The PHASES Project: Pregnancy and HIV/AIDS-Seeking Equitable Study

PHASES 项目：怀孕和艾滋病毒/艾滋病寻求公平研究

• 批准号: 9306752
• 负责人: ANNE Drapkin LYERLY
• 金额: $ 83.72万
• 依托单位: UNIV OF NORTH CAROLINA CHAPEL HILL
• 依托单位国家: 美国
• 财政年份: 2015
• 资助国家: 美国
• 起止时间: 2015-08-01 至 2019-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9306752
• 关键词: AIDS prevention; AIDS/HIV problem; Address; Adoption; Affect; African; Anti-Retroviral Agents; Area; Benefits and Risks; Caring; Child; Clinical; Communities; Comorbidity; Complex; Confusion; Consensus; Consultations; Data; Development; Device or Instrument Development; Dose; Drug Kinetics; Drug resistance in tuberculosis; Empirical Research; Equilibrium; Ethical Analysis; Ethical Theory; Ethics; Fetal Development; Fetus; Foundations; Funding; Goals; Guidelines; HIV; HIV Infections; HIV risk; Health; Health Policy; Individual; Infection; International; Knowledge; Laws; Legal; Life Cycle Stages; Maternal and Child Health; Mediation; Methodology; Mission; Morals; Patients; Pharmaceutical Preparations; Pharmacodynamics; Physiological; Policies; Pregnancy; Pregnancy Rate; Pregnant Women; Prevention; Prevention strategy; Preventive; Public Health; Published Comment; Research; Research Design; Research Ethics; Research Personnel; Risk; Risk Factors; Safety; Schedule; Science; Series; Social Responsibility; Southern Africa; Toxic effect; United States National Institutes of Health; Woman; Women' s Health; base; burden of illness; co-infection; condoms; design; disability; disorder risk; drug development; drug metabolism; effective therapy; evidence base; experience; improved; microbicide; minimal risk; novel; offspring; pre-exposure prophylaxis; pregnant; prevent; public health relevance; transmission process; treatment strategy

 DESCRIPTION (provided by applicant): Evidence to inform treatment and prevention strategies for the 16 million women living with HIV worldwide, 280,000 in the US, and millions more women at risk for HIV infection, is critically thwarted by questions and confusions about the ethical and legal permissibility of including pregnant women in various stages of research trials. Concerns have led to a dearth of evidence to guide pressing areas of HIV management, including dose, schedule and toxicity of new antiretrovirals for pregnant women, treatments for drug- resistant TB co-infection, and preventive agents for women who are pregnant. This leads to suboptimal care, since pregnancy entails physiologic changes affecting drug metabolism and the presence of the fetus raises particular concerns about safety. Both emphasize the importance of reasoned decisions about treatment regime, based on evidence garnered in research settings. Instead, the tendency has been to preclude research and export risk to clinical settings. Progress on this complex and multifaceted issue requires engaging research, ethics, regulatory and legal communities to develop sustainable and practical ways forward for HIV research and pregnancy. Initiated with NIH R56 bridge funding and led by a team of internationally recognized leaders in ethics, law, HIV and women's health and through integrated empirical research, stakeholder engagement, and ethical and legal analyses, the PHASES (Pregnancy and HIV/AIDs: Seeking Equitable Study) Project aims to develop guidance critical to advancing the health needs of pregnant women with and at risk for HIV through responsible research strategies, specifically: 1) To expand identification of scientific priorities in, perceived barriers to and novel research design solutions to the conduct of HIV research in pregnancy through engagement with the HIV research community in the US and Southern Africa, including HIV investigators, IRB professionals, and policy officials; and to characterize reasoning around participation in such studies through engagement with pregnant women with or at risk for HIV - in both U.S. and African settings, 2) To conduct scholarly legal and ethical analysis of conditions for responsible HIV research with pregnant women that is responsive to these priorities, barriers and viewpoints and developed through iterative engagement with academic and regulatory experts; and 3) To develop and aggressively disseminate to the HIV research community a Concrete, Engagement-Driven Guidance Document , whose utility has been established by a series of expert vetting panels, delineating when and under what circumstances pregnant women should be included in HIV research. Given the diverse groups engaged, rigorous design, and the individual and collaborative experience of the investigators, this project will identify a clear path forward for HIV research i pregnancy that will be instrumental in shifting policies and practices that have hampered the evidence base for optimizing the health of women and offspring at risk or infected with HIV.

 描述（适用于适用）：为全世界享有艾滋病毒的1600万妇女，280,000名妇女的治疗和预防策略提供信息的证据，以及数百万妇女有艾滋病毒感染风险的妇女，对有关包括研究试验的各个孕妇在内的伦理和法律权限的问题和困惑都严重阻碍了艾滋病毒感染的风险。担心导致了证据死亡，以指导艾滋病毒管理的压迫区域，包括针对孕妇的新抗逆转录病毒剂的剂量，时间表和毒性，耐药结核病的治疗方法以及针对怀孕妇女的预防剂。这导致了次优护理，因为妊娠实体生理变化影响了药物代谢，并且胎儿的存在引起了人们对安全的特别关注。两者都强调了基于研究环境中获得的证据的有关治疗制度的共鸣的重要性。相反，这种趋势是排除研究和出口风险到临床环境。在这个复杂而多方面的问题上的进展需要参与研究，道德，监管和法律社区，以发展可持续和实用的艾滋病毒研究和妊娠方面。由NIH R56桥梁资金发起，由一支由国际公认的伦理，法律，艾滋病毒和妇女健康领域的领导者领导，通过综合经验研究，利益相关者的参与以及伦理和法律分析，阶段（怀孕和艾滋病毒/艾滋病/艾滋病：寻求公平研究）的策略，旨在促进健康的妇女的策略，并促进孕妇的健康范围。通过与美国和南部非洲的艾滋病毒研究社区的参与，包括艾滋病毒研究者，IRB专业人员和政策官员，确定了对怀孕艾滋病毒研究的障碍，对艾滋病毒研究进行艾滋病毒研究的障碍和新颖研究设计解决方案的识别；并通过与患有艾滋病毒或有艾滋病毒风险的孕妇参与或有艾滋病毒风险的孕妇参与来表征推理 - 在美国和非洲环境中，2）对与孕妇的负责任艾滋病毒研究的科学法律和道德分析，对这些优先级，障碍和观点有反应，并通过与学术和监管专家的迭代参与而发展； 3）要开发和积极向艾滋病毒研究界传播一个具体，参与驱动的指导文件，其效用是由一系列专家审查小组建立的，并在何时以及在何时应将孕妇包括在艾滋病毒研究中。鉴于潜水员团体参与，严格的设计以及调查人员的个人和协作经验，该项目将确定艾滋病毒研究的明确途径，这将有助于转移政策和实践，这些政策和实践妨碍了证据基础，以妨碍优化妇女健康和后代处于风险或感染艾滋病毒或感染HIV的证据基础。