Annual anal sampling using DNA screening to identify men who have sex with men at increased risk for anal cancer

每年使用 DNA 筛查进行肛门取样，以识别患有肛门癌风险较高的男男性行为者

基本信息

批准号：
10006511
负责人：
ALAN GASPAR NYITRAY
金额：
$ 68.05万
依托单位：
MEDICAL COLLEGE OF WISCONSIN
依托单位国家：
美国
项目类别：
财政年份：
2017
资助国家：
美国
起止时间：
2017-09-15 至 2022-08-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/10006511
关键词：
Adult African American Anal Sex Anal canal Anus Appointment Biopsy Bisexual Cervical Cancer Screening Characteristics Clinic Collection Consent DNA Disease Eligibility Determination Gays Goals HIV HIV Seronegativity HIV Seropositivity HPV-High Risk Heterosexuals Home environment Human Papilloma Virus Vaccine Human Papillomavirus Human immunodeficiency virus test Incidence Instruction Investigation Knowledge Latino Lesion Light Malignant Neoplasms Malignant neoplasm of anus Malignant neoplasm of cervix uteri Morbidity - disease rate Nature Outcome Pap smear Persons Predisposition Prevalence Procedures Process Public Health Randomized Readiness Recommendation Regimen Reporting Research Resolution Resources Risk Sampling Screening for cancer Screening procedure Specimen Surveys Testing Time Tissues Visit Visualization Work aged anal canal Carcinoma arm base chronic infection experimental study follow-up high risk high risk men high risk population men men who have sex with men mortality premalignant recruit routine screening sample collection screening screening program sex uptake

项目摘要

Project Summary/Abstract Since anal cancer incidence is increasing, a uniform standard for anal cancer screening procedures is under investigation with men having sex with men (MSM). But since public health screening is, by nature, a repeated activity, it is not known what proportion of MSM might comply with a repeated screening regimen. Also, as with cervical cancer, anal cancer screening is likely to include HPV DNA testing and visualization of tissue at increased risk for precancerous lesions. This affords the opportunity to investigate home-based screening since it is easier to collect DNA specimens in the home as compared to anal Pap specimens. It also affords the opportunity to assess the proportion of men who will agree to clinic-based visualization of the anal canal using high-resolution anoscopy. Thus, an experiment of repeated DNA screening can efficiently test the following questions: Will MSM comply with annual DNA screening? Will home-based sampling increase compliance? What other factors are associated with repeated annual screening? And, what proportion of men will agree to high-resolution anoscopy? Our long-term goal is to reduce morbidity and mortality from anal cancer given increasing incidence of disease. Our primary objective is to determine compliance with annual DNA-based screening among Houston HIV-positive and HIV-negative MSM, aged ≥27 years, after randomizing the men to home-based DNA collection (arm 1) or clinic-based collection (arm 2). Men randomized to arm 1 will receive an HPV DNA home-based collection kit in the mail at 0 and 12 months and those in arm 2 will be invited to attend an appointment at a clinic where a clinician will collect the DNA specimen at 0 and 12 months. Then, men complying at both time points will be invited in a second consenting process to receive high-resolution anoscopy-directed biopsy to determine the proportion of men who will do this invasive procedure. We will recruit a total of 400 men, with oversampling of African American and Latino men. We hypothesize that a majority of men will comply with annual screening with increased compliance among men in the home-based arm vs clinic-based arm. We will test our hypothesis with 3 specific aims: 1. Determine men's compliance with annual anal HPV DNA specimen collection; 2. Determine factors associated with annual screening compliance. 3. Of those men who comply, establish the proportion in each arm who agree to have HRA. The current research will deliver: 1) The first estimates of compliance with an annual DNA screening program among MSM; 2) The first estimates of the relative ability of HPV DNA home-based screening to increase annual compliance; and 3) Evidence of the influence that home-based vs clinic-based screening has on uptake of HRA. We believe the proposed research could indicate that inexpensive and simple annual PCR testing may identify at-risk MSM who then agree to follow up with HRA; thus, we will determine how high-risk men are identified in light of limited screening resources - crucial knowledge regardless of what anal cancer screening protocol is ultimately recommended.

项目概要/摘要由于肛门癌发病率不断增加，肛门癌筛查程序的统一标准正在制定中但由于公共卫生筛查本质上是重复性的。活动，目前尚不清楚有多少比例的 MSM 可能符合重复筛查方案。宫颈癌、肛门癌筛查可能包括 HPV DNA 检测和组织可视化癌前病变的风险增加，这提供了研究家庭筛查的机会。因为与肛门巴氏样本相比，在家中收集 DNA 样本更容易。有机会评估同意临床肛管可视化的男性比例因此，重复 DNA 筛查实验可以有效地测试以下内容。问题： MSM 是否会遵守年度 DNA 筛查规定？家庭采样是否会提高合规性？还有哪些其他因素与每年重复筛查有关？有多少比例的男性会同意？高分辨率肛门镜检查？我们的长期目标是降低肛门癌的发病率和死亡率我们的主要目标是确定每年基于 DNA 的遵守情况。对年龄≥27 岁的休斯顿 HIV 阳性和 HIV 阴性 MSM 进行筛查，将男性随机分组后家庭 DNA 采集（第 1 组）或诊所采集（第 2 组）随机分配到第 1 组的男性将接受 DNA 采集。 0个月和12个月时邮寄的HPV DNA家庭采集套件以及第2臂的人将被邀请参加预约临床医生在 0 个月和 12 个月时采集 DNA 样本。在两个时间点都遵守规定的人将被邀请参加第二次同意程序，以获得高分辨率我们将进行肛门镜检查活检，以确定进行这种侵入性手术的男性比例。总共招募了 400 名男性，其中对非裔美国人和拉丁裔男性进行了超抽样。大多数男性将遵守年度筛查，并且在家中的男性中的遵守情况会有所提高我们将通过 3 个具体目标来检验我们的假设： 1. 确定男性的依从性。每年进行肛门 HPV DNA 样本采集； 2. 确定与年度筛查依从性相关的因素。 3. 在遵守规定的男性中，确定每个组中同意进行 HRA 的比例。研究将提供： 1) 对 MSM 中年度 DNA 筛查计划的遵守情况进行初步估计； 2) 首次估计 HPV DNA 家庭筛查提高年度依从性的相对能力； 3) 我们认为家庭筛查与诊所筛查对 HRA 的影响的证据。拟议的研究可能表明，廉价且简单的年度 PCR 检测可以识别有风险的人群然后同意跟进 HRA 的 MSM；因此，我们将根据以下情况确定如何识别高风险男性；有限的筛查资源 - 无论最终的肛门癌筛查方案如何，都至关重要的知识受到推崇的。