Development And Utilization Of A Novel Cervical Visualization Tool, The Callascope, For Home-Based Self-Exams

Objectives: Invasive cervical cancer is preventable yet it affects 500,000 women annually. Barriers to screening include lack of awareness of cervical cancer, fear of the speculum, and lack of affordable screening technologies. We developed a low-cost, cervical imaging device, the Callascope, as an alternative to the traditional speculum and colposcope to enable self-cervical visualization. In this study, we sought to access women's perceptions and ability to independently use the Callascope for self-cervix imaging at home. This is an important step in our development of the Callascope as a home-based tool for cervical cancer screening. Methods: This Duke IRB approved self-exam study under written informed consent involved training healthy volunteers to use the Callascope and usage of the device over a one-week period to assess ease-of-use and feasibility of imaging the cervix at home without physician guidance. This involved (1) on-site training at the Duke Clinic with initial self-imaging of the cervix, and (2) repeated self-imaging at home. (1) On-site training and initial cervix imaging. Healthy volunteers (n=12), were given a user kit containing a Callascope, an android phone and phone charger, Sani wipes, vaginal wipes, lubricating jelly, printed user guide, and audio reflection guide. After watching the tutorial, participants proceeded to capture an image of their cervix with the Callascope in a private room. After the self-exam, participants were asked to indicate ease of use and their level of discomfort on a Likert scale. (2) Home self-exam. After completing their on-site training and initial self-imaging session, the participants were sent home with the Calla user kit for a week to capture images of their cervix, and complete surveys and an audio reflection. Results: 10 out of 12 (83%) of participants were able to visualize their cervix with the Callascope on the first try during on-site training, and 100% at home following the on-site exam. Results from the pre-insertion survey found that 50% of participants found to speculum to be a barrier to cervical cancer screening. Based on appearance only, more women were ‘very/extremely willing’ to use the Callascope over the speculum for a self-exam (100% vs 25%). Most of the participants found the instructions easy to use and half of the participants found it extremely easy to slightly easy to find their cervix and this improved with repeat insertions at home (fig 1.). They also mentioned feeling empowered and having improved cervix awareness by being able to visualize their reproductive anatomy themselves, which they did not have previously. Key words associated with use of the Callascope include ‘comfortable’, ‘tampon-like’, ‘easy to use’, ‘empowering’, and ‘fascinating’. Conclusions: We have developed a device, the Callascope for comfortable, low-cost and portable visualization of the cervix. The Callascope has the potential to reduce loss to follow-up rates, encourage cervical cancer screening and reduce mortality from the disease. Since it enables cervix visualization, it can also potentially be used by women in the comfort of their homes to view the cervix and vaginal walls for infections, IUD strings, labor dilations and reproductive anatomy education. Future studies will investigate contrast agent administration. The Callascope has the potential to increase cervical cancer screening rates through reducing barriers including cost, discomfort, lack of awareness and stigma, particularly in among underrepresented minorities and rural populations. Invasive cervical cancer is preventable yet it affects 500,000 women annually. Barriers to screening include lack of awareness of cervical cancer, fear of the speculum, and lack of affordable screening technologies. We developed a low-cost, cervical imaging device, the Callascope, as an alternative to the traditional speculum and colposcope to enable self-cervical visualization. In this study, we sought to access women's perceptions and ability to independently use the Callascope for self-cervix imaging at home. This is an important step in our development of the Callascope as a home-based tool for cervical cancer screening. This Duke IRB approved self-exam study under written informed consent involved training healthy volunteers to use the Callascope and usage of the device over a one-week period to assess ease-of-use and feasibility of imaging the cervix at home without physician guidance. This involved (1) on-site training at the Duke Clinic with initial self-imaging of the cervix, and (2) repeated self-imaging at home. (1) On-site training and initial cervix imaging. Healthy volunteers (n=12), were given a user kit containing a Callascope, an android phone and phone charger, Sani wipes, vaginal wipes, lubricating jelly, printed user guide, and audio reflection guide. After watching the tutorial, participants proceeded to capture an image of their cervix with the Callascope in a private room. After the self-exam, participants were asked to indicate ease of use and their level of discomfort on a Likert scale. (2) Home self-exam. After completing their on-site training and initial self-imaging session, the participants were sent home with the Calla user kit for a week to capture images of their cervix, and complete surveys and an audio reflection. 10 out of 12 (83%) of participants were able to visualize their cervix with the Callascope on the first try during on-site training, and 100% at home following the on-site exam. Results from the pre-insertion survey found that 50% of participants found to speculum to be a barrier to cervical cancer screening. Based on appearance only, more women were ‘very/extremely willing’ to use the Callascope over the speculum for a self-exam (100% vs 25%). Most of the participants found the instructions easy to use and half of the participants found it extremely easy to slightly easy to find their cervix and this improved with repeat insertions at home (fig 1.). They also mentioned feeling empowered and having improved cervix awareness by being able to visualize their reproductive anatomy themselves, which they did not have previously. Key words associated with use of the Callascope include ‘comfortable’, ‘tampon-like’, ‘easy to use’, ‘empowering’, and ‘fascinating’. We have developed a device, the Callascope for comfortable, low-cost and portable visualization of the cervix. The Callascope has the potential to reduce loss to follow-up rates, encourage cervical cancer screening and reduce mortality from the disease. Since it enables cervix visualization, it can also potentially be used by women in the comfort of their homes to view the cervix and vaginal walls for infections, IUD strings, labor dilations and reproductive anatomy education. Future studies will investigate contrast agent administration. The Callascope has the potential to increase cervical cancer screening rates through reducing barriers including cost, discomfort, lack of awareness and stigma, particularly in among underrepresented minorities and rural populations.