HITCH: A Study of HPV Transmission in Young Couples

描述(由研究人员提供)：人类乳头瘤病毒(HPV)感染是宫颈癌的主要原因。大多数性生活活跃的女性一生中都会感染HPV。这些感染绝大多数是短暂的，但一小部分会持续下去，最终导致癌前病变。HPV检测在宫颈癌筛查和HPV疫苗接种中的应用受到了极大的关注。然而，由于缺乏关于HPV性传播的信息，这些策略受到了阻碍。HPV感染和通过异性性行为在夫妇中的传播(HITCH)队列研究是由CIHR于2004年资助的，以加深我们对HPV传播性的了解。具体目标是：(1)描述异性伴侣中年轻女性和男性之间HPV感染的流行率和具体类型的一致性；(2)详细描述和量化年轻女性和男性中发生HPV感染的危险因素；(3)估计男性对女性和女性对男性的HPV传播率；(4)确定接触HPV时传播HPV的行为危险因素和生物学决定因素；以及(5)描述口腔和手指中的HPV感染特征及其与生殖器感染和伴侣感染状况的一致性。Hitch的人口由就读于蒙特利尔麦吉尔大学和康科迪亚大学以及邻近的专科学校的年轻女性(年龄在18-24岁)和她们的男性伴侣组成。600对夫妇将被招募来评估性史和HPV DNA检测，在基线和后续的多个机会。这项研究还将招募这些女性在后续行动中获得的新伴侣。将使用基于互联网的自我管理的问卷来收集性行为信息。HPVDNA分型将通过PGMY09/11聚合酶链式反应进行，而选定的人类白细胞抗原基因座的分型将通过等位基因特异性的聚合酶链式反应分析进行。具体类型的一致性和不一致性将使用蒙特卡罗模拟和最大似然法进行分析。将使用泊松和考克斯回归以及广义估计方程技术来分析随时间推移的HPV获取和传播的速率。这项研究有两个独特的特点。这是第一次涉及性伴侣的关于HPV感染的大规模研究。在世界范围内，Hitch是目前对夫妇进行的最大的队列研究。其次，这是唯一一项将招募对象限制在新婚夫妇的研究，据信这段时间是传播最多的时候。此外，Hitch将提供比以前的研究更详细的性行为信息。我们的发现可能会对HPV和宫颈癌的预防工作产生影响，包括降低风险的行为策略，以及改进对传播参数的估计，以用于基于HPV的筛查和免疫的成本效益模型。 公共卫生相关性：生殖器HPV感染是当今最常见的性传播感染。大多数这样的感染不会被注意到，或者只会引起外部疣。疣很难治疗，并会导致社会污名化。一些HPV感染可能会导致宫颈癌。拟议的研究将有助于我们了解HPV感染的传播性，这将使基于HPV筛查和HPV疫苗接种的成本效益策略能够预防宫颈癌和其他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.