'Well, It's the Risk of the Unknown… Right?': A Qualitative Study of Perceived Risks and Benefits of HIV Cure Research in the United States

Abstract

IntroductionBiomedical 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.MethodsWe 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.ResultsWe 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.ConclusionOur 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.

Crowdsourcing contests to facilitate community engagement in HIV cure research: a qualitative evaluation of facilitators and barriers of participation

“…1), including nine trial participants, 16 contest participants, and six contest organizers. Our sample included men who have sex with men (20), people living with HIV (14), and people who inject drugs (5). Facilitators of crowdsourcing contest participation included responsiveness of the contest to lived experiences, high community interest in HIV treatments, and strong trust in medical professionals and related groups (see Table 2).…”

“…There has been some HIV cure community engagement in high-income countries (HICs), but less in lowand middle-income countries (LMICs) [10,[13][14][15]. As HIV cure research advances, there is an increasing need for community engagement, especially in LMIC settings with ongoing clinical trials.…”

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

“…Early BSSR studies indicate that many PLHIV have adjusted well to the chronic condition of HIV and life‐long ART adherence, and have learned to “co‐exist” with the disease . In some cases, living with HIV is associated with receiving social protection, such as social security, disability or housing benefits that may not be available to others . More BSSR is needed to understand how HIV cure research would affect the fluidity of HIV‐related identities, memberships and social positions.…”

“…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 . Furthermore, the margin of risk that ought to be tolerated by withdrawing ART even temporarily and under rigorous monitoring is smaller than in the early days of the HIV epidemic when no life‐saving option was available .…”

“…Furthermore, the margin of risk that ought to be tolerated by withdrawing ART even temporarily and under rigorous monitoring is smaller than in the early days of the HIV epidemic when no life‐saving option was available . Preliminary supportive BSSR revealed a complex matrix of demographic, experiential, psychosocial, ethical, logistical, economic and evidence‐based factors influencing decisions to participate in HIV cure research . Supportive BSSR could also help understand how insights from PLHIV, and relevant stakeholders, are collectively constructed, and how these could in turn strengthen the design and outcomes of biomedically focused clinical trials.…”