systematic literature search was conducted in Embase, MEDLINE, and PubMed in April 2023. Articles were included if (1) their target participants were aged between 25 and 70 years; (2) participants in the intervention arm were randomized to receive HPV self-sampling devices through various invitation strategies; (3) participants in the control arm who either received invitations for cervical cancer screening other than HPV self-sampling or opportunistic screening as usual care; (4) studies that provided sufficient data on screening participation in HPV self-sampling as outcome measured. The study design of the included articles was limited to randomized controlled trials. RESULTS: A total of 15 articles were included in this review. Invitation strategies of disseminating HPV self-sampling devices included opt-out and opt-in. Meta-analysis revealed screening participation in the self-sampling group was significantly greater than control arm (OR 3.43, 95% CI 1.59-7.38), irrespective of the invitation strategy employed. Among invitation strategies, opt-out appeared to be more effective on increasing screening participation, compared to control and opt-in strategy (opt-out vs. control OR 3.91, 95% CI 1.82-8.42; opt-in vs. control OR 1.34, 95% CI 0.28-6.39). CONCLUSIONS: Opt-out strategy is more successful at improving screening participation compared to opt-in and routine invitation to cervical screening. It is therefore a promising way to improve participation in cervical cancer screening. The findings of this review provide important inputs to optimize strategies for inviting women to participate in vaginal HPV self-sampling across the study setting, thus improving participation in cervical cancer screening.