Patterns of patient and healthcare provider viewpoints regarding participation in HIV cure-related clinical trials. Findings from a multicentre French survey using Q methodology (ANRS-APSEC)

Abstract

ContextDespite huge advances in the fight against HIV concerning diagnosis, clinical efficacy of antiretroviral treatments (ART), patient survival and quality of life, there is still no cure. Recent developments in HIV cure research have opened the way for clinical trials which could lead to a temporary or definitive end to ART. However, ethical questions exist about related trial-participation risks. The main goal of the ANRS-APSEC survey was, using Q-methodology, to investigate the viewpoints of people living with HIV (PLWH) and HIV healthcare providers (HHP) regarding motivations for and barriers to participation in HIV Cure-related clinical trials (HCRCT).Materials and methodsThirty-three statements were defined encompassing seven dimensions: treatment and follow-up; risks; benefits; patient-physician relationship; beliefs and attitudes; information; target population. Forty-one PLWH and 41 HHP from five French HIV services were asked to rank-order the statements.ResultsFive main viewpoints were elicited from “the most motivated” to “the most reluctant” vis-à-vis HCRCT participation. All placed importance on the wish to participate in HIV research. This result is in line with the HIV-specific culture of joint mobilization. For some viewpoints, the motivation to participate in/propose HCRCT was primarily conditioned by side-effects and/or by constraints, which overall were more accepted by PLWH than HHP. Some viewpoints placed particular importance on HCRCT recruitment strategies. Finally, some expressed a high acceptance of risks and constraints but emphasized the need for information.ConclusionHIV cure research clinical trials (HCRCT) constitute a risky yet unavoidable step towards the goal of finding a cure. To improve future HCRCT and informed consent designs, based on PLWH and HHP preferences and expectations, we need greater knowledge about how these populations perceive the risks and the benefits of HCRCT. Our results confirmed the importance of careful, studied HCRCT design, management and communication, to ensure PLWH and HHP acceptability and convergence of their expectations.

Differences in HIV cure clinical trial preferences of French people living with HIV and physicians in the ANRS‐APSEC study: a discrete choice experiment

“…The biggest difference in trade-offs was that physicians were more concerned about outcomes whereas PLWH were more concerned about their quality of life (consultation frequency and moderate SE). In line with previous research [3,12,15,18], this result might indicate that PLWH motivations to participate were more altruistic than individual. It also underlines the need for physicians to consider moderate SE and not only severe SE.…”

“…On the contrary, gene therapy was the least preferred HCRCT, because of the associated risk of cancer, and probably also because of the uncertainty related to this risk. Aversion to uncertainty was observed in previous analyses . In terms of the profiles, the order of preference for the HCRCT was similar for both PLWH and physicians.…”

“…Physicians and physician‐patient relationships can also influence PLWH motivations to participate. As physicians are not all equally motivated to propose HCRCT, it is important to also compare and contrast their preferences with those of PLWH .…”

“…HIV altruism is one important motivator influencing willingness to participate in HCRCT [3,12,15,18], reflecting the historical advocacy and joint mobilization of PLWH in response to HIV epidemic [1,2,20,21]. Altruistic-based benefits, such as participating in research for the benefit of future generations, have been shown to be part of the value associated with some health programmes [22][23][24].…”

Acceptability, motivation and the prospect of cure for people living with HIV and their healthcare providers in HIV cure-focused treatment interruption studies

“…Despite great interest in ATI, understanding of ATI acceptability amongst people living with HIV (PLHIV) and their HIV healthcare providers (HHP) is limited. In previous surveys of PLHIV, acceptability of ATI has ranged from 34-68% (3)(4)(5), and small qualitative studies have explored understanding and acceptance of ATI (6,7). Knowledge of healthcare provider acceptance of, or support for HIV curefocused research is even more limited.…”