Protière Christel, Spire Bruno, Mora Marion, Poizot-Martin Isabelle, Préau Marie, Doumergue Marjolaine, Morlat Philippe, Zucman David, Goujard Cécile, Raffi François, Lambotte Olivier, Suzan-Monti Marie
Aix Marseille Univ, INSERM, IRD, SESSTIM, Sciences Economiques & Sociales de la Santé & Traitement de l'Information Médicale, Marseille, France.
ORS PACA, Observatoire régional de la santé Provence-Alpes-Côte d'Azur, Marseille, France.
PLoS One. 2017 Nov 2;12(11):e0187489. doi: 10.1371/journal.pone.0187489. eCollection 2017.
Despite 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).
Thirty-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.
Five 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.
HIV 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.
尽管在抗击艾滋病病毒方面，在诊断、抗逆转录病毒治疗（ART）的临床疗效、患者生存及生活质量等方面取得了巨大进展，但仍无法治愈。艾滋病病毒治愈研究的最新进展为临床试验开辟了道路——这些试验可能会导致抗逆转录病毒治疗暂时或最终结束。然而，关于相关试验参与风险存在伦理学问题。法国国家艾滋病研究机构（ANRS）-艾滋病特殊人群关怀与教育项目（APSEC）调查的主要目标是，采用Q方法，调查艾滋病病毒感染者（PLWH）及艾滋病医疗服务提供者（HHP）对于参与艾滋病病毒治愈相关临床试验（HCRCT）的动机及障碍的观点。
定义了33条陈述，涵盖七个维度：治疗与随访；风险；益处；医患关系；信念与态度；信息；目标人群。来自法国五个艾滋病服务机构的41名艾滋病病毒感染者及41名艾滋病医疗服务提供者被要求对这些陈述进行排序。
就参与艾滋病病毒治愈相关临床试验而言，从“最积极”到“最不情愿”引出了五种主要观点。所有人都重视参与艾滋病研究的愿望。这一结果与艾滋病领域联合动员的特定文化相符。对于某些观点而言，参与/提议艾滋病病毒治愈相关临床试验的动机主要受副作用和/或限制条件的制约，总体而言，艾滋病病毒感染者比艾滋病医疗服务提供者更能接受这些副作用和限制条件。一些观点特别重视艾滋病病毒治愈相关临床试验的招募策略。最后，一些人表示对风险和限制条件接受度较高，但强调了信息需求。
艾滋病病毒治愈研究临床试验是朝着找到治愈方法这一目标迈出的有风险但又不可避免的一步。为了基于艾滋病病毒感染者及艾滋病医疗服务提供者的偏好和期望改进未来的艾滋病病毒治愈相关临床试验及知情同意设计，我们需要更深入了解这些人群如何看待艾滋病病毒治愈相关临床试验的风险和益处。我们的结果证实了精心、深入设计、管理和沟通艾滋病病毒治愈相关临床试验的重要性，以确保艾滋病病毒感染者及艾滋病医疗服务提供者的接受度以及他们期望的趋同。
