PHASES Adolescence

项目总结/摘要 怀孕少女在艾滋病毒方面面临着协同作用的挑战-孕产妇感染的风险增加， 垂直传播以及与感染艾滋病毒的成年妇女相比的孕产妇和胎儿发病率和死亡率- 以及在很大程度上缺乏为预防和治疗战略提供信息的证据基础。尽管全球 关注少女和年轻妇女中的艾滋病毒问题，并就迫切需要 在艾滋病毒研究议程中关注孕妇， 和青春期加剧了人们对将他们纳入研究的沉默。该项目旨在解决 这些问题和困惑围绕着将怀孕的青少年纳入研究的道德允许性。 为此，我们将在我们的团队通过R 01 NIAID资助的 PHASES项目（怀孕与艾滋病毒/艾滋病：寻求公平研究），该项目制定了一项道德准则， 促进负责任地将成年孕妇纳入预防和治疗艾滋病毒/艾滋病的研究， 感染.基于PHASES研究结果和PHASES伦理指南中的核心共识原则，我们的目标是 是提供经验指导，进行道德上负责的艾滋病毒/合并感染研究， 怀孕少女为了实现这一目标，青少年阶段的目标是：1）确定科学的优先事项， 开展艾滋病毒/合并感染预防和治疗研究的已知障碍和有利因素， 通过与艾滋病毒研究和宣传方面的利益攸关方进行访谈和接触， 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， 艾滋病毒青年倡导者和;并说明参与这类研究的理由， 通过与艾滋病毒感染或有感染风险的怀孕少女的访谈， 美国和南部非洲; 2）确定负责的艾滋病毒/合并感染研究的条件， 通过学术交流，鼓励对上述优先事项、障碍、促进因素和观点作出反应的青少年， 道德和监管分析，与参与道德和监管的利益相关者进行访谈和接触， 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 伦理委员会成员;以及3）制定一个推进艾滋病毒研究的具体框架 在怀孕期间，其效用和可接受性将由艾滋病毒研究和宣传的利益攸关方审查。 社区，以及那些参与研究的伦理和监管监督，划定何时和 在什么情况下怀孕少女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和项目的个人和协作经验， 在实证研究，道德分析和道德指导发展的调查，这个项目的目的是 为怀孕少女的艾滋病毒/合并感染研究确定明确的前进道路， 以及监管方面的担忧，这些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.