"I Know That I Was a Part of Making a Difference": Participant Motivations for Joining a Cure-Directed HIV Trial with an Analytical Treatment Interruption
"I Know That I Was a Part of Making a Difference": Participant Motivations for Joining a Cure-Directed HIV Trial with an Analytical Treatment Interruption
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DOI：
10.1089/aid.2022.0040
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发表时间：
2022-09-15
影响因子：
1.5
通讯作者：
Barg, Frances K.
中科院分区：
文献类型：
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作者：
Neergaard, Rebecca;Jones, Nora L.;Barg, Frances K.
分析治疗中断(ATI)被定义为在抗逆转录病毒治疗(ART)中被密切监测的临床暂停，是许多针对HIV治愈的临床研究的核心组成部分。ATI可能会给艾滋病毒携带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整合到包括ATI的临床试验设计中，对于确保成功和以人为中心的试验至关重要。我们对参加BEAT-2治愈定向试验(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。访谈被记录、转录，并使用定向内容分析进行分析。15名试验参与者中有14人完成了访谈。大多数是黑人(79%)，顺性别男性(79%)。与会者指出，几个重要的动机因素促使他们渴望参加艾滋病毒治愈指导的临床试验，其中最突出的是希望找到治愈艾滋病毒的方法并帮助艾滋病毒社区中的其他人。HIV护理团队是患者在决定参加试验时最常见的资源，家人、朋友和恋人也发挥了重要作用。利他主义是参与的主要动机，尽管参与者对了解艾滋病毒科学和研究也有共同的兴趣。参与者对试验程序有很强的了解，并对研究团队表现出极大的信任，使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，一旦他们恢复抗逆转录病毒疗法(ART)，他们之前的抗逆转录病毒疗法(ART)将不再有效。尽管存在这些担忧，但参与者对继续参与试验并成为艾滋病毒治愈方法研究的一部分感到相当兴奋。
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.