Integrating Decision Making Studies into HIV Cure Trials: A real-time longitudinal assessment

项目摘要/摘要 艾滋病毒治愈试验为改变患者及其伴侣的生活提供了一个强大的机会。然而， 这些前沿研究提出了一些伦理问题，包括如何在面临 不确定的科学效用加上高潜在风险，以及如何确保关于参与的决策 消息灵通。这项拟议的研究采用了一种动态的生命伦理学方法，将概念 以及艾滋病毒治疗研究的实证评估，以推动解决伦理挑战。这个 这项研究利用了目前正在进行的第一批也是规模最大的一组艾滋病毒治愈试验 世界上任何地方。泰国的五项计划试验采用了各种研究设计，所有这些设计都包括分析 治疗中断，所有新兵都来自一个相对健康的、艾滋病毒+患者的独特队列，在 感染的急性期。HIV治愈临床试验团队，敏锐地意识到相关的伦理问题 通过这项研究，邀请我们的团队在这些试验中嵌套一项纵向决策和伦理研究。 我们在泰国的初步工作包括培训社会科学研究人员，开发仪器 通过社区参与，并在试验前从队列中的个人获得基线调查数据 招聘。拟议的项目包括三个相互关联的目标。1)评估与加入有关的因素 或拒绝参与、试验经历的心理社会影响和决策满意度。该项目的 纵向设计允许评估意图、行为以及对风险和收益感知的变化 随着时间的推移，这比以前的大多数临床试验决策研究都有了进步。2)发展一种透明、 与临床试验团队分享研究结果的伦理方法，以改进研究过程 和参与者在试验过程中的体验。这一目标解决了未被充分探索的问题，即 以及这些发现应该如何分享。3)运用深思熟虑的方法，为改进创造指导 艾滋病毒治愈试验的道德行为。这一目标需要一个由多方利益相关者组成的委员会来严格审查 目标1和目标2的规范性和经验性结论，以制定伦理建议。建议数 该项目整合了多个传播点的共享研究成果和审议结果。我们预计 我们的发现将对未来的艾滋病毒临床试验研究产生广泛的影响。

Project Summary/ Abstract HIV cure trials present a powerful opportunity to change the lives of patients and their partners. However, these cutting-edge studies raise a number of ethical concerns, including how to conduct trials in the face of uncertain scientific utility coupled with high potential risk, as well as how to ensure decisions about participation are well informed. The proposed study employs a dynamic approach to bioethics that combines conceptual and empirical assessments of HIV cure research in order to advance solutions to ethical challenges. The study takes advantage of one of the first, and certainly the largest, set of HIV cure trials currently underway anywhere in the world. Five planned trials in Thailand employ a variety of study designs that all include analytic treatment interruption, and all recruit from a unique cohort of relatively healthy, HIV+ individuals identified at the acute stage of infection. The HIV cure clinical trials team, keenly aware of the ethical concerns associated with this research, invited our group to nest a longitudinal decision-making and ethics study within these trials. Our preliminary work in Thailand has included training social science researchers, developing instruments through community engagement, and obtaining baseline survey data from individuals in the cohort prior to trial recruitment. The proposed project includes three interrelated aims. 1) To assess factors associated with joining or declining participation, psychosocial impacts of trial experiences, and decision satisfaction. The project's longitudinal design allows assessment of intentions, behaviors, and changes in perception of risks and benefits over time, an advance over most previous clinical trial decision-making studies. 2) To develop a transparent, ethical approach to sharing study outcomes with the clinical trials team, in order to improve study processes and participant experiences during the course of trials. This aim addresses under-explored questions of when and how such findings should be shared. 3) To apply deliberative methods to create guidance for improving the ethical conduct of HIV cure trials. This aim convenes a multi-stakeholder committee to critically examine normative and empirical findings of Aims 1 and 2, in order to develop ethical recommendations. The proposed project integrates sharing study outcomes and deliberative results at multiple dissemination points. We expect that our findings will have broad implications for future HIV clinical trials research.