Administrative supplement to Lifecourse study for replacement freezer

更换冰箱生命历程研究的行政补充

• 批准号: 9127424
• 负责人: Raymond Scott McClelland
• 金额: $ 3.02万
• 依托单位: UNIVERSITY OF WASHINGTON
• 依托单位国家: 美国
• 财政年份: 2015
• 资助国家: 美国
• 起止时间: 2015-09-01 至 2016-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9127424
• 关键词: AIDS prevention; Abstinence; Accounting; Acquired Immunodeficiency Syndrome; Address; Adherence; Administrative Supplement; Affect; Africa; Africa South of the Sahara; African; Area; Behavior; Behavioral; Biological; Biological Markers; Clinic; Clinical Trials; Cohort Studies; Collection; Contraceptive methods; Couples; Data; Data Collection; Development; Dose; Event; Failure; Female; Fertility; Focus Groups; Frequencies; Generations; Goals; HIV; HIV Infections; HIV Seropositivity; HIV-1; Hour; Individual; Infection; Interview; Life; Link; Longevity; Longitudinal Studies; Maternal and Child Health; Measurement; Menopause; Outcome; Participant; Patient Self-Report; Pattern; Pharmaceutical Preparations; Plasma; Population; Population Study; Pregnancy; Prevention; Prevention Research; Prevention program; Prevention strategy; Prostate-Specific Antigen; Public Health; Questionnaires; Recruitment Activity; Reproductive Health; Research; Research Priority; Risk; Risk Behaviors; Risk Factors; Series; Sexual Partners; Sexually Transmitted Diseases; Social Behavior; Time; Treatment Efficacy; Treatment Failure; United States National Institutes of Health; Unsafe Sex; Variant; Viral Load result; Virus; Woman; antiretroviral therapy; base; cohort; condoms; design; experience; genital secretion; improved; interdisciplinary approach; multidisciplinary; pandemic disease; pregnant; primary outcome; programs; prospective; randomized trial; reproductive; sex; sex risk; sperm cell; therapy adherence; therapy development; transmission process

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.

描述（由申请人提供）：2009 年估计有 260 万艾滋病毒新增感染者，世界距离实现联合国艾滋病规划署零新增感染的雄心勃勃的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 财年跨 NIH 艾滋病研究的首要任务。最近的观察和随机试验证据表明，为 HIV 阳性个体提供的治疗可以将病毒传播给其性伴侣的机会减少多达 96%，因此迫切需要一种新的范式来重新定义我们对传播的理解潜力，因为它同时与性风险行为和 ART 暴露相关。对于艾滋病毒呈阳性的女性来说，现在可以在终身治疗的情况下预期延长生存期，这将需要了解传播潜力在整个生命周期中与关键生殖健康事件的关系如何变化，包括避孕、生育愿望、怀孕、产后期和更年期（以下简称生命历程事件）。我们在这一系列多学科定量和定性研究中的目标是描述与这些重要的生命历程事件相关的艾滋病毒阳性肯尼亚妇女传播潜力的变化的存在、程度和背景基础。收集互补的行为和生物学终点的前瞻性队列设计将提供关于生命历程事件与传播潜力之间关联的存在和时间顺序的有力证据，传播潜力被定义为晚期 ART 补充中的无保护​​性行为。这项开放队列研究将包括 360 名艾滋病毒呈阳性的肯尼亚妇女，她们在蒙巴萨和内罗毕接受了抗逆转录病毒治疗。将招募参与者代表三个不同且重要的风险群体；夫妻关系不和的妇女、妇幼保健院的孕妇和产后妇女、女性性工作者。这种多样性将提供实质性的普遍性，并有机会识别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加深我们对行为变化的社会行为背景的理解。我们能够利用蒙巴萨一群艾滋病毒阳性女性的持续数据收集提供了独特的优势，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疗法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的生殖生命过程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。这些数据预计将指导项目的实施，并为新一代临床试验的开发提供信息，以在有效使用抗逆转录病毒治疗将与安全套和禁欲并列的时代，作为积极预防的基石，优化预防。