Integration of mHealth with Scalable Screening Tool for Cervical Cancer in LMICs
Cervical cancer affects the lives of 500,000 women worldwide each year, and results in more than 270,000 deaths. More than 75% of cervical cancer incidence is in Africa, and the highest incidence is in East Africa. Screening for cervical cancer in East Africa is performed using visual inspection with acetic acid (VIA). Women who are identified as VIA positive are treated with cryotherapy. There are significant issues with the implementation of VIA in low resource countries. Colposcopy, which is the technology used for VIA in the U.S. is not available for use in limited resource settings. Thus, VIA is performed with a light source and the naked eye. Even with appropriate training, however, there can be large variations in accuracy due to the highly subjective nature of the test and variation in health worker experience. Furthermore, in Tanzania, where the incidence of cervical cancer is highest, the health-worker-to-population ratio is one of the lowest globally (1:45,000), and this dearth of trained screeners is a significant bottleneck. The overall consequence is that only 6,000 of the eligible 4 million women in Tanzania are screened for cervical cancer annually. Our vision is to develop and implement a technological strategy that will improve task shifting (from operator to technology) and is grounded in stakeholders’ needs and experiences surrounding cervical cancer screening to improve scalability of cervical cancer screening in limited resource settings. We have developed a novel technology called a trans-vaginal digital colposcope (TVDC) that has the form factor of a tampon and is significantly less expensive (several hundreds of dollars), than a state-of-the-art digital colposcope (tens of thousands of dollars). We have evaluated the TVDC on more than 40 patients and demonstrated that it has equivalent image quality to a state- of-the-art digital colposcope. Highly sensitive testing for human papillomavirus (HPV) infection is on the horizon and has the potential to be used for primary screening technique, but lacks sufficient specificity for CIN-2 detection; thus a secondary test is recommended to confirm an HPV-positive result. State-of-the-art conventional colposcopy has higher specificity for CIN-2 detection and can be used as a confirmatory test for women with positive screening results. However, it represents a bottleneck in screening programs given the general lack of highly trained colposcopists and its relative high cost. The development of simple, affordable, and scalable diagnostic methods with a higher specificity for CIN-2 detection are urgently needed to triage women with HPV-positive or VIA-positive results to reduce overtreatment among women in resource-limited settings. Dr. Ramanujam and her team have developed an innovative technology: a transvaginal digital colposcope (TVDC) that has the form factor of a tampon, and the performance of a state-of-the-art digital colposcope. It is significantly less expensive than a conventional colposcope but has comparable image quality because it is placed inside the vagina like a trans-vaginal ultrasound probe at a much closer working distance than a traditional colposcope. Specifically, the goal of this project will be to develop and deliver the technology and to conduct clinical validation of the system.