Home-based urinary HPV self-sampling for the detection of cervical cancer precursor lesions: attitudes and preferences from Belgian females participating in the CASUS study

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Hendrickx, Severien Van Keer, Gilbert Donders, Steven Weyers, and 6 more This is a preprint; it has not been peer reviewed by a journal. https://doi.org/ 10.21203/rs.3.rs-4430311/v1 This work is licensed under a CC BY 4.0 License Status: Published Journal Publication published 12 Feb, 2025 Read the published version in Archives of Public Health → Version 1 posted 11 You are reading this latest preprint version Abstract Background Cervical cancer (CC) is the fourth most common cancer globally in females, caused by oncogenic infections with high-risk human papillomavirus (hrHPV) strains. Successful CC screening programs strongly depend on the participation rate of the target populationNevertheless, it remains challenging to reach under screened populations, including those with an increased CC risk. The CASUS study aimed to develop a complete CC screening solution based on first-void urine (FVU) self-sampling. Here we report on the usability perceptions and preferences from females that participated in the CASUS study by collecting FVU, also referred to as first-catch urine, as a liquid biopsy. Methods Females self-collected FVU samples at home the day before colposcopy using the Colli-Pee® UCM FV-5010, a FVU collection device prefilled with 3 mL of UCM preservative, collecting a total volume of 10mL. Afterwards, they completed a questionnaire expressing their usability perceptions and preferences regarding the device. Results A total of 332 females (26-70y) were enrolled in the CASUS study of which 210 completed the questionnaire. Overall, 66.6% of females preferred FVU self-sampling over a physician taken cervical sample (PTS) (32.9%) for their next CC screening. Out of 159 women who reported prior experience with a urine cup, 79.2% () expressed a preference for using the Colli-Pee® UCM FV-5010, while 20.8% favored the traditional urine cup. Additionally, 96.6% () of females found Colli-Pee® UCM FV-5010 easy to use and 97.1% would use the device again. A total of 208 valid System Usability Score (SUS) scores were received with an average of 86.17 ± 1.03 Standard Error of Mean (SEM). Conclusion The results of this study show that the majority of females in this referral cohort would prefer to self-collect a FVU sample at-home over a PTS for their next CC screening. Moreover, Colli-Pee® UCM FV-5010 was considered an easy-to-use and well-accepted self-sampling device for CC screening in a Belgian colposcopy referral population. From a future perspective, these results highlight the possibility of home-based FVU self-sampling as a liquid biopsy in CC screening where under screened populations could be approached more easily. Trial registration: The CASUS study was registered in ClinicalTrials.gov (identifier: NCT04530201). HPV first-void urine self-sampling attitudes preferences cervical cancer screening CASUS Figures Figure 1 Figure 2 Figure 3 Contributions to the literature This study provides new evidence on the preferences and usability of FVU self-sampling for CC screening. It highlights a significant preference among women for FVU self-sampling over traditional PTS, which can enhance participation rates in cervical cancer screening programs. By facilitating home-based sampling, this approach could improve CC screening access for under-screened populations, potentially reducing CC incidence and mortality. 1. Introduction Cervical cancer (CC) is the fourth most common cancer globally among females, caused by oncogenic infections with high-risk human papillomavirus (hrHPV) strains [ 1 , 2 ]. There were an estimated 604 000 new CC cases and 342 000 related deaths worldwide in 2020, with about 90% occurring in low- and middle-income countries [ 3 ]. A recent modelling study suggests that widespread coverage of both HPV vaccination and CC screening from 2020 onwards could prevent 12.5–13.4 million new cases of CC by 2070, leading to near-elimination of CC in most countries by the end of the century [ 4 ]. Successful CC screening programs strongly depend on the participation rate of the target population. However, challenges are being faced with including hard to reach and under screened females, leading to an increased risk for CC [ 5 ]. A decade ago, the overall coverage of European CC screening programs was below 80%, ranging from 10–79%. In only five countries (France, England, Finland, The Netherlands, and Sweden) screening coverage was 70% or more [ 6 ]. The Belgian Center for Cancer Detection, CvKO, recently published data regarding the CC screening coverage in 2021, revealing a 64% coverage [ 7 , 8 ]. Screening in most European countries is based on cytology, which requires a PTS, is challenged by low sensitivity, and knows a subjective review [ 9 ]. Several barriers have been identified that lead to reluctance towards CC screening, including lack of time and limited access to health services, physical discomfort, cultural barriers, and lack of knowledge about the benefits of CC screening [ 10 – 15 ]. For over 60 years, cervical cytology has been considered the gold standard for CC screening, looking for precancers or abnormal cell changes in the cervix [ 16 – 18 ]. Considering that the majority of cervical cancer cases are diagnosed in screening non-attendees [ 19 ], opting for HPV testing over cytology is a viable choice due to its higher sensitivity and a reduced cumulative risk of developing high-grade diseases. Randomized population-based controlled trials have demonstrated that HPV-based screening, compared to cytology-based CC screening, offers an early detection of hrHPV types and thus risk of incident CC [ 20 , 21 ]. An additional advantage of CC screening using HPV assays is that these tests can be performed on self-samples. Self-sampling collection methods may include a (cervico)vaginal swab or brush, vaginal lavage, vaginal patch or a urine sample, with a particular emphasis on first-void urine (FVU) as this is more accurate than testing on a random or midstream urine sample [ 22 ]. Recent studies have shown that hrHPV DNA testing on self-samples, compared to PTS, is equally accurate in detecting underlying CC using validated PCR-based hrHPV tests [ 23 – 26 ]. Furthermore, previous studies have shown that providing participants with a self-sampling kit, offering options such as a vaginal swab, brush, lavage, tampon, urine, labial padette, or a combination of these, leads to higher participation rates compared to traditional invitations for PTS and is preferred by participants. [ 23 , 27 – 31 ]. In 2018, the World Health Organization called for coordinated global action to eradicate CC, emphasizing screening for individuals aged 30–60 years, and strongly supporting the inclusion of HPV testing on self-sampling as an add-on in CC screening services [ 32 , 33 ]. Approximately 99% of hrHPV infections are transient and do not lead to CC. Therefore, triage is necessary to identify only hrHPV-positive cases with clinically relevant disease to have control over referral, overtreatment, and costs [ 34 – 37 ]. Currently, triage relies heavily on cytology-outcomes which requires repetitive testing on PTS [ 38 , 39 ]. This two-step process is associated with 25–40% loss to follow-up [ 40 , 41 ]. The CASUS study aimed to develop a complete CC screening solution based on FVU self-sampling, identifying females with clinically relevant disease in need of treatment in a one-step triage manner. Here, we report usability perceptions and preferences from females participating in the CASUS study. 2. Materials and Methods 2.1. Study population The CASUS study (ClinicalTrials.gov identifier: NCT04530201) is an interventional study, which aimed to develop the first fully molecular integrated cervical cancer screening approach, based on FVU as an easily accessible and non-invasive source of biomarkers. Ethical approval for the CASUS study was provided by the Medical Ethical Committee of the University Hospital Antwerp (20/21/271, Antwerp, Belgium) on the 4th of August 2020. At three Belgian colposcopy clinics (UZ Ghent, Ghent, Belgium; CHU de Liège, Liège, Belgium; The General Regional Hospital Heilig Hart Tienen, Tienen, Belgium), females between 26 and 70 years of age referred to colposcopy due to a (probable) hrHPV infection and/or abnormal cervical squamous intraepithelial/glandular lesion were recruited. This recruitment took place between August 2020 and February 2022 by the medical staff of the participating colposcopy clinics when a date for a colposcopy examination was set. Hysterectomized females, females with known pregnancy, females being treated for CC in the last six months before participating in this study, females participating in another (low-) interventional study, non-consenting females, and females that were not able to understand and to sign the informed consent form were excluded. A study package, sent to the females' home address by regular mail, contained an information brochure and informed consent form, two Colli-Pee® UCM FV-5010 devices containing 3.4 mL of UCM preservative [ 42 ] and collecting a total sample of approximately 10 mL (Novosanis, Wijnegem, Belgium), instructions for use, and safety bags. The safety bags included absorbing tissues for storage of the collector tubes after FVU collection. Furthermore, along with the study package a link was provided to a digital questionnaire on the usability of the device and/or a paper version in either Dutch or French. One day prior to the colposcopy, study participants who gave their consent self-collected two FVU samples at home using the Colli-Pee® UCM FV-5010. Participants were asked to space the two collections with a minimum of one hour. Females were asked to fill in a questionnaire at home between the two FVU collections. After collecting the FVU samples, the participant stored the collector tubes in individual plastic safety bags at room temperature with absorbing tissues. At the day of colposcopy, the participant brought the FVU samples to the colposcopy clinic and handed them over to the study team. During the colposcopy appointment, a trained physician collected a cervical sample using the Cervex-Brush (Rovers Medical Devices B.V., Oss, The Netherlands), which was subsequently transferred/preserved in ThinPrep PreservCyt solution (Hologic Inc., Bedford, Massachusetts, United States of America). This cervical sample was collected before colposcopy, during the same medical exam. Hereafter, colposcopy (with biopsy/ambulant conization if considered necessary) was performed as usual. 2.2. CASUS questionnaire The questionnaire consisted of 38 questions divided into six categories: (1) general, (2) experience prior to using Colli-Pee®, (3) experience while using Colli-Pee®, (4) experience after using Colli-Pee®, (5) feedback on the use of Colli-Pee®, and (6) feedback on the use of Colli-Pee® through a System Usability Scale (SUS) [ 43 , 44 ]. The SUS questionnaire system was used to evaluate user satisfaction and consisted of 10 open-ended polarity-balanced questions with a five-point Likert scale, ranging from 1 (Strongly disagree) to 5 (Strongly agree), for responses. The SUS score, as a composite measure of the overall usability of the Colli-Pee® device, was calculated as described previously [ 43 ]. A SUS score greater than 68 is considered above average, and a SUS score greater than 80.3 indicates that the device is user-friendly and will be recommended by users. Responses regarding the experiences were gathered with an 8-point Likert scale ranging from 1 (Completely disagree) to 8 (Completely agree). The original Dutch/French questionnaire was translated to English and added as Supplement A. 2.3. Statistical methods Online questionnaire answers were exported from Qualtrics XM (Seattle, Washington, USA, 2020) in an Excel database. Paper questionnaire forms were encoded manually into the Excel database. A full check was done after data entry by the encoder. In addition, an independent check of a 25% random selection of the answer forms was performed by a CASUS researcher to pick-up possible data entry errors. Frequency distributions, showing the number of answers and relative percentages, were tabulated for each question followed by statistical analysis for normality with a Shapiro-Wilk test. As the proportion of missing values was small (< 5%), it was decided to include the missing data in the descriptive statistics without data imputation [ 45 ]. Multiple logistic regression analysis was used to model correlations. Statistical significance was accepted when p-values < 0.05 and statistical analyses were conducted with GraphPad Prism (version 9.4.0 for Windows, GraphPad Software, San Diego, CA, USA). 