Decision Support for Early-Phase HIV Remission Trials

点击翻译按钮获取中文摘要

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.