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

项目总结/摘要 由于肛门癌的发病率正在上升，肛门癌筛查程序的统一标准正在制定中。 男男性接触者（MSM）。但由于公共卫生筛查本质上是一种重复的 活动，目前还不知道有多少比例的男男性接触者可能符合重复筛选方案。此外，与 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。这提供了调查家庭筛查的机会 因为与肛门巴氏涂片标本相比，在家里收集DNA标本更容易。它还提供了 有机会评估同意使用基于临床的肛管可视化的男性比例 高分辨率肛门镜检查因此，重复DNA筛选的实验可以有效地测试以下内容 问：男男性接触者是否会遵守每年一次的DNA筛查？家庭抽样是否会提高依从性？ 还有哪些因素与重复的年度筛查有关？有多少男性会同意 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， 发病率不断上升。我们的主要目标是确定符合年度DNA为基础的 在休斯顿HIV阳性和HIV阴性MSM中进行筛查，年龄≥27岁，在将男性随机分配到 基于家庭DNA收集（组1）或基于诊所的收集（组2）。随机分配至组1的男性将接受 在0和12个月时邮寄HPV DNA家庭收集试剂盒，并邀请第2组的人参加 在诊所预约，临床医生将在0和12个月时收集DNA样本。然后，男人们 在这两个时间点遵守将被邀请在第二个同意过程中，以获得高分辨率 肛门镜引导活检，以确定将进行这种侵入性手术的男性比例。我们将 总共招募了400名男性，对非洲裔美国人和拉丁裔男性进行了过度抽样。我们假设 大多数男性将遵守年度筛查，家庭中的男性遵守情况有所增加。 我们将用3个具体目标来检验我们的假设：1.确定男性遵守 每年肛门HPV DNA标本采集; 2.确定与年度筛查依从性相关的因素。 3.在那些遵守的男性中，确定每组中同意接受HRA的比例。当前 研究将提供：1）首次估计男男性行为者对年度DNA筛查计划的依从性; 2)首次估计HPV DNA家庭筛查增加年度依从性的相对能力; 和3）家庭筛查与诊所筛查对HRA摄取的影响的证据。我们认为 拟议的研究可能表明，廉价和简单的年度PCR检测可以识别风险 男男性接触者然后同意跟进HRA;因此，我们将根据以下因素确定如何识别高危男性： 有限的筛查资源-无论肛门癌筛查方案最终是什么， 推荐

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.