3. Results 3.1. Population characteristics Between the 20th of August 2020 and the 28th of February 2022, 332 females were enrolled in the CASUS study. The number of enrolled patients per colposcopy clinic was provided by the responsible gynecologists. A total of 210 questionnaires (N = 210/332, 63%) from the total enrolled cohort (age 25–64 years) were obtained and analyzed. The median age of the included females was 37 years (IQR: 30–48). The distribution of the number of enrolled patients per colposcopy clinic and general characteristics of the enrolled study participants are depicted in Table 1 . Table 1 Characteristics of enrolled participants (N = 210) in the CASUS study Characteristics N % 5-year age groups (years) 210 100 25–30 57 27.1 31–35 40 19.0 36–40 26 12.4 41–45 25 11.9 46–50 23 11.0 51–55 23 11.0 56–60 14 6.7 61–65 2 1.0 Recruitment at each colposcopy clinic 210 100 UZ Ghent 79 37.6 CHU de Liège 60 28.6 RZ Tienen 71 33.8 Self-reported HPV vaccination status 210 100 Vaccinated 41 19.5 Unvaccinated 157 74.8 Unknown 11 5.2 Missing value 1 0.5 Prior history of an oncologic disease 210 100 Yes 6 2.9 No 200 95.2 Unknown 3 1.4 Missing value 1 0.5 3.2. Experiences and intentions regarding prior and future use of urinary self-samples The level of use and understanding of the instructions for use of the FVU self-sampling device are described in Table 2 . The large majority of females (N = 174/210, 82.9%) indicated that they consulted the instructions for use that came along with the study package. Of those females, 97.7% (N = 170/174) thought that the instructions for use of the Colli-Pee® device were clear. Some of the reasons why females found the instructions for use unclear included the following: ‘The instructions didn't make it very clear what the do's and don'ts for use were.’, ‘I have not read the instructions or can’t remember doing so’, ‘I didn’t think about using the instructions.’. Table 2 Use and understanding of the instructions for use of the Colli-Pee® device (N = 210). Question N % I used the instructions for use that came along with the device 210 100 Yes 174 82.9 No 35 7 Missing value 1 0.5 The instructions for use were clear (for those who used the instructions for use) 174 100 Yes 170 97.7 No 4 2.3 Females were asked for their prior experience in self-collecting a urine sample. Most females (N = 159/210, 75.7%) indicated that they self-collected a urine sample before with a urine cup. Of those females, 79.2% (N = 126/159) indicated that they prefer Colli-Pee® over a urine cup for urinary self-collection (Table 3 ). On a Likert-scale from 1 (strongly disagree) to 8 (strongly agree) a large amount (p < 0.0001) of females (N = 102/210, 48.6%) agreed that they had the impression it did not take them a long time before knowing how to use the device (Fig. 1 . A ). A total of 31.9% (N = 67/210), 49.1% (N = 103/210) and 19.0% (N = 40/210) of participants indicated that it took them respectively less than 2 minutes. between 2 and 5 minutes. or more than five minutes in total (from reading the instructions to collecting the sample) to self-collect a FVU sample with Colli-Pee® (Data not shown). Most females answered that it was clear how to use Colli-Pee® during urination (N = 121/210 57.6%, p < 0.01) and that they had the impression that they took the FVU sample correctly (N = 143/210, 68.1%, p < 0.001) (Fig. 1 . B.C ). Participants also reported their intention to recommend the Colli-Pee® device to others whereby the majority of females indicated that they strongly agree in recommending Colli-Pee® to others (N = 142/209, 67.9%, p < 0.0001, 1 missing value). Overall, 97.6% of females (N = 205/210) indicated that they would use Colli-Pee® again and 97.1% (N = 204/210) of females felt that Colli-Pee® was easy to use (Table 3 ). Table 3 Experiences and opinions on urine self-collection (N = 210). Question N % I already took a urine sample (with a urine cup) 210 100 Yes 159 75.7 No 51 24.3 Which urinary collection method do you prefer? (for those having a prior experience) 159 100 Colli-Pee® 126 79.2 Urine cup 33 20.8 I would use Colli-Pee® again to collect urine 210 100 Yes 204 97.1 No 5 2.4 Missing value 1 0.5 Colli-Pee® is easy to use 210 100 Yes 203 96.6 No 6 2.9 Missing value 1 0.5 Preferences of females regarding the sample collection method for their next CC screening are represented in Fig. 2 . Overall. 66.6% (N = 140/210) of females would opt a FVU self-sample taken with Colli-Pee® compared to 32.9% (N = 69/210) of females who would prefer a PTS. These sample type preferences were not correlated with age, colposcopy center, self-reported HPV vaccination status, prior oncologic disease, or prior participation in the VALHUDES trial in which Colli-Pee® UCM FV-5020 was evaluated in a colposcopy referral population. 3.3. Usability results based on SUS-scores SUS scores are shown in Fig. 3 . The color-based heatmap visualization scheme is a modified version of that recommended by Smaradottir et al. [ 46 ]. wherein white represents a positive response. grey a neutral response. and black a negative response. A total of 208 completed SUS scoring questionnaires were received with an average SUS score of 86.17 ± 1.03 (out of 100), categorizing it as "excellent" [ 47 ]. 4. Discussion Within the CASUS study, our objective was to gather information about the usability perceptions and preferences of female participants who self-collected a FVU sample using Colli-Pee®. In our study design, we selected the Colli-Pee® UCM FV-5010 device, which is pre-filled with 3.4 mL of non-toxic and non-lytic UCM preservative. This choice was informed by our prior research, which examined the impact of different Colli-Pee® volume variants on HPV DNA detection in FVU [ 48 ]. The Colli-Pee® UCM FV-5010 design enables the immediate mixing of FVU and the UCM preservative during collection and allows a total sample collection of approximately 10mL. Our previous study evaluated the effectiveness of this UCM preservative in optimizing HPV DNA detection in FVU, demonstrating its ability to improve the collection. storage. and extraction processes [ 42 ]. A total of 332 females (26-64y) were enrolled and consented their participation in the CASUS study of which 210 females completed the questionnaire. Overall, 66.6% of females indicated to prefer to self-collect a FVU sample over a PTS (32.9%) for their next CC screening. Additionally. 79.2% of females indicated to prefer the use of Colli-Pee® over a urine cup (20.8%) whereby 96.6% of females experienced Colli-Pee® as easy to use and 97.1% would use the device again. The majority of female participants indicated that they had not previously taken part in the VALHUDES study [ 49 ], which utilized the larger Colli-Pee® UCM FV-5020 device variant prefilled with 7mL of UCM and designed to collect a total sample volume of approximately 20mL. This underscores that most participants did not have any prior bias due to their previous experience with Colli-Pee®. Moreover, the majority of females reported using the instructions for use of the Colli-Pee® device and found them to be clear. However, some females cited reasons for finding the instructions unclear, such as: "The instructions did not clearly outline the do's and don'ts for use.", "I either have not read or cannot recall reading the instructions", and "I did not consider using the instructions.". Most females indicated that it did not take long to collect a FVU sample using Colli-Pee®, that the instructions for use were clear. that they were confident that they took the sample correctly and that they would recommend the device to others. These findings align with previous results from the VALHUDES and Predictor’s 5.1 studies where participants used the Colli-Pee® UCM FV5020 device at the colposcopy clinic compared to different vaginal self-samples and a PTS [ 50 , 51 ]. In addition, the SUS-scoring system was used as a composite measure of the overall usability of the Colli-Pee® device and user satisfaction and consisted of 10 open-ended polarity-balanced questions. An average SUS score 86.17 ± 1.03 was calculated, categorized as “excellent”. A total of 66.6% of participants indicated they would prefer a FVU self-sample compared to a PTS (32.9%) for their next CC screening and 0.5% of females not disclosing a preferential sampling method. Similar results were previously obtained in referral populations in the EVAH [ 52 ], VALHUDES [ 50 ] and BM-SOP [ 53 ] studies featuring Colli-Pee® device variants. Nevertheless, some females showed hesitancy for a FVU sample and a preference for a PTS. Most of these females indicated that they find a PTS more reliable and a more thorough method than a FVU self-sample for CC screening, which can be combined on an annual basis during a gynecological examination. Nonetheless. a noteworthy percentage of female participants expressed that they found the usage of the Colli-Pee® to be clear (57.6%) and felt confident that they had correctly collected the FVU sample (68.1%). These results align with prior research that has investigated the Colli-Pee® device [ 50 , 52 , 54 ], emphasizing the non-invasive and user-friendly attributes of FVU as a liquid biopsy for CC screening. Furthermore. this suggests the potential for FVU to reduce hesitation among non-attendees. Participants from the BM-SOP study in 2018 [ 53 ] indicated to prefer FVU collection at home over collection at the clinic or the general practitioner’s office. Additionally. recent screening study in a general Japanese study population showed an improvement of CC screening participation in under-screened females when mailing HPV self‑sampling kits featuring Colli-Pee® and a vaginal self-sample [ 55 ]. Concerning self-collection for HPV testing, recent insights were obtained from a cervical cancer screening study that focused on African-American females in the Mississippi Delta. The study evaluated the efficacy of a patient-centered approach, comparing self-collection for HPV testing at home with the existing standard of care in the U.S. public health system [ 56 ]. Aside from the increased participation rates that were perceived with a patient-centered approach for HPV self-collection at home, the study also showed a higher cost-effectiveness when offering HPV self-collection for CC screening in the USA [ 56 ]. Similar results were obtained in a randomized clinical trial in a health plan from Kaiser Permanente Washington, a US-based integrated health care system, where mailing HPV self-collection kits was cost-effective for increased screening uptake relative to usual care [ 57 ]. Similarly, a UK-based research team recently assessed the cost of CC screening using self-collected FVU with Colli-Pee® or vaginal swab compared with the current strategy of PTS within the context of England’s National Health Service Cervical Screening Program [ 58 ]. They found that HPV self-sampling could provide a less costly alternative to a PTS for routine HPV primary screening. More specifically, the average cost per complete screen was lowest for FVU self-sampling with Colli-Pee®, followed by vaginal self-sampling and highest for a PTS. The increase in recent and ongoing research endeavors around FVU self-collection for HPV testing and CC screening [ 49 , 59 – 61 ] highlights its promise as an alternative and non-invasive sampling method to extend the scope of CC screening to women who are not adequately screened. Some limitations of our study should be addressed. First, the choice of a colposcopy setting provided sufficient statistical power to ask sensitivity questions and had minimal risk of partial verification bias inherent in screening settings. Since the females enrolled are not representative of a typical screening population, the questionnaire results should be interpreted with caution. We must also be aware that responses can be influenced to some degree towards plausible expectations and that communicated intentions do not necessarily correspond to future behavior. Additional population-based studies are recommended to assess whether home-based FVU self-collection is effectively preferable to vaginal self-collection and PTS. However, there are ongoing initiatives in France [ 61 ] and Belgium (NCT05996783) aimed at investigating FVU self-collection using the Colli-Pee® device within a population-based framework. 