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

项目负责人/主要研究者（最后，第一，中间）：Dubé，Karine 项目摘要： 艾滋病毒治疗研究是美国国立卫生研究院（NIH）、国际艾滋病研究所（IAIDS）和美国国家卫生研究院（NIH）的战略重点。 社会（IAS）和制药行业。虽然已经有超过240项生物医学研究与 艾滋病毒治愈在世界各地进行，这一领域的研究不断增长和创新，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 考虑、进入和参与这些临床研究的人员。虽然初步研究发现， 影响假设参与HIV治疗相关研究的因素超出了个人临床风险， 包括社会心理、精神、情感、后勤、道德、社会和经济因素，我们对这些因素知之甚少。 艾滋病毒感染者如何理解和体验实际艾滋病毒治疗研究参与，包括影响 他们决定加入、推迟、继续或退出这些高风险/低获益的HIV治疗研究。数据很少，因为 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。我们 一个由社会科学家、生物医学艾滋病治疗研究人员和艾滋病患者倡导者组成的多学科小组提出， 在HIV治愈临床研究的关键时间点纵向捕获以参与者为中心的结局， 在美国进行，包括不同人群的性/性别，健康状况和 慢性/急性艾滋病毒感染状况和传播群体（如男男性行为者、注射毒品者）。当病人- 集中的结果已广泛用于艾滋病毒治疗，丙型肝炎和肿瘤学，它们还没有 应用于艾滋病毒治疗研究试验的参与者。我们将整合新的，纵向的，混合的方法 艾滋病临床试验组（ACTG）下属的至少三项正在进行的艾滋病治愈临床研究的评估 研究中心：1）“最后一份礼物”队列，涉及生命末期（EOL）将中断HIV治疗的PLWHIV（n=30）; 2） ACTG 5345/A5347 s（涉及集中监测抗逆转录病毒暂停（IMAPs）和广泛组织的研究 活组织检查; n=66）; 3）ACTG 5366（女性潜伏期逆转研究; n=30）。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）定量和定性评估PLWHIV经验， 入组HIV治愈临床研究，包括其决策过程（例如，进入与不进入）， 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 PLWHIV经验前瞻性参与艾滋病毒治疗研究使用强大的参与者为中心的结果; 3)从关键利益相关者那里制定一般和研究特定的伦理、实践和战术建议， 为今后艾滋病毒治疗研究的设计和实施提供信息。我们预计，以参与者为中心的结果将 成为生物医学艾滋病毒治疗研究工作的关键支持者，并将改善知情决策， 这些调查的设计和实施。 项目摘要/摘要

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