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

描述（由申请方提供）：尽管生殖器人乳头瘤病毒（HPV）感染是全球性活跃年轻人群中最常诊断的性传播感染，但尚未在波多黎各进行肛门生殖器HPV感染的流行病学研究。鉴于某些类型的HPV感染与肛门和宫颈癌有关，关于肛门生殖器部位HPV类型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。由于缺乏可用的数据，波多黎各，本研究旨在确定宫颈，肛门和并发宫颈/肛门HPV感染的患病率和HPV肛门生殖器感染的相关因素之间的人口为基础的样本600名妇女，年龄在18至64岁，生活在圣胡安，大都会区的波多黎各，使用自我采样收集方法，以前测试的诊所为基础的样本人群。此外，我们的目的是确定感染妇女肛门和宫颈HPV类型的一致性，并探讨HPV变异体在同时感染HPV 16，18和31型的妇女中的频率分布。一个面对面的访谈和一个计算机辅助的自我访谈（音频CASI系统）将收集有关HPV感染的风险因素，包括人口特征和生活方式的信息。将使用Dracon拭子采集肛门和宫颈标本，将拭子置于单独的5 mL小瓶中，小瓶中含有1 mL Qiagen标本样本运输培养基（Qiagen Corp.）收集后。HPV DNA检测将在加州大学旧金山分校弗朗西斯科进行，使用改良的MY 09/MY 11共有HPV L1引物池以及用于扩增人β-珠蛋白基因的引物。阳性样本的PCR产物将使用39个单独的类型特异性探针通过斑点杂交进行分型。还将进行E6区域的菌株变体分型。HPV-DNA患病率将按HPV类型和所有类型合并计算。将通过logistic回归模型估计粗患病率比值和协变量校正患病率比值。将构建三种不同的逻辑回归模型以评价与以下感染状态相关的因素：1）肛门HPV+/宫颈HPV-，2）肛门HPV-/宫颈HPV+，和3）肛门HPV+/宫颈HPV+。在这些模型中，肛门和宫颈HPV感染均为阴性的女性（肛门HPV-/宫颈HPV-）将用作参考组。将通过kappa统计量和一致率评估HPV感染个体中HPV类型的一致性。这项研究将提供有关肛门生殖器HPV感染流行病学的见解，并将探讨波多黎各妇女中HPV 16，18和31变异体在该人群中的分布。这些信息与确定HPV感染和相关肛门生殖器癌风险人群以及评估HPV疫苗计划的影响有关。 公共卫生相关性：拟议的研究将是第一个估计肛门生殖器和并发（肛门和宫颈）HPV感染的患病率，描述HPV类型的分布，并评估与波多黎各妇女人群样本中HPV肛门生殖器感染相关的因素。此外，我们还将探索HPV 16、18和31变异体在该人群中的分布。据我们所知，这将是第一项研究，以评估肛门感染的同质西班牙裔人口在美国这项研究将提供对HPV感染的流行病学和肛门和宫颈HPV感染之间的关系，在这一人群的见解，信息，这将有助于未来的研究发展的病原学和传播动力学的HPV感染在波多黎各。此外，它将使我们能够探索目前包括的HPV类型（6，11，16和18）和未包括在现有疫苗中的负担。这些评估对于了解该人群中HPV的负担，识别HPV感染，宫颈癌和其他HPV相关恶性肿瘤的风险群体以及确定疫苗计划的影响是必要的。关于肛门生殖器部位HPV类型分布的信息还将指导制定有效的一级和二级预防干预措施，以减少波多黎各人口中HPV感染和肛门生殖器癌症的负担，并将有助于设计和实施该岛未来的HPV疫苗和疫苗研究。

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.