RESUMO
Background: Barriers that prevent adherence to cervical cancer screening programs in low-income communities include, among others, fear of and discomfort associated with the speculum during pelvic exams and difficulties in accessing health facilities. To address these barriers, a low-cost medical device, the Callascope was developed for self-imaging of the cervix. The device has a 2 MP camera connected to a smartphone and a disposable inserter with an asymmetrical tip to replace the speculum. A pilot study was performed to 1) evaluate the feasibility, acceptability, and comfort of women imaging their own cervix with the Callascope, 2) collect information to improve the design of the Callascope prototype, and 3) identify factors related with the ease of use, discomfort of the self-exam technique and quality of images. Methods: The pilot study included women (n=15) who were either current or former community-health volunteers from Ventanilla, Peru with the HOPE program. Participants completed a pre-exam survey to assess demographics and establish reproductive medical history. Each participant was provided with a self-exam kit. They were asked to perform a self-exam and take pictures of their cervix with the Callascope at home at their convenience. They submitted an audio reflection immediately post-examination via WhatsApp. A post-insertion survey to assess user experience and a focus group discussion were performed 72 hours post-insertion. Conclusions: The Callascope self-imaging of the cervix was reported to be more acceptable and comfortable than the traditional speculum-based gynecologic exam. All participants indicated that they would use the device again and recommend to a friend. Recommendations to improve the prototype design were identified: lengthen handle, overlay asymmetrical tip with softer silicon, and optimize manual focus mechanism. The Body Mass Index (BMI) was found to be a factor associated to the ease of device use and comfort.
RESUMO
Fear of the speculum and feelings of vulnerability during the gynecologic exams are two of the biggest barriers to cervical cancer screening for women. To address these barriers, we have developed a novel, low-cost tool called the Callascope to reimagine the gynecological exam, enabling clinician and self-imaging of the cervix without the need for a speculum. The Callascope contains a 2 megapixel camera and contrast agent spray mechanism housed within a form factor designed to eliminate the need for a speculum during contrast agent administration and image capture. Preliminary bench testing for comparison of the Callascope camera to a $20,000 high-end colposcope demonstrated that the Callascope camera meets visual requirements for cervical imaging. Bench testing of the spray mechanism demonstrates that the contrast agent delivery enables satisfactory administration and cervix coverage. Clinical studies performed at Duke University Medical Center, Durham, USA and in Greater Accra Regional Hospital, Accra, Ghana assessed (1) the Callascope's ability to visualize the cervix compared to the standard-of-care speculum exam, (2) the feasibility and willingness of women to use the Callascope for self-exams, and (3) the feasibility and willingness of clinicians and their patients to use the Callascope for clinician-based examinations. Cervix visualization was comparable between the Callascope and speculum (83% or 44/53 women vs. 100%) when performed by a clinician. Visualization was achieved in 95% (21/22) of women who used the Callascope for self-imaging. Post-exam surveys indicated that participants preferred the Callascope to a speculum-based exam. Our results indicate the Callascope is a viable option for clinician-based and self-exam speculum-free cervical imaging.Clinical study registration ClinicalTrials.gov https://clinicaltrials.gov/ct2/show/record/ NCT00900575, Pan African Clinical Trial Registry (PACTR) https://www.pactr.org/ PACTR201905806116817.
