HIV cure trials present a powerful opportunity to change the lives of patients and their partners. However, these cutting-edge studies raise a number of ethical concerns, including how to conduct trials in the face of uncertain scientific utility coupled with high potential risk, as well as how to ensure decisions about participation are well informed. The proposed study employs a dynamic approach to bioethics that combines conceptual and empirical assessments of HIV cure research in order to advance solutions to ethical challenges. The study takes advantage of one of the first, and certainly the largest, set of HIV cure trials currently underway anywhere in the world. Five planned trials in Thailand employ a variety of study designs that all include analytic treatment interruption, and all recruit from a unique cohort of relatively healthy, HIV+ individuals identified at the acute stage of infection. The HIV cure clinical trials team, keenly aware of the ethical concerns associated with this research, invited our group to nest a longitudinal decision-making and ethics study within these trials. Our preliminary work in Thailand has included training social science researchers, developing instruments through community engagement, and obtaining baseline survey data from individuals in the cohort prior to trial recruitment. The proposed project includes three interrelated aims. 1) To assess factors associated with joining or declining participation, psychosocial impacts of trial experiences, and decision satisfaction. The project's longitudinal design allows assessment of intentions, behaviors, and changes in perception of risks and benefits over time, an advance over most previous clinical trial decision-making studies. 2) To develop a transparent, ethical approach to sharing study outcomes with the clinical trials team, in order to improve study processes and participant experiences during the course of trials.
This aim addresses under-explored questions of when and how such findings should be shared. 3) To apply deliberative methods to create guidance for improving the ethical conduct of HIV cure trials.
This aim convenes a multi-stakeholder committee to critically examine normative and empirical findings of Aims 1 and 2, in order to develop ethical recommendations. The proposed project integrates sharing study outcomes and deliberative results at multiple dissemination points. We expect that our findings will have broad implications for future HIV clinical trials research.
It is in the best interest of patients, clinician investigators, and public health to develop new therapeutics to combat and eventually cure HIV infection. However, it is vital that ethical, legal and social issues are addressed to ensure informed consent, reasonable expectations, and acceptable protocols for clinical trial participants. This study aims to explore Thai HIV patients' expectations, intentions, decision-making, and decision satisfaction related to HIV cure clinical trials to inform HIV cure research education and informed consent processes. One outcome of this study is the development of tools and guidelines for nesting decision making studies in subsequent HIV cure research.
| Henderson, Gail E; Peay, Holly L; Kroon, Eugene et al. (2018) Ethics of treatment interruption trials in HIV cure research: addressing the conundrum of risk/benefit assessment. J Med Ethics 44:270-276 |
