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

将决策研究纳入艾滋病毒治疗试验：实时纵向评估

• 批准号: 9297219
• 负责人: Gail E HENDERSON
• 金额: $ 54.99万
• 依托单位: UNIV OF NORTH CAROLINA CHAPEL HILL
• 依托单位国家: 美国
• 财政年份: 2016
• 资助国家: 美国
• 起止时间: 2016-06-15 至 2020-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9297219
• 关键词: Acute; Address; Advocate; Awareness; Baseline Surveys; Behavior; Beneficence; Benefits and Risks; Bioethics; Clinical Trials; Clinical trial protocol document; Collaborations; Communities; Consent Forms; Coupled; Data; Decision Making; Developing Countries; Development; Disease; Disease remission; Educational Materials; Enrollment; Ensure; Epidemic; Ethical Analysis; Ethics; Feedback; Funding; Future; Goals; Guidelines; HIV; HIV Infections; Individual; Infection; Informed Consent; Interruption; Light; Measures; Methods; Motivation; NIH Program Announcements; National Institute of Allergy and Infectious Disease; Nonmaleficence; Outcome; Outcome Study; Participant; Patients; Perception; Phase; Procedures; Process; Protocols documentation; Public Health; Race; Recommendation; Recruitment Activity; Research; Research Design; Research Personnel; Risk; Shapes; Social Sciences; Testing; Thailand; Time; Training; Trust; Uncertain Risk; United States National Institutes of Health; Virus; Virus Replication; Work; antiretroviral therapy; behavior change; cohort; combat; design; education research; ethical legal social implication; expectation; experience; high risk; improved; innovation; instrument; interest; longitudinal design; member; novel therapeutics; patient expectation; phrases; psychosocial; public health relevance; research study; risk perception; satisfaction; shared decision making; tool development; treatment planning; trial design

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.

项目总结/摘要 艾滋病毒治疗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，在这方面， 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定 消息灵通拟议的研究采用了一种动态的方法，生物伦理学，结合概念 和艾滋病毒治疗研究的经验评估，以推进道德挑战的解决方案。的 这项研究利用了目前正在进行的首批，当然也是规模最大的一组艾滋病毒治疗试验之一 世界上任何地方。泰国计划进行的五项试验采用了各种研究设计，所有研究设计都包括分析 治疗中断，所有招募者均来自一个独特的相对健康的HIV+个体队列， 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，邀请我们的小组在这些试验中嵌套一个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，开发工具， 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)评估与加入相关的因素 或参与率下降，试验经历的心理社会影响，以及决策满意度。该项目的 纵向设计允许对意图、行为以及风险和收益感知的变化进行评估 随着时间的推移，这是对大多数以前的临床试验决策研究的进步。2)建立一个透明的， 与临床试验团队分享研究结果的伦理方法，以改善研究过程 和参与者在试验过程中的经历。这一目标解决了未充分探讨的问题， 以及如何分享这些发现。3)应用审议方法，为改进提供指导 艾滋病治疗试验的道德行为这一目标召集了一个多方利益相关者委员会， 目标1和2的规范性和经验性研究结果，以便制定道德建议。拟议 该项目整合了在多个传播点分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临床试验研究产生广泛的影响。