Pilot Integration of Participant-Centered Outcomes in HIV Cure Research in the United States: Implications for Ethical Conduct

美国艾滋病毒治疗研究中以参与者为中心的成果试点整合：对道德行为的影响

• 批准号: 9905559
• 负责人: Karine Dube
• 金额: $ 22.2万
• 依托单位: UNIV OF NORTH CAROLINA CHAPEL HILL
• 依托单位国家: 美国
• 财政年份: 2019
• 资助国家: 美国
• 起止时间: 2019-05-01 至 2022-10-01
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9905559
• 关键词: AIDS clinical trial group; Acute; Advocate; Affect; Anti-Retroviral Agents; Anxiety; Area; Behavioral Sciences; Benefits and Risks; Bioethics Consultants; Biopsy; Catalogs; Chronic; Clinical Research; Consensus; Consent; Consultations; Data; Decision Making; Development; Drug Industry; Economic Factors; Emotional; Enrollment; Ensure; Ethics; Future; Gender; Gifts; Goals; HIV; Health Status; Hepatitis; Hepatitis C; Individual; Injecting drug user; International AIDS; Interruption; Intervention; Interview; Investigation; Logistics; Methods; Monitor; Motivation; National Institute of Mental Health; Oncology; Outcome; Participant; Patient Recruitments; Patient-Focused Outcomes; Patients; Perception; Population Heterogeneity; Principal Investigator; Procedures; Process; Psyche structure; Quality of life; Recommendation; Reporting; Research; Research Design; Research Personnel; Science; Scientist; Site; Social Behavior; Societal Factors; Societies; Structure; Surveys; Thailand; Time; Tissues; United States; United States National Institutes of Health; Woman; Work; clinical investigation; clinical risk; cohort; design; drug development; end of life; expectation; experience; high risk; improved; innovation; insight; meetings; men who have sex with men; multidisciplinary; novel; participant retention; patient oriented; programs; prospective; psychosocial; public health relevance; recruit; risk perception; sex; social; tool; transmission process

Program Director/Principal Investigator (Last, First, Middle): Dubé, Karine Project Abstract: HIV cure research is a strategic priority of the National Institutes of Health (NIH), the International AIDS Society (IAS), and the pharmaceutical industry. While there have been over 240 biomedical studies related to HIV cure conducted around the world, and this field of research continues to grow and innovate, there has been limited work dedicated to understanding the motivations and experiences of people living with HIV (PLWHIV) who consider, enter, and participate in these clinical investigations. While preliminary research found a number of factors influence hypothetical participation in HIV cure-related research beyond personal clinical risks, including psychosocial, mental, emotional, logistical, ethical, societal and economic factors, we know little about how PLWHIV understand and experience actual HIV cure research participation, including factors that affect their decision to join, defer, continue or exit these high-risk/low-benefit HIV cure studies. Very little data exist as to participant experiences within HIV cure trials, and how they view these trials after participating. Our multidisciplinary team of social scientists, biomedical HIV cure researchers, and HIV patient advocates proposes to capture participant-centered outcomes longitudinally at critical time points in HIV cure clinical studies being conducted in the U.S. that include diverse populations with respect to sex/gender, health status and chronic/acute HIV status, and transmission groups (e.g. MSM, people who inject drugs (PWIDs). While patient- centered outcomes have been used extensively in HIV treatment, Hepatitis C and oncology, they have yet to be applied to participants of HIV cure research trials. We will integrate novel, longitudinal, mixed-methods assessments into at least three ongoing HIV cure clinical studies at AIDS Clinical Trials Group (ACTG)-affiliated sites: 1) “Last Gift” cohort involving PLWHIV at the end-of-life (EOL) who will interrupt HIV treatment (n=30); 2) ACTG 5345/A5347s (study involving intensively monitored antiretroviral pauses (IMAPs) and extensive tissue biopsies; n=66); 3) ACTG 5366 (latency-reversing study in women; n=30). Studies were selected because biomedical teams sought out this socio-behavioral research and expertise. We propose three specific aims: 1) Quantitatively and qualitatively assess PLWHIV experiences with enrollment into HIV cure clinical studies, including their decision-making processes (e.g., entry vs. non-entry), perceptions of risks and benefits, and understanding of the study; 2) Quantitatively and qualitatively assess how PLWHIV experience prospective participation in HIV cure studies using robust participant-centered outcomes; 3) Develop general and study-specific ethical, practical and tactical recommendations from key stakeholders to inform the design and conduct of future HIV cure studies. We anticipate that participant-centered outcomes will become critical adjuncts to biomedical HIV cure research efforts and will improve informed decision-making, design and conduct of these investigations. Project Abstract/Summary

项目主任/首席调查员(最后、第一、中间)：杜贝，卡琳 项目摘要： HIV治愈研究是美国国立卫生研究院(NIH)、国际艾滋病组织的战略重点 协会(IAS)和制药行业。虽然已经有240多项生物医学研究与 艾滋病毒的治疗在世界各地进行，并且这一领域的研究不断增长和创新，出现了 致力于了解艾滋病毒携带者的动机和经历的工作有限 他们考虑、参与和参与这些临床研究。虽然初步研究发现了一些 影响个人临床风险以外的艾滋病毒治疗相关研究的假设参与的因素， 包括心理社会、精神、情感、后勤、伦理、社会和经济因素，我们对此知之甚少 PLWHIV如何理解和体验实际的HIV治疗研究参与，包括影响因素 他们决定加入、推迟、继续或退出这些高风险/低收益的艾滋病毒治疗研究。只有很少的数据以 了解参与者在HIV治愈试验中的经历，以及他们在参与后如何看待这些试验。我们的 由社会科学家、生物医学艾滋病毒治疗研究人员和艾滋病毒患者倡导者组成的多学科团队提出 在HIV治愈临床研究的关键时间点纵向捕捉以参与者为中心的结果 在美国进行的包括不同性别/性别、健康状况和 慢性/急性艾滋病毒状况和传播群体(例如男男性接触者、注射毒品者(PWID))。在耐心等待时- 集中结果已被广泛用于艾滋病毒治疗、丙型肝炎和肿瘤学，但它们尚未被 适用于艾滋病毒治愈研究试验的参与者。我们将把新的、纵向的、混合的方法结合起来 对艾滋病临床试验小组(ACTG)附属的至少三项正在进行的HIV治愈临床研究的评估 地点：1)涉及临终前艾滋病病毒(PLWHIV)的“最后一份礼物”队列，他们将中断艾滋病毒治疗(n=30)； ACTG 5345/A5347s(涉及密集监测抗逆转录病毒暂停(IMAP)和广泛组织的研究 活检(n=66)；3)ACTG 5366(女性潜伏期逆转研究；n=30)。之所以选择研究，是因为 生物医学团队寻求这种社会行为研究和专业知识。 我们提出了三个具体目标：1)定量和定性地评估PLWHIV经历 参加艾滋病毒治愈临床研究，包括他们的决策过程(例如，进入与不进入)， 对风险和收益的看法，以及对研究的理解；2)定量和定性地评估如何 PLWHIV使用以参与者为中心的结果，在HIV治愈研究中的预期参与； 3)制定来自主要利益攸关方的一般性和具体研究的伦理、实践和战术建议，以 为未来艾滋病毒治愈研究的设计和实施提供信息。我们预计，以参与者为中心的成果将 成为生物医学艾滋病毒治疗研究工作的关键助手，并将改善知情决策， 设计和进行这些调查。 项目摘要/摘要