Anogenital HPV Infection in a Population-Based Sample of Puerto Rican Women

描述（由申请人提供）：虽然生殖器人类乳头瘤病毒（HPV）感染是世界范围内年轻性活跃人群中最常见的性传播感染，但在波多黎各没有进行肛门生殖器HPV感染的流行病学研究。鉴于某些类型的HPV感染与肛门和子宫颈癌有关，有关HPV类型在肛门生殖器部位分布的信息对于疫苗研究和计划的设计、实施和评估至关重要。鉴于波多黎各缺乏可用的数据，本研究旨在确定宫颈、肛门和并发宫颈/肛门HPV感染的患病率，以及与HPV肛门生殖器感染相关的因素，在以人群为基础的样本中，600名年龄在18至64岁的女性居住在波多黎各圣胡安大都会区，使用之前在诊所样本人群中测试过的自我抽样收集方法。此外，我们的目的是确定感染女性肛门和宫颈HPV类型的一致性，并探讨HPV变异在同时感染HPV 16型，18型和31型的女性中的频率分布。面对面访谈和计算机辅助自我访谈（音频CASI系统）将收集HPV感染危险因素的信息，包括人口统计学特征和生活方式。肛门和宫颈标本将使用龙拭子收集，收集后将放置在单独的5毫升小瓶中，其中含有1毫升Qiagen标本样本运输介质（Qiagen公司）。HPV DNA检测将在加州大学旧金山分校进行，使用改良的MY09/MY11共识型HPV L1引物池以及用于扩增人β -珠蛋白基因的引物。阳性样品的PCR产物将使用39个单独的类型特异性探针进行点印迹杂交。来自E6地区的菌株变异分型也将完成。HPV-DNA患病率将根据hpv类型和所有类型的总和来计算。粗糙和协变量调整后的患病率将通过逻辑回归模型估计。构建三种不同的logistic回归模型来评估以下感染状态的相关因素：1)肛门HPV+/宫颈HPV-， 2)肛门HPV-/宫颈HPV+， 3)肛门HPV+/宫颈HPV+。在这些模型中，肛门和宫颈HPV感染（肛门HPV-/宫颈HPV-）均阴性的女性将被用作参照组。HPV感染个体的HPV型别一致性将通过kappa统计量和一致性率进行评估。本研究将对肛门生殖器HPV感染的流行病学提供见解，并将探索HPV 16、18和31变体在波多黎各女性人群中的分布。这一信息对于确定HPV感染和相关的肛门生殖器癌症的高危人群以及评估HPV疫苗计划的影响具有重要意义。

DESCRIPTION (provided by applicant): Although genital human papilloma virus (HPV) infection is the most commonly diagnosed sexually transmitted infection among young sexually active populations worldwide, no epidemiological studies of anogenital HPV infection have been conducted in Puerto Rico. Given that infection with certain types of HPV has been associated with cancer of the anus and cervix, information on the distribution of HPV types at anogenital sites is essential for the design, implementation and evaluation of vaccine studies and programs. Given the lack of available data for Puerto Rico, this study aims to determine the prevalence of cervical, anal and concurrent cervical/anal HPV infection and factors associated to HPV anogenital infection among a population-based sample of 600 women aged 18 to 64 years living in the San Juan, Metropolitan area of Puerto Rico, using a self-sampling collection methodology previously tested in a clinic-based sample population. In addition, we aim to determine the concordance of HPV types in the anus and cervix among infected women and to explore the frequency distribution of HPV variants among women with concurrent infection with HPV types 16, 18 and 31. A face-to-face interview and a computer-assisted self-interview (Audio CASI system) will collect information on risk factors for HPV infection including demographic characteristics and lifestyles. Anal and cervical specimens will be collected using Dracon swabs, which will be placed in separate 5-mL vials containing 1 mL Qiagen Specimen Sample Transport Medium (Qiagen Corp.) after collection. HPV DNA testing will be performed at the University of California, San Francisco, using a modified pool of MY09/MY11 consensus HPV L1 primers as well as primers for amplification of the human beta-globin gene. PCR products from positive samples will be typed by dot-blot hybridization using 39 individual type-specific probes. Strain variant typing from the E6 region will also be done. HPV-DNA prevalence will be calculated by HPV-type and all types combined. Crude and covariate adjusted Prevalence Odds will be estimated by logistic regression models. Three different logistic regression models will be constructed to evaluate factors associated with the following infection status: 1) anus HPV+/cervix HPV- , 2) anus HPV-/cervix HPV+, and 3) anus HPV+/cervix HPV+. On each of these models, women negative for both anal and cervical HPV infection (anal HPV-/ cervix HPV-) will be used as the reference group. Concordance of HPV-type among HPV infected individuals will be assessed by the kappa statistic and the concordance rate. This study will provide insights on the epidemiology of anogenital HPV infection and it will explore the distribution of HPV 16, 18 and 31 variants in this population in Puerto Rican women. This information is relevant to identify groups of population at risk for HPV infection and related anogenital cancers and to assess the impact of HPV vaccine programs. PUBLIC HEALTH RELEVANCE: The proposed study will be the first to estimate the prevalence of anogenital and concurrent (anus and cervix) HPV infection, to describe the distribution of HPV types, and to assess factors associated with HPV anogenital infection in a population-based sample of Puerto Rican women. In addition we will explore the distribution of HPV 16, 18 and 31 variants in this population. To our knowledge, this will be the first study to assess anal infection among a homogenous Hispanic population in the U.S. This study will provide insights on the epidemiology of HPV infection and of the relationship between anal and cervical HPV infection in this population, information that will contribute to the development of future studies of the etiology and transmission dynamics of HPV infection in Puerto Rico. Further, it will allow us to explore the burden of HPV types currently included (6, 11, 16 and 18) and not included in the available vaccines. These assessments are necessary to understand the burden of HPV in this population, to identify groups at risk for HPV infection, cervical cancer and other HPV related malignancies, and to determine the impact of vaccine programs. Information on the distribution of HPV types at anogenital sites will also guide the development of effective primary and secondary prevention interventions to reduce the burden of HPV infection and anogenital cancers among the Puerto Rican population and will aid in the design and implementation of future HPV vaccines and vaccine studies in the island.