The Effectiveness of Screening HIV-Infected Women for Anal Cancer Precursors

对感染艾滋病毒的女性进行肛门癌前体筛查的有效性

基本信息

批准号：
8519386
负责人：
Elizabeth Chiao
金额：
$ 26.74万
依托单位：
BAYLOR COLLEGE OF MEDICINE
依托单位国家：
美国
项目类别：
财政年份：
2011
资助国家：
美国
起止时间：
2011-09-19 至 2016-07-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/8519386
关键词：
Accounting Address Anal Intraepithelial Neoplasia Anal carcinoma Anus Behavioral Biological Assay Biopsy CD4 Lymphocyte Count Cancerous Cause of Death Cervical Cervical Cancer Screening Characteristics Cohort Studies Cost-Benefit Analysis Cytology Data Detection Economics Effectiveness Epidemiologic Studies Epidemiology Epithelial General Population Gold Guidelines HIV HPV-High Risk Healthcare High Prevalence Highly Active Antiretroviral Therapy Histology Human Papillomavirus Human papilloma virus infection Hybrids Immunologics Incidence Individual Intraepithelial Neoplasia Lesion Life Longitudinal Studies Malignant Neoplasms Malignant Squamous Cell Neoplasm Malignant neoplasm of anus Malignant neoplasm of cervix uteri Messenger RNA Methods Morbidity - disease rate Natural History Neoplasms New York Opportunistic Infections Participant Persons Policy Making Population Study Premalignant Prevalence Primary Health Care Publishing Quality of life Recommendation Recording of previous events Reporting Research Resolution Resources Risk Risk Factors Sampling Sensitivity and Specificity Site Specificity Testing Time Triage Visit Vulva Woman antiretroviral therapy cancer prevention clinical decision-making cohort condyloma cost effective economic evaluation economic impact high risk high standard improved men mortality multidisciplinary screening therapy adherence

项目摘要

DESCRIPTION (provided by applicant): HIV-infected women have at least fourteen times the risk of developing anal carcinoma compared with the general population despite the widespread use of highly active antiretroviral therapy (HAART). Like cervical cancer, anal cancer appears to be preceded by high-grade intraepithelial neoplasia and is strongly associated with human papillomavirus (HPV) infection. The prevalence of anal precancerous lesions among HIV-infected women has been shown to be as high as 10%. Due to this alarming increase in anal precancerous and cancerous lesions among HIV-infected women, there has been an increasing emphasis on anal cancer prevention, including recommendations in the 2007 New York state HIV primary care guidelines to perform annual anal cytology testing among HIV-infected women with a history of abnormal cervical or vulvar histology or history of anogenital condyloma. However, little to no evidence exists to define the optimal screening strategy for anal intraepithelial neoplasia (AIN) in the context of HIV-infected women. In the HAART era, there have been no studies of HIV-infected women in which high resolution anoscopy (HRA) with directed biopsy was performed on all participants with concurrent sampling for anal cytology and HPV testing. Therefore the prevalence of high-grade anal intraepithelial neoplasia (HGAIN) is not known, nor are the risk factors for developing this lesion. HPV testing has been shown to be a useful adjunct to cervical cytology for cervical cancer screening , however, we do not know if using HPV to triage HIV-infected women with abnormal anal cytology would be of benefit. Therefore, our specific aims are: Specific aim 1a: to determine the sensitivity (through confirmation of cytological abnormalities using HRA-guided anal biopsies) and specificity (through HRA confirmation of normal cytology) of anal cytology testing at the initial study visit among HIV-infected women. Specific aim 1b: to determine if anal high risk (HR) HPV testing using different methods of HPV detection, including HPV Hybrid Capture 2 (HC2) and HPV mRNA assays (APTIMA), will improve the screening test characteristics of routine anal cytology testing alone. Specific Aim 2: to determine the baseline prevalence rate, and risk factors associated with HGAIN and anal HPV; and to quantify HGAIN and anal HPV incidence, and prevalence rate changes over time among HIV-infected women undergoing routine anal cytologic testing, and specific Aim 3: to perform an economic evaluation of different anal cytology testing strategies among HIV-infected women. In order to address these aims, we propose a two-site, multidisciplinary study, utilizing data collected from a 2-year longitudinal cohort study of 300 HIV-infected women who will be evaluated at 6 month intervals. This cohort study will be the first to provide important information regarding the test characteristics, epidemiology, and natural history of anal HPV infection and HGAIN among a cohort of HIV-infected women undergoing routine anal cytology testing. The data will then be utilized to perform comprehensive cost-benefit analyses, which will direct clinical decision making on an optimal anal cancer screening approach for these women.

描述（由申请人提供）：尽管广泛使用高度活跃的抗逆转录病毒疗法（HAART），但受HIV感染的妇女与普通人群相比至少是患肛门癌发展的14倍。像宫颈癌一样，肛门癌似乎先于高级上皮肿瘤，并且与人乳头瘤病毒（HPV）感染密切相关。艾滋病毒感染妇女中肛门前癌性病变的患病率已显示高达10％。由于艾滋病毒感染妇女的肛门癌前病和癌性病变令人震惊，人们对预防肛门癌的预防越来越重视，包括2007年纽约州HIV初级保健指南中的建议，以对艾滋病毒感染的艾滋病毒感染史进行年度肛门细胞学测试，患有异常宫颈或外阴组织学史的史。但是，在艾滋病毒感染的妇女的背景下，几乎没有任何证据来定义肛门上皮内肿瘤（AIN）的最佳筛查策略。在HAART时代，尚无对感染HIV的妇女的研究，其中对所有同时进行肛门细胞学和HPV测试的参与者进行了高分辨率抗体（HRA）。因此，高级肛门上皮内肿瘤（HGAIN）的患病率尚不清楚，发展这种病变的危险因素也不知道。 HPV测试已被证明是宫颈癌筛查的宫颈细胞学的有用辅助，但是，我们不知道使用HPV对患有异常肛门肛门细胞学异常的分类HIV感染的妇女是否有益。因此，我们的具体目的是：具体目标1a：确定敏感性（通过使用HRA引导的肛门活检确认细胞学异常）和在HIV感染的女性中对肛门细胞学测试进行肛门细胞学测试的特异性（通过HRA确认）（通过HRA确认）。具体目标1B：为了确定使用不同的HPV检测方法（包括HPV混合捕获2（HC2）和HPV mRNA分析（APTIMA））的肛门高风险（HR）HPV测试是否会改善单独的常规肛门细胞学测试的筛选测试特征。特定目的2：确定基线患病率和与HGAN和肛门HPV相关的风险因素；为了量化HGAIN和肛门HPV的发病率，以及接受常规肛门细胞学测试的HIV感染妇女的流行率随时间变化，并具体目标3：对HIV感染的妇女的不同肛门细胞学测试策略进行经济评估。为了解决这些目标，我们提出了一项两次多学科研究，利用从一项为期2年的300名HIV感染妇女进行的2年纵向队列研究收集的数据，这些妇女将以6个月的间隔进行评估。这项队列研究将是第一个提供有关肛门HPV感染的测试特征，流行病学和自然史和HGAIN的重要信息，其中一组HIV感染的妇女接受常规肛门细胞学测试。然后，数据将用于进行全面的成本效益分析，该分析将针对这些女性的最佳肛门癌筛查方法指导临床决策。