The AIDS Clinical Trials Group A5345 study (NCT03001128) included an intensively monitored antiretroviral pause (IMAP), during which participants living with HIV temporarily stopped antiretroviral treatment (ART) in an effort to identify biomarkers that could predict HIV rebound. We evaluated the potential impact of the IMAP on A5345 study participants in the United States by questioning them immediately after the IMAP and at the end of the study. We administered longitudinal sociobehavioral questionnaires to participants following the IMAP when they resumed ART and at the end of the study. We summarized descriptive data from the post-IMAP and end-of-study questionnaires. Open-ended responses were analyzed using conventional content analysis. Reactions to pausing ART involved a mixture of curiosity and satisfaction from contributing to science. All participants indicated adherence with the ART interruption. About half (9/17) of post-IMAP questionnaire respondents reported having sexual partner(s) during the IMAP, and of those, nearly all (8/9) did not find it difficult to use measures to prevent HIV transmission to partners. The majority believed that they benefited from the study, yet some had elevated anxiety following the IMAP and at the end of the study. Most (24/29) respondents who completed the end-of-study questionnaire would recommend the study to other people living with HIV. Our findings underscore the relevance of the psychosocial aspects of participating in studies that involve interruptions of ART. Understanding how participants experience this research is invaluable for informing the design of future research aimed at sustained ART-free virologic suppression.

中文翻译：

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美国严格监测的抗逆转录病毒暂停后参与者的观点和经验：艾滋病临床试验组 A5345 生物标志物研究的结果

艾滋病临床试验组 A5345 研究 (NCT03001128) 包括一个密集监测的抗逆转录病毒暂停 (IMAP)，在此期间，感染 HIV 的参与者暂时停止抗逆转录病毒治疗 (ART)，以努力确定可以预测 HIV 反弹的生物标志物。我们通过在 IMAP 之后和研究结束时立即询问他们，评估了 IMAP 对美国 A5345 研究参与者的潜在影响。当参与者恢复 ART 和研究结束时，我们对遵循 IMAP 的参与者进行了纵向社会行为问卷调查。我们总结了来自 IMAP 后和研究结束问卷的描述性数据。使用常规内容分析来分析开放式响应。对暂停 ART 的反应包括好奇心和对科学做出贡献的满足感。所有参与者都表示遵守 ART 中断。大约一半 (9/17) 的 IMAP 后调查问卷受访者报告说在 IMAP 期间有性伴侣，而在这些受访者中，几乎所有 (8/9) 都认为采取措施防止 HIV 传播给伴侣并不困难。大多数人认为他们从这项研究中受益，但有些人在 IMAP 之后和研究结束时焦虑加剧。完成研究结束调查问卷的大多数 (24/29) 受访者会向其他 HIV 感染者推荐该研究。我们的研究结果强调了参与涉及中断 ART 的研究的社会心理方面的相关性。了解参与者如何体验这项研究对于为旨在持续的无 ART 病毒学抑制的未来研究设计提供信息非常宝贵。