Effect of Male Circumcision on Penile HPV Infection

男性包皮环切术对阴茎 HPV 感染的影响

• 批准号: 6908640
• 负责人: JENNIFER SUSAN SMITH
• 金额: $ 47.44万
• 依托单位: UNIV OF NORTH CAROLINA CHAPEL HILL
• 依托单位国家: 美国
• 财政年份: 2005
• 资助国家: 美国
• 起止时间: 2005-09-12 至 2009-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6908640
• 关键词: adolescence (12-20); cancer prevention; cervix neoplasms; clinical research; clinical trials; communicable disease control; endoscopy; histopathology; human papillomavirus; human subject; human therapy evaluation; male; male reproductive system surgery; penis; polymerase chain reaction; sex partner; sexually transmitted diseases; virus diseases; virus related neoplasm /cancer; young adult human (21-34)

DESCRIPTION (provided by applicant): Human papillomavirus (HPV) is the central cause of invasive cervical cancer (ICC) in women, and other anogenital cancers, including anal, penile, vaginal and vulvar cancers. Public health intervention strategies are needed to reduce the genital acquisition of high-risk HPV types to prevent these cancers that affect women and men. Given that men are important in transmitting HPV to their female sexual partners, interventions that reduce HPV acquisition and persistence in men could be an important HPV prevention strategy benefiting both men and women. Limited cross-sectional data suggest that male circumcision may reduce the carriage of penile HPV infection. However, proof that male circumcision reduces HPV penile infection acquisition and/or persistence can only be obtained through the conduct of a prospective, randomized clinical trial (RCT). The University of North Carolina, in collaboration with the UNIM (Universities of Nairobi, Illinois and Manitoba Reproductive Health Project) Male Health Clinic, The University of Illinois at Chicago, the University of Nairobi, the Albert Einstein College of Medicine in New York City, and the Vrije Universiteit Medical Center in Amsterdam proposes to study of the effect of male circumcision on the risk and natural history of penile HPV infection in young, sexually active men in Kisumu, Kenya. This proposed study of penile HPV infection is nested within an ongoing "parent" RCT to assess the effect of male circumcision in reducing HIV incidence in 18-24 year-old men in Kisumu that began in February 2002. This HPV project proposes to determine the type-specific HPV DNA prevalence in penile exfoliated cell samples currently being collected as part of the ongoing RCT of male circumcision. An estimated 2,442 men are expected to contribute penile exfoliated cell specimens from two anatomical sites (the shaft and glans/coronal sulcus). These sample are being collected at enrollment and at the 6-, 12-, 18- and 24- month follow-up visits. Specimens will be tested using a sensitive PCR assay to detect a wide-range of HPV DNA types. HPV viral load of samples positive for HPV types 16, 18, 31, 33 and 45 will be determined using a real-time PCR. A new clinical examination (a visual inspection with 3% acetic acid and aided magnification) will be added to this ongoing RCT at the final 24-month visit to determine the presence of penile lesions (i.e., flat lesions, papular lesions, or condolymata acuminate). Study results will provide the most definitive evidence to date regarding the effect of male circumcision on HPV infection and penile lesions in men. If male circumcision is found to be effective and safe in reducing HPV infection or penile lesions in men, it could in turn reduce HPV prevalence and associated cervical neoplasia in women.

描述（由申请人提供）：人乳头瘤病毒（HPV）是女性侵袭性宫颈癌（ICC）和其他肛门生殖器癌（包括肛门癌、阴茎癌、阴道癌和外阴癌）的主要原因。需要采取公共卫生干预战略，减少高危型人乳头瘤病毒的生殖器感染，以预防影响妇女和男子的这些癌症。鉴于男性在将HPV传播给女性性伴侣方面发挥着重要作用，减少男性HPV感染和持续存在的干预措施可能是一种重要的HPV预防策略，对男性和女性都有益。有限的横断面数据表明，男性包皮环切术可能减少阴茎HPV感染的携带。然而，男性包皮环切术减少HPV阴茎感染的获得和/或持续性的证据只能通过前瞻性随机临床试验（RCT）获得。