5. Conclusion In conclusion, the CASUS study successfully enrolled 332 females, with 210 participants providing valuable insights into their experiences with FVU self-sampling using the Colli-Pee® device. Our findings indicate a high level of user satisfaction. Moreover, the positive response to usability, as indicated by an average SUS score of 86.17, further supports the device's user-friendly nature and underscores the overall success and acceptability of Colli-Pee® in the context of FVU self-sampling for CC screening. These encouraging results not only highlight the feasibility and acceptance of Colli-Pee® but also emphasize its potential as a preferred method for future CC screening. The study participants' favorable opinions, coupled with their willingness to use Colli-Pee® again, position this device as a promising tool for future home-based FVU self-sampling as a liquid biopsy in CC screening where under screened populations could be approached more easily. Declarations Authorship contributions Conceptualization. S.V.K., G.D., S.W., J.D., V.V., K.B.; Methodology. J.OH., S.V.K., G.D., S.W., J.D., L.T., V.V., K.B., N.M., A.R.C.; Formal analysis. J.OH.; Resources. J.O.H, S.V.K., G.D., S.W., J.D., L.T., V.V., K.B., N.M., A.R.C.; Data curation. J.OH.; Writing—original draft preparation. J.O.H.; Writing—review and editing. JO.H, S.V.K., G.D., S.W., J.D., V.V.; Visualization. J.O.H; Supervision. S.V.K., V.V., K.B.; Project administration. J.O.H., S.V.K., V.V., K.B.; Funding acquisition. S.V.K., V.V., K.B. All authors have read and agreed to the published version of the manuscript. Funding This research was funded by H2020 Eurostars (grant number 12396). The funder did not play a role in this research. S. Van Keer is supported by a postdoctoral fellowship of the Research Foundation-Flanders (1240220N). Acknowledgements First. we would like to thank all females participating and completing the questionnaires in the CASUS study. We would also like to thank the study nurses and study teams at UZ Ghent. CHU de Liège. and the General Regional Hospital Heilig Hart Tienen for their collaboration and support in recruiting participants and documenting study data. We are grateful for the excellent scientific. administrative and logistical assistance of Nancy Kemland (Novosanis). Frank van Batenburg (Novosanis) and Annemie De Smet (VAXINFECTIO) . Disclosures J. O. Hendrickx, A. Rios-Cortes, N. Meers are employees of Novosanis. V.V.J. 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Clinical performance and acceptability of self-collected vaginal and urine samples compared with clinician-taken cervical samples for HPV testing among women referred for colposcopy. A cross-sectional study. BMJ open. 2021;11(3):e041512. Verhoef VM, et al. Triage by methylation-marker testing versus cytology in women who test HPV-positive on self-collected cervicovaginal specimens (PROHTECT-3): a randomised controlled non-inferiority trial. Lancet Oncol. 2014;15(3):315–22. Racey CS, Withrow DR, Gesink D. Self-collected HPV testing improves participation in cervical cancer screening: a systematic review and meta-analysis. Can J Public Health. 2013;104(2):e159–66. Verdoodt F, et al. Reaching women who do not participate in the regular cervical cancer screening programme by offering self-sampling kits: a systematic review and meta-analysis of randomised trials. Eur J Cancer. 2015;51(16):2375–85. Costa S, et al. Offering HPV self-sampling kits: an updated meta-analysis of the effectiveness of strategies to increase participation in cervical cancer screening. Br J Cancer. 2023;128(5):805–13. Nishimura H, et al. HPV self-sampling for cervical cancer screening: a systematic review of values and preferences. BMJ Global Health. 2021;6(5):e003743. Organization WH. WHO consolidated guideline on self-care interventions for health: sexual and reproductive health and rights: web supplement: GRADE tables. World Health Organization; 2019. Maver P, Poljak M. Primary HPV-based cervical cancer screening in Europe: implementation status, challenges, and future plans. Clin Microbiol Infect. 2020;26(5):579–83. Arbyn M et al. Perinatal mortality and other severe adverse pregnancy outcomes associated with treatment of cervical intraepithelial neoplasia: meta-analysis. BMJ, 2008. 337. Kyrgiou M et al. Fertility and early pregnancy outcomes after treatment for cervical intraepithelial neoplasia: systematic review and meta-analysis. BMJ, 2014. 349. Bruinsma F, Quinn M. The risk of preterm birth following treatment for precancerous changes in the cervix: a systematic review and meta-analysis. BJOG: Int J Obstet Gynecol. 2011;118(9):1031–41. Deen S, et al. The day we started HPV triage. J Clin Pathol. 2016;69(9):822–5. Hesselink AT, et al. Combined Promoter Methylation Analysis of CADM1 and MAL: An Objective Triage Tool for High-Risk Human Papillomavirus DNA–Positive WomenMethylation Markers to Triage hrHPV-Positive Women. Clin Cancer Res. 2011;17(8):2459–65. Carozzi F, et al. Risk of high-grade cervical intraepithelial neoplasia during follow-up in HPV-positive women according to baseline p16-INK4A results: a prospective analysis of a nested substudy of the NTCC randomised controlled trial. Lancet Oncol. 2013;14(2):168–76. Bulkmans N, et al. Human papillomavirus DNA testing for the detection of cervical intraepithelial neoplasia grade 3 and cancer: 5-year follow-up of a randomised controlled implementation trial. Lancet. 2007;370(9601):1764–72. Kitchener HC, et al. HPV testing in combination with liquid-based cytology in primary cervical screening (ARTISTIC): a randomised controlled trial. Lancet Oncol. 2009;10(7):672–82. Vorsters A, et al. Optimization of HPV DNA detection in urine by improving collection, storage, and extraction. Eur J Clin Microbiol Infect Dis. 2014;33:2005–14. Brooke J. SUS-A quick and dirty usability scale. Usability evaluation Ind. 1996;189(194):4–7. Brooke J. SUS: A ‘quick and dirty’usability scale. Usability Evaluation in Industry. PW Jordan, B Thomas, BA Weerdmeester and AL McClelland. London: Taylor and Francis; 1996. Schafer JL. Multiple imputation: a primer. Stat Methods Med Res. 1999;8(1):3–15. Smaradottir B et al. Usability evaluation of a collaborative health information system. lessons from a user-centred design process. 2016. Grasaas E, et al. iCanCope with pain: cultural adaptation and usability testing of a self-management app for adolescents with persistent pain in Norway. JMIR Res Protocols. 2019;8(6):e12940. Téblick L et al. Impact of collection volume and DNA extraction method on the detection of biomarkers and HPV DNA in first-void urine. Molecules, 2021. 26(7): p. 1989. Arbyn M, et al. VALHUDES: a protocol for validation of human papillomavirus assays and collection devices for HPV testing on self-samples and urine samples. J Clin Virol. 2018;107:52–6. De Pauw H, et al. Cervical cancer screening using HPV tests on self-samples: attitudes and preferences of women participating in the VALHUDES study. Archives Public Health. 2021;79(1):1–9. Cadman L, et al. A Randomized Comparison of Different Vaginal Self-sampling Devices and Urine for Human Papillomavirus Testing—Predictors 5.1. Cancer Epidemiol Biomarkers Prev. 2021;30(4):661–8. Leeman A, et al. HPV testing in first-void urine provides sensitivity for CIN 2 + detection comparable with a smear taken by a clinician or a brush‐based self‐sample: cross‐sectional data from a triage population. BJOG: Int J Obstet Gynecol. 2017;124(9):1356–63. Van Keer S, et al. Human papillomavirus genotype and viral load agreement between paired first-void urine and clinician-collected cervical samples. Eur J Clin Microbiol Infect Dis. 2018;37:859–69. Ertik FC, et al. CoCoss-Trial: Concurrent Comparison of Self-Sampling Devices for HPV-Detection. Int J Environ Res Public Health. 2021;18(19):10388. Nishimura Y, et al. Mailing human papillomavirus self-sampling kits to women under-screened for cervical cancer improved detection in cervical cancer screening in a general population study in Japan. BMC Public Health. 2023;23(1):473. Campos NG, et al. Cost-effectiveness of offering cervical cancer screening with HPV self-sampling among African-American women in the Mississippi Delta. Cancer Epidemiol Biomarkers Prev. 2021;30(6):1114–21. Meenan RT, et al. Economic Evaluation of Mailed Home-Based Human Papillomavirus Self-sampling Kits for Cervical Cancer Screening. JAMA Netw Open. 2023;6(3):e234052–234052. Huntington S, et al. Two self-sampling strategies for HPV primary cervical cancer screening compared with clinician-collected sampling: an economic evaluation. BMJ open. 2023;13(6):e068940. Cocuzza C. Extended validation of human papillomavirus assays and collection devices for HPV testing on self-samples and first-void urine samples. 2021 . ISRCTN. ISRCTN13132810: urine human papillomavirus (HPV)testing for cervical pre-cancer screening . Lefeuvre C et al. Study protocol: randomised controlled trial assessing the efficacy of strategies involving self-sampling in cervical cancer screening. International Journal of Public Health, 2022. 67: p. 1604284. Additional Declarations Competing interest reported. J. O. Hendrickx, A. Rios-Cortes, N. Meers are employees of Novosanis. V.V.J. Vankerckhoven is co-founder and was board member and CEO of Novosanis until October 2022. K.C.L. Beyers is co-founder and was board member until December 2022 and CTO of Novosanis until July 2023. Novosanis was founded as a spin-off company of the University of Antwerp, Belgium and is a subsidiary of OraSure Technologies Inc. since Jan 2019. The University of Antwerp received payment for participation of S. Van Keer in an Advisory Board of Novosanis (Subsidiary of OraSure Technologies Inc. Wijnegem, Belgium). Supplementary Files SupplementA.docx Cite Share Download PDF Status: Published Journal Publication published 12 Feb, 2025 Read the published version in Archives of Public Health → Version 1 posted Editorial decision: Revision requested 08 Sep, 2024 Reviews received at journal 16 Jul, 2024 Reviews received at journal 16 Jul, 2024 Reviews received at journal 15 Jul, 2024 Reviewers agreed at journal 03 Jul, 2024 Reviewers agreed at journal 02 Jul, 2024 Reviewers agreed at journal 02 Jul, 2024 Reviewers invited by journal 09 Jun, 2024 Editor assigned by journal 24 May, 2024 Submission checks completed at journal 24 May, 2024 First submitted to journal 16 May, 2024 You are reading this latest preprint version Research Square lets you share your work early, gain feedback from the community, and start making changes to your manuscript prior to peer review in a journal. As a division of Research Square Company, we’re committed to making research communication faster, fairer, and more useful. We do this by developing innovative software and high quality services for the global research community. Our growing team is made up of researchers and industry professionals working together to solve the most critical problems facing scientific publishing. Also discoverable on Platform About Our Team In Review Editorial Policies Advisory Board Help Center Resources Author Services Accessibility API Access RSS feed Manage Cookie Preferences © Research Square 2026 | ISSN 2693-5015 (online) Privacy Policy Terms of Service Do Not Sell My Personal Information {"props":{"pageProps":{"initialData":{"identity":"rs-4430311","acceptedTermsAndConditions":true,"allowDirectSubmit":false,"archivedVersions":[],"articleType":"Research Article","associatedPublications":[],"authors":[{"id":309307185,"identity":"5d58f25a-a7c2-4fd7-812d-564426eeaba1","order_by":0,"name":"Jhana O. Hendrickx","email":"data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAAZAAAAAyAQMAAABI0h/eAAAABlBMVEX///8AAABVwtN+AAAACXBIWXMAAA7EAAAOxAGVKw4bAAAA1ElEQVRIiWNgGAWjYBACxhlg6oCcAZg2sCBei7EBAzNIiwQR1kDUHEjcANbCQIQW5tnNzx78YLiTvp29/+iGHwUSDPzt3Qn4HTbnmLlhD8Oz3J09h9lu9gAdJnHm7Ab8WmYkmEnwMBzO3XAjme0GD1CLgUQuIS3p3yT/MBxONwBqufmHOC05ZtJAWxJAWm4TaUtOmbQMw2HDDWcOm92WMZDgIegXwxnp2yTfMByWNzje+Ozmmz82cvztvQS0NICs+ocQ4MGrHATkCaoYBaNgFIyCUQAAiJVHODfGe44AAAAASUVORK5CYII=","orcid":"","institution":"Novosanis","correspondingAuthor":true,"prefix":"","firstName":"Jhana","middleName":"O.","lastName":"Hendrickx","suffix":""},{"id":309307186,"identity":"a94be0e8-ad3a-4950-b355-6df152fc9413","order_by":1,"name":"Severien Van Keer","email":"","orcid":"","institution":"Vaccine \u0026 Infectious Disease Institute (VAXINFECTIO), Faculty of Medicine and Health Sciences, University of Antwerp","correspondingAuthor":false,"prefix":"","firstName":"Severien","middleName":"Van","lastName":"Keer","suffix":""},{"id":309307187,"identity":"c46e8943-755b-4cfa-bd6f-77ea3d8fe4eb","order_by":2,"name":"Gilbert Donders","email":"","orcid":"","institution":"Femicare vzw, Clinical Research for Women","correspondingAuthor":false,"prefix":"","firstName":"Gilbert","middleName":"","lastName":"Donders","suffix":""},{"id":309307188,"identity":"8ce67134-76d1-4528-9ad6-045db864f893","order_by":3,"name":"Steven Weyers","email":"","orcid":"","institution":"Department of Obstetrics and Gynecology, Ghent University