MICROBICIDE DEVELOPMENT PROGRAM

这个子项目是许多研究子项目中利用 资源由NIH/NCRR资助的中心拨款提供。子项目和 调查员(PI)可能从NIH的另一个来源获得了主要资金， 并因此可以在其他清晰的条目中表示。列出的机构是 该中心不一定是调查人员的机构。 导言：这项拟议的研究是一项横断面、观察性、单次访问的研究，涉及加利福尼亚州洛杉矶和马里兰州巴尔的摩的896名男性和女性，包括：(1)计算机辅助访谈，重点关注围绕接受性肛交(RAI)、肛门症状和行为的多维评估的行为指标，(2)肛门直肠检查，以及(3)艾滋病毒和性传播感染(STI)检测。这项研究的总体目标是收集有关男女肛门性行为和肛门健康的描述性数据，以便为未来直肠杀菌剂的研究和开发提供基线信息。 背景与理由：洛杉矶和巴尔的摩是性传播感染和艾滋病毒大流行的城市，需要使用避孕套以外的替代预防方法。直肠杀微生物剂在这些环境中具有巨大的潜力，可以影响其蓬勃发展的艾滋病毒流行。肛交是一种很有可能传播性病和艾滋病毒的性行为，然而，关于在性交过程中可能影响感染传播率的因素的描述性数据很少。将需要描述性基线数据，以便充分设计旨在通过使用新的预防方法，如直肠杀微生物剂来降低感染传播率的干预措施。关于直肠杀菌剂的临床试验很少，现有的几项研究也得出了混合的结果。研究可能会更好地描述可能出现的不同情况，因为使用该产品的伙伴类型(即稳定的伴侣与不稳定的伙伴)、物理位置(在家与外出)以及性行为的情况可能会限制该产品的给药方法。需要进行形成性研究，以探索在持续的伙伴关系之外使用直肠杀菌剂的效用和自我效能的看法，以及性行为发生的情况的动态。 研究问题(目标)：目标1：描述影响杀菌剂使用和给药的肛交行为特征。关于肛交周围的行为，目前还缺乏观察数据。我们建议描述448名在过去一个月中报告有接受性肛交(RAI)的男性和448名报告在过去12个月中有接受性肛交(RAI)的女性的肛交行为的物理和机械细节，包括HIV阳性和阴性受试者。目的：评估已报道的肛交男女的肛门症状水平和预测准确性，以及肛交对症状的影响。 研究人群：在四年的时间里，马里兰州巴尔的摩和加利福尼亚州洛杉矶将招募896名成年人参加。样本将包括448名年龄在18岁或以上的男性和448名女性。符合研究资格标准的受试者将根据性别、性行为和艾滋病毒状况被分成8个研究组中的一个。 结果指标：这是一项观察性研究。我们将建立与性行为相关的基线肛门直肠症状，比较不同组之间的报告，并与包括感染在内的临床诊断相关联。肛交的各个方面将根据性别、伴侣类型、性行为地点和艾滋病毒状况进行比较。

This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. Introduction: The proposed research study is a cross-sectional, observational, single-visit study of 896 men and women in Los Angeles, California, and Baltimore, Maryland, including: (1) a computer-assisted interview focusing on the behavioral repertoire surrounding receptive anal intercourse (RAI), anal symptomology, and a multidimensional assessment of behaviors, (2) an anorectal examination, and (3) testing for HIV and sexually transmitted infections (STIs). The overall aim of the study is to collect descriptive data regarding anal sexual behaviors and anal health for both women and men in order to provide baseline information for the future study and development of rectal microbicides. Background & Rationale: Los Angeles and Baltimore are cities with large epidemics of STIs and HIV that are in need of alternative methods of prevention to condom use. Rectal microbicides have great potential in these environments to impact their thriving HIV epidemics. Anal intercourse is a sexual practice with high probability of transmission of STIs and HIV, however, there is little descriptive data about factors that may affect infection transmissibility during intercourse. Descriptive baseline data will be needed in order to adequately design interventions that aim to reduce infection transmissibility through the use of novel prevention methods, such as rectal microbicides. There have been few clinical trials on rectal microbicides and mixed findings from the few existing studies. Research may better characterize the different circumstances that may arise given the types of partnerships in which the product is used (i.e. steady partners vs. non-steady partners), physical locations (home vs. outside the home), and circumstances in which sex is performed, that may restrict methods of administration of the product. Formative research is needed to explore perceptions of the utility and self-efficacy of using rectal microbicides outside of an ongoing partnership and the dynamics of situations in which sex occurs. Study Questions (Objectives): Objective 1: To describe behavioral features of anal intercourse that will affect microbicide utilization and administration. There is a dearth of observational data on the behaviors surrounding anal intercourse. We propose to describe physical and mechanical details of behaviors surrounding anal intercourse of 448 men who report practice of receptive anal intercourse (RAI) in the past month and 448 women who report practice of RAI in the past 12 months, including both HIV-positive and negative subjects. Objective 2: To assess the level of and predictive accuracy of reported anal symptomology among women and men who practice anal intercourse and the effect of anal coitus on symptoms. Study Population: 896 adults will be recruited for participation in Baltimore, Maryland, and Los Angeles, California, over a four year period. The sample will include 448 men and 448 women aged 18 or older. Subjects meeting study eligibility criteria will be sorted into 1 of 8 study groups, based on gender, sexual practice, and HIV status. Outcome Measures: This is an observational study. We will establish baseline anorectal symptomology related to sexual activity, compare reports between groups and correlate with clinical diagnoses, including infections. Aspects of anal intercourse will be compared by gender, partner type, location of sex, and HIV status.