Development and validation of patient-ready Callascope for cervical imaging

Cytology-based screening, diagnostic colposcopy and excisional treatment are proven solutions for cervical cancer prevention in high-income countries (HICs). Affordable tools for screening, diagnosis, and treatment in low- and middle-income countries (LMICs) are either lacking or the few health facilities with access to them are frequently out of reach; resulting in low screening and follow up rates. Vaccination does not benefit the millions of women who already have the Human Papilloma Virus (HPV) or who will contract it before vaccination is widely available. As a result, women present with advanced disease untreatable by currently available modalities, leading to over 300,000 deaths each year. The number of expected deaths will continue to increase and is expected to double by 2050. These facts are sobering - another generation of women will die at the prime of their lives, devastating their families and their children’s health. We have developed a robust health care model to resolve the incongruity between highly effective biomedical engineering solutions and their uptake into care delivery systems for global cervical cancer prevention. There are three facets to our model: (1) Technology: a suite of point of care solutions to provide screening, diagnosis and treatment alternatives to those used in high- resource settings, (2) Community-based health care: community-based clinics in which screening, diagnosis and treatment are provided community health workers and midwives, and (3) Communication: a virtual hub to link community health workers, midwives and physicians to ensure seamless continuum of care. The key attribute of our model is that it shifts care from hospitals and physicians to community health workers and midwives dramatically increasing access to care. We have observed that access continues to be a problem, one that is observed globally by implementers and program planners. This is related to both population and health infrastructure barriers. The inability of certain segments of the population to visit a clinic includes but is not limited to the lack of resources, geographic barriers that make it challenging to reach a clinic, and the trepidation of receiving the exam in an unfamiliar environment. Barriers related to health resources include lack of sufficient health providers, limited medical supplies, and the unavailability of administrative support, and medical record keeping. There is a critical need for solutions to address uneven access to care even when health care delivery is decentralized from hospitals to communities, therefore, we propose an innovative technology called the Callascope to transform provider-controlled speculum-based imaging in a clinic to a patient-controlled self- imaging procedure at home that affords privacy and autonomy of an otherwise intrusive exam. Our long-term goal is to develop a fully functional Callascope that meets the requirements for triage of screen-positive populations (women who are HPV positive). Given the low prevalence of disease, this will reduce unnecessary clinic visits by 20-fold (50 out of every 1000 women) thereby allowing for efficient use of limited resources for high-risk populations and alleviating the burden of follow up care to those who are at low-risk.