Population Representation in HIV Cure Research: A Review of Diversity within HIV Cure Studies based in the United States

Abstract Background: HIV cure research involving cell and gene therapy has intensified in recent years. There is a growing need to identify standards, safeguards, and protections to ensure cell and gene therapy HIV cure research remains ethical and acceptable to as many stakeholders as possible as it advances on a global scale.Methods: To elicit ethical and practical considerations to guide cell and gene therapy HIV cure research, we implemented a qualitative, in-depth interview study with three key stakeholder groups in the United States: 1) biomedical HIV cure researchers, 2) bioethicists, and 3) community stakeholders. Interviews were transcribed verbatim. We applied conventional content analysis focused on inductive reasoning to analyze the rich qualitative data and derive key ethical and practical considerations related to cell and gene therapy towards an HIV cure.Results: We interviewed 13 biomedical researchers, 5 community members, and 1 bioethicist. Informants generated considerations related to: perceived benefits of cell and gene therapy towards an HIV cure, perceived risks, considerations necessary to ensure an acceptable benefit/risk balance, cell and gene therapy strategies considered unacceptable, additional ethical considerations, considerations for first-in-human cell and gene therapy HIV cure trials. Informants also proposed important safeguards to developing cell and gene therapy approaches towards an HIV cure, such as the importance of mitigating off-target effects, mitigating risks associated with long-term duration of cell and gene therapy interventions, and mitigating risks of immune overreactions.Conclusion: Rapidly evolving cell and gene therapy towards an HIV cure is accompanied by a host of ethical and practical challenges. To minimize risks to potential participants and facilitate the translation of scientific advancements from the bench to the clinic, cell and gene therapy HIV cure research must be thoughtfully developed and implemented. To protect the public trust in cell and gene therapy HIV cure research, ethical and practical considerations should be periodically revisited and updated as the science continues to evolve.

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Emerging results of an extensive survey of potential participants’ willingness to take risks in and donate to HIV cure research in the United States

Journal of Virus Eradication ◽

10.1016/s2055-6640(20)31329-7 ◽

2015 ◽

Vol 1 ◽

pp. 13

Author(s):

J. Taylor ◽

K. Dubé ◽

D. Evans ◽

L. Sylla ◽

A. Burton ◽

...

Keyword(s):

United States ◽

The United States ◽

Hiv Cure ◽

Extensive Survey ◽

Hiv Cure Research

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OA1-3 Factors affecting participation in HIV cure-related research in the United States: implications for effective and ethical implementation

Journal of Virus Eradication ◽

10.1016/s2055-6640(20)31007-4 ◽

2016 ◽

Vol 2 ◽

pp. 1-2

Author(s):

K. Dubé ◽

J. Taylor ◽

D. Evans ◽

L. Sylla ◽

L. Dee ◽

...

Keyword(s):

United States ◽

The United States ◽

Hiv Cure ◽

Factors Affecting ◽

Related Research

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Ethical and practical considerations for interventional HIV cure-related research at the end-of-life: A qualitative study with key stakeholders in the United States

PLoS ONE ◽

10.1371/journal.pone.0254148 ◽

2021 ◽

Vol 16 (7) ◽

pp. e0254148

Author(s):

John Kanazawa ◽

Sara Gianella ◽

Susanna Concha-Garcia ◽

Jeff Taylor ◽

Andy Kaytes ◽

...

Keyword(s):

United States ◽

End Of Life ◽

Community Support ◽

The United States ◽

Empirical Ethics ◽

Hiv Care ◽

Hiv Cure ◽

Related Research ◽

Stakeholder Groups ◽

The Impact

Background A unique window of opportunity currently exists to generate ethical and practical considerations presented by interventional HIV cure-related research at the end-of-life (EOL). Because participants would enroll in these studies for almost completely altruistic reasons, they are owed the highest ethical standards, safeguards, and protections. This qualitative empirical ethics study sought to identify ethical and practical considerations for interventional HIV cure-related research at the EOL. Methods and findings We conducted 20 in-depth interviews and three virtual focus groups (N = 36) with four key stakeholder groups in the United States: 1) bioethicists, 2) people with HIV, 3) HIV care providers, and 4) HIV cure researchers. This study produced six key themes to guide the ethical implementation of interventional HIV cure-related research at the EOL: 1) all stakeholder groups supported this research conditioned upon a clearly delineated respect for participant contribution and autonomy, participant understanding and comprehension of the risks associated with the specific intervention(s) to be tested, and broad community support for testing of the proposed intervention(s); 2) to ensure acceptable benefit-risk profiles, researchers should focus on limiting the risks of unintended effects and minimizing undue pain and suffering at the EOL; 3) only well-vetted interventions that are supported by solid pre-clinical data should be tested in the EOL translational research model; 4) the informed consent process must be robust and include process consent; 5) research protocols should be flexible and adopt a patient/participant centered approach to minimize burdens and ensure their overall comfort and safety; and 6) a participant’s next-of-kin/loved ones should be a major focus of EOL research but only if the participant consents to such involvement. Conclusions To our knowledge, this empirical ethics study generated the first ethical and practical considerations for interventional HIV cure-related research at the EOL. The ethical complexities of such research must be considered now. We must navigate this ethical conundrum so that we are good stewards of the participants’ extremely altruistic gifts by maximizing the impact and social value of this research. We hope that this study will serve as the foundation for future research and discussion on this topic.

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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

Journal of Empirical Research on Human Research Ethics ◽

10.1177/1556264617734061 ◽

2017 ◽

Vol 13 (1) ◽

pp. 3-17 ◽

Cited By ~ 11

Author(s):

Karine Dubé ◽

Lynda Dee ◽

David Evans ◽

Laurie Sylla ◽

Jeff Taylor ◽

...

Keyword(s):

Healthy Volunteers ◽

Early Phase ◽

The United States ◽

Qualitative Inquiry ◽

People Living With Hiv ◽

Hiv Cure ◽

Policy Makers ◽

Key Informants ◽

Study Participants ◽

Hiv Cure Research

Early-phase HIV cure research is conducted against a background of highly effective antiretroviral therapy, and involves risky interventions in individuals who enjoy an almost normal life expectancy. To explore perceptions of three ethical topics in the context of HIV cure research—(a) equipoise, (b) risk–benefit ratios, and (c) “otherwise healthy volunteers”—we conducted 36 in-depth interviews (IDIs) with three groups of purposively selected key informants: clinician-researchers ( n = 11), policy-makers and bioethicists ( n = 13), and people living with HIV (PLWHIV; n = 12). Our analysis revealed variability in perceptions of equipoise. Second, most key informants believed there was no clear measure of risk–benefit ratios in HIV cure research, due in part to the complexity of weighing (sometimes unknown) risks to participants and (sometimes speculative) benefits to science and society. Third, most clinician-researchers and policy-makers/bioethicists viewed potential HIV cure study participants as “otherwise healthy volunteers,” but this perception was not shared among PLWHIV in our study.

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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

BMC Medical Ethics ◽

10.1186/s12910-022-00741-8 ◽

2022 ◽

Vol 23 (1) ◽

Author(s):

John Kanazawa ◽

Sara Gianella ◽

Susanna Concha-Garcia ◽

Jeff Taylor ◽

Andy Kaytes ◽

...

Keyword(s):

United States ◽

End Of Life ◽

Community Involvement ◽

Ethical Issues ◽

The United States ◽

Hiv Cure ◽

Undue Influence ◽

Focus Group Study ◽

Related Research ◽

Context Specific

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.

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