Perceptions of Equipoise, Risk–Benefit Ratios, and “Otherwise Healthy Volunteers” in the Context of Early-Phase HIV Cure Research in the United States: A Qualitative Inquiry

Dubé, Karine; Dee, Lynda; Evans, David; Sylla, Laurie; Taylor, Jeff; Brown, Brandon; Miller, Veronica; Corneli, Amy; Skinner, Asheley Cockrell; Greene, Sheila; Tucker, Joseph D.; Rennie, Stuart

doi:10.1177/1556264617734061

Cited by 34 publications

(44 citation statements)

References 39 publications

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“…The U.S. Food and Drug Administration (FDA) defines HIV cure research as “any investigation that evaluates: 1) a therapeutic intervention or approach that controls or eliminates HIV infection to the point that no further medical interventions are needed to maintain health; and 2) preliminary scientific concepts that might ultimately lead to such a therapeutic intervention [ 7 ].” HIV cure or remission research includes both observational assessments, such as the measurement and characterization of HIV reservoirs, and interventional approaches, including early ART, latency-reversing agents, immune-based strategies, gene editing or modification, stem cell transplantation, or combination approaches [ 6 ]. While most HIV cure-related studies occur in ‘otherwise healthy volunteers’ [ 8 ], a new research priority for the U.S. National Institute of Allergies and Infectious Diseases (NIAID) and the National Institute of Mental Health (NIMH) involves the inclusion of PLWHIV who are terminally ill [ 9 , 10 ]. End-of-life (EOL) HIV cure research is currently limited to observational assessments at one clinical research site in the United States: The University of California, San Diego (UCSD).…”

Section: Introductionmentioning

confidence: 99%

Ethical considerations for HIV cure-related research at the end of life

et al. 2018

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BackgroundThe U.S. National Institute of Allergies and Infectious Diseases (NIAID) and the National Institute of Mental Health (NIMH) have a new research priority: inclusion of terminally ill persons living with HIV (PLWHIV) in HIV cure-related research. For example, the Last Gift is a clinical research study at the University of California San Diego (UCSD) for PLWHIV who have a terminal illness, with a prognosis of less than 6 months.DiscussionAs end-of-life (EOL) HIV cure research is relatively new, the scientific community has a timely opportunity to examine the related ethical challenges. Following an extensive review of the EOL and HIV cure research ethics literature, combined with deliberation from various stakeholders (biomedical researchers, PLWHIV, bioethicists, and socio-behavioral scientists) and our experience with the Last Gift study to date, we outline considerations to ensure that such research with terminally ill PLWHIV remains ethical, focusing on five topics: 1) protecting autonomy through informed consent, 2) avoiding exploitation and fostering altruism, 3) maintaining a favorable benefits/risks balance, 4) safeguarding against vulnerability through patient-participant centeredness, and 5) ensuring the acceptance of next-of-kin/loved ones and community stakeholders.ConclusionEOL HIV cure-related research can be performed ethically and effectively by anticipating key issues that may arise. While not unique to the fields of EOL or HIV cure-related research, the considerations highlighted can help us support a new research approach. We must honor the lives of PLWHIV whose involvement in research can provide the knowledge needed to achieve the dream of making HIV infection curable.

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Section: Introductionmentioning

confidence: 99%

Ethical considerations for HIV cure-related research at the end of life

et al. 2018

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“…Although researchers and ethicists may be prone to think primarily about the health risk‐benefit ratio of clinical trial participation 18 and to view people living with HIV as “healthy volunteers,” 19 the themes that arose in these interviews tapped into perceived benefits and values much deeper than health. One theme reflects a broader conception of benefits in risk‐benefit assessment; and the other, considerations about risk taking, reasonableness, and altruism.…”

Section: Discussionmentioning

confidence: 99%

HIV Cure Research: Risks Patients Expressed Willingness to Accept

Kratka

Ubel

Scherr

et al. 2019

Ethics & Human Research

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Despite doing well on antiretroviral therapy, many people living with HIV have expressed a willingness to accept substantial risks for an HIV cure. To date, few studies have assessed the specific quantitative maximal risk that future participants might take; probed whether, according to future participants, the risk can be offset by the benefits; and examined whether taking substantial risk is a reasonable decision. In this qualitative study, we interviewed 22 people living with HIV and used standard gamble methodology to assess the maximum chance of death a person would risk for an HIV cure. We probed participants’ reasoning behind their risk‐taking responses. Conventional inductive content analysis was used to categorize key themes regarding decision‐making. We found that some people would be willing to risk even death for an HIV cure, and some of their reasons were plausible and went far beyond the health‐related utility of an HIV cure. We contend that people's expressed willingness to take substantial risk for an HIV cure should not be dismissed out of hand.

