Automated Digital Imaging for Cervical Cancer Screening

项目摘要/总结： 宫颈癌筛查计划仍然是减少妇女宫颈癌的关键， 人乳头瘤病毒（HPV）疫苗的可用性。筛查对所有女性都很重要 但对于感染艾滋病毒的女性来说尤其重要，因为HPV在这一人群中的患病率很高， 组和风险与进展尽管抗逆转录病毒治疗。这里我们 我建议研究一种新的宫颈自动数字成像方法的临床实用性 在MobileODT平台上作为一种筛选和治疗方法。我们建立在长期合作的基础上 在开普敦大学和哥伦比亚大学之间， 宫颈癌的筛查和治疗。目前，筛查和治疗项目 使用HPV DNA检测是世界卫生组织推荐的。我们有 证明了这种方法的安全性、有效性和成本效益， 艾滋病毒在妇女中的高流行率。在这种情况下，我们目前正在完成一项NCI- 支持的研究证明了HPV DNA检测的可行性和出色性能 可以在护理点使用，用于单次访问，筛选和治疗程序。在这里我们建议 为了扩展这项工作，以调查具体目标1：自动化的性能特征， 数字成像作为一种独立的初级筛查测试，以取代HPV DNA测试，用于 单次访视、筛选和治疗方法;具体目标2： 自动数字成像作为筛查中HPV DNA检测阳性的女性的分诊测试- 具体目标3：设施层面的运营挑战和促进者， 将这种新的成像技术整合到单次就诊的筛查和治疗计划中。我们提出 开展研究，在感染和未感染艾滋病毒的妇女中实现这些目标， 南非开普敦的临床研究中心。我们的总体目标是加强宫颈癌 筛选方法，以降低成本，提高筛选的有效性。

Project Abstract/Summary: Cervical cancer screening programs remain essential to reduce cervical cancer in women despite the availability of human papilloma virus (HPV) vaccines. Screening is important for all women but is particularly important for women living with HIV given the high prevalence of HPV in this group and risks associated with progression notwithstanding antiretroviral therapy. Here we propose to investigate the clinical utility of a new method of automated digital imaging of the cervix on the MobileODT platform as a screen-and-treat approach. We build on a long-term collaboration between the University of Cape Town and Columbia University investigating how to strengthen cervical cancer screening and treatment in South Africa. Currently, screen-and-treat programs utilizing HPV DNA testing are recommended by the World Health Organization. We have demonstrated the safety, efficacy and cost-effectiveness of this approach for the South African setting with its high HIV prevalence in women. In this setting, we are currently completing an NCI- supported study demonstrating the feasibility and outstanding performance of an HPV DNA assay that can be used at the point-of-care for a single-visit, screen-and-treat program. Here we propose to extend this work to investigate in Specific Aim 1: the performance characteristics of automated digital imaging as a standalone, primary screening test to replace HPV DNA testing for use in the single-visit, screen-and-treat approach; Specific Aim 2: the performance characteristics of automated digital imaging as a triage test for women who test HPV DNA positive in the screen- and-treat approach; and Specific Aim 3: facility-level operational challenges and facilitators to integrating this new imaging technology into single-visit screen-and-treat programs. We propose to undertake the studies to address these aims among women living with and without HIV at clinical sites in Cape Town, South Africa. Our overall goal is to strengthen cervical cancer screening approaches to reduce cost and improve the effectiveness of screening.