HITCH: A Study of HPV Transmission in Young Couples

描述（由研究者提供）：人乳头瘤病毒（HPV）感染是宫颈癌的主要原因。大多数性活跃的女性在一生中获得HPV感染。这些感染中的绝大多数是短暂的，但一小部分会持续存在，最终导致癌前病变。HPV检测在宫颈癌筛查中的应用和HPV疫苗的使用有很大的热情。然而，这些策略受到HPV性传播信息缺乏的阻碍。2004年，CIHR资助了HPV感染和通过异性恋活动在夫妇之间传播（HITCH）队列研究，以进一步了解HPV的传播性。具体目标是：（1）描述异性恋夫妇中年轻女性和男性之间HPV感染的患病率和类型特异性一致性;（2）精细描述和量化年轻女性和男性中HPV感染事件的风险因素;（3）估计男性对女性和女性对男性HPV传播的比率;（4）确定暴露后HPV传播的行为风险因素和生物决定因素;（5）口腔和手指HPV感染的特征及其与生殖器感染和伴侣感染状况的一致性。HITCH的人口由就读于麦吉尔大学和康考迪亚大学以及蒙特利尔附近大专院校的年轻（18-24岁）女性及其男性伴侣组成。将招募600对夫妇，在基线和随访期间多次评估性史和HPV DNA检测。该研究还将招募女性在随访期间获得的新伴侣。将使用基于互联网的自填问卷来收集性行为信息。将通过PGMY 09/11聚合酶链反应方案进行HPV DNA分型，并通过等位基因特异性PCR检测对选定的HLA基因座进行分型。将使用蒙特-卡罗模拟和最大似然法分析类型特异性一致性和不一致性。将使用Poisson和考克斯回归以及广义估计方程技术分析HPV获得率和传播率随时间的变化。这项研究有两个独特的特点。这是第一个涉及性伴侣的HPV感染的大规模研究。在世界范围内，HITCH是目前最大的夫妇队列研究。其次，这是唯一一项将招募限制在新婚夫妇的研究，据信这是大多数传播发生的时间。此外，HITCH将提供比以前的研究更精细的详细性行为信息。我们的研究结果可能会影响HPV和宫颈癌的预防工作，包括降低风险的行为策略和改进的传播参数估计，用于HPV筛查和免疫的成本效益模型。 生殖器HPV感染是目前最常见的性传播感染。大多数此类感染不会被注意到或仅引起外部疣。疣很难治疗，并导致社会污名化。宫颈癌的早期症状有哪些？这项拟议的研究将有助于我们了解HPV感染的可传播性，这将允许基于HPV筛查和HPV疫苗接种的成本效益策略，以预防宫颈癌和其他HPV相关疾病。

DESCRIPTION (provided by investigator): Human papillomavirus (HPV) infection is the central cause of cervical cancer. Most sexually-active women acquire HPV infection over a lifetime. The vast majority of these infections are transient, but a small proportion becomes persistent and eventually lead to pre-cancerous lesions. There is great enthusiasm concerning the application of HPV testing in cervical cancer screening and use of HPV vaccination. Yet, these strategies are hampered by the paucity of information on the sexual transmissibility of HPV. The HPV Infection and Transmission among Couples through Heterosexual activity (HITCH) cohort study was funded by CIHR in 2004 to further our understanding of the transmissibility of HPV. Specific aims are: (1) to describe the prevalence and type-specific concordance of HPV infection between young women and men in heterosexual couples; (2) to finely characterize and quantify risk factors for incident HPV infection among young women and men; (3) to estimate rates of male-to-female and female-to-male HPV transmission; (4) to identify behavioural risk factors and biological determinants for HPV transmission upon exposure; and (5) to characterize HPV infection in the oral tract and fingers and its agreement with genital infection and partner's infection status. HITCH's population consists of young (aged 18-24) women attending McGill and Concordia universities and neighboring junior colleges in Montreal and their male partners. 600 couples will be recruited for assessment of sexual histories and HPV DNA testing at baseline and at multiple opportunities during follow-up. The study will also enroll new partners acquired by the women during follow-up. Internet- based, self-administered questionnaires will be used to collect sexual behavioral information. HPV DNA typing will be done by the PGMY09/11 polymerase chain reaction protocol and typing of selected HLA loci will be done by allele-specific PCR assays. Type-specific concordance and discordance will be analyzed using Monte-Carlo simulation and maximum likelihood methods. Rates of HPV acquisition and transmission over time will be analyzed using Poisson and Cox regression, and with generalized estimating equation techniques. There are two unique features of the study. It is the first large-scale study of HPV acquisition that involves sexual partners. Worldwide, HITCH is presently the largest cohort study of couples. Second, it is the only study to limit recruitment to new couples, a time at which most transmission is believed to occur. Moreover, HITCH will provide a much finer level of detailed sexual behavioral information than previous studies. Our findings are likely to impact on HPV and cervical cancer prevention efforts, including behavioral strategies to reduce risk and improved estimates of transmission parameters to be used in models of the cost effectiveness of HPV-based screening and immunization. PUBLIC HEALTH RELEVANCE: Genital HPV infection is the most common sexually transmitted infection today. Most such infections are not noticed or cause only external warts. Warts are difficult to treat and lead to social stigmatization. Some HPV infections may lead to cervical cancer. The proposed study will help our understanding of the transmissibility of HPV infection, which will permit cost-effective strategies based on HPV screening and HPV vaccination to prevent cervical cancer and other HPV-associated diseases.