When risk cannot be eliminated in HIV "cure" trials
Saturday, October 14, 2023
1:15 PM – 2:30 PM ET
Location: Galena (Fourth Floor)
Analytic treatment interruption (ATI) is scientifically necessary in HIV remission (“cure”) studies to test the effects of new interventions. Such trials have been conducted as early as 2010. However, stopping antiretroviral treatment (ART) of research participants living with HIV poses risks to themselves and their sexual partners. In early trials, the duration of ATI was kept short to minimize the risks to participants associated with treatment interruption, yet all failed to demonstrate success of the interventions. Recently, evidence has emerged that a longer period of viral rebound might be needed to demonstrate a positive impact for the interventions. Ethical debate about whether and how to conduct such studies has largely centered on designing risk mitigation strategies and identifying research stakeholder responsibilities. In this paper, we argue that because the risk of HIV transmission from research participants to sexual partners during ATI is “ineliminable”, the successful conduct of such trials ultimately depends on relationships of trust and trustworthiness. We describe our experiences studying HIV remission trials with ATI in Thailand to explore ways in which trust- and trustworthiness-building may help enhance the scientific, practical, and ethical dimensions of these trials. Following Hawley, we understand trust in terms of reliance on some party to fulfill a commitment, and trustworthiness in terms of honoring one’s commitments in actions, and we make use of Stern and Coleman’s ecological trust model and its four types of trust. We offer examples of how a “trust ecology” for such trials can be practically implemented.
Holly Peay – Senior Research Scientist, Genomics, Ethics, and Translational Research Program, RTI International; Stuart Rennie, PhD – Associate Professor, Social Medicine, UNC-Chapel Hill