Following a U.S. National Cohort of Vulnerable Men to Improve HIV Prevention and Care

项目摘要 RFA-AI-16-031（LITE）旨在通过使用创新的方法来满足艾滋病毒预防研究的关键需求。 在这方面，我们需要一种新的技术，以登记和跟踪感染风险最高者的大规模流行病学队列。的 拟议的项目将利用既定的基于互联网的战略，以前成功地用于研究 研究小组招募了5,000名高风险的艾滋病毒阴性同性恋、双性恋和其他男男性行为者的样本 (GBM)年龄在16至49岁之间的人-这一人群每年新感染的比例最高， 跟踪他们四年。我们建议的设计特点是专门为：（a） 鉴定HIV血清转化个体、网络和背景水平的预测因子和相关因子，（B）鉴定 在研究过程中，在血清转化者中错过了艾滋病毒预防机会，因此（c） 采取知情干预措施，进一步减少感染和传播。 我们将“高风险”定义为符合CDC的PrEP治疗指南，但不服用PrEP。 完成每年一次的自我管理的家庭快速艾滋病毒检测（通过检测的数码照片提交结果 桨）以及简短的（约20分钟）在家里的计算机化调查。除了接受治疗外， 血清转换的研究参与者将完成半结构化电话访谈，以确定遗漏的HIV 预防机会和所涉及的背景因素。我们将监测新诊断的参与者 通过艾滋病毒护理连续体的运动。根据目前的发病率，我们预计 研究期间约有252例感染;然而，由于我们针对的是高危男性，因此这个数字可能是 高 目标1（UG 3阶段）：建立一个由5,000名未接受PrEP的高危HIV阴性GBM组成的队列，所有患者均为 完成基线在线调查和在家自我管理的艾滋病毒检测，以及同意 纵向随访。确定研究入组后12个月的PrEP摄取和HIV发病率。 补充目的：使用筛选期间被视为不合格的GBM的横断面数据 资格：UP。目标1a-估计PrEP的摄取;和Sup.目标1b-鉴别漏诊的艾滋病毒 预防机会（例如，没有事先使用PrEP的原因）。 目标2（UH 3阶段）：跟踪队列4年，以表征（2a）个人/网络/背景水平 PrEP摄取/中止的决定因素;（2b）新的HIV血清转换和错过的HIV预防 机会，包括个人/网络/背景一级的决定因素;（2c） 艾滋病毒发病率及其随时间的趋势;（2d）PrEP摄取对种族/民族差异的影响。

Project Summary RFA-AI-16-031 (LITE) is designed to address critical needs in HIV prevention research by using innovative technology to enroll and follow large-scale epidemiological cohorts of those at highest risk of infection. The proposed project will utilize established Internet-based strategies, previously used successfully by the research team, to enroll a sample of 5,000 high-risk HIV-negative gay, bisexual, and other men who have sex with men (GBM) ages 16 to 49—the population representing the highest percentage of new infections annually—and follow them prospectively for four years. The design features of our proposal were chosen specifically to: (a) identify individual-, network-, and contextual-level predictors and correlates of HIV seroconversion, (b) identify missed HIV prevention opportunities among those seroconverting during the course of the study, and, thus (c) inform interventions to further reduce acquisition and transmission. We define “high-risk” as meeting CDC guidelines for PrEP treatment, but not taking PrEP. Participants will complete annual self-administered at-home rapid HIV testing (results submitted via digital photo of the test paddle) as well as brief (~20 min) at-home computerized surveys. In addition to being referred for treatment, study participants who seroconvert will complete a semi-structured telephone interview to identify missed HIV prevention opportunities and the contextual factors involved. We will monitor newly diagnosed participants' movement through the HIV care continuum. Based on current incidence rates, we anticipate accumulating ~252 infections during the study; however, because we are targeting high-risk men, this number could be higher. Aim 1 (UG3 Phase): Establish a cohort of 5,000 high-risk HIV-negative GBM who are not on PrEP, all of whom complete baseline online surveys and at-home self-administered HIV testing, as well as consent for longitudinal follow-up. Determine PrEP uptake and HIV incidence 12 months after study enrollment. Supplemental Aims: Using the cross sectional data from GBM deemed ineligible during screening for study eligibility: Sup. Aim 1a—Estimate the uptake of PrEP; and Sup. Aim 1b—Characterize missed HIV prevention opportunities (e.g., reasons for no prior PrEP use) among recent HIV seroconverters. Aim 2 (UH3 Phase): Follow the cohort for four years to characterize (2a) individual/network/contextual-level determinants of PrEP uptake/discontinuation; (2b) new HIV seroconversions and missed HIV prevention opportunities, including individual/network/contextual-level determinants; (2c) racial/ethnic disparities in HIV incidence and their trends over time; and (2d) the influence of PrEP uptake on racial/ethnic disparities.