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

项目总监/首席研究员（最后、第一、中间）：Dubé、Karine 项目摘要： HIV 治疗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）和制药行业已有超过 240 项相关的生物医学研究。 世界各地都在进行艾滋病毒治疗，并且这一研究领域不断发展和创新，已经有 致力于了解艾滋病毒感染者 (PLWHIV) 的动机和经历的工作有限 初步研究发现了一些考虑、参与和参与这些临床研究的人。 除了个人临床风险之外，影响艾滋病毒治疗相关研究假设参与的因素有很多， 包括社会心理、精神、情感、后勤、道德、社会和经济因素，我们知之甚少 艾滋病毒携带者如何理解和体验实际的艾滋病毒治疗研究参与，包括影响因素 他们决定加入、推迟、继续或退出这些高风险/低效益的艾滋病治疗研究的数据很少。 参与者在艾滋病毒治疗试验中的经历，以及他们在参与后如何看待这些试验。 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 在艾滋病毒治愈临床研究的关键时间点捕获以纵向参与者为中心的结果 在美国进行，包括性别、健康状况和性别等方面的不同人群 慢性/急性 HIV 状况和传播群体（例如 MSM、注射吸毒者 (PWID)）。 以结果为中心主要用于艾滋病毒治疗、丙型肝炎和肿瘤学，但尚未得到广泛应用。 应用于艾滋病毒治疗研究试验的参与者我们将整合新颖的、纵向的、混合的方法。 对艾滋病临床试验组 (ACTG) 附属机构的至少三项正在进行的艾滋病毒治愈临床研究进行评估 地点：1) 涉及临终 (EOL) 的 PLWHIV 患者的“最后礼物”队列，他们将中断 HIV 治疗 (n=30)； ACTG 5345/A5347s（涉及抗逆转录病毒暂停 (IMAP) 和广泛组织的集中监测研究 活检；n=66)；3) ACTG 5366（女性潜伏期逆转研究；n=30）。 生物医学团队寻求这种社会行为研究和专业知识。 我们提出三个具体目标： 1) 定量和定性评估 PLWHIV 经历 参加艾滋病毒治愈临床研究，包括其决策过程（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) 定量和定性评估如何 使用以参与者为中心的稳健结果，艾滋病毒感染者可以前瞻性地参与艾滋病毒治疗研究； 3) 制定主要利益相关者的一般性和针对特定研究的道德、实践和战术建议 我们预计以参与者为中心的结果将为未来艾滋病毒治疗研究的设计和实施提供信息。 成为生物医学艾滋病毒治疗研究工作的重要辅助手段，并将改善明智的决策， 设计和进行这些调查。 项目摘要/总结