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 population. Nevertheless, it remains challenging to reach under screened populations. 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 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 http://www. CLINICALTRIALS: gov (identifier: NCT04530201).