van Paassen Pien, Dijkstra Maartje, Peay Holly L, Rokx Casper, Verbon Annelies, Reiss Peter, Prins Jan M, Henderson Gail E, Rennie Stuart, Nieuwkerk Pythia T, de Bree Godelieve J
Department of Internal Medicine, Division of Infectious Diseases, Amsterdam UMC, Academic Medical Center, Amsterdam, the Netherlands.
Department of Infectious Diseases, Public Health Service of Amsterdam, Amsterdam, the Netherlands.
J Virus Erad. 2022 Jun 15;8(2):100072. doi: 10.1016/j.jve.2022.100072. eCollection 2022 Jun.
People who initiate antiretroviral therapy (ART) during acute HIV infection are potential candidates for HIV cure-related clinical trials, as early ART reduces the size of the HIV reservoir. These trials, which may include ART interruption (ATI), might involve potential risks. We explored knowledge and perception of HIV cure and willingness to participate in cure-related trials among participants of the Netherlands Cohort Study on Acute HIV infection (NOVA study), who started antiretroviral therapy immediately after diagnosis of acute HIV infection.
We conducted 20 in-depth qualitative interviews with NOVA study participants between October-December 2018. Data were analyzed thematically, using inductive and iterative coding techniques.
Most participants had limited knowledge of HIV cure and understood HIV cure as complete eradication of HIV from their bodies. HIV cure was considered important to most participants, mostly due to the stigma surrounding HIV. More than half would consider undergoing brief ATI during trial participation, but only one person considered extended ATI. Viral rebound and increased infectiousness during ATI were perceived as large concerns. Participants remained hopeful of being cured during trial participation, even though they were informed that no personal medical benefit was to be expected.
Our results highlight the need for thorough informed consent procedures with assessment of comprehension and exploration of personal motives prior to enrollment in cure-related trials. Researchers might need to moderate their expectations about how many participants will enroll in a trial with extended ATI.
在急性HIV感染期间开始抗逆转录病毒治疗（ART）的人是与HIV治愈相关临床试验的潜在候选人，因为早期ART可减少HIV储存库的大小。这些试验可能包括ART中断（ATI），可能存在潜在风险。我们在荷兰急性HIV感染队列研究（NOVA研究）的参与者中探讨了对HIV治愈的认识和看法，以及参与治愈相关试验的意愿，这些参与者在诊断为急性HIV感染后立即开始抗逆转录病毒治疗。
2018年10月至12月期间，我们对NOVA研究的参与者进行了20次深入的定性访谈。使用归纳和迭代编码技术对数据进行主题分析。
大多数参与者对HIV治愈的了解有限，将HIV治愈理解为从体内完全清除HIV。对大多数参与者来说，HIV治愈被认为很重要，主要是因为围绕HIV的污名。超过一半的人会考虑在试验参与期间接受短暂的ATI，但只有一人考虑延长ATI。ATI期间的病毒反弹和传染性增加被视为重大担忧。尽管被告知不会有个人医疗益处，但参与者在试验参与期间仍希望被治愈。
我们的结果强调，在参与治愈相关试验之前，需要进行全面的知情同意程序，评估理解情况并探索个人动机。研究人员可能需要调整他们对有多少参与者会参加延长ATI试验的期望。