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“…An important aspect of conducting HIV cure research will involve communicating and framing expectations around early‐phase HIV cure experiments and scientific advances . Stakeholders often overestimate the possibility of clinical benefits and underestimate the likelihood of risks in early‐phase clinical research in general , and the same is true in early‐phase HIV cure research . While benefits of HIV cure research at this stage should be evaluated in terms of the production of incremental scientific knowledge , an increasing number of social sciences studies reveal that study participants in HIV cure research strongly value the benefits of inclusion (such as increased HIV knowledge or psychosocial benefits) .…”

Section: Discussionmentioning

confidence: 99%

“…There have been a number of studies assessing willingness to participate in HIV cure research, risk acceptability, barriers and motivators to participation, as well as perceptions, beliefs, needs and concerns of potential study participants around the world . Early findings indicate that there likely will be disagreements between stakeholders about what constitutes acceptable risks for HIV cure studies, and a triangulation of these views will be necessary .…”

Section: Discussionmentioning

confidence: 99%

Applying the Behavioural and Social Sciences Research (BSSR) Functional Framework to HIV Cure Research

et al. 2019

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Introduction The search for an HIV cure involves important behavioural and social processes that complement the domains of biomedicine. However, the field has yet to tap into the full potential of behavioural and social sciences research (BSSR). In this article, we apply Gaist and Stirratt’s BSSR Functional Framework to the field of HIV cure research. Discussion The BSSR Functional Framework describes four key research domains: (1) basic BSSR (understanding basic behavioural and social factors), (2) elemental BSSR (advancing behavioural and social interventions), (3) supportive BSSR (strengthening biomedically focused clinical trials), and (4) integrative BSSR (building multi‐disciplinary combination approaches for real‐world implementation). In revisiting and applying the BSSR Functional Framework, we clarify the importance of BSSR in HIV cure research by drawing attention to such things as: how language and communication affect the meaning of “cure” to people living with HIV (PLHIV) and broader communities; how cure affects the identity and social position of PLHIV; counselling and support interventions to address the psychosocial needs and concerns of study participants related to analytical treatment interruptions (ATIs); risk reduction in the course of ATI study participation; motivation, acceptability, and decision‐making processes of potential study participants related to different cure strategies; HIV care providers’ perceptions and attitudes about their patients’ participation in cure research; potential social harms or adverse social events associated with cure research participation; and the scalability of a proven cure strategy in the context of further advances in HIV prevention and treatment. We also discuss the BSSR Functional Framework in the context of ATIs, which involve processes at the confluence of the BSSR domains. Conclusions To move HIV cure regimens through the translational research pathway, attention will need to be paid to both biomedical and socio‐behavioural elements. BSSR can contribute an improved understanding of the human and social dimensions related to HIV cure research and the eventual application of HIV cure regimens. The BSSR Functional Framework provides a way to identify advances, gaps and opportunities to craft an integrated, multi‐disciplinary approach at all stages of cure research to ensure the real‐world applicability of any strategy that shows promise.

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Perceptions of Equipoise, Risk–Benefit Ratios, and “Otherwise Healthy Volunteers” in the Context of Early-Phase HIV Cure Research in the United States: A Qualitative Inquiry

Cited by 34 publications

References 39 publications

Ethical considerations for HIV cure-related research at the end of life

Ethical considerations for HIV cure-related research at the end of life

HIV Cure Research: Risks Patients Expressed Willingness to Accept

Applying the Behavioural and Social Sciences Research (BSSR) Functional Framework to HIV Cure Research

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