PHASES Adolescence

项目概要/摘要 怀孕青少年在艾滋病毒背景下面临协同挑战——孕产妇感染风险增加， 与感染艾滋病毒的成年女性相比，垂直传播以及孕产妇和胎儿的发病率和死亡率 – 基本上缺乏为预防和治疗策略提供信息的证据基础。尽管全球范围不断增加 对少女和年轻妇女艾滋病毒的关注，并就迫切需要 在艾滋病毒研究议程中关注孕妇，在怀孕交叉点持续存在复杂性 青少年时期对于将其纳入研究更加沉默。该项目旨在解决 这些问题和困惑围绕着将怀孕青少年纳入研究的伦理许可性。 为此，我们将在我们团队通过 R01 NIAID 资助的重大贡献的基础上继续努力 PHASES 项目（怀孕与艾滋病毒/艾滋病：寻求公平研究），制定了道德指南 促进成年孕妇负责任地参与预防和治疗艾滋病毒/艾滋病的研究 感染。我们的目标以 PHASES 调查结果和 PHASES 道德指南中的核心共识原则为基础 旨在为开展符合伦理道德的艾滋病毒/合并感染研究提供经验指导 怀孕的青少年。为了实现这一目标，青春期阶段的目标是： 1) 确定以下方面的科学优先事项： 开展艾滋病毒/合并感染预防和治疗研究的已知障碍和推动因素 通过与艾滋病毒研究和宣传中的利益相关者进行访谈和接触，对怀孕青少年进行调查 美国和南部非洲的社区，包括调查人员、社区咨询委员会成员，以及 艾滋病毒青年倡导者；并描述围绕参与此类研究的推理 通过对感染艾滋病毒或有感染艾滋病毒风险的怀孕青少年进行访谈，了解受影响青少年的观点 美国和南部非洲； 2) 确定孕妇进行负责任的艾滋病毒/合并感染研究的条件 通过学术研究对上述优先事项、障碍、推动因素和观点做出反应的青少年 道德和监管分析，以及与参与道德和监管的利益相关者的访谈和互动 对研究的监管审查和监督，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) 制定一个针对青少年的框架来推进艾滋病毒研究 怀孕期间，其效用和可接受性将由艾滋病毒研究和宣传的利益相关者进行审查 社区以及参与研究伦理和监管监督的人员，描述何时和 在什么情况下怀孕青少年可以而且应该被纳入艾滋病毒/合并感染研究。 通过严格的方法设计以及项目的个人和协作经验 实证研究、道德分析和道德指导发展的研究者，该项目旨在 为怀孕青少年的艾滋病毒/合并感染研究确定一条明确的前进道路，并响应伦理道德 以及监管方面的担忧阻碍了这一关键的、被忽视的群体的证据基础。

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.