The broad goal of this project is to adapt a portable, low-cost, easy-to-use Pocket-sized Colposcope (developed under other funding) for use in a community setting, and develop automated algorithms that combine neovascularization, glycogen depletion and acetowhitening to provide comparable diagnosis to an expert. This work will be done in a collaboration between 3rd Stone Design, Inc, Duke University and Kenya Medical Research Institute. The specific aims of this proposal are: Aim 1 (Phase I): Improve Pocket colposcope by designing continuous magnification mechanism and improving device workflow integration to eliminate between-use disinfection through the use of a disposable optically clear sterile sleeve. Provider feedback on our previously developed Pocket colposcope has unanimously suggested the addition of a slider mechanism to control coarse zoom and a sleeve consumable to the Pocket colposcope design. Aim 2 (Phase I): Automated algorithms and software for cervical pre-cancer detection We will improve the specificity of VIA using a novel software application with embedded machine learning diagnostic algorithms for automated cervical cancer screening. We will apply and validate the individual algorithms for VIA and GIVI (green illumination vascular imaging) to existing images obtained from a 200-patient clinical study with the Pocket colposcope. We will then compare the performance of the algorithms to expert physician interpretation of the same images, with pathology serving as the gold standard. Aim 3 (Phase II): Document user experience with Pocket colposcope in Kenya. We will develop a culturally relevant training package directly in the community healthcare setting. We will collect quantitative and qualitative data including surveys, in-depth interviews, and clinic observations from both naive providers and patients and use these findings to and use these findings to improve the introduction of the Pocket colposcope in Kenya and simultaneously, inform the clinical investigations in Aim 4. Aim 4 (Phase II): Compare the performance of the Pocket colposcope to Visual Inspection with Acetic Acid for triage of HPV+ women in Kenya. We will carry out a cluster-randomized trial among 400 HPV+ women to compare the standard triage with that using the Pocket colposcope in Kisumu, Kenya. All HPV+ women will undergo biopsy to determine sensitivity, specificity and positive and negative predictive values of the different triage strategies. Data will be used to model the performance of the algorithm against that of expert colposcopists. Aim 5 (Phase II): Assess the costs, incremental cost-effectiveness and population health impact of HPV-based cervical cancer screening programs with proposed triage strategies. We will determine the incremental cost-effectiveness ratio and the absolute and relative costs for four triage strategies by measuring the costs and model population health outcomes (cancer cases, deaths and disability adjusted life years).

NARRATIVE The SBIR activities proposed by 3rd Stone Design and Duke University will advance the state of the art in cervical cancer imaging through the R&D of novel optics for a portable colposcope combined with automated algorithms for diagnosis. The project will confirm the benefits of these innovations through a clinical trial in Kenya conducted by the Kenya Medical Research Institutes. The innovations developed have tremendous potential to effect public health by increasing diagnostic acuity and decreasing costs of healthcare delivery which ultimately will reduce the impact of the deadly disease.