Hospital","correspondingAuthor":false,"prefix":"","firstName":"Steven","middleName":"","lastName":"Weyers","suffix":""},{"id":309307189,"identity":"fe7cf3a7-0c29-4bf2-8083-fd849c8d0d44","order_by":4,"name":"Jean Doyen","email":"","orcid":"","institution":"Department Gynaecology-Obstetrics, University Hospital Liège","correspondingAuthor":false,"prefix":"","firstName":"Jean","middleName":"","lastName":"Doyen","suffix":""},{"id":309307190,"identity":"2aa3d4db-ffc9-4a9c-b408-32e49f2e8602","order_by":5,"name":"Koen C.L. Beyers","email":"","orcid":"","institution":"Novosanis","correspondingAuthor":false,"prefix":"","firstName":"Koen","middleName":"C.L.","lastName":"Beyers","suffix":""},{"id":309307191,"identity":"b2fa33b6-45dc-4f6f-8df5-5fceb7e8fc25","order_by":6,"name":"Alejandra Rios-Cortes","email":"","orcid":"","institution":"Novosanis","correspondingAuthor":false,"prefix":"","firstName":"Alejandra","middleName":"","lastName":"Rios-Cortes","suffix":""},{"id":309307192,"identity":"1ceb5ea7-f1db-43d2-bf2e-561818b33533","order_by":7,"name":"Nette Meers","email":"","orcid":"","institution":"Novosanis","correspondingAuthor":false,"prefix":"","firstName":"Nette","middleName":"","lastName":"Meers","suffix":""},{"id":309307193,"identity":"144cab2c-076f-45a6-93eb-76ab3cbb0c08","order_by":8,"name":"Laura Téblick","email":"","orcid":"","institution":"Vaccine \u0026 Infectious Disease Institute (VAXINFECTIO), Faculty of Medicine and Health Sciences, University of Antwerp","correspondingAuthor":false,"prefix":"","firstName":"Laura","middleName":"","lastName":"Téblick","suffix":""},{"id":309307194,"identity":"e0c3df9f-de8a-4c3a-a4e3-80ad2539d4db","order_by":9,"name":"Vanessa V.J. Vankerckhoven","email":"","orcid":"","institution":"Novosanis","correspondingAuthor":false,"prefix":"","firstName":"Vanessa","middleName":"V.J.","lastName":"Vankerckhoven","suffix":""}],"badges":[],"createdAt":"2024-05-16 10:15:27","currentVersionCode":1,"declarations":"","doi":"10.21203/rs.3.rs-4430311/v1","doiUrl":"https://doi.org/10.21203/rs.3.rs-4430311/v1","draftVersion":[],"editorialEvents":[{"content":"https://doi.org/10.1186/s13690-024-01490-3","type":"published","date":"2025-02-12T15:57:50+00:00"}],"editorialNote":"","failedWorkflow":false,"files":[{"id":57782122,"identity":"095d7c96-b13f-4584-9116-441a51e3650e","added_by":"auto","created_at":"2024-06-05 15:15:31","extension":"png","order_by":1,"title":"Figure 1","display":"","copyAsset":false,"role":"figure","size":638340,"visible":true,"origin":"","legend":"\u003cp\u003e\u003cstrong\u003eExperiences of FVU self-collection with Colli-Pee®\u003c/strong\u003e. Bar graphs represent the relative percentage of the total number of answers to a Likert scale ranging from 1: Strongly disagree to 8: Strongly agree per statement questioned. Per Likert-Scale category. The number of answers is mentioned on top of each bar.\u003c/p\u003e","description":"","filename":"OnlineFigure1.png","url":"https://assets-eu.researchsquare.com/files/rs-4430311/v1/bd3a6824e6e699ae2fc18805.png"},{"id":57782108,"identity":"fa123078-4963-4b53-bb2e-1a99a8e464c3","added_by":"auto","created_at":"2024-06-05 15:15:31","extension":"png","order_by":2,"title":"Figure 2","display":"","copyAsset":false,"role":"figure","size":179246,"visible":true,"origin":"","legend":"\u003cp\u003e\u003cstrong\u003ePreferred sample collection method for participant’s next cervical cancer (CC) screening: \u003c/strong\u003ea PTS (N=69/210). FVU (N=140/210) and missing values (N=1/210). Relative percentages are indicated between brackets.\u003c/p\u003e","description":"","filename":"OnlineFigure2.png","url":"https://assets-eu.researchsquare.com/files/rs-4430311/v1/1277326cb8cdff90789d924e.png"},{"id":57782109,"identity":"f51fa36e-2b33-45a4-8472-a23ebae66680","added_by":"auto","created_at":"2024-06-05 15:15:31","extension":"jpeg","order_by":3,"title":"Figure 3","display":"","copyAsset":false,"role":"figure","size":388813,"visible":true,"origin":"","legend":"\u003cp\u003e\u003cstrong\u003eSUS questionnaire scores (N=208). \u003c/strong\u003eEach row in the heatmap contains the amount of answers for each of the 10 questions (Q1 – Q10) per Likert score ranging from 1: Strongly disagree to 5: Strongly agree in each column. The color-legend of the heatmap is depicted in the separate bar graph on the right. White represents a positive response, grey a neutral response, and black a negative response.†: 4 incomplete SUS-scores, ‡: 3 incomplete SUS-scores, ††: 6 incomplete SUS-scores\u003c/p\u003e","description":"","filename":"floatimage3.jpeg","url":"https://assets-eu.researchsquare.com/files/rs-4430311/v1/e2bedf126cbb8684c6e5b000.jpeg"},{"id":76487608,"identity":"8cdf1f74-d7e0-442a-92ae-8dd42c4ed468","added_by":"auto","created_at":"2025-02-17 16:09:52","extension":"pdf","order_by":0,"title":"","display":"","copyAsset":false,"role":"manuscript-pdf","size":2616488,"visible":true,"origin":"","legend":"","description":"","filename":"manuscript.pdf","url":"https://assets-eu.researchsquare.com/files/rs-4430311/v1/b6c81ec8-0f30-4e86-a61a-39861575658c.pdf"},{"id":57782110,"identity":"2f5372e5-1946-4d12-b322-928144dad4df","added_by":"auto","created_at":"2024-06-05 15:15:31","extension":"docx","order_by":1,"title":"","display":"","copyAsset":false,"role":"supplement","size":455720,"visible":true,"origin":"","legend":"","description":"","filename":"SupplementA.docx","url":"https://assets-eu.researchsquare.com/files/rs-4430311/v1/0cb0bf518bef3e757be93f3b.docx"}],"financialInterests":"Competing interest reported. J. O. Hendrickx, A. Rios-Cortes, N. Meers are employees of Novosanis. V.V.J. Vankerckhoven is co-founder and was board member and CEO of Novosanis until October 2022. K.C.L. Beyers is co-founder and was board member until December 2022 and CTO of Novosanis until July 2023. Novosanis was founded as a spin-off company of the University of Antwerp, Belgium and is a subsidiary of OraSure Technologies Inc. since Jan 2019. The University of Antwerp received payment for participation of S. Van Keer in an Advisory Board of Novosanis (Subsidiary of OraSure Technologies Inc. Wijnegem, Belgium).","formattedTitle":"Home-based urinary HPV self-sampling for the detection of cervical cancer precursor lesions: attitudes and preferences from Belgian females participating in the CASUS study","fulltext":[{"header":"Contributions to the literature","content":"\u003cul\u003e\n \u003cli\u003eThis study provides new evidence on the preferences and usability of FVU self-sampling for CC screening.\u003c/li\u003e\n \u003cli\u003eIt highlights a significant preference among women for FVU self-sampling over traditional PTS, which can enhance participation rates in cervical cancer screening programs.\u003c/li\u003e\n \u003cli\u003eBy facilitating home-based sampling, this approach could improve CC screening access for under-screened populations, potentially reducing CC incidence and mortality.\u003c/li\u003e\n\u003c/ul\u003e"},{"header":"1. Introduction","content":"\u003cp\u003eCervical cancer (CC) is the fourth most common cancer globally among females, caused by oncogenic infections with high-risk human papillomavirus (hrHPV) strains [\u003cspan citationid=\"CR62\" class=\"CitationRef\"\u003e1\u003c/span\u003e, \u003cspan citationid=\"CR64\" class=\"CitationRef\"\u003e2\u003c/span\u003e]. There were an estimated 604 000 new CC cases and 342 000 related deaths worldwide in 2020, with about 90% occurring in low- and middle-income countries [\u003cspan citationid=\"CR72\" class=\"CitationRef\"\u003e3\u003c/span\u003e]. A recent modelling study suggests that widespread coverage of both HPV vaccination and CC screening from 2020 onwards could prevent 12.5\u0026ndash;13.4\u0026nbsp;million new cases of CC by 2070, leading to near-elimination of CC in most countries by the end of the century [\u003cspan citationid=\"CR66\" class=\"CitationRef\"\u003e4\u003c/span\u003e].\u003c/p\u003e \u003cp\u003eSuccessful CC screening programs strongly depend on the participation rate of the target population. However, challenges are being faced with including hard to reach and under screened females, leading to an increased risk for CC [\u003cspan citationid=\"CR5\" class=\"CitationRef\"\u003e5\u003c/span\u003e]. A decade ago, the overall coverage of European CC screening programs was below 80%, ranging from 10\u0026ndash;79%. In only five countries (France, England, Finland, The Netherlands, and Sweden) screening coverage was 70% or more [\u003cspan citationid=\"CR6\" class=\"CitationRef\"\u003e6\u003c/span\u003e]. The Belgian Center for Cancer Detection, CvKO, recently published data regarding the CC screening coverage in 2021, revealing a 64% coverage [\u003cspan citationid=\"CR7\" class=\"CitationRef\"\u003e7\u003c/span\u003e, \u003cspan citationid=\"CR8\" class=\"CitationRef\"\u003e8\u003c/span\u003e]. Screening in most European countries is based on cytology, which requires a PTS, is challenged by low sensitivity, and knows a subjective review [\u003cspan citationid=\"CR9\" class=\"CitationRef\"\u003e9\u003c/span\u003e]. Several barriers have been identified that lead to reluctance towards CC screening, including lack of time and limited access to health services, physical discomfort, cultural barriers, and lack of knowledge about the benefits of CC screening [\u003cspan additionalcitationids=\"CR11 CR12 CR13 CR14\" citationid=\"CR10\" class=\"CitationRef\"\u003e10\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR15\" class=\"CitationRef\"\u003e15\u003c/span\u003e].\u003c/p\u003e \u003cp\u003eFor over 60 years, cervical cytology has been considered the gold standard for CC screening, looking for precancers or abnormal cell changes in the cervix [\u003cspan additionalcitationids=\"CR17\" citationid=\"CR16\" class=\"CitationRef\"\u003e16\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR18\" class=\"CitationRef\"\u003e18\u003c/span\u003e]. Considering that the majority of cervical cancer cases are diagnosed in screening non-attendees [\u003cspan citationid=\"CR19\" class=\"CitationRef\"\u003e19\u003c/span\u003e], opting for HPV testing over cytology is a viable choice due to its higher sensitivity and a reduced cumulative risk of developing high-grade diseases. Randomized population-based controlled trials have demonstrated that HPV-based screening, compared to cytology-based CC screening, offers an early detection of hrHPV types and thus risk of incident CC [\u003cspan citationid=\"CR20\" class=\"CitationRef\"\u003e20\u003c/span\u003e, \u003cspan citationid=\"CR21\" class=\"CitationRef\"\u003e21\u003c/span\u003e]. An additional advantage of CC screening using HPV assays is that these tests can be performed on self-samples. Self-sampling collection methods may include a (cervico)vaginal swab or brush, vaginal lavage, vaginal patch or a urine sample, with a particular emphasis on first-void urine (FVU) as this is more accurate than testing on a random or midstream urine sample [\u003cspan citationid=\"CR22\" class=\"CitationRef\"\u003e22\u003c/span\u003e].\u003c/p\u003e \u003cp\u003eRecent studies have shown that hrHPV DNA testing on self-samples, compared to PTS, is equally accurate in detecting underlying CC using validated PCR-based hrHPV tests [\u003cspan additionalcitationids=\"CR24 CR25\" citationid=\"CR23\" class=\"CitationRef\"\u003e23\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR26\" class=\"CitationRef\"\u003e26\u003c/span\u003e]. Furthermore, previous studies have shown that providing participants with a self-sampling kit, offering options such as a vaginal swab, brush, lavage, tampon, urine, labial padette, or a combination of these, leads to higher participation rates compared to traditional invitations for PTS and is preferred by participants. [\u003cspan citationid=\"CR23\" class=\"CitationRef\"\u003e23\u003c/span\u003e, \u003cspan additionalcitationids=\"CR28 CR29 CR30\" citationid=\"CR27\" class=\"CitationRef\"\u003e27\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR31\" class=\"CitationRef\"\u003e31\u003c/span\u003e]. In 2018, the World Health Organization called for coordinated global action to eradicate CC, emphasizing screening for individuals aged 30\u0026ndash;60 years, and strongly supporting the inclusion of HPV testing on self-sampling as an add-on in CC screening services [\u003cspan citationid=\"CR32\" class=\"CitationRef\"\u003e32\u003c/span\u003e, \u003cspan citationid=\"CR33\" class=\"CitationRef\"\u003e33\u003c/span\u003e]. Approximately 99% of hrHPV infections are transient and do not lead to CC. Therefore, triage is necessary to identify only hrHPV-positive cases with clinically relevant disease to have control over referral, overtreatment, and costs [\u003cspan additionalcitationids=\"CR35 CR36\" citationid=\"CR34\" class=\"CitationRef\"\u003e34\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR37\" class=\"CitationRef\"\u003e37\u003c/span\u003e]. Currently, triage relies heavily on cytology-outcomes which requires repetitive testing on PTS [\u003cspan citationid=\"CR38\" class=\"CitationRef\"\u003e38\u003c/span\u003e, \u003cspan citationid=\"CR39\" class=\"CitationRef\"\u003e39\u003c/span\u003e]. This two-step process is associated with 25\u0026ndash;40% loss to follow-up [\u003cspan citationid=\"CR40\" class=\"CitationRef\"\u003e40\u003c/span\u003e, \u003cspan citationid=\"CR41\" class=\"CitationRef\"\u003e41\u003c/span\u003e]. The CASUS study aimed to develop a complete CC screening solution based on FVU self-sampling, identifying females with clinically relevant disease in need of treatment in a one-step triage manner. Here, we report usability perceptions and preferences from females participating in the CASUS study.