Automated Visual Evaluation for Cervical Cancer Screening in HIV-positive Women

HIV 阳性女性宫颈癌筛查的自动视觉评估

• 批准号: 10401380
• 负责人: Lynette Denny
• 金额: $ 33.59万
• 依托单位: UNIVERSITY OF CAPE TOWN
• 依托单位国家: 美国
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-06-01 至 2025-05-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10401380
• 关键词: Address; Biological Assay; Biopsy; Car Phone; Cervical; Cervical Cancer Screening; Cervical Intraepithelial Neoplasia; Cervix Uteri; Characteristics; Clinical; Clinical Research; Collaborations; Colposcopy; Country; Cytology; Decision Making; Development; Diagnosis; Diagnostic; Disadvantaged; Discipline of obstetrics; Electrocoagulation; Generations; Gold; Guidelines; Gynecology; HIV; HIV Seronegativity; HIV Seropositivity; HPV-High Risk; Health Services; High Risk Woman; Histologic; Human Papilloma Virus Vaccine; Human Papillomavirus; Human papilloma virus infection; Income; Infrastructure; Institution; Lead; Lesion; Malignant neoplasm of cervix uteri; Methods; Minor; Modeling; Modification; Morbidity - disease rate; Pap smear; Performance; Primary Prevention; Procedures; Province; Recurrence; Resource-limited setting; Resources; Sampling; Secondary Prevention; Services; South Africa; System; Technology; Testing; Training; Treatment Failure; Triage; Universities; Vagina; Viral Load result; Visual; Woman; Women' s Group; Work; World Health Organization; ablative procedure; antiretroviral therapy; automated visual evaluation; base; cancer therapy; digital; digital imaging; high risk population; histological specimens; mortality; new technology; overtreatment; point of care; premalignant; recruit; screening; screening guidelines; screening program; screening services; success; viral DNA

Project Abstract/Summary: HIV-positive (HIV+) women are at high risk of developing cervical cancer even when treated with antiretroviral therapy. Current World Health Organization guidelines recommend screen-and-treat with human papilloma virus (HPV) DNA testing as the optimal approach for cervical cancer screening in low resource settings. However, HIV+ women have exceptionally high rates of HPV infection which lead, in the screen-and-treat approach, to substantial overtreatment. What is needed is a simple method to triage HPV+HIV+ women. We propose to build on more than two decades of collaboration between the University of Cape Town and Columbia University investigating how to strengthen cervical cancer screening in South Africa. We have recently demonstrated that a point-of-care HPV DNA assay can be adapted for screen-and-treat for HIV-positive women. We propose to extend this work to investigate whether new technologies of automated visual evaluation of digital images of the cervix have clinical utility in conjunction with HPV testing. We propose to utilize our established clinical research platform in Cape Town to recruit HIV-positive and HIV-negative women to address the following two specific aims. Specific Aim 1 will investigate the clinical utility of automated visual evaluation of digital images taken using the MobileODT platform as a triage assessment method for HPV+HIV+ women compared to other alternatives, including adaptation of HPV DNA tests, cytology and expert colposcopy. Specific Aim 2 will investigate the clinical utility of automated visual evaluation as an assessment method to detect treatment failure among women who have undergone ablative treatment procedures as part of prior rounds of screening. Over the course of undertaking this clinical study, Specific Aim 3 will support capacity development and training to implement and evaluate effective cervical cancer screening technologies into low resource settings within the Eastern Cape and Limpopo Provinces in South Africa. This will be done through existing capacity development initiatives in the Department of Obstetrics and Gynaecology at the University of Cape Town.

项目摘要/摘要： 艾滋病毒阳性(HIV+)妇女即使接受抗逆转录病毒治疗也有患宫颈癌的高风险 心理治疗。世界卫生组织最新指南建议对人乳头瘤病毒进行筛查和治疗 (HPV)DNA检测是在资源匮乏的情况下进行宫颈癌筛查的最佳方法。然而， HIV+妇女的HPV感染率非常高，这导致在筛查和治疗方法中， 严重的过度治疗。现在需要的是一种简单的方法来对HPV+HIV+女性进行分类。我们计划建造一座 关于开普敦大学和哥伦比亚大学二十多年的合作 研究如何在南非加强宫颈癌筛查。我们最近证明了 点式HPV DNA检测可用于HIV阳性妇女的筛查和治疗。我们建议 将这项工作扩展到调查数字图像的自动视觉评估的新技术是否 宫颈结合HPV检测具有临床应用价值。我们建议利用我们已有的临床研究 在开普敦平台招募艾滋病毒阳性和艾滋病毒阴性妇女解决以下两个具体问题 目标。具体目标1将调查自动视觉评估数字图像的临床应用 MobileODT平台作为HPV+HIV+女性的分诊评估方法与其他替代方案进行比较， 包括适应HPV DNA检测、细胞学和专家阴道镜检查。特定目标2将调查临床 自动化视觉评估作为一种评估方法在发现治疗失败的妇女中的应用 作为前几轮筛查的一部分，已经接受了消融治疗程序。在整个过程中 开展这项临床研究，具体目标3将支持能力发展和培训，以实施和 在东开普省的低资源环境中评估有效的宫颈癌筛查技术 南非的林波波省。这将通过现有的能力发展倡议在 开普敦大学妇产科。