Decision Support for Early-Phase HIV Remission Trials

早期艾滋病毒缓解试验的决策支持

• 批准号: 10380763
• 负责人: Gail E HENDERSON
• 金额: $ 37.26万
• 依托单位: UNIV OF NORTH CAROLINA CHAPEL HILL
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-04-01 至 2024-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10380763
• 关键词: AIDS clinical trial group; Address; Adherence; Advisory Committees; Advocate; Area; Attitude; Automobile Driving; Behavioral Sciences; Clinical Research; Clinical Trials; Conflict (Psychology); Consent; Custom; Data; Decision Aid; Decision Making; Development; Disease remission; Elements; Enrollment; Ethics; Feedback; Goals; HIV; Health; Human Characteristics; Individual; Informed Consent; Interruption; Intervention; Interview; Lead; Literature; Measures; National Institute of Mental Health; Outcome; Participant; Personal Satisfaction; Persons; Phase; Pilot Projects; Procedures; Process; Recommendation; Research; Research Personnel; Risk; Science; Sexual Partners; Site; Structure; Surveys; Testing; Therapeutic; Treatment outcome; Uncertain Risk; Well in self; Withdrawal; base; cost; decision research; design; early phase trial; evidence base; evidence based guidelines; expectation; experience; flexibility; formative assessment; improved; innovation; meetings; member; multidisciplinary; optimism; phase 2 testing; randomized controlled study; randomized trial; recruit; satisfaction; systematic review; tool

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.

项目总结/摘要 早期HIV缓解（“治愈”）研究具有挑战良好决策的特征。的目标 这项建议是开发一个可定制的决策辅助工具（DA）， 内容，用于早期HIV缓解试验。它将涉及知情选择的要素， 艾滋病毒感染者发现最有问题的，首先是对个人利益的期望， 可预见的试验风险和潜在的非预期伤害。“治愈”试验的长期目标可以 产生不合理的期望和尖端，研究程序的技术方面， 拟议的干预措施往往难以理解。此外，试验要求参与者理解， 当试验涉及分析时，评估并权衡对自身健康的不确定风险和对性伴侣的风险 治疗中断，对艾滋病毒科学的潜在好处，以及他们所关注的其他价值和考虑， 可能会对他们的决定很重要。这些研究通常使用的标准同意流程 已经被经验证明具有显著的缺点。DA是一种很有前途的方法， 研究知情同意质量，提高决策满意度，最终改善心理 参与试验的受试者的健康状况。我们建议使用RTI的适应性决策辅助平台进行试验 （ADAPT）开发和测试可定制的DA，以在具有挑战性的早期- 艾滋病缓解期研究。由此产生的DA将根据我们先前的研究开发;伦理 原则和框架;发展议程制定中的标准、系统评价和最佳实践;以及投入 来自试验中心的研究者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HIV研究者那里收集关于未满足的缓解决策需求的信息 试验，以及对DA的可接受性，效用和影响的态度。目标2：我们将制定和评估第1阶段 DA在缓解试验中将由艾滋病临床试验组（ACTG）进行。我们将收集纵向 来自30名被邀请参加试验的个人的数据，并采访了ACTG研究人员， 目标3：我们将进行两次审议性参与，利益相关者 会议使用目标1和2的数据来制定基于证据的建议， 在目的4，我们会与30名艾滋病毒感染者进行第二阶段DA的使用者测试面谈， 8名艾滋病研究人员。访谈将用于对DA内容和用户进行迭代改进 经验（基于艾滋病毒感染者和研究人员的反馈）和工具的定制能力 （根据研究人员的反馈）。因此，我们提出了一个以证据为基础和以用户为中心的方法， DA开发。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 对早期HIV缓解试验中决策结果的影响。从长远来看，该工具可以轻松 适应于其他类型的早期临床研究。