MICROBICIDE DEVELOPMENT PROGRAM

杀菌剂开发计划

• 批准号: 7604699
• 负责人: John B. Hylton
• 金额: $ 0.18万
• 依托单位: JOHNS HOPKINS UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2006
• 资助国家: 美国
• 起止时间: 2006-12-01 至 2007-09-16
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7604699
• 关键词: Adult; Affect; Anus; Baltimore; Behavior; Behavior assessment; Behavioral; California; Cities; Clinical Trials; Coitus; Computer Assisted; Computer Retrieval of Information on Scientific Projects Database; Data; Development; Eligibility Determination; Environment; Epidemic; Funding; Future; Gender; Grant; HIV; HIV Seropositivity; Health; Home environment; Human immunodeficiency virus test; Infection; Institution; Interview; Location; Los Angeles; Maryland; Mechanics; Methods; Observational Study; Outcome Measure; Perception; Population Study; Prevention; Probability; Program Development; Recruitment Activity; Reporting; Research; Research Personnel; Resources; Sampling; Self Efficacy; Sex Behavior; Sexually Transmitted Diseases; Sorting - Cell Movement; Source; Symptoms; United States National Institutes of Health; Visit; Woman; aged; base; clinical Diagnosis; condoms; men; microbicide; novel; rectal microbicide; research study; sex; therapy design; transmission process

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.

这个子项目是许多研究子项目中的一个 由NIH/NCRR资助的中心赠款提供的资源。子项目和 研究者（PI）可能从另一个NIH来源获得了主要资金， 因此可以在其他CRISP条目中表示。所列机构为 研究中心，而研究中心不一定是研究者所在的机构。 简介：拟议的研究是一项在加州洛杉矶和马里兰州巴尔的摩的896名男性和女性中进行的横断面、观察性、单次访视研究，包括：（1）计算机辅助访谈，重点关注接受性肛交（RAI）、肛门直肠病学和行为的多维评估的行为库，（2）肛门直肠检查，以及（3）检测艾滋病毒和性传播感染（STI）。 本研究的总体目的是收集关于女性和男性肛门性行为和肛门健康的描述性数据，以便为未来的研究和直肠杀微生物剂的开发提供基线信息。 背景和理由：洛杉矶和巴尔的摩是性传播感染和艾滋病毒流行严重的城市，需要使用避孕套以外的其他预防方法。 直肠杀微生物剂在这些环境中具有很大的潜力，可以影响其蓬勃发展的艾滋病毒流行。 肛交是一种传播性传播疾病和艾滋病毒的高概率性行为，然而，很少有关于性交过程中可能影响感染传播性的因素的描述性数据。 需要描述性基线数据，以便充分设计旨在通过使用新型预防方法（如直肠杀微生物剂）降低感染传播性的干预措施。 关于直肠杀微生物剂的临床试验很少，现有的几项研究结果也不一致。 研究可以更好地描述可能出现的不同情况，考虑到使用产品的伴侣关系类型（即稳定伴侣与非稳定伴侣），物理位置（家庭与家庭外）以及可能限制产品给药方法的性行为环境。 需要进行形成性研究，以探讨在持续的伙伴关系之外使用直肠杀微生物剂的效用和自我效能的看法，以及发生性行为的情况的动态。 研究问题（目标）：目标一：描述影响杀微生物剂使用和给药的肛交行为特征。 关于肛交行为的观察数据非常缺乏。 我们建议描述的物理和机械细节的行为周围的肛交的448名男性谁报告的做法接受肛交（RAI）在过去的一个月和448名女性谁报告的做法RAI在过去的12个月，包括艾滋病毒阳性和阴性的科目。 目标二：评估肛交女性和男性中报告的肛交学水平和预测准确性，以及肛交对症状的影响。 研究人群：将招募896名成年人参加巴尔的摩、马里兰州和洛杉矶、加州的研究，为期4年。 样本将包括448名男性和448名女性，年龄在18岁或以上。符合研究合格性标准的受试者将根据性别、性行为和HIV状态分为8个研究组之一。 结果测量：这是一项观察性研究。 我们将建立与性活动相关的基线肛门直肠病理学，比较各组之间的报告，并与临床诊断（包括感染）相关。 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。