\u003c/p\u003e"},{"header":"2. Materials and Methods","content":"\u003cdiv id=\"Sec3\" class=\"Section2\"\u003e \u003ch2\u003e2.1. Study population\u003c/h2\u003e \u003cp\u003eThe CASUS study (ClinicalTrials.gov identifier: NCT04530201) is an interventional study, which aimed to develop the first fully molecular integrated cervical cancer screening approach, based on FVU as an easily accessible and non-invasive source of biomarkers. Ethical approval for the CASUS study was provided by the Medical Ethical Committee of the University Hospital Antwerp (20/21/271, Antwerp, Belgium) on the 4th of August 2020.\u003c/p\u003e \u003cp\u003e At three Belgian colposcopy clinics (UZ Ghent, Ghent, Belgium; CHU de Li\u0026egrave;ge, Li\u0026egrave;ge, Belgium; The General Regional Hospital Heilig Hart Tienen, Tienen, Belgium), females between 26 and 70 years of age referred to colposcopy due to a (probable) hrHPV infection and/or abnormal cervical squamous intraepithelial/glandular lesion were recruited. This recruitment took place between August 2020 and February 2022 by the medical staff of the participating colposcopy clinics when a date for a colposcopy examination was set. Hysterectomized females, females with known pregnancy, females being treated for CC in the last six months before participating in this study, females participating in another (low-) interventional study, non-consenting females, and females that were not able to understand and to sign the informed consent form were excluded. A study package, sent to the females' home address by regular mail, contained an information brochure and informed consent form, two Colli-Pee\u0026reg; UCM FV-5010 devices containing 3.4 mL of UCM preservative [\u003cspan citationid=\"CR42\" class=\"CitationRef\"\u003e42\u003c/span\u003e] and collecting a total sample of approximately 10 mL (Novosanis, Wijnegem, Belgium), instructions for use, and safety bags. The safety bags included absorbing tissues for storage of the collector tubes after FVU collection. Furthermore, along with the study package a link was provided to a digital questionnaire on the usability of the device and/or a paper version in either Dutch or French.\u003c/p\u003e \u003cp\u003eOne day prior to the colposcopy, study participants who gave their consent self-collected two FVU samples at home using the Colli-Pee\u0026reg; UCM FV-5010. Participants were asked to space the two collections with a minimum of one hour. Females were asked to fill in a questionnaire at home between the two FVU collections. After collecting the FVU samples, the participant stored the collector tubes in individual plastic safety bags at room temperature with absorbing tissues. At the day of colposcopy, the participant brought the FVU samples to the colposcopy clinic and handed them over to the study team. During the colposcopy appointment, a trained physician collected a cervical sample using the Cervex-Brush (Rovers Medical Devices B.V., Oss, The Netherlands), which was subsequently transferred/preserved in ThinPrep PreservCyt solution (Hologic Inc., Bedford, Massachusetts, United States of America). This cervical sample was collected before colposcopy, during the same medical exam. Hereafter, colposcopy (with biopsy/ambulant conization if considered necessary) was performed as usual.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec4\" class=\"Section2\"\u003e \u003ch2\u003e2.2. CASUS questionnaire\u003c/h2\u003e \u003cp\u003eThe questionnaire consisted of 38 questions divided into six categories: (1) general, (2) experience prior to using Colli-Pee\u0026reg;, (3) experience while using Colli-Pee\u0026reg;, (4) experience after using Colli-Pee\u0026reg;, (5) feedback on the use of Colli-Pee\u0026reg;, and (6) feedback on the use of Colli-Pee\u0026reg; through a System Usability Scale (SUS) [\u003cspan citationid=\"CR43\" class=\"CitationRef\"\u003e43\u003c/span\u003e, \u003cspan citationid=\"CR44\" class=\"CitationRef\"\u003e44\u003c/span\u003e]. The SUS questionnaire system was used to evaluate user satisfaction and consisted of 10 open-ended polarity-balanced questions with a five-point Likert scale, ranging from 1 (Strongly disagree) to 5 (Strongly agree), for responses. The SUS score, as a composite measure of the overall usability of the Colli-Pee\u0026reg; device, was calculated as described previously [\u003cspan citationid=\"CR43\" class=\"CitationRef\"\u003e43\u003c/span\u003e]. A SUS score greater than 68 is considered above average, and a SUS score greater than 80.3 indicates that the device is user-friendly and will be recommended by users. Responses regarding the experiences were gathered with an 8-point Likert scale ranging from 1 (Completely disagree) to 8 (Completely agree). The original Dutch/French questionnaire was translated to English and added as Supplement A.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec5\" class=\"Section2\"\u003e \u003ch2\u003e2.3. Statistical methods\u003c/h2\u003e \u003cp\u003eOnline questionnaire answers were exported from Qualtrics XM (Seattle, Washington, USA, 2020) in an Excel database. Paper questionnaire forms were encoded manually into the Excel database. A full check was done after data entry by the encoder. In addition, an independent check of a 25% random selection of the answer forms was performed by a CASUS researcher to pick-up possible data entry errors. Frequency distributions, showing the number of answers and relative percentages, were tabulated for each question followed by statistical analysis for normality with a Shapiro-Wilk test. As the proportion of missing values was small (\u0026lt;\u0026thinsp;5%), it was decided to include the missing data in the descriptive statistics without data imputation [\u003cspan citationid=\"CR45\" class=\"CitationRef\"\u003e45\u003c/span\u003e]. Multiple logistic regression analysis was used to model correlations. Statistical significance was accepted when p-values\u0026thinsp;\u0026lt;\u0026thinsp;0.05 and statistical analyses were conducted with GraphPad Prism (version 9.4.0 for Windows, GraphPad Software, San Diego, CA, USA).\u003c/p\u003e \u003c/div\u003e"},{"header":"3. Results","content":"\u003cdiv id=\"Sec7\" class=\"Section2\"\u003e \u003ch2\u003e3.1. Population characteristics\u003c/h2\u003e \u003cp\u003eBetween the 20th of August 2020 and the 28th of February 2022, 332 females were enrolled in the CASUS study. The number of enrolled patients per colposcopy clinic was provided by the responsible gynecologists. A total of 210 questionnaires (N = 210/332, 63%) from the total enrolled cohort (age 25–64 years) were obtained and analyzed. The median age of the included females was 37 years (IQR: 30–48). The distribution of the number of enrolled patients per colposcopy clinic and general characteristics of the enrolled study participants are depicted in Table\u0026nbsp;\u003cspan refid=\"Tab1\" class=\"InternalRef\"\u003e1\u003c/span\u003e.\u003c/p\u003e \u003cp\u003e \u003c/p\u003e\u003cdiv class=\"gridtable\"\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c1\" colnum=\"1\"\u003e\u003c/div\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c2\" colnum=\"2\"\u003e\u003c/div\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c3\" colnum=\"3\"\u003e\u003c/div\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c4\" colnum=\"4\"\u003e\u003c/div\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c5\" colnum=\"5\"\u003e\u003c/div\u003e\u003ctable float=\"Yes\" id=\"Tab1\" border=\"1\"\u003e\u003ccaption language=\"En\"\u003e \u003cdiv class=\"CaptionNumber\"\u003eTable 1\u003c/div\u003e \u003cdiv class=\"CaptionContent\"\u003e \u003cp\u003eCharacteristics of enrolled participants (N = 210) in the CASUS study\u003c/p\u003e \u003c/div\u003e \u003c/caption\u003e\u003ccolgroup cols=\"5\"\u003e\u003c/colgroup\u003e\u003cthead\u003e\u003ctr\u003e\u003cth align=\"left\" colspan=\"2\" nameend=\"c2\" namest=\"c1\"\u003e \u003cp\u003eCharacteristics\u003c/p\u003e \u003c/th\u003e\u003cth align=\"left\" colspan=\"2\" nameend=\"c4\" namest=\"c3\"\u003e \u003cp\u003eN\u003c/p\u003e \u003c/th\u003e\u003cth align=\"left\" colname=\"c5\"\u003e \u003cp\u003e%\u003c/p\u003e \u003c/th\u003e\u003c/tr\u003e\u003c/thead\u003e\u003ctbody\u003e\u003ctr\u003e\u003ctd align=\"left\" colspan=\"2\" nameend=\"c2\" namest=\"c1\"\u003e \u003cp\u003e\u003cem\u003e5-year age groups (years)\u003c/em\u003e\u003c/p\u003e \u003c/td\u003e\u003ctd align=\"left\" colspan=\"2\" nameend=\"c4\" namest=\"c3\"\u003e \u003cp\u003e210\u003c/p\u003e \u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e100\u003c/p\u003e \u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colspan=\"2\" nameend=\"c2\" namest=\"c1\"\u003e \u003cp\u003e25–30\u003c/p\u003e \u003c/td\u003e\u003ctd align=\"left\" colspan=\"2\" nameend=\"c4\" namest=\"c3\"\u003e \u003cp\u003e57\u003c/p\u003e \u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e27.1\u003c/p\u003e \u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colspan=\"2\" nameend=\"c2\" namest=\"c1\"\u003e \u003cp\u003e31–35\u003c/p\u003e \u003c/td\u003e\u003ctd align=\"left\" colspan=\"2\" nameend=\"c4\" namest=\"c3\"\u003e \u003cp\u003e40\u003c/p\u003e \u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e19.0\u003c/p\u003e \u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colspan=\"2\" nameend=\"c2\" namest=\"c1\"\u003e \u003cp\u003e36–40\u003c/p\u003e \u003c/td\u003e\u003ctd align=\"left\" colspan=\"2\" nameend=\"c4\" namest=\"c3\"\u003e \u003cp\u003e26\u003c/p\u003e \u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e12.4\u003c/p\u003e \u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colspan=\"2\" nameend=\"c2\" namest=\"c1\"\u003e \u003cp\u003e41–45\u003c/p\u003e \u003c/td\u003e\u003ctd align=\"left\" colspan=\"2\" nameend=\"c4\" namest=\"c3\"\u003e \u003cp\u003e25\u003c/p\u003e \u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e11.9\u003c/p\u003e \u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colspan=\"2\" nameend=\"c2\" namest=\"c1\"\u003e \u003cp\u003e46–50\u003c/p\u003e \u003c/td\u003e\u003ctd align=\"left\" colspan=\"2\" nameend=\"c4\" namest=\"c3\"\u003e \u003cp\u003e23\u003c/p\u003e \u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e11.0\u003c/p\u003e \u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colspan=\"2\" nameend=\"c2\" namest=\"c1\"\u003e \u003cp\u003e51–55\u003c/p\u003e \u003c/td\u003e\u003ctd align=\"left\" colspan=\"2\" nameend=\"c4\" namest=\"c3\"\u003e \u003cp\u003e23\u003c/p\u003e \u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e11.0\u003c/p\u003e \u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colspan=\"2\" nameend=\"c2\" namest=\"c1\"\u003e \u003cp\u003e56–60\u003c/p\u003e \u003c/td\u003e\u003ctd align=\"left\" colspan=\"2\" nameend=\"c4\" namest=\"c3\"\u003e \u003cp\u003e14\u003c/p\u003e \u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e6.7\u003c/p\u003e \u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colspan=\"2\" nameend=\"c2\" namest=\"c1\"\u003e \u003cp\u003e61–65\u003c/p\u003e \u003c/td\u003e\u003ctd align=\"left\" colspan=\"2\" nameend=\"c4\" namest=\"c3\"\u003e \u003cp\u003e2\u003c/p\u003e \u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e1.0\u003c/p\u003e \u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colspan=\"2\" nameend=\"c2\" namest=\"c1\"\u003e \u003cp\u003e\u003cem\u003eRecruitment at each colposcopy clinic\u003c/em\u003e\u003c/p\u003e \u003c/td\u003e\u003ctd align=\"left\" colspan=\"2\" nameend=\"c4\" namest=\"c3\"\u003e \u003cp\u003e210\u003c/p\u003e \u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e100\u003c/p\u003e \u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colspan=\"2\" nameend=\"c2\" namest=\"c1\"\u003e \u003cp\u003eUZ Ghent\u003c/p\u003e \u003c/td\u003e\u003ctd align=\"left\" colspan=\"2\" nameend=\"c4\" namest=\"c3\"\u003e \u003cp\u003e79\u003c/p\u003e \u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e37.6\u003c/p\u003e \u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colspan=\"2\" nameend=\"c2\" namest=\"c1\"\u003e \u003cp\u003eCHU de Liège\u003c/p\u003e \u003c/td\u003e\u003ctd align=\"left\" colspan=\"2\" nameend=\"c4\" namest=\"c3\"\u003e \u003cp\u003e60\u003c/p\u003e \u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e28.6\u003c/p\u003e \u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colspan=\"2\" nameend=\"c2\" namest=\"c1\"\u003e \u003cp\u003eRZ Tienen\u003c/p\u003e \u003c/td\u003e\u003ctd align=\"left\" colspan=\"2\" nameend=\"c4\" namest=\"c3\"\u003e \u003cp\u003e71\u003c/p\u003e \u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e33.8\u003c/p\u003e \u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cem\u003eSelf-reported HPV vaccination status\u003c/em\u003e\u003c/p\u003e \u003c/td\u003e\u003ctd align=\"left\" colspan=\"2\" nameend=\"c3\" namest=\"c2\"\u003e \u003cp\u003e210\u003c/p\u003e \u003c/td\u003e\u003ctd align=\"left\" colspan=\"2\" nameend=\"c5\" namest=\"c4\"\u003e \u003cp\u003e100\u003c/p\u003e \u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colspan=\"2\" nameend=\"c2\" namest=\"c1\"\u003e \u003cp\u003eVaccinated\u003c/p\u003e \u003c/td\u003e\u003ctd align=\"left\" colspan=\"2\" nameend=\"c4\" namest=\"c3\"\u003e \u003cp\u003e41\u003c/p\u003e \u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e19.5\u003c/p\u003e \u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colspan=\"2\" nameend=\"c2\" namest=\"c1\"\u003e \u003cp\u003eUnvaccinated\u003c/p\u003e \u003c/td\u003e\u003ctd align=\"left\" colspan=\"2\" nameend=\"c4\" namest=\"c3\"\u003e \u003cp\u003e157\u003c/p\u003e \u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e74.8\u003c/p\u003e \u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colspan=\"2\" nameend=\"c2\" namest=\"c1\"\u003e \u003cp\u003eUnknown\u003c/p\u003e \u003c/td\u003e\u003ctd align=\"left\" colspan=\"2\" nameend=\"c4\" namest=\"c3\"\u003e \u003cp\u003e11\u003c/p\u003e \u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e5.2\u003c/p\u003e \u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colspan=\"2\" nameend=\"c2\" namest=\"c1\"\u003e \u003cp\u003eMissing value\u003c/p\u003e \u003c/td\u003e\u003ctd align=\"left\" colspan=\"2\" nameend=\"c4\" namest=\"c3\"\u003e \u003cp\u003e1\u003c/p\u003e \u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e0.5\u003c/p\u003e \u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colspan=\"2\" nameend=\"c2\" namest=\"c1\"\u003e \u003cp\u003e\u003cem\u003ePrior history of an oncologic disease\u003c/em\u003e\u003c/p\u003e \u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e210\u003c/p\u003e \u003c/td\u003e\u003ctd align=\"left\" colspan=\"2\" nameend=\"c5\" namest=\"c4\"\u003e \u003cp\u003e100\u003c/p\u003e \u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colspan=\"2\" nameend=\"c2\" namest=\"c1\"\u003e \u003cp\u003eYes\u003c/p\u003e \u003c/td\u003e\u003ctd align=\"left\" colspan=\"2\" nameend=\"c4\" namest=\"c3\"\u003e \u003cp\u003e6\u003c/p\u003e \u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e2.9\u003c/p\u003e \u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colspan=\"2\" nameend=\"c2\" namest=\"c1\"\u003e \u003cp\u003eNo\u003c/p\u003e \u003c/td\u003e\u003ctd align=\"left\" colspan=\"2\" nameend=\"c4\" namest=\"c3\"\u003e \u003cp\u003e200\u003c/p\u003e \u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e95.2\u003c/p\u003e \u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colspan=\"2\" nameend=\"c2\" namest=\"c1\"\u003e \u003cp\u003eUnknown\u003c/p\u003e \u003c/td\u003e\u003ctd align=\"left\" colspan=\"2\" nameend=\"c4\" namest=\"c3\"\u003e \u003cp\u003e3\u003c/p\u003e \u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e1.4\u003c/p\u003e \u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colspan=\"2\" nameend=\"c2\" namest=\"c1\"\u003e \u003cp\u003eMissing value\u003c/p\u003e \u003c/td\u003e\u003ctd align=\"left\" colspan=\"2\" nameend=\"c4\" namest=\"c3\"\u003e \u003cp\u003e1\u003c/p\u003e \u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e0.5\u003c/p\u003e \u003c/td\u003e\u003c/tr\u003e\u003c/tbody\u003e\u003c/table\u003e\u003c/div\u003e \u003cp\u003e\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec8\" class=\"Section2\"\u003e \u003ch2\u003e3.2. Experiences and intentions regarding prior and future use of urinary self-samples\u003c/h2\u003e \u003cp\u003eThe level of use and understanding of the instructions for use of the FVU self-sampling device are described in Table\u0026nbsp;\u003cspan refid=\"Tab2\" class=\"InternalRef\"\u003e2\u003c/span\u003e. The large majority of females (N = 174/210, 82.9%) indicated that they consulted the instructions for use that came along with the study package. Of those females, 97.7% (N = 170/174) thought that the instructions for use of the Colli-Pee® device were clear. Some of the reasons why females found the instructions for use unclear included the following: ‘The instructions didn't make it very clear what the do's and don'ts for use were.’, ‘I have not read the instructions or can’t remember doing so’, ‘I didn’t think about using the instructions.’.\u003c/p\u003e \u003cp\u003e \u003c/p\u003e\u003cdiv class=\"gridtable\"\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c1\" colnum=\"1\"\u003e\u003c/div\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c2\" colnum=\"2\"\u003e\u003c/div\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c3\" colnum=\"3\"\u003e\u003c/div\u003e\u003ctable float=\"Yes\" id=\"Tab2\" border=\"1\"\u003e\u003ccaption language=\"En\"\u003e \u003cdiv class=\"CaptionNumber\"\u003eTable 2\u003c/div\u003e \u003cdiv class=\"CaptionContent\"\u003e \u003cp\u003eUse and understanding of the instructions for use of the Colli-Pee® device (N = 210).\u003c/p\u003e \u003c/div\u003e \u003c/caption\u003e\u003ccolgroup cols=\"3\"\u003e\u003c/colgroup\u003e\u003cthead\u003e\u003ctr\u003e\u003cth align=\"left\" colname=\"c1\"\u003e \u003cp\u003eQuestion\u003c/p\u003e \u003c/th\u003e\u003cth align=\"left\" colname=\"c2\"\u003e \u003cp\u003eN\u003c/p\u003e \u003c/th\u003e\u003cth align=\"left\" colname=\"c3\"\u003e \u003cp\u003e%\u003c/p\u003e \u003c/th\u003e\u003c/tr\u003e\u003c/thead\u003e\u003ctbody\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cem\u003eI used the instructions for use that came along with the device\u003c/em\u003e\u003c/p\u003e \u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e210\u003c/p\u003e \u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e100\u003c/p\u003e \u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eYes\u003c/p\u003e \u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e174\u003c/p\u003e \u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e82.9\u003c/p\u003e \u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eNo\u003c/p\u003e \u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e35\u003c/p\u003e \u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e7\u003c/p\u003e \u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eMissing value\u003c/p\u003e \u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e1\u003c/p\u003e \u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e0.5\u003c/p\u003e \u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cem\u003eThe instructions for use were clear (for those who used the instructions for use)\u003c/em\u003e\u003c/p\u003e \u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e174\u003c/p\u003e \u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e100\u003c/p\u003e \u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eYes\u003c/p\u003e \u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e170\u003c/p\u003e \u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e97.7\u003c/p\u003e \u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eNo\u003c/p\u003e \u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e4\u003c/p\u003e \u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e2.3\u003c/p\u003e \u003c/td\u003e\u003c/tr\u003e\u003c/tbody\u003e\u003c/table\u003e\u003c/div\u003e \u003cp\u003e\u003c/p\u003e \u003cp\u003eFemales were asked for their prior experience in self-collecting a urine sample. Most females (N = 159/210, 75.7%) indicated that they self-collected a urine sample before with a urine cup. Of those females, 79.2% (N = 126/159) indicated that they prefer Colli-Pee® over a urine cup for urinary self-collection (Table\u0026nbsp;\u003cspan refid=\"Tab3\" class=\"InternalRef\"\u003e3\u003c/span\u003e).\u003c/p\u003e \u003cp\u003eOn a Likert-scale from 1 (strongly disagree) to 8 (strongly agree) a large amount (p \u0026lt; 0.0001) of females (N = 102/210, 48.6%) agreed that they had the impression it did not take them a long time before knowing how to use the device (Fig.\u0026nbsp;\u003cspan refid=\"Fig1\" class=\"InternalRef\"\u003e1\u003c/span\u003e. \u003cb\u003eA\u003c/b\u003e). A total of 31.9% (N = 67/210), 49.1% (N = 103/210) and 19.0% (N = 40/210) of participants indicated that it took them respectively less than 2 minutes. between 2 and 5 minutes. or more than five minutes in total (from reading the instructions to collecting the sample) to self-collect a FVU sample with Colli-Pee® (Data not shown).\u003c/p\u003e \u003cp\u003eMost females answered that it was clear how to use Colli-Pee® during urination (N = 121/210 57.6%, p \u0026lt; 0.01) and that they had the impression that they took the FVU sample correctly (N = 143/210, 68.1%, p \u0026lt; 0.001) (Fig.\u0026nbsp;\u003cspan refid=\"Fig1\" class=\"InternalRef\"\u003e1\u003c/span\u003e. \u003cb\u003eB.C\u003c/b\u003e). Participants also reported their intention to recommend the Colli-Pee® device to others whereby the majority of females indicated that they strongly agree in recommending Colli-Pee® to others (N = 142/209, 67.9%, p \u0026lt; 0.0001, 1 missing value).\u003c/p\u003e \u003cp\u003eOverall, 97.6% of females (N = 205/210) indicated that they would use Colli-Pee® again and 97.1% (N = 204/210) of females felt that Colli-Pee® was easy to use (Table\u0026nbsp;\u003cspan refid=\"Tab3\" class=\"InternalRef\"\u003e3\u003c/span\u003e).\u003c/p\u003e \u003cp\u003e \u003c/p\u003e\u003cdiv class=\"gridtable\"\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c1\" colnum=\"1\"\u003e\u003c/div\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c2\" colnum=\"2\"\u003e\u003c/div\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c3\" colnum=\"3\"\u003e\u003c/div\u003e\u003ctable float=\"Yes\" id=\"Tab3\" border=\"1\"\u003e\u003ccaption language=\"En\"\u003e \u003cdiv class=\"CaptionNumber\"\u003eTable 3\u003c/div\u003e \u003cdiv class=\"CaptionContent\"\u003e \u003cp\u003e\u003cb\u003eExperiences and opinions on urine self-collection (N = 210).\u003c/b\u003e\u003c/p\u003e \u003c/div\u003e \u003c/caption\u003e\u003ccolgroup cols=\"3\"\u003e\u003c/colgroup\u003e\u003cthead\u003e\u003ctr\u003e\u003cth align=\"left\" colname=\"c1\"\u003e \u003cp\u003eQuestion\u003c/p\u003e \u003c/th\u003e\u003cth align=\"left\" colname=\"c2\"\u003e \u003cp\u003eN\u003c/p\u003e \u003c/th\u003e\u003cth align=\"left\" colname=\"c3\"\u003e \u003cp\u003e%\u003c/p\u003e \u003c/th\u003e\u003c/tr\u003e\u003c/thead\u003e\u003ctbody\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cem\u003eI already took a urine sample (with a urine cup)\u003c/em\u003e\u003c/p\u003e \u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e210\u003c/p\u003e \u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e100\u003c/p\u003e \u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eYes\u003c/p\u003e \u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e159\u003c/p\u003e \u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e75.7\u003c/p\u003e \u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eNo\u003c/p\u003e \u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e51\u003c/p\u003e \u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e24.3\u003c/p\u003e \u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cem\u003eWhich urinary collection method do you prefer? (for those having a prior experience)\u003c/em\u003e\u003c/p\u003e \u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e159\u003c/p\u003e \u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e100\u003c/p\u003e \u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eColli-Pee®\u003c/p\u003e \u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e126\u003c/p\u003e \u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e79.2\u003c/p\u003e \u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eUrine cup\u003c/p\u003e \u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e33\u003c/p\u003e \u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e20.8\u003c/p\u003e \u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cem\u003eI would use Colli-Pee® again to