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.