Analytical treatment interruption (ATI), defined as a closely monitored clinical pause in antiretroviral therapy (ART), is a core component of many HIV cure-directed clinical studies. ATIs may cause significant physical and psychosocial risks for people living with HIV and, as a result, integrating participant and community perspectives into clinical trial designs that include an ATI is crucial to ensuring a successful and person-centered trial. We conducted semi-structured interviews with participants enrolling in the BEAT-2 cure-directed trial (NCT03588715). Interviews elicited participant motivations and decision-making processes for trial participation along with participants' perceptions of the ATI. Interviews were recorded, transcribed, and analyzed using a directed content analysis. Fourteen of 15 trial participants completed interviews. The majority were Black (79%) cisgender male (79%). Participants noted several significant motivating factors contributing to their desire to enroll in the HIV cure-directed clinical trial, the most prominent being a desire to find a cure for HIV and help others in the HIV community. HIV care teams were the most commonly identified resource for patients when making the decision to enroll in the trial, and family, friends, and romantic partners also played a significant role. Altruism was a primary motivation for participation, although participants also shared interest in learning about HIV science and research. Participants had a strong understanding of trial procedures and displayed significant trust in the study team to keep them informed and healthy during their participation. The ATI was a significant source of anxiety for participants. Their primary worry was that their prior antiretroviral therapy (ART) regimen would no longer be effective once they resumed ART. Despite these concerns, participants shared considerable excitement for continued participation in the trial and being a part of the search toward an HIV cure.

中文翻译：

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“我知道我是做出改变的一部分”：参与者参加带有分析治疗中断的治疗导向艾滋病毒试验的动机


分析治疗中断 (ATI) 被定义为抗逆转录病毒治疗 (ART) 中密切监测的临床暂停，是许多 HIV 治愈导向临床研究的核心组成部分。 ATI 可能会给 HIV 感染者带来重大的身体和心理社会风险，因此，将参与者和社区的观点纳入包括 ATI 的临床试验设计中对于确保成功和以人为本的试验至关重要。我们对参加 BEAT-2 治疗导向试验 (NCT03588715) 的参与者进行了半结构化访谈。访谈引出了参与者参与试验的动机和决策过程以及参与者对 ATI 的看法。使用定向内容分析对访谈进行记录、转录和分析。 15 名试验参与者中有 14 名完成了访谈。大多数是黑人（79%）和顺性别男性（79%）。参与者指出了促使他们参加以艾滋病毒治疗为导向的临床试验的几个重要激励因素，其中最突出的是希望找到艾滋病毒治疗方法并帮助艾滋病毒社区中的其他人。当患者决定参加试验时，艾滋病毒护理团队是最常见的资源，家人、朋友和浪漫伴侣也发挥了重要作用。尽管参与者也对了解艾滋病毒科学和研究感兴趣，但利他主义是参与的主要动机。参与者对试验程序有深入的了解，并对研究团队表现出极大的信任，以确保他们在参与过程中了解情况并保持健康。 ATI 是参与者焦虑的一个重要来源。 他们主要担心的是，一旦恢复 ART，之前的抗逆转录病毒治疗 (ART) 方案将不再有效。尽管存在这些担忧，参与者仍对继续参与试验并成为艾滋病毒治疗探索的一部分感到相当兴奋。