INSERM, IRD, SESSTIM, Sciences Economiques & Sociales de la Santé & Traitement de l'Information Médicale, Aix Marseille Univ, Marseille, France.
ORS PACA, Observatoire régional de la santé Provence-Alpes-Côte d'Azur, Marseille, France.
J Int AIDS Soc. 2020 Feb;23(2):e25443. doi: 10.1002/jia2.25443.
Despite the advent of HIV cure-related clinical trials (HCRCT) for people living with HIV (PLWH), the risks and uncertainty involved raise ethical issues. Although research has provided insights into the levers and barriers to PLWH and physicians' participation in these trials, no information exists about stakeholders' preferences for HCRCT attributes, about the different ways PLWH and physicians value future HCRCT, or about how personal characteristics affect these preferences. The results from the present study will inform researchers' decisions about the most suitable HCRCT strategies to implement, and help them ensure ethical recruitment and well-designed informed consent.
Between October 2016 and March 2017, a discrete choice experiment was conducted among 195 virally controlled PLWH and 160 physicians from 24 French HIV centres. Profiles within each group, based on individual characteristics, were obtained using hierarchical clustering. Trade-offs between five HCRCT attributes (trial duration, consultation frequency, moderate (digestive disorders, flu-type syndrome, fatigue) and severe (allergy, infections, risk of cancer) side effects (SE), outcomes) and utilities associated with four HCRCT candidates (latency reactivation, immunotherapy, gene therapy and a combination of latency reactivation and immunotherapy), were estimated using a mixed logit model.
Apart from severe SE - the most decisive attribute in both groups - PLWH and physicians made different trade-offs between HCRCT attributes, the latter being more concerned about outcomes, the former about the burden of participation (consultation frequency and moderate SE). These different trades-offs resulted in differences in preferences regarding the four candidate HCRCT. PLWH significantly preferred immunotherapy, whereas physicians preferred immunotherapy and combined therapy. Despite the heterogeneity of characteristics within the PLWH and physician profiles, results show some homogeneity in trade-offs and utilities regarding HCRCT.
Severe SE, not outcomes, was the most decisive attribute determining future HCRCT participation. Particular attention should be paid to providing clear information, in particular on severe SE, to potential participants. Immunotherapy would appear to be the best HCRCT candidate for both PLWH and physicians. However, if the risk of cancer could be avoided, gene therapy would become the preferred strategy for the latter and the second choice for the former.
尽管针对艾滋病毒感染者（PLWH）的艾滋病毒治愈相关临床试验（HCRCT）已经出现，但所涉及的风险和不确定性引发了伦理问题。尽管研究已经深入了解了 PLWH 和医生参与这些试验的杠杆和障碍，但没有关于利益相关者对 HCRCT 属性的偏好、PLWH 和医生对未来 HCRCT 的不同重视程度，或个人特征如何影响这些偏好的信息。本研究的结果将为研究人员提供有关实施最合适的 HCRCT 策略的信息，并帮助他们确保招募的伦理和精心设计的知情同意。
在 2016 年 10 月至 2017 年 3 月期间，对来自 24 个法国 HIV 中心的 195 名病毒控制良好的 PLWH 和 160 名医生进行了离散选择实验。根据个体特征，在每个组中获得基于个人特征的不同群体。使用分层聚类。使用混合对数模型估计了五个 HCRCT 属性（试验持续时间、咨询频率、中度（消化紊乱、流感样综合征、疲劳）和严重（过敏、感染、癌症风险）副作用（SE）、结果）与四个 HCRCT 候选物（潜伏期再激活、免疫疗法、基因疗法和潜伏期再激活与免疫疗法的组合）之间的权衡。
除了严重 SE（两组中最关键的属性）之外，PLWH 和医生对 HCRCT 属性的权衡也不同，后者更关心结果，前者更关心参与的负担（咨询频率和中度 SE）。这些不同的权衡导致了对四种候选 HCRCT 的偏好差异。PLWH 显著更喜欢免疫疗法，而医生更喜欢免疫疗法和联合疗法。尽管 PLWH 和医生群体特征存在异质性，但研究结果表明，HCRCT 的权衡和效用存在一定程度的同质性。
严重 SE 而不是结果是决定未来 HCRCT 参与的最关键属性。应特别注意向潜在参与者提供有关严重 SE 的明确信息。免疫疗法似乎是 PLWH 和医生的最佳 HCRCT 候选物。但是，如果可以避免癌症风险，基因疗法将成为后者的首选策略，也是前者的第二选择。
