Date Published: January 25, 2017
Publisher: Public Library of Science
Author(s): Karine Dubé, Jeff Taylor, Laurie Sylla, David Evans, Lynda Dee, Alasdair Burton, Loreen Willenberg, Stuart Rennie, Asheley Skinner, Joseph D. Tucker, Bryan J. Weiner, Sandra B. Greene, Peter A. Newman.
Biomedical research towards an HIV cure is advancing in the United States and elsewhere, yet little is known about perceptions of risks and benefits among potential study participants and other stakeholders. We conducted a qualitative study to explore perceived risks and benefits of investigational HIV cure research among people living with HIV (PLWHIV), biomedical HIV cure researchers, policy-makers and bioethicists.
We conducted a qualitative research study using in-depth interviews with a purposive sample of PLWHIV, biomedical HIV cure researchers, policy-makers and bioethicists in 2015–2016. We analysed interview transcripts using thematic analysis anchored in grounded theory.
We conducted and analyzed 36 key informant interviews. Qualitative analysis revealed four main findings. 1) Potential HIV cure study volunteers noted needing more information and education about the potential risks of HIV cure research. 2) Biomedical HIV cure researchers, policy-makers and bioethicists showed less awareness of social and financial risks of HIV cure research than PLWHIV. 3) Most respondents across the different categories of informants identified some risks that were too great to be acceptable in HIV cure research, although a subset of PLWHIV did not place an upper limit on acceptable risk. 4) PLWHIV showed a better awareness of potential psychological benefits of participating in HIV cure research than other groups of stakeholders.
Our research suggests that PLWHIV have a variable understanding of the individual risks, sometimes substantial, associated with participating in biomedical HIV cure research studies. Community engagement and increased research literacy may help improve community understanding. Intensive informed consent procedures will be necessary for ethical study implementation. The current state of HIV cure research offers greater potential benefits to society than to participants. There is likely to be disagreement among regulators, researchers, clinicians, and potential participants about what constitutes acceptable risk for HIV cure studies.
Most HIV cure studies ask participants to undertake substantial individual risk with little to no corresponding individual and direct clinical benefit . Especially in the context of highly effective modern combined antiretroviral therapy (cART), biomedical HIV cure research that includes treatment interruption may confer risk of viral rebound that could be avoided by the current standard of care . As revealed from a previous quantitative study in people living with HIV (PLWHIV) about cure research , there may be psychological and emotional attachments to the benefits of current HIV treatment. PLWHIV place value on how HIV treatment reduces the risk of passing on the virus to one’s sex partner(s) and fear losing viral suppression achieved with newer antiretroviral drugs, particularly if viral suppression was previously impossible with older drugs .
Our qualitative data revealed four main themes. 1) Potential HIV cure study volunteers noted needing more information and education about the potential risks of HIV cure research. 2) Clinician-researchers, policy-makers and bioethicists showed less awareness of social and financial risks of HIV cure research than PLWHIV. 3) Most respondents across the different categories of informants identified some risks that were too great to be acceptable in HIV cure research, although a subset of PLWHIV did not place an upper limit on acceptable risk in the search for a cure. 4) PLWHIV showed a greater awareness of potential psychological benefits of participating in HIV cure research than other groups of stakeholders.
Our findings provide unique insight into the perspectives and preferences of various stakeholders regarding HIV cure research in the United States. The study extends the literature by focusing on HIV cure research perceptions in the United States, including PLWHIV, clinician-researchers, and policy-makers/bioethicists’ perspectives, as similar stakeholder perception studies have been published in other countries . The qualitative inquiry yielded a rich understanding anchored in the participants’ own categories of meaning and knowledge base. Narratives around perceived risks and benefits of HIV cure research modalities revealed different notions about these concepts among stakeholder types. For example, while clinician-researchers focused on clinical risks of HIV cure research, PLWHIV had a deeper connection with perceived social and financial risks, as well as potential non-clinical benefits. Overall, the results offer guidance about which risks and/or benefits biomedical HIV cure researchers should take into consideration when designing, implementing, and communicating about HIV cure studies and provided a foundation for identifying some of the factors that influence decision-making in HIV cure clinical research.
In sum, while perceived risks/benefits may differ from actual risks/benefits, it is important to understand the perspectives of various stakeholders involved in HIV cure research, since these have consequences for the effective and ethical implementation of HIV cure research, including how study protocols and informed consent forms are designed. The possibility of exposing PLWHIV to anything that harbors unacceptable risk appears unethical, and HIV cure research protocols should have clear safety and tolerability criteria that can be acted upon promptly during the conduct of HIV cure research. Further, because HIV cure research remains a relatively recent endeavor, we have a unique opportunity to develop high ethical standards surrounding risks and benefits. Policy-makers/bioethicists have a role to play in creating policies that address the category of unacceptable risks in HIV cure research. It is also crucial to manage expectations around what the science can deliver in early-phase experiments , and to provide adequate education to potential study participants. While our study attempted to bridge social sciences with the biomedical research on HIV cure , more formative research will be needed to understand the evolving public discourse on specific types of HIV cure studies, and this will need to involve the close collaboration of biomedical researchers,social scientists and community representatives. Emerging results around perceived risks and benefits of HIV cure research can serve as an empirical foundation for knowledge translation and community engagement strategies to support the long-term development of a cure with an acceptable risk and benefit profile. Finally, community and participant confidence regarding the safety and acceptability of a cure should be a compelling driver for discovery and progress towards such a cure.