Clinical Cancer Center, Medical College of Wisconsin, Milwaukee, Wisconsin, USA
Center for AIDS Intervention Research, Department of Psychiatry and Behavioural Medicine, Medical College of Wisconsin, Milwaukee, Wisconsin, USA.
BMJ Open. 2021 Jun 29;11(6):e051118. doi: 10.1136/bmjopen-2021-051118.
Squamous cell carcinoma of the anus is a common cancer among sexual minority men, especially HIV-positive sexual minority men; however, there is no evidenced-based national screening protocol for detection of anal precancers. Our objective is to determine compliance with annual anal canal self-sampling or clinician-sampling for human papillomavirus (HPV) DNA.
This is a prospective, randomised, two-arm clinical study to evaluate compliance with annual home-based versus clinic-based HPV DNA screening of anal canal exfoliated cells. The setting is primary care community-based clinics. Recruitment is ongoing for 400 HIV-positive and HIV-negative sexual minority men and transgender persons, aged 25 years, English or Spanish speaking, no current use of anticoagulants other than nonsteroidal anti-inflammatory drugs and no prior diagnosis of anal cancer. Participants are randomised to either receive a swab in the mail for home-based collection of an anal canal specimen at 0 and 12 months (arm 1) or attend a clinic for clinician collection of an anal canal specimen at 0 and 12 months (arm 2). Persons will receive clinic-based Digital Anal Rectal Examinations and high-resolution anoscopy-directed biopsy to assess precancerous lesions, stratified by study arm. Anal exfoliated cells collected in the study are assessed for high-risk HPV persistence and host/viral methylation. The primary analysis will use the intention-to-treat principle to compare the proportion of those who comply with 0-month and 12-month sampling in the home-based and clinic-based arms. The a priori hypothesis is that a majority of persons will comply with annual screening with increased compliance among persons in the home-based arm versus clinic-based arm.
The study has been approved by the Medical College of Wisconsin Human Protections Committee. Results will be disseminated to communities where recruitment occurred and through peer-reviewed literature and conferences.
NCT03489707.
肛门鳞状细胞癌是性少数男性群体中常见的癌症，尤其是 HIV 阳性的性少数男性群体；然而，目前尚无针对肛门癌前病变的基于循证的全国性筛查方案。我们的目的是确定每年对肛门进行自行取样或由临床医生取样以检测人乳头瘤病毒（HPV）DNA 的依从性。
这是一项前瞻性、随机、两臂临床研究，旨在评估每年在家中进行基于 HPV DNA 的肛门管脱落细胞筛查与在诊所进行筛查的依从性。该研究地点为初级保健社区诊所。正在招募 400 名 HIV 阳性和 HIV 阴性的性少数男性和跨性别者，年龄在 25 岁及以上，会讲英语或西班牙语，目前除非甾体抗炎药外不使用任何抗凝药物，并且没有肛门癌的既往诊断。参与者随机分为两组：一组通过邮件收到拭子，用于在家中收集 0 个月和 12 个月时的肛门管标本（第 1 组）；另一组在 0 个月和 12 个月时在诊所收集肛门管标本（第 2 组）。将对患者进行基于诊所的数字肛门直肠检查和高分辨率肛门镜下活检，以评估癌前病变，分层依据研究臂。在研究中收集的肛门脱落细胞用于评估高危 HPV 持续性以及宿主/病毒甲基化。主要分析将使用意向治疗原则比较在家中组和诊所组 0 个月和 12 个月采样的依从者比例。先验假设是，大多数人将遵守年度筛查，在家中组比诊所组的依从性更高。
该研究已获得威斯康星医学院人类保护委员会的批准。研究结果将在招募发生的社区以及通过同行评议文献和会议进行传播。
NCT03489707。
