PDF(Pubmed)
Abstract：
A feature of HIV cure trials is the need to interrupt treatment to test the efficacy of experimental interventions-a process known as analytical treatment interruptions (ATIs).
We report the experiences of participants after they completed an extended ATI.
From April to November 2022, we conducted post-ATI in-depth interviews with BEAT2 clinical trial (NCT03588715) participants who stopped ART while receiving an immunotherapy regimen. We used conventional content analysis to code the data.
We conducted interviews with 11 Black/African American and three White/Caucasian participants (11 males, two females, and one transgender woman). The mean ATI was 38 weeks. Participants noted several significant experiences surrounding the interventions\' side effects, ATI, and returning to medication. Some participants had positive experiences with their ATI. Other participants were nervous during the ATI. Rising viral loads led some to feel a sense of failure. Although trial experiences were heterogeneous, participants unanimously had positive interactions with the clinical trial staff which facilitated their retention in the trial. Participants shared their experiences with the trial, including changes in expectations, experiences with experimental interventions and procedures, compensation as a measure of respect, effort, transportation, and effects of COVID-19 during the trial. Based on these results, we provide considerations for the conduct of future HIV cure-directed clinical trials involving ATIs.
Managing expectations, focusing on participants\' contributions, and providing support to reduce feelings of having failed the research team and/or the HIV community following viral rebound should be part of HIV cure trial design. Discussing the mental health impact of rebound during consent, distinct from risk, is needed. Continued efforts to understand how people with HIV experience ATIs will improve future designs of HIV cure clinical trials.
We report the experiences of participants after they completed an extended ATI.
From April to November 2022, we conducted post-ATI in-depth interviews with BEAT2 clinical trial (NCT03588715) participants who stopped ART while receiving an immunotherapy regimen. We used conventional content analysis to code the data.
We conducted interviews with 11 Black/African American and three White/Caucasian participants (11 males, two females, and one transgender woman). The mean ATI was 38 weeks. Participants noted several significant experiences surrounding the interventions\' side effects, ATI, and returning to medication. Some participants had positive experiences with their ATI. Other participants were nervous during the ATI. Rising viral loads led some to feel a sense of failure. Although trial experiences were heterogeneous, participants unanimously had positive interactions with the clinical trial staff which facilitated their retention in the trial. Participants shared their experiences with the trial, including changes in expectations, experiences with experimental interventions and procedures, compensation as a measure of respect, effort, transportation, and effects of COVID-19 during the trial. Based on these results, we provide considerations for the conduct of future HIV cure-directed clinical trials involving ATIs.
Managing expectations, focusing on participants\' contributions, and providing support to reduce feelings of having failed the research team and/or the HIV community following viral rebound should be part of HIV cure trial design. Discussing the mental health impact of rebound during consent, distinct from risk, is needed. Continued efforts to understand how people with HIV experience ATIs will improve future designs of HIV cure clinical trials.
摘要：
■HIV治愈试验的一个特征是需要中断治疗以测试实验性干预措施的功效-该过程称为分析治疗中断（ATIs）。
■我们报告参与者完成扩展ATI后的经历。
■从2022年4月至11月，我们对BEAT2临床试验（NCT03588715）在接受免疫治疗方案时停止ART的参与者进行了ATI后深度访谈。我们使用常规的内容分析来对数据进行编码。
■我们采访了11名黑人/非洲裔美国人和3名白人/高加索人（11名男性，两个女人,和一名变性人妇女）。平均ATI是38周。参与者注意到围绕干预措施副作用的几个重要经验，ATI,回到药物治疗。一些参与者对他们的ATI有积极的经验。其他参与者在ATI期间感到紧张。病毒载量的上升导致一些人感到失败。虽然试验经验是异质的，参与者一致与临床试验人员进行了积极互动,这有助于他们在试验中的保留.参与者分享了他们在试验中的经验，包括期望的变化，实验干预和程序的经验，补偿作为一种尊重的衡量标准，努力,交通运输,以及COVID-19在试验期间的影响。基于这些结果,我们为将来开展涉及ATI的HIV治愈导向临床试验提供了考虑因素.
■管理期望，专注于参与者的贡献，并提供支持以减少病毒反弹后研究团队和/或HIV社区失败的感觉应该是HIV治愈试验设计的一部分。讨论同意期间反弹对心理健康的影响，不同于风险，是需要的。继续努力了解HIV感染者如何经历ATI将改善HIV治愈临床试验的未来设计。
■我们报告参与者完成扩展ATI后的经历。
■从2022年4月至11月，我们对BEAT2临床试验（NCT03588715）在接受免疫治疗方案时停止ART的参与者进行了ATI后深度访谈。我们使用常规的内容分析来对数据进行编码。
■我们采访了11名黑人/非洲裔美国人和3名白人/高加索人（11名男性，两个女人,和一名变性人妇女）。平均ATI是38周。参与者注意到围绕干预措施副作用的几个重要经验，ATI,回到药物治疗。一些参与者对他们的ATI有积极的经验。其他参与者在ATI期间感到紧张。病毒载量的上升导致一些人感到失败。虽然试验经验是异质的，参与者一致与临床试验人员进行了积极互动,这有助于他们在试验中的保留.参与者分享了他们在试验中的经验，包括期望的变化，实验干预和程序的经验，补偿作为一种尊重的衡量标准，努力,交通运输,以及COVID-19在试验期间的影响。基于这些结果,我们为将来开展涉及ATI的HIV治愈导向临床试验提供了考虑因素.
■管理期望，专注于参与者的贡献，并提供支持以减少病毒反弹后研究团队和/或HIV社区失败的感觉应该是HIV治愈试验设计的一部分。讨论同意期间反弹对心理健康的影响，不同于风险，是需要的。继续努力了解HIV感染者如何经历ATI将改善HIV治愈临床试验的未来设计。
