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

调查长期艾滋病毒治疗中断的艾滋病毒治疗试验参与者的心理社会经历：对道德行为的影响

• 批准号: 10647752
• 负责人: Karine Dube
• 金额: $ 69.46万
• 依托单位: UNIVERSITY OF CALIFORNIA, SAN FRANCISCO
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-09-01 至 2026-06-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10647752
• 关键词: AIDS clinical trial group; Acceleration; Address; Affect; Anxiety; Attention; Bioethics Consultants; Biological Markers; CD4 Lymphocyte Count; COVID-19; California; Caring; Clinical; Clinical Research; Color; Communication; Communities; Complex; Consensus; Consent; Data; Decision Making; Development; Ensure; Ethical Analysis; Ethics; Evaluation; Expert Opinion; Goals; HIV; HIV Infections; Hybrids; Informed Consent; International; Interruption; Interview; Knowledge; Measures; Medical; Monitor; Outcome; Participant; Persons; Population; Procedures; Process; Psychosocial Factor; Recommendation; Regrets; Reporting; Research; Research Personnel; Risk; San Francisco; Sex Differences; Sexual Partners; Stress; Surveys; Symptoms; Techniques; Testing; Therapeutic; Time; Treatment Efficacy; United States National Institutes of Health; Universities; Viral; Viral Load result; Viremia; Virus; Woman; antiretroviral therapy; anxiety states; demographics; early phase trial; efficacy evaluation; efficacy testing; ethnic difference; expectation; experience; gender difference; meetings; member; novel; patient safety; prospective; psychologic; psychosocial; racial difference; resilience; risk mitigation; social stigma; therapeutic misconception; therapy resistant; trait; transgender; transmission process

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.

7. 项目概要/摘要 HIV 治疗研究是美国国立卫生研究院的高度优先事项，其目标是制定一项战略， 然而，由于没有明确的生物标志物，因此无法持续进行抗逆转录病毒治疗（ART）抑制。 与作为 ART 疗效标志的 CD4+ 计数和病毒载量不同，这是评估 HIV 治愈效果的唯一方法 一项策略的有效性是要求其他方面健康的艾滋病毒感染者 (PLWH) 达到病毒水平 抑制以暂停他们的 ART。这种暂停称为分析治疗中断 (ATI)，是最严重的。 HIV 治愈研究存在争议的方面 此外，为了推进 HIV 治愈研究，需要 耐受长期 ATI，即长时间处于高水平不受控制的病毒血症。 研究的目的是调查知情同意过程以及参与者的理解和经验 扩展 ATI，并使用强大的共识构建技术来解决最紧迫的道德挑战 HIV 治疗研究中的目标 1 – 2 包含在美国各地进行的四项完全独特的试验中。 这些研究共有 120 名参与者，是通过艾滋病临床试验组网络 (ACTG) 进行的。 加州大学旧金山分校 (UCSF) 的目标 1 将在 30 年内评估知情同意的质量。 参加 ATI 研究的参与者将收集调查数据，衡量感知的收益、风险、 了解研究程序、期望和相关心理社会领域（例如，艾滋病毒耻辱、 目标 2 将前瞻性地定量和定性地评估心理社会体验。 ATI 之前、期间和之后的 HIV 治疗研究参与者这涉及到战略性放置的分析。 并完全整合前瞻性心理社会调查评估和从研究进入到退出的访谈。 调查包括衡量与焦虑相关的结果，以监测潜在的心理伤害和压力 ATI（以及其他领域）期间的水平此外，目标 3 涉及使用混合 Delphi 流程来 专家小组就解决艾滋病毒治疗研究中不断变化的伦理挑战的策略达成共识。 从美国各地选出参与四轮调查，社区合作伙伴提供意见 目标是就如何解决种族和问题达成共识。 种族差异和医疗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中的女性） HIV）、如何安全实施 ATI、如何解决社会心理伤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前沿技术。 只能通过扩展 ATI 来评估的 HIV 治疗策略 这项研究的潜在影响将。 产生一套具体的建议和可操作的项目，以加强知情同意过程 减少同意误解，报告任何社会心理伤害并制定风险缓解计划， 围绕重点人群的需求制定艾滋病毒治疗研究实施指南。