Administrative supplement to Lifecourse study for replacement freezer

描述（由申请人提供）：2009年估计有260万新的艾滋病毒感染，世界距离实现联合国艾滋病规划署雄心勃勃的零新感染目标还有很长的路要走。在此背景下，预防HIV-1传播已被确定为2012财政年度跨nih艾滋病研究的首要任务。最近的观察性和随机试验证据表明，向艾滋病毒阳性个体提供治疗可将病毒传播给其性伴侣的几率降低多达96%，因此迫切需要一种新的范式，重新定义我们对传播潜力的理解，因为它同时涉及性风险行为和抗逆转录病毒治疗。对于艾滋病毒阳性妇女来说，她们现在可以在终身治疗的情况下延长生存期，这将需要了解在整个生命周期中传播可能性与关键生殖健康事件的关系，包括避孕决定、生育愿望、怀孕、产后期和更年期（以下简称生命过程事件）。在这个多学科的定量和定性研究系列中，我们的目标是描述艾滋病病毒阳性肯尼亚妇女传播潜力变化的存在、幅度和背景基础，这些变化与这些重要的生命历程事件有关。收集补充性行为和生物学终点的前瞻性队列设计将提供强有力的证据，证明生命过程事件与传播潜力（定义为晚期抗逆转录病毒治疗背景下的无保护性行为）之间存在关联和时间顺序。这项公开队列研究将包括360名艾滋病毒阳性的肯尼亚妇女，她们在蒙巴萨和内罗毕接受抗逆转录病毒治疗。参与者将被招募来代表三个不同且重要的风险群体；不和谐夫妻中的妇女、妇幼保健诊所的孕妇和产后妇女以及女性性工作者。这种多样性将提供实质性的普遍性，并有机会确定三个风险群体之间传播潜力的重要差异。深入访谈和焦点小组讨论将增加我们对行为变化的社会行为背景的理解。我们利用蒙巴萨一组艾滋病毒阳性妇女的持续数据收集能力提供了独特的优势，因为这将使我们能够评估研究人群子集10多年来传播潜力的变化。这些研究将提供最全面的数据，以了解接受抗逆转录病毒治疗的艾滋病毒阳性非洲妇女的传播潜力。这项研究将直接改善公共卫生，从认识到艾滋病毒阳性妇女生殖生命周期事件对其传播潜力的潜在深远影响的角度，扩大我们对艾滋病毒预防的理解。预计这些数据将指导规划的实施，并为开展新一代临床试验提供信息，以优化预防工作。在这个时代，有效使用抗逆转录病毒药物将与避孕套和禁欲一起成为预防阳性病例的基石。

DESCRIPTION (provided by applicant): With an estimated 2.6 million new HIV infections in 2009, the world remains a long way from reaching the ambitious UNAIDS goal of zero new infections. In this context, prevention of HIV-1 transmission has been identified as a top Fiscal Year 2012 Trans-NIH AIDS Research Priority. In the wake of recent observational and randomized trial evidence that treatment provided to HIV-positive individuals can reduce transmission of the virus to their sex partners by as much as 96%, there is an urgent need for a new paradigm that redefines our understanding of transmission potential as it relates simultaneously to both sexual risk behavior and ART exposure. For HIV-positive women, who can now anticipate prolonged survival in the context of lifelong treatment, this will require an understanding of how transmission potential varies across the lifespan in relation to key reproductive health events including decisions about contraception, fertility desire, pregnancy, the post partum period, and menopause (hereafter, lifecourse events). Our objective in this multidisciplinary series of quantitative and qualitative studies is to characterize the presence, magnitude, and contextual basis of variations in HIV-positive Kenyan women's transmission potential in relation to these important lifecourse events. A prospective cohort design with collection of complementary behavioral and biological endpoints will provide strong evidence regarding the presence and temporal sequence of associations between lifecourse events and transmission potential, defined as unprotected sex in the setting of late ART refills. The open cohort study will include 360 HIV-positive Kenyan women who are offered ART in Mombasa and Nairobi. Participants will be recruited to represent three distinct and important risk groups; women in discordant couples, pregnant and post-partum women from maternal and child health clinics, and female sex workers. This diversity will provide substantial generalizability, as well s an opportunity to identify important differences in transmission potential between the three risk groups. In-depth interviews and focus group discussions will add to our understanding of the sociobehavioral context for changes in behavior. Our ability to leverage ongoing data collection from a cohort of HIV-positive women in Mombasa provides a unique advantage, as this will allow us to evaluate changes in transmission potential over more than 10 years in a subset of the study population. These studies will provide the most comprehensive data available to understand transmission potential in HIV-positive African women treated with ART. This research will directly improve public health, expanding our understanding of HIV prevention from a perspective that recognizes the potentially profound influence of HIV-positive women's reproductive lifecourse events on their transmission potential. These data are expected guide program implementation and inform development of a new generation of clinical trials to optimize prevention in an era where effective use of ART will take its place alongside condoms and abstinence as a cornerstone of prevention in positives.