PHASES Adolescence

项目摘要/摘要 在艾滋病毒--产妇感染风险增加的背景下，怀孕的青少年面临协同作用的挑战， 与感染艾滋病毒的成年妇女相比，垂直传播、孕产妇和胎儿发病率和死亡率- 以及基本缺乏为预防和治疗战略提供信息的证据基础。尽管全球范围内 关注青春期女孩和年轻妇女的艾滋病毒问题，并就迫切需要 关注艾滋病毒研究议程中的孕妇，在怀孕的交叉点上持续存在复杂性 青春期扩大了对他们参与研究的沉默。该项目旨在解决 这些问题和困惑围绕着将怀孕青少年纳入研究的伦理允许性。 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再接再厉 阶段项目(怀孕和艾滋病毒/艾滋病：寻求公平研究)，制定了道德指导 推动将成年孕妇负责任地纳入预防和治疗艾滋病毒/艾滋病的研究 感染。以阶段性成果和核心共识原则为基础的阶段性道德指导，我们的目标 是为进行道德上负责任的艾滋病毒/联合感染研究提供经验性的指导 怀孕的青少年。为了实现这一目标，青春期阶段的目标是：1)确定科学优先事项， 开展艾滋病毒/联合感染预防和治疗研究的公认障碍和推动因素 通过与艾滋病毒研究和宣传中的利益攸关方面谈和接触怀孕青少年 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和 艾滋病毒青年倡导者和；并描述关于参与此类研究的理由 通过对中国艾滋病毒携带者或有感染风险的怀孕青少年的访谈，了解受影响青少年的观点 美国和南部非洲；2)确定负责任的艾滋病毒/孕妇合并感染研究的条件 对上述优先事项、障碍、促进因素和观点作出反应的青少年，通过学术 道德和法规分析，以及与参与道德和法规分析的利益相关者进行访谈和接触 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 伦理委员会成员；以及3)制定专门针对青少年的框架，以推动艾滋病毒研究 怀孕期间，其效用和可接受性将由艾滋病毒研究和宣传中的利益攸关方审查 社区，以及参与研究的道德和监管监督的社区，描述何时和 在什么情况下，怀孕的青少年可以而且应该被纳入艾滋病毒/联合感染研究。 通过严格的方法论设计和项目的个人和协作体验 研究人员在实证研究、道德分析和伦理指导方面的发展，本项目旨在 确定对怀孕青少年进行艾滋病毒/联合感染研究的明确前进道路，以响应伦理道德 以及监管方面的担忧，这些担忧阻碍了这一关键、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.