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

描述(申请人提供)：虽然生殖器人类乳头瘤病毒(HPV)感染是全世界年轻性行为活跃人群中最常见的性传播感染，但波多黎各尚未对肛门HPV感染进行流行病学研究。鉴于某些类型的HPV感染与肛门和子宫颈癌有关，有关肛门生殖部位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。鉴于波多黎各缺乏可用的数据，本研究旨在确定在波多黎各大都会地区圣胡安居住的600名年龄在18岁至之间的女性中，宫颈、肛门和宫颈/肛门HPV感染的患病率以及与HPV肛门感染相关的因素，采用先前在诊所样本人群中测试的自我抽样收集方法。此外，我们的目标是确定感染妇女中HPV在肛门和宫颈中的一致性，并探索HPV变异在合并感染HPV 16、18和31的妇女中的频率分布。面对面访谈和计算机辅助自我访谈(Audio CASI系统)将收集有关HPV感染风险因素的信息，包括人口特征和生活方式。将使用Dracon拭子收集肛门和宫颈样本，这些样本将被放置在单独的5毫升小瓶中，其中包含1毫升的启根样本传输介质(启根公司)。在收集完之后。HPV DNA检测将在加州大学旧金山分校进行，使用修改后的MY09/MY11共识HPVL1引物池以及用于扩增人β-珠蛋白基因的引物库。阳性样本的聚合酶链式反应产物将通过使用39个单独的类型特异性探针的斑点杂交进行分型。还将进行E6区的菌株变异分型。HPV-DNA感染率将按HPV类型和所有类型组合计算。粗略和协变量调整后的患病率将通过Logistic回归模型进行估计。将建立三个不同的Logistic回归模型来评估与下列感染状态相关的因素：1)肛门HPV/宫颈HPV-，2)肛门HPV-/宫颈HPV，以及3)肛门HPV/宫颈HPV。在每一种模型中，肛门和宫颈HPV感染(肛门HPV-/宫颈HPV-)阴性的女性将被用作参照组。用Kappa统计量和符合率评价HPV感染者HPV型的符合率。这项研究将对肛门生殖道HPV感染的流行病学提供见解，并将探索HPV16、18和31变种在波多黎各妇女中的分布。这一信息与确定HPV感染和相关肛门生殖道癌的风险人群以及评估HPV疫苗计划的影响有关。 公共卫生相关性：这项拟议的研究将首次估计以波多黎各妇女为基础的人口样本中的肛门和同时(肛门和宫颈)HPV感染的流行率，描述HPV类型的分布，并评估与HPV肛门感染相关的因素。此外，我们还将探索HPV16、18和31变异在这一人群中的分布情况。据我们所知，这将是第一项评估美国同种拉美裔人群肛门感染的研究。这项研究将为这一人群中HPV感染的流行病学以及HPV感染与宫颈感染之间的关系提供见解，这些信息将有助于未来波多黎各HPV感染的病原学和传播动力学研究的发展。此外，它将使我们能够探索目前包括在现有疫苗中和未包括在现有疫苗中的HPV类型(6、11、16和18)的负担。这些评估对于了解HPV在这一人群中的负担，识别HPV感染、宫颈癌和其他HPV相关恶性肿瘤的风险人群，以及确定疫苗计划的影响是必要的。关于人乳头瘤病毒在肛门生殖部位的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，以减轻波多黎各人口中人乳头瘤病毒感染和肛门癌的负担，并将有助于设计和实施未来的人乳头瘤病毒疫苗和该岛的疫苗研究。

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.