collect urine\u003c/em\u003e\u003c/p\u003e \u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e210\u003c/p\u003e \u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e100\u003c/p\u003e \u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eYes\u003c/p\u003e \u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e204\u003c/p\u003e \u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e97.1\u003c/p\u003e \u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eNo\u003c/p\u003e \u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e5\u003c/p\u003e \u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e2.4\u003c/p\u003e \u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eMissing value\u003c/p\u003e \u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e1\u003c/p\u003e \u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e0.5\u003c/p\u003e \u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cem\u003eColli-Pee® is easy to use\u003c/em\u003e\u003c/p\u003e \u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e210\u003c/p\u003e \u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e100\u003c/p\u003e \u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eYes\u003c/p\u003e \u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e203\u003c/p\u003e \u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e96.6\u003c/p\u003e \u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eNo\u003c/p\u003e \u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e6\u003c/p\u003e \u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e2.9\u003c/p\u003e \u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eMissing value\u003c/p\u003e \u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e1\u003c/p\u003e \u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e0.5\u003c/p\u003e \u003c/td\u003e\u003c/tr\u003e\u003c/tbody\u003e\u003c/table\u003e\u003c/div\u003e \u003cp\u003e\u003c/p\u003e \u003cp\u003e \u003c/p\u003e \u003cp\u003ePreferences of females regarding the sample collection method for their next CC screening are represented in Fig.\u0026nbsp;\u003cspan refid=\"Fig2\" class=\"InternalRef\"\u003e2\u003c/span\u003e. Overall. 66.6% (N = 140/210) of females would opt a FVU self-sample taken with Colli-Pee® compared to 32.9% (N = 69/210) of females who would prefer a PTS. These sample type preferences were not correlated with age, colposcopy center, self-reported HPV vaccination status, prior oncologic disease, or prior participation in the VALHUDES trial in which Colli-Pee® UCM FV-5020 was evaluated in a colposcopy referral population.\u003c/p\u003e \u003cp\u003e \u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec9\" class=\"Section2\"\u003e \u003ch2\u003e3.3. Usability results based on SUS-scores\u003c/h2\u003e \u003cp\u003eSUS scores are shown in Fig.\u0026nbsp;\u003cspan refid=\"Fig3\" class=\"InternalRef\"\u003e3\u003c/span\u003e. The color-based heatmap visualization scheme is a modified version of that recommended by Smaradottir \u003cem\u003eet al.\u003c/em\u003e [\u003cspan citationid=\"CR46\" class=\"CitationRef\"\u003e46\u003c/span\u003e]. wherein white represents a positive response. grey a neutral response. and black a negative response. A total of 208 completed SUS scoring questionnaires were received with an average SUS score of 86.17 ± 1.03 (out of 100), categorizing it as \"excellent\" [\u003cspan citationid=\"CR47\" class=\"CitationRef\"\u003e47\u003c/span\u003e].\u003c/p\u003e \u003cp\u003e \u003c/p\u003e \u003cdiv class=\"BlockQuote\"\u003e\u003c/div\u003e\u003cp\u003e\u003c/p\u003e \u003c/div\u003e"},{"header":"4. Discussion","content":"\u003cp\u003eWithin the CASUS study, our objective was to gather information about the usability perceptions and preferences of female participants who self-collected a FVU sample using Colli-Pee®. In our study design, we selected the Colli-Pee® UCM FV-5010 device, which is pre-filled with 3.4 mL of non-toxic and non-lytic UCM preservative. This choice was informed by our prior research, which examined the impact of different Colli-Pee® volume variants on HPV DNA detection in FVU [\u003cspan citationid=\"CR48\" class=\"CitationRef\"\u003e48\u003c/span\u003e]. The Colli-Pee® UCM FV-5010 design enables the immediate mixing of FVU and the UCM preservative during collection and allows a total sample collection of approximately 10mL. Our previous study evaluated the effectiveness of this UCM preservative in optimizing HPV DNA detection in FVU, demonstrating its ability to improve the collection. storage. and extraction processes [\u003cspan citationid=\"CR42\" class=\"CitationRef\"\u003e42\u003c/span\u003e].\u003c/p\u003e\u003cp\u003eA total of 332 females (26-64y) were enrolled and consented their participation in the CASUS study of which 210 females completed the questionnaire. Overall, 66.6% of females indicated to prefer to self-collect a FVU sample over a PTS (32.9%) for their next CC screening. Additionally. 79.2% of females indicated to prefer the use of Colli-Pee® over a urine cup (20.8%) whereby 96.6% of females experienced Colli-Pee® as easy to use and 97.1% would use the device again.\u003c/p\u003e\u003cp\u003eThe majority of female participants indicated that they had not previously taken part in the VALHUDES study [\u003cspan citationid=\"CR49\" class=\"CitationRef\"\u003e49\u003c/span\u003e], which utilized the larger Colli-Pee® UCM FV-5020 device variant prefilled with 7mL of UCM and designed to collect a total sample volume of approximately 20mL. This underscores that most participants did not have any prior bias due to their previous experience with Colli-Pee®.\u003c/p\u003e\u003cp\u003eMoreover, the majority of females reported using the instructions for use of the Colli-Pee® device and found them to be clear. However, some females cited reasons for finding the instructions unclear, such as: \"The instructions did not clearly outline the do's and don'ts for use.\", \"I either have not read or cannot recall reading the instructions\", and \"I did not consider using the instructions.\".\u003c/p\u003e\u003cp\u003eMost females indicated that it did not take long to collect a FVU sample using Colli-Pee®, that the instructions for use were clear. that they were confident that they took the sample correctly and that they would recommend the device to others. These findings align with previous results from the VALHUDES and Predictor’s 5.1 studies where participants used the Colli-Pee® UCM FV5020 device at the colposcopy clinic compared to different vaginal self-samples and a PTS [\u003cspan citationid=\"CR50\" class=\"CitationRef\"\u003e50\u003c/span\u003e, \u003cspan citationid=\"CR51\" class=\"CitationRef\"\u003e51\u003c/span\u003e]. In addition, the SUS-scoring system was used as a composite measure of the overall usability of the Colli-Pee® device and user satisfaction and consisted of 10 open-ended polarity-balanced questions. An average SUS score 86.17 ± 1.03 was calculated, categorized as “excellent”.\u003c/p\u003e\u003cp\u003eA total of 66.6% of participants indicated they would prefer a FVU self-sample compared to a PTS (32.9%) for their next CC screening and 0.5% of females not disclosing a preferential sampling method. Similar results were previously obtained in referral populations in the EVAH [\u003cspan citationid=\"CR52\" class=\"CitationRef\"\u003e52\u003c/span\u003e], VALHUDES [\u003cspan citationid=\"CR50\" class=\"CitationRef\"\u003e50\u003c/span\u003e] and BM-SOP [\u003cspan citationid=\"CR53\" class=\"CitationRef\"\u003e53\u003c/span\u003e] studies featuring Colli-Pee® device variants. Nevertheless, some females showed hesitancy for a FVU sample and a preference for a PTS. Most of these females indicated that they find a PTS more reliable and a more thorough method than a FVU self-sample for CC screening, which can be combined on an annual basis during a gynecological examination. Nonetheless. a noteworthy percentage of female participants expressed that they found the usage of the Colli-Pee® to be clear (57.6%) and felt confident that they had correctly collected the FVU sample (68.1%). These results align with prior research that has investigated the Colli-Pee® device [\u003cspan citationid=\"CR50\" class=\"CitationRef\"\u003e50\u003c/span\u003e, \u003cspan citationid=\"CR52\" class=\"CitationRef\"\u003e52\u003c/span\u003e, \u003cspan citationid=\"CR54\" class=\"CitationRef\"\u003e54\u003c/span\u003e], emphasizing the non-invasive and user-friendly attributes of FVU as a liquid biopsy for CC screening. Furthermore. this suggests the potential for FVU to reduce hesitation among non-attendees.\u003c/p\u003e\u003cp\u003eParticipants from the BM-SOP study in 2018 [\u003cspan citationid=\"CR53\" class=\"CitationRef\"\u003e53\u003c/span\u003e] indicated to prefer FVU collection at home over collection at the clinic or the general practitioner’s office. Additionally. recent screening study in a general Japanese study population showed an improvement of CC screening participation in under-screened females when mailing HPV self‑sampling kits featuring Colli-Pee® and a vaginal self-sample [\u003cspan citationid=\"CR55\" class=\"CitationRef\"\u003e55\u003c/span\u003e].\u003c/p\u003e\u003cp\u003eConcerning self-collection for HPV testing, recent insights were obtained from a cervical cancer screening study that focused on African-American females in the Mississippi Delta. The study evaluated the efficacy of a patient-centered approach, comparing self-collection for HPV testing at home with the existing standard of care in the U.S. public health system [\u003cspan citationid=\"CR56\" class=\"CitationRef\"\u003e56\u003c/span\u003e]. Aside from the increased participation rates that were perceived with a patient-centered approach for HPV self-collection at home, the study also showed a higher cost-effectiveness when offering HPV self-collection for CC screening in the USA [\u003cspan citationid=\"CR56\" class=\"CitationRef\"\u003e56\u003c/span\u003e]. Similar results were obtained in a randomized clinical trial in a health plan from Kaiser Permanente Washington, a US-based integrated health care system, where mailing HPV self-collection kits was cost-effective for increased screening uptake relative to usual care [\u003cspan citationid=\"CR57\" class=\"CitationRef\"\u003e57\u003c/span\u003e]. Similarly, a UK-based research team recently assessed the cost of CC screening using self-collected FVU with Colli-Pee® or vaginal swab compared with the current strategy of PTS within the context of England’s National Health Service Cervical Screening Program [\u003cspan citationid=\"CR58\" class=\"CitationRef\"\u003e58\u003c/span\u003e]. They found that HPV self-sampling could provide a less costly alternative to a PTS for routine HPV primary screening. More specifically, the average cost per complete screen was lowest for FVU self-sampling with Colli-Pee®, followed by vaginal self-sampling and highest for a PTS. The increase in recent and ongoing research endeavors around FVU self-collection for HPV testing and CC screening [\u003cspan citationid=\"CR49\" class=\"CitationRef\"\u003e49\u003c/span\u003e, \u003cspan additionalcitationids=\"CR60\" citationid=\"CR59\" class=\"CitationRef\"\u003e59\u003c/span\u003e–\u003cspan citationid=\"CR61\" class=\"CitationRef\"\u003e61\u003c/span\u003e] highlights its promise as an alternative and non-invasive sampling method to extend the scope of CC screening to women who are not adequately screened.\u003c/p\u003e\u003cp\u003eSome limitations of our study should be addressed. First, the choice of a colposcopy setting provided sufficient statistical power to ask sensitivity questions and had minimal risk of partial verification bias inherent in screening settings. Since the females enrolled are not representative of a typical screening population, the questionnaire results should be interpreted with caution. We must also be aware that responses can be influenced to some degree towards plausible expectations and that communicated intentions do not necessarily correspond to future behavior. Additional population-based studies are recommended to assess whether home-based FVU self-collection is effectively preferable to vaginal self-collection and PTS. However, there are ongoing initiatives in France [\u003cspan citationid=\"CR61\" class=\"CitationRef\"\u003e61\u003c/span\u003e] and Belgium (NCT05996783) aimed at investigating FVU self-collection using the Colli-Pee® device within a population-based framework.