Novel see and treat strategies for cervical cancer prevention in low-resource settings

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Cervical cancer is the second leading cause of death for women worldwide; 85% of deaths occur in low and middle- income countries (LMICs), despite the fact that well-established interventions exist for pre-invasive disease. In the U.S., screening for cervical cancer is performed with the Papanicolaou (Pap) smear. Colposcopy, which visualizes the acetic acid stained cervix with a low power microscope, followed by biopsy of cervical abnormalities, serves as a confirmatory test for women with positive screening results. Women with pre-cancer are treated via excision of a portion of the cervix using Loop Electrosurgical Excision Procedure (LEEP). Women with cancer are referred to a combination of local and/or systemic therapy depending on the stage of invasive disease. This model is not practical to implement in medically-underserved regions due to lack of resources to procure, implement, and maintain the technologies in the care cascade. Thus, alternative protocols that employ low-cost, simple-to-use technologies are needed to mitigate cervical cancer. Our vision is to develop high quality, low-cost interventions that will be effective in low-resource health facilities to address shortcomings of current technological solutions to cervical cancer prevention. This vision requires 3 distinct innovations: 1) an ultra-portable visualization device coupled with routinely used contrast agents to reduce discomfort, enable visualization of microscopic disease, and provide quality control through image review and archiving (Aim 1); 2) enhanced contrast and smart algorithms to reduce unnecessary referrals or treatment of screen positive women (in the absence of confirmatory biopsy) (Aim 2); and 3) a low-cost therapeutic that is as effective as current ablative approaches but more readily accessible to treat pre-invasive disease (Aim 3). These innovations build upon: 1) a novel Pocket colposcope developed under previous funding that enables portable colposcopy of the cervix; and 2) preliminary results that support these new innovations.