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，但一小部分会持续并最终导致癌前病变。人们对HPV检测在宫颈癌筛查和HPV疫苗接种中的应用有很大的热情。然而，由于缺乏关于HPV性传播的信息，这些策略受到阻碍。HPV通过异性恋行为在夫妻之间的感染和传播（HITCH）队列研究是由CIHR于2004年资助的，旨在进一步了解HPV的传播性。具体目的是：(1)描述异性恋夫妇中年轻女性和男性HPV感染的患病率和类型特异性一致性；(2)精细表征和量化年轻女性和男性HPV感染事件的危险因素；(3)估计男性与女性和女性与男性之间的HPV传播率；(4)确定HPV接触后传播的行为风险因素和生物学决定因素；(5)了解口腔和手指的HPV感染情况及其与生殖器感染和伴侣感染状况的一致性。HITCH的人口由McGill和Concordia大学以及蒙特利尔附近大专院校的年轻（18-24岁）女性和她们的男性伴侣组成。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。基于互联网的、自我管理的调查问卷将用于收集性行为信息。HPV DNA分型将通过PGMY09/11聚合酶链反应方案完成，选定的HLA位点分型将通过等位基因特异性PCR检测完成。将使用蒙特卡罗模拟和最大似然方法分析特定类型的一致性和不一致性。随着时间的推移，HPV的获得率和传播率将使用泊松和考克斯回归以及广义估计方程技术进行分析。这项研究有两个独特之处。这是首例涉及性伴侣的HPV感染的大规模研究。全球范围内，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，而据信大多数传播发生在新婚夫妇身上。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和改进传播参数的估计，这些参数将用于基于HPV的筛查和免疫的成本效益模型。

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.