Ethical and practical considerations for HIV cure-related research at the end-of-life: a qualitative interview and focus group study in the United States

Abstract

Background One of the next frontiers in HIV research is focused on finding a cure. A new priority includes people with HIV (PWH) with non-AIDS terminal illnesses who are willing to donate their bodies at the end-of-life (EOL) to advance the search towards an HIV cure. We endeavored to understand perceptions of this research and to identify ethical and practical considerations relevant to implementing it. Methods We conducted 20 in-depth interviews and 3 virtual focus groups among four types of key stakeholders in the United States (PWH, biomedical HIV cure researchers, HIV clinicians, and bioethicists) to obtain triangulated viewpoints because little was known about the ethics of this topic. Each group was queried as to ethical considerations, safeguards, and protections for conducting HIV cure-related research at the EOL to ensure this research remains acceptable. Results All four key stakeholder groups generally supported HIV cure-related research conducted at the EOL because of the history of altruism within the PWH community and the potential for substantial scientific knowledge to be gained. Our informants expressed that: (1) Strong stakeholder and community involvement are integral to the ethical and effective implementation, as well as the social acceptability of this research; (2) PWH approaching the EOL should not inherently be considered a vulnerable class and their autonomy must be respected when choosing to participate in HIV cure-related research at the EOL; (3) Greater diversity among study participants, as well as multi-disciplinary research teams, is necessitated by HIV cure-related research at the EOL; (4) The sensitive nature of this research warrants robust oversight to ensure a favorable risk/benefit balance and to minimize the possibility of therapeutic misconception or undue influence; and (5) Research protocols should remain flexible to accommodate participants’ comfort and needs at the EOL. Conclusion Because of the ethical issues presented by HIV cure-related research at the EOL, robust ethical safeguards are of utmost importance. The proposed ethical and practical considerations presented herein is a first step in determining the best way to maximize this research’s impact and social value. More much inquiry will need to be directed towards understanding context-specific and cultural considerations for implementing EOL HIV cure research in diverse settings.

Lessons learned from the Last Gift study: ethical and practical challenges faced while conducting HIV cure-related research at the end of life

“…Potential participants do not have to have an advanced care directive document to participate. Although advance directives may lack specificity for the EOL HIV cure research context, 27 they serve as a catalyst for meaningful conversations. In the Last Gift, we view advance directives as taking precedence over the aims of the research protocol.…”

Lessons for Understanding Central Nervous System HIV Reservoirs from the Last Gift Program

“…At inception, we sought bioethics expertise to establish detailed ethical considerations for HIV reservoir research at the EOL [ 122 , 123 ]. We emphasized five ethical domains: (1) protection of autonomy through informed consent, (2) avoidance of exploitation and fostering of altruism, (3) maintenance of favorable benefits/risks, (4) safeguarding against vulnerability through patient/participant-centeredness, and (5) acceptance of research by next-of-kin/loved ones and community.…”

“…The next research frontier will be evaluating the effects of interventions on the CNS and deep tissue compartments. Our team is proactively evaluating ethical considerations of interventional HIV cure-related research at the EOL [ 123 ]. As with all clinical research, we have an ethical obligation to limit risk of undue pain, suffering, and accelerated death at the end of life [ 123 ].…”

“…Our team is proactively evaluating ethical considerations of interventional HIV cure-related research at the EOL [ 123 ]. As with all clinical research, we have an ethical obligation to limit risk of undue pain, suffering, and accelerated death at the end of life [ 123 ]. Only well-vetted interventions supported by robust pre-clinical data should be considered for testing at the EOL [ 123 ].…”

Distinct Plasma Concentrations of Acyl-CoA-Binding Protein (ACBP) in HIV Progressors and Elite Controllers

“…The recent description of the Esperanza patient who achieved a possible spontaneous HIV sterilizing cure represents a beacon of hope for people living with HIV (PLWH) [ 1 , 2 , 3 , 4 ].…”