Decision Support for Early-Phase HIV Remission Trials

项目摘要/摘要 早期的艾滋病毒缓解(“治愈”)研究具有挑战良好决策的特点。的目标是 这项建议是开发一个可定制的决策辅助(DA)，具有经验和规范的信息 内容，用于早期艾滋病毒缓解试验。它将解决知情选择的要素，调查人员和 PLHIV发现最有问题的是，首先是对个人利益的期望、类型和规模 可预见的试验风险，以及意外伤害的可能性。“治愈”试验的长期目标是 产生不合理的期望和研究程序的前沿、技术方面和 提议的干预措施往往令人费解。此外，试验需要参与者理解， 当试验涉及分析时，评估和权衡对自己健康的不确定风险，对性伴侣的风险 治疗中断，对艾滋病毒科学的潜在好处，以及他们所考虑的任何其他价值和考虑 可能会发现这对他们做出决定很重要。通常用于这些研究的标准同意程序 已经被经验证明有明显的缺陷。DAS是一种很有前途的方法，可以增强 研究质量知情同意，提高决策满意度，最终改善心理 登记参加试验的参与者的幸福感。我们建议使用RTI的适应性决策辅助平台进行试验 (适应)开发和测试可定制的发展议程，以在具有挑战性的早期- 艾滋病缓解阶段研究。由此产生的DA将基于我们之前的研究进行开发；合乎道德的 原则和框架；发展议程发展中的标准、系统审查和最佳做法；以及投入 来自审判现场的调查人员和我们的多学科顾问。为了实现这一目标，我们有四个目标。 目标1：我们将从50名艾滋病毒调查人员那里收集有关未得到满足的缓解决策需求的信息 试验，以及对DA的可接受性、实用性和影响的态度。目标2：我们将制定和评估阶段1 由艾滋病临床试验小组(ACTG)进行的缓解试验中的DA。我们会收集纵向的 受邀参加试验的30名个人的数据，并就进行知情的ACTG调查人员进行采访 参与者使用DA后同意。目标3：我们将进行两个深思熟虑的参与方 使用目标1和目标2的数据来制定基于证据的建议的会议，以提炼和 扩展到第二阶段DA。在目标4中，我们将对30名艾滋病病毒感染者进行第二阶段发展援助的用户测试性访谈 和8名艾滋病毒研究人员。访谈将用于对DA内容和用户进行反复改进 经验(基于PLHIV和研究人员的反馈)以及该工具的定制能力 (基于研究人员的反馈)。因此，我们提出了一种基于证据和以用户为中心的方法 DA开发公司。由此产生的决策辅助将在随后的随机试验中进行评估，以衡量其 对艾滋病毒早期缓解试验决策结果的影响。从长远来看，该工具可以很容易地 适应其他类型的早期临床研究。

PROJECT SUMMARY/ABSTRACT Early phase HIV remission (“cure”) research has features that challenge good decision making. The goal of this proposal is to develop a customizable decision aid (DA), with empirically and normatively-informed content, for early phase HIV remission trials. It will address elements of informed choice that investigators and PLHIV find most problematic, starting with expectations for personal benefit, type and magnitude of foreseeable trial risks, and the potential for unanticipated harms. The long-term aim of “cure” trials can engender unreasonable expectations and the cutting-edge, technical aspects of study procedures and proposed interventions are often difficult to understand. Furthermore, trials require participants to understand, evaluate, and weigh uncertain risks to their own health, risks to sexual partners when trials involve analytic treatment interruption, potential benefits to HIV science, and whatever other values and considerations they may find important in reaching their decisions. Standard consent processes typically used for these studies have been empirically shown to have significant shortcomings. DAs are a promising approach to enhance the quality of research informed consent, improve decision satisfaction, and ultimately improve the psychological wellbeing of participants enrolled in trials. We propose to use RTI's Adaptable Decision Aid Platform for Trials (ADAPT) to develop and test a customizable DA to augment informed consent in the challenging case of early- phase HIV remission research. The resulting DA will be developed based on our prior research; ethical principles and frameworks; standards, systematic reviews, and best practices in DA development; and input from investigators at the trial sites and our multidisciplinary advisors. To accomplish this, we have four aims. Aim 1: We will collect information from 50 HIV investigators about unmet decision-making needs for remission trials, and attitudes about DA acceptability, utility, and impact. Aim 2: We will develop and assess a phase 1 DA in remission trials to be conducted by the AIDS Clinical Trials Group (ACTG). We will collect longitudinal data from 30 individuals invited to the trials and interview ACTG investigators about conducting informed consent after participants use the DA. Aim 3: We will conduct two deliberative engagement stakeholder meetings that use data from Aims 1 and 2 to develop evidence-based recommendations for refining and expanding to the phase 2 DA. In Aim 4, we will conduct user test interviews of the phase 2 DA with 30 PLHIV and 8 HIV researchers. Interviews will be used to make iterative refinements to the DA content and user experience (based on feedback from PLHIV and researchers) and to the customization capabilities of the tool (based on feedback from researchers). Thus, we propose an evidence-based and user-centered approach to DA development. The resulting decision aid will be evaluated in a subsequent randomized trial to measure its impact on decision-making outcomes in early phase HIV remission trials. Long term, the tool can be easily adapted to other types of early-phase clinical research.