Investigating Psychosocial Experiences of HIV Cure Trial Participants Undergoing Extended HIV Treatment Interruptions: Implications for Ethical Conduct

7.项目总结/摘要 艾滋病毒治疗研究是美国国立卫生研究院的一个高度优先事项， 持续的抗逆转录病毒治疗（ART）免费抑制。然而，由于没有明确的生物标志物， 与作为ART疗效标志的CD 4+计数和病毒载量不同， 一项战略的有效性是要求在其他方面健康的艾滋病毒感染者（PLWH） 这种暂停被称为分析性治疗中断（ATI）， 艾滋病治疗研究的争议方面。此外，为了推进艾滋病毒治疗研究，要求参与者 耐受延长的ATI，这是长时间的高水平不受控制的病毒血症。拟议的目标 研究是调查知情同意过程和参与者的理解和经验， 扩展ATI，并使用强大的共识建立技术来解决最紧迫的道德挑战 艾滋病治疗研究目标1 - 2嵌套在美国四个完全独特的试验中， 共有120名参与者。这些研究是通过艾滋病临床试验小组网络（ACTG）进行的 和加州大学弗朗西斯科分校（UCSF）。目标1将评估30个国家的知情同意质量 参与者通过ATI研究，调查数据将收集测量感知的好处，风险， 了解研究程序、期望和相关的心理社会领域（例如，艾滋病污名化， 弹性）。目标2将从定量和定性两个方面前瞻性地评估下列人员的心理社会经验： 艾滋病毒治疗研究参与者在ATI之前，期间和之后。这涉及到分析战略地位， 从研究进入到退出，完全整合了前瞻性心理社会调查评估和访谈。 调查包括焦虑相关结果的测量，以监测潜在的心理伤害和压力 在ATI期间的级别（以及其他域）。此外，Aim 3还涉及使用混合德尔菲过程， 就应对艾滋病毒治疗研究中不断变化的伦理挑战的战略达成共识。一个专家小组 从美国各地挑选出来参加四轮调查，社区合作伙伴提供意见 在两轮之间的调查结果。目标是围绕如何解决种族和 种族差异和医学上的不信任是参与艾滋病毒治疗研究的障碍（包括生活在 艾滋病毒感染者），如何安全地实施ATI，如何解决心理社会危害，以及如何保护性伴侣 在ATI期间。拟议的目标将展示艾滋病毒感染者如何理解和体验尖端的 艾滋病毒治疗策略只能通过扩展的ATI进行评估。这项研究的潜在影响将 产生一套具体的建议和可采取行动的项目，以加强知情同意程序， 减少对同意的误解，报告任何社会心理伤害并制定风险缓解计划， 制定了以重点人群需求为中心开展艾滋病治愈研究的指导方针。

7. PROJECT SUMMARY/ABSTRACT HIV cure research is a high-priority for the National Institutes of Health and is targeting a strategy that can lead to sustained antiretroviral treatment (ART)-free suppression. However, because there are no clear biomarkers for an HIV cure – unlike CD4+ count and viral load as markers of ART efficacy – the only way to evaluate the efficacy of a strategy is to require otherwise healthy people living with HIV (PLWH) who have achieved viral suppression to pause their ART. This pausing is called an analytical treatment interruption (ATI) and is the most controversial aspect of HIV cure research. Further, to advance HIV cure research, participants are required to tolerate extended ATIs, which are long periods of high levels of uncontrolled viremia. The goals of the proposed research are to investigate the informed consent process and participants' understanding and experiences with extended ATIs, and use a robust consensus-building technique to resolve the most pressing ethical challenges in HIV cure research. Aims 1 – 2 are nested within four entirely unique trials across the U.S. with a combined total of 120 participants. The studies are taking place through the AIDS Clinical Trials Group Network (ACTG) and the University of California, San Francisco (UCSF). Aim 1 will evaluate the quality of informed consent in 30 participants going through an ATI study, and survey data will be collected measuring perceived benefits, risks, understanding of study procedures, expectations, and relevant psychosocial domains (e.g., HIV stigma, resilience). Aims 2 will prospectively evaluate the psychosocial experiences, quantitatively and qualitatively, of HIV cure research participants before, during and after ATIs. This involves the analysis of strategically placed, and fully integrated prospective psychosocial survey assessments and interviews from study entry to exit. Surveys include measures of anxiety-related outcomes to monitor potential for psychological harm and stress levels during the ATI (among other domains). In addition, Aim 3 involves the use of a hybrid Delphi process to build consensus for strategies to address evolving ethical challenges in HIV cure research. A panel of experts are selected from across the U.S. to engage in four rounds of surveys, with community partners providing input on survey results in between rounds. The goal is to hone in on consensus around how to address racial and ethnic differences and medical mistrust as a barrier to engagement in HIV cure research (including women living with HIV), how to implement ATIs safely, how to address psychosocial harms, and how to protect sexual partners during ATIs. The proposed aims will show how people living with HIV understand and experience cutting-edge HIV cure strategies that can only be evaluated through extended ATIs. The potential impact of this research will result in concrete sets of recommendations and actionable items to enhance the informed consent process to reduce consent misunderstanding, report on any psychosocial harms and development of risk mitigation plans, and set guidance on implementation of HIV cure research centering on needs of priority populations.