\u003c/p\u003e"},{"header":"5. Conclusion","content":"\u003cp\u003e \u003cdiv class=\"BlockQuote\"\u003e \u003cp\u003eIn conclusion, the CASUS study successfully enrolled 332 females, with 210 participants providing valuable insights into their experiences with FVU self-sampling using the Colli-Pee\u0026reg; device. Our findings indicate a high level of user satisfaction. Moreover, the positive response to usability, as indicated by an average SUS score of 86.17, further supports the device's user-friendly nature and underscores the overall success and acceptability of Colli-Pee\u0026reg; in the context of FVU self-sampling for CC screening. These encouraging results not only highlight the feasibility and acceptance of Colli-Pee\u0026reg; but also emphasize its potential as a preferred method for future CC screening. The study participants' favorable opinions, coupled with their willingness to use Colli-Pee\u0026reg; again, position this device as a promising tool for future home-based FVU self-sampling as a liquid biopsy in CC screening where under screened populations could be approached more easily.\u003c/p\u003e \u003c/div\u003e \u003c/p\u003e"},{"header":"Declarations","content":"\u003cp\u003e\u003cstrong\u003eAuthorship contributions\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eConceptualization. S.V.K., G.D., S.W., J.D., V.V., K.B.; Methodology. J.OH., S.V.K., G.D., S.W., J.D., L.T., V.V., K.B., N.M., A.R.C.; Formal analysis. J.OH.; Resources. J.O.H, S.V.K., G.D., S.W., J.D., L.T., V.V., K.B., N.M., A.R.C.; Data curation. J.OH.; Writing\u0026mdash;original draft preparation. J.O.H.; Writing\u0026mdash;review and editing. JO.H, S.V.K., G.D., S.W., J.D., V.V.; Visualization. J.O.H; Supervision. S.V.K., V.V., K.B.; Project administration. J.O.H., S.V.K., V.V., K.B.; Funding acquisition. S.V.K., V.V., K.B. All authors have read and agreed to the published version of the manuscript.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eFunding\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThis research was funded by H2020 Eurostars (grant number 12396). The funder did not play a role in this research. S. Van Keer is supported by a postdoctoral fellowship of the Research Foundation-Flanders (1240220N).\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eAcknowledgements\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eFirst. we would like to thank all females participating and completing the questionnaires in the CASUS study. We would also like to thank the study nurses and study teams at UZ Ghent. CHU de Li\u0026egrave;ge. and the General Regional Hospital Heilig Hart Tienen for their collaboration and support in recruiting participants and documenting study data. We are grateful for the excellent scientific. administrative and logistical assistance of Nancy Kemland (Novosanis). Frank van Batenburg (Novosanis) and Annemie De Smet (VAXINFECTIO) .\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eDisclosures\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eJ. O. Hendrickx, A. Rios-Cortes, N. Meers are employees of Novosanis. V.V.J. Vankerckhoven is co-founder and was board member and CEO of Novosanis until October 2022. K.C.L. Beyers is co-founder and was board member until December 2022 and CTO of Novosanis until July 2023. \u0026nbsp;Novosanis was founded as a spin-off company of the University of Antwerp, Belgium and is a subsidiary of OraSure Technologies Inc. since Jan 2019. The University of Antwerp received payment for participation of S. Van Keer in an Advisory Board of Novosanis (Subsidiary of OraSure Technologies Inc. Wijnegem, Belgium). \u003c/p\u003e"},{"header":"References","content":"\u003col\u003e\u003cli\u003e\u003cspan\u003eTorre LA, et al. Global Cancer in Women: Burden and TrendsGlobal Cancer in Women: Burden and Trends. 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Int J Environ Res Public Health. 2021;18(19):10388.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eNishimura Y, et al. Mailing human papillomavirus self-sampling kits to women under-screened for cervical cancer improved detection in cervical cancer screening in a general population study in Japan. BMC Public Health. 2023;23(1):473.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eCampos NG, et al. Cost-effectiveness of offering cervical cancer screening with HPV self-sampling among African-American women in the Mississippi Delta. Cancer Epidemiol Biomarkers Prev. 2021;30(6):1114\u0026ndash;21.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eMeenan RT, et al. Economic Evaluation of Mailed Home-Based Human Papillomavirus Self-sampling Kits for Cervical Cancer Screening. JAMA Netw Open. 2023;6(3):e234052\u0026ndash;234052.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eHuntington S, et al. Two self-sampling strategies for HPV primary cervical cancer screening compared with clinician-collected sampling: an economic evaluation. BMJ open. 2023;13(6):e068940.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eCocuzza C. \u003cem\u003eExtended validation of human papillomavirus assays and collection devices for HPV testing on self-samples and first-void urine samples. 2021\u003c/em\u003e.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eISRCTN. \u003cem\u003eISRCTN13132810: urine human papillomavirus (HPV)testing for cervical pre-cancer screening\u003c/em\u003e.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eLefeuvre C et al. \u003cem\u003eStudy protocol: randomised controlled trial assessing the efficacy of strategies involving self-sampling in cervical cancer screening.\u003c/em\u003e International Journal of Public Health, 2022. 67: p. 1604284. \u003c/li\u003e\u003c/ol\u003e"}],"fulltextSource":"","fullText":"","funders":[],"hasAdminPriorityOnWorkflow":false,"hasManuscriptDocX":true,"hasOptedInToPreprint":true,"hasPassedJournalQc":"","hasAnyPriority":false,"hideJournal":false,"highlight":"","institution":"","isAcceptedByJournal":true,"isAuthorSuppliedPdf":false,"isDeskRejected":"","isHiddenFromSearch":false,"isInQc":false,"isInWorkflow":false,"isPdf":false,"isPdfUpToDate":true,"isWithdrawnOrRetracted":false,"journal":{"display":true,"email":"[email protected]","identity":"archives-of-public-health","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":false,"externalIdentity":"aoph","sideBox":"Learn more about [Archives of Public Health](http://archpublichealth.biomedcentral.com/)","snPcode":"13690","submissionUrl":"https://submission.nature.com/new-submission/13690/3","title":"Archives of Public Health","twitterHandle":"@Archpubhealth","acdcEnabled":true,"dfaEnabled":true,"editorialSystem":"em","reportingPortfolio":"BMC/SO AJ","inReviewEnabled":true,"inReviewRevisionsEnabled":true},"keywords":"HPV, first-void urine, self-sampling, attitudes, preferences, cervical cancer screening, CASUS","lastPublishedDoi":"10.21203/rs.3.rs-4430311/v1","lastPublishedDoiUrl":"https://doi.org/10.21203/rs.3.rs-4430311/v1","license":{"name":"CC BY 4.0","url":"https://creativecommons.org/licenses/by/4.0/"},"manuscriptAbstract":"\u003ch2\u003eBackground\u003c/h2\u003e \u003cp\u003eCervical cancer (CC) is the fourth most common cancer globally in females, caused by oncogenic infections with high-risk human papillomavirus (hrHPV) strains. Successful CC screening programs strongly depend on the participation rate of the target populationNevertheless, it remains challenging to reach under screened populations, including those with an increased CC risk. The CASUS study aimed to develop a complete CC screening solution based on first-void urine (FVU) self-sampling. Here we report on the usability perceptions and preferences from females that participated in the CASUS study by collecting FVU, also referred to as first-catch urine, as a liquid biopsy.\u003c/p\u003e\u003ch2\u003eMethods\u003c/h2\u003e \u003cp\u003eFemales self-collected FVU samples at home the day before colposcopy using the Colli-Pee\u0026reg; UCM FV-5010, a FVU collection device prefilled with 3 mL of UCM preservative, collecting a total volume of 10mL. Afterwards, they completed a questionnaire expressing their usability perceptions and preferences regarding the device.\u003c/p\u003e\u003ch2\u003eResults\u003c/h2\u003e \u003cp\u003eA total of 332 females (26-70y) were enrolled in the CASUS study of which 210 completed the questionnaire. Overall, 66.6% of females preferred FVU self-sampling over a physician taken cervical sample (PTS) (32.9%) for their next CC screening. Out of 159 women who reported prior experience with a urine cup, 79.2% () expressed a preference for using the Colli-Pee\u0026reg; UCM FV-5010, while 20.8% favored the traditional urine cup. Additionally, 96.6% () of females found Colli-Pee\u0026reg; UCM FV-5010 easy to use and 97.1% would use the device again. A total of 208 valid System Usability Score (SUS) scores were received with an average of 86.17\u0026thinsp;\u0026plusmn;\u0026thinsp;1.03 Standard Error of Mean (SEM).\u003c/p\u003e\u003ch2\u003eConclusion\u003c/h2\u003e \u003cp\u003eThe results of this study show that the majority of females in this referral cohort would prefer to self-collect a FVU sample at-home over a PTS for their next CC screening. Moreover, Colli-Pee\u0026reg; UCM FV-5010 was considered an easy-to-use and well-accepted self-sampling device for CC screening in a Belgian colposcopy referral population. From a future perspective, these results highlight the possibility of home-based FVU self-sampling as a liquid biopsy in CC screening where under screened populations could be approached more easily.\u003c/p\u003e\u003ch2\u003eTrial registration:\u003c/h2\u003e \u003cp\u003eThe CASUS study was registered in ClinicalTrials.gov (identifier: NCT04530201).\u003c/p\u003e","manuscriptTitle":"Home-based urinary HPV self-sampling for the detection of cervical cancer precursor lesions: attitudes and preferences from Belgian females participating in the CASUS study","msid":"","msnumber":"","nonDraftVersions":[{"code":1,"date":"2024-06-05 15:15:26","doi":"10.21203/rs.3.rs-4430311/v1","editorialEvents":[{"type":"communityComments","content":0},{"type":"decision","content":"Revision requested","date":"2024-09-08T11:43:39+00:00","index":"","fulltext":""},{"type":"editorInvitedReview","content":"","date":"2024-07-16T16:02:24+00:00","index":"hide","fulltext":""},{"type":"editorInvitedReview","content":"","date":"2024-07-16T15:14:13+00:00","index":"hide","fulltext":""},{"type":"editorInvitedReview","content":"","date":"2024-07-15T07:25:10+00:00","index":"hide","fulltext":""},{"type":"reviewerAgreed","content":"189418534314686745264398960981967315549","date":"2024-07-03T05:58:53+00:00","index":"hide","fulltext":""},{"type":"reviewerAgreed","content":"32990198069543615141463574406302355255","date":"2024-07-02T08:21:48+00:00","index":"hide","fulltext":""},{"type":"reviewerAgreed","content":"182859092429064499793020812023667322958","date":"2024-07-02T08:09:06+00:00","index":"hide","fulltext":""},{"type":"reviewersInvited","content":"","date":"2024-06-09T15:47:44+00:00","index":"","fulltext":""},{"type":"editorAssigned","content":"","date":"2024-05-24T05:10:52+00:00","index":"","fulltext":""},{"type":"checksComplete","content":"","date":"2024-05-24T05:10:51+00:00","index":"","fulltext":""},{"type":"submitted","content":"Archives of Public Health","date":"2024-05-16T10:14:04+00:00","index":"","fulltext":""}],"status":"published","journal":{"display":true,"email":"[email protected]","identity":"archives-of-public-health","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":false,"externalIdentity":"aoph","sideBox":"Learn more about [Archives of Public Health](http://archpublichealth.biomedcentral.com/)","snPcode":"13690","submissionUrl":"https://submission.nature.com/new-submission/13690/3","title":"Archives of Public Health","twitterHandle":"@Archpubhealth","acdcEnabled":true,"dfaEnabled":true,"editorialSystem":"em","reportingPortfolio":"BMC/SO AJ","inReviewEnabled":true,"inReviewRevisionsEnabled":true}}],"origin":"","ownerIdentity":"be5860c5-c8f8-49ee-9147-1e4d8257bde4","owner":[],"postedDate":"June 5th, 2024","published":true,"recentEditorialEvents":[],"rejectedJournal":[],"revision":"","amendment":"","status":"published-in-journal","subjectAreas":[],"tags":[],"updatedAt":"2025-02-17T16:03:25+00:00","versionOfRecord":{"articleIdentity":"rs-4430311","link":"https://doi.org/10.1186/s13690-024-01490-3","journal":{"identity":"archives-of-public-health","isVorOnly":false,"title":"Archives of Public Health"},"publishedOn":"2025-02-12 15:57:50","publishedOnDateReadable":"February 12th, 2025"},"versionCreatedAt":"2024-06-05 15:15:26","video":"","vorDoi":"10.1186/s13690-024-01490-3","vorDoiUrl":"https://doi.org/10.1186/s13690-024-01490-3","workflowStages":[]},"version":"v1","identity":"rs-4430311","journalConfig":"researchsquare"},"__N_SSP":true},"page":"/article/[identity]/[[...version]]","query":{"redirect":"/article/rs-4430311","identity":"rs-4430311","version":["v1"]},"buildId":"qtupq5eGEP_6zYnWcrvyt","isFallback":false,"isExperimentalCompile":false,"dynamicIds":[84888],"gssp":true,"scriptLoader":[]}