PHASES Adolescence

阶段青春期

• 批准号: 10326668
• 负责人: ANNE Drapkin LYERLY
• 金额: $ 75.3万
• 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 2025-07-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10326668
• 关键词: AIDS/HIV problem; Address; Adolescence; Adolescent; Adult; Advocacy; Advocate; Affect; Africa South of the Sahara; Area; Attention; Birth; Child; Committee Members; Communities; Complex; Confusion; Consensus; Consent; Development; Empirical Research; Ethicists; Ethics; Face; Female Adolescents; Funding; Goals; HIV; Health; Individual; Infection; International; Interview; Methodology; Minor; Mission; Morals; Morbidity - disease rate; National Institute of Allergy and Infectious Disease; Parents; Policies; Pregnancy; Pregnant Women; Prevention; Prevention Research; Prevention strategy; Public Health; Published Comment; Qualitative Research; Recommendation; Research; Research Ethics Committees; Research Personnel; Resources; Risk; Safety; Science; Social Responsibility; Southern Africa; Surface; Time; United States National Institutes of Health; Ursidae Family; Vertical Disease Transmission; Woman; Youth; base; burden of illness; co-infection; design; disability; effective therapy; evidence base; experience; fetal; improved; maternal risk; member; mortality; neglect; offspring; pandemic disease; pregnant; pregnant teen; prevent; treatment research; treatment strategy; waiver; working group; young woman

PROJECT SUMMARY/ABSTRACT Pregnant adolescents face synergistic challenges in the context of HIV – heightened risk of maternal infection, vertical transmission, and maternal and fetal morbidity and mortality compared to adult women living with HIV – and a largely absent evidence base to inform prevention and treatment strategies. Despite increasing global attention on HIV among adolescent girls and young women, and strong consensus around the urgent need to attend to pregnant women in the HIV research agenda, persisting complexities at the intersection of pregnancy and adolescence have amplified reticence around their inclusion in research. This project seeks to address these questions and confusions around the ethical permissibility of including pregnant adolescents in research. To this end, we will build on the substantial contributions our team has made through the R01 NIAID funded PHASES Project (Pregnancy and HIV/AIDS: Seeking Equitable Study), which developed an Ethics Guidance to advance the responsible inclusion of adult pregnant women in research to prevent and treat HIV/co- infections. Building on PHASES findings and core consensus principles in PHASES Ethics Guidance, our goal is to provide empirically informed guidance for conducting ethically responsible HIV/co-infections research with pregnant adolescents. To achieve this goal, PHASES Adolescence aims: 1) To identify scientific priorities in, perceived barriers and enablers to conducting HIV/co-infections prevention and treatment research with pregnant adolescents through interviews and engagement with stakeholders in the HIV research and advocacy communities in the US and Southern Africa, including investigators, community advisory board members, and HIV youth advocates and; and to characterize reasoning around participation in such studies from the viewpoints of affected adolescents through interviews with pregnant adolescents with or at risk for HIV in the US and Southern Africa; 2) To identify conditions for responsible HIV/co-infections research with pregnant adolescents that are responsive to the above priorities, barriers, enablers and viewpoints, through scholarly ethical and regulatory analysis, and interviews and engagement with stakeholders involved in the ethical and regulatory review and oversight of research, including ethicists, regulatory and policy experts, and research ethics committee members; and 3) To develop an adolescence-specific framework for advancing HIV research in pregnancy, whose utility and acceptability will be vetted by stakeholders in the HIV research and advocacy communities, and those involved in the ethical and regulatory oversight of research, delineating when and under what circumstances pregnant adolescents can and should be included in HIV/co-infections research. Through a rigorous methodological design and the individual and collaborative experience of project investigators in empirical research, moral analysis, and ethics guidance development, this project aims to identify a clear path forward for HIV/co-infections research with pregnant adolescents, responsive to ethical and regulatory concerns that have hampered the evidence base for this critical, neglected group.

项目摘要/摘要 怀孕的青少年在艾滋病毒的背景下面临协同挑战 - 造物感染的风险增加， 与患有艾滋病毒的成年妇女相比 以及在很大程度上没有证据基础，以告知预防和治疗策略。尽管全球增加 对青春期女孩和年轻女性中的艾滋病毒的关注，以及围绕迫切需要的强烈共识 参加艾滋病毒研究议程中的孕妇 青少年对他们在研究中的包含围绕着沉默。这个项目旨在解决 这些问题和困惑围绕包括怀孕青少年在研究中的道德权限。 为此，我们将建立我们团队通过R01 NIAID资助的实质性贡献 阶段项目（怀孕和艾滋病毒/艾滋病：寻求公平研究），该研究制定了道德指导 促进负责任的成年孕妇研究以预防和治疗艾滋病毒/共同 感染。我们的目标是基于阶段的发现和核心共识原则，我们的目标 是为了通过经验知情的指导来进行道德责任的艾滋病毒/共同感染研究 怀孕的青少年。为了实现这一目标，青少年的目标是：1）确定科学的优先级， 感知的障碍和促成者可以通过 通过访谈和与利益相关者参与艾滋病毒研究和倡导，怀孕的青少年 美国和南部非洲的社区，包括调查人员，社区顾问委员会成员以及 艾滋病毒青年倡导者；并表征围绕参与此类研究的推理 通过与怀孕的青少年的访谈或有艾滋病毒风险的孕育青少年的观点 美国和南部非洲； 2）确定怀孕的负责HIV/共同感染研究的条件 通过科学响应上述优先事项，障碍，推动者和观点的青少年 道德和监管分析，以及与参与道德和的利益相关者的访谈和参与 监管审查和研究，包括伦理学家，监管和政策专家，以及研究 道德委员会成员； 3）开发一个针对艾滋病毒研究的青少年特定框架 在怀孕中，艾滋病毒研究与倡导的利益相关者将审查其效用和可接受性 社区，以及参与研究道德和监管监督的人们，何时及 在什么情况下，孕妇的青少年可以并且应该包括在艾滋病毒/共同感染研究中。 通过严格的方法论设计以及项目的个人和协作经验 研究人员在实证研究，道德分析和道德指导开发方面，该项目旨在 确定与怀孕青少年有关艾滋病毒/共同感染研究的明确途径，对伦理的反应 和监管问题，阻碍了这个批判性，被忽视的群体的证据基础。