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: 9417113
• 负责人: ANNE Drapkin LYERLY
• 金额: $ 9.93万
• 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/9417113
• 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; Institutional Review Boards; 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（由申请人提供）：为全球1600万女性艾滋病毒感染者、美国28万女性艾滋病毒感染者以及数百万有艾滋病毒感染风险的女性提供治疗和预防策略的证据，受到有关在研究试验的各个阶段纳入孕妇的伦理和法律的允许性的问题和困惑的严重阻碍。人们的关切导致缺乏证据来指导艾滋病毒管理的紧迫领域，包括孕妇新的抗逆转录病毒药物的剂量、时间表和毒性，耐药结核病合并感染的治疗，以及孕妇的预防药物。这导致了次优护理，因为怀孕会引起影响药物代谢的生理变化，胎儿的存在引起了对安全性的特别关注。两者都强调根据研究环境中收集的证据，对治疗方案作出合理决定的重要性。相反，趋势是排除研究和出口风险的临床设置。要在这一复杂和多方面的问题上取得进展，就需要让研究、伦理、监管和法律的界参与进来，为艾滋病毒研究和怀孕制定可持续和切实可行的前进道路。由美国国立卫生研究院R56桥梁基金发起，由国际公认的伦理、法律、艾滋病毒和妇女健康领导者团队领导，通过综合实证研究、利益相关者参与以及伦理和法律的分析，（怀孕和艾滋病毒/艾滋病：寻求公平的研究）该项目旨在通过负责任的研究，制定对促进感染艾滋病毒和有感染艾滋病毒风险的孕妇的健康需求至关重要的指导意见1）通过与美国和南部非洲的艾滋病毒研究界（包括艾滋病毒调查人员、IRB专业人员和政策官员）的接触，扩大对妊娠期艾滋病毒研究的科学优先事项、感知障碍和新的研究设计解决方案的识别;并通过与感染艾滋病毒或有感染艾滋病毒风险的孕妇的接触来描述参与此类研究的理由--在美国和非洲，2）对孕妇进行负责任的艾滋病毒研究的条件进行学术法律的和伦理分析，这些研究应响应这些优先事项、障碍和观点，并通过与学术和监管专家的反复接触而发展;和3）制定并积极向艾滋病毒研究界传播一份具体的、以参与为导向的指导文件，该文件的效用已由一系列专家审查小组确定，界定何时以及在何种情况下应将孕妇纳入艾滋病毒研究。鉴于参与的不同群体，严格的设计以及研究人员的个人和合作经验，该项目将为妊娠期艾滋病毒研究确定一条明确的前进道路，这将有助于改变阻碍优化风险或感染艾滋病毒的妇女和后代健康的证据基础的政策和做法。