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

• 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
• 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

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.

项目摘要/摘要 由于肛门癌的发生率正在增加，因此肛门癌筛查程序的统一标准不在 与男性与男性发生性关系的调查（MSM）。但是由于公共卫生筛查本质上是重复的 活性，尚不清楚MSM的比例可能符合重复的筛选方案。另外，就像 宫颈癌，肛门癌筛查可能包括HPV DNA测试和组织的可视化 确切病变的风险增加。这为调查家庭筛查提供了机会 由于与肛门子Pap样品相比，在家庭中收集DNA标本更容易。它也提供 有机会评估同意使用基于诊所可视化肛管可视化的男性的比例 高分辨率抗态。这是重复筛选的实验可以有效地测试以下 问题：MSM会遵守年度DNA筛查吗？基于家庭的抽样会增加合规性吗？ 与重复的年度筛查有关其他哪些因素？而且，有多少比例的人同意 高分辨率抗态？我们的长期目标是降低肛门癌的发病率和死亡率 疾病发生率的增加。我们的主要目标是确定符合年度基于DNA的符合 在将男性随机筛查≥27岁的休斯顿HIV阳性和HIV阴性MSM中 基于家庭的DNA收集（ARM 1）或基于诊所的收集（ARM 2）。随机分配手臂1的男人将收到 HPV DNA家庭收集套件在0和12个月中邮寄，ARM 2中的邮件将被邀请参加 在临床上的诊所的预约将在0和12个月收集DNA标本。然后，男人 在两个时间点遵守这两个时间点将邀请第二次同意接收高分辨率 隔离指导的活检确定将执行这种侵入性手术的男性的比例。我们将 总共招募了400名男子，并对非裔美国人和拉丁裔男子进行了过度采样。我们假设一个 大多数男性将遵守年度筛查，而男性在家庭中的遵守情况提高 ARM与诊所的ARM。我们将以3个具体目的测试我们的假设：1。确定男人对 年度肛门HPV DNA标本集合； 2。确定与年度筛查合规性相关的因素。 3。在那些完成的男人中，在同意拥有HRA的每个手臂中建立比例。电流 研究将提供：1）对MSM中年度DNA筛查计划的首次估计； 2）首先估计了HPV DNA家庭筛查增加年度合规性的相对能力； 3）证据表明，基于家庭与诊所的筛查对HRA的吸收有影响。我们相信 拟议的研究可能表明，廉价且简单的年度PCR测试可以识别出危险 MSM然后同意跟进HRA；因此，我们将根据 有限的筛查资源 - 重要的知识，无论最终是什么肛门癌筛查方案 受到推崇的。