Dubé Karine, Eskaf Shadi, Barr Liz, Palm David, Hogg Evelyn, Simoni Jane M, Sugarman Jeremy, Brown Brandon, Sauceda John A, Henley Laney, Deeks Steven, Fox Lawrence, Gandhi Rajesh T, Smith Davey, Li Jonathan Z
Public Health Leadership Program and Health Policy and Management, UNC Gillings School of Global Public Health, Chapel Hill, North Carolina, USA.
UNC School of Government, Chapel Hill, North Carolina, USA.
AIDS Res Hum Retroviruses. 2022 Jun;38(6):510-517. doi: 10.1089/AID.2021.0170. Epub 2022 Apr 21.
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.
艾滋病临床试验组A5345研究（NCT03001128）纳入了一项强化监测的抗逆转录病毒治疗中断（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），以努力识别能够预测HIV反弹的生物标志物。我们通过在IMAP结束后及研究结束时对美国A5345研究的参与者进行询问，评估了IMAP对他们的潜在影响。在IMAP之后参与者恢复ART时以及研究结束时，我们向他们发放了纵向社会行为问卷。我们总结了IMAP后和研究结束时问卷中的描述性数据。采用传统内容分析法对开放式回答进行分析。对暂停ART的反应既有好奇心，也有因对科学有所贡献而产生的满足感。所有参与者均表示遵守了ART中断规定。在IMAP后问卷的受访者中，约一半（9/17）报告在IMAP期间有性伴侣，其中几乎所有人（8/9）认为使用预防HIV传播给伴侣的措施并不困难。大多数人认为他们从研究中受益，但有些人在IMAP之后及研究结束时焦虑有所增加。在完成研究结束时问卷的受访者中，大多数（24/29）会向其他感染HIV的人推荐这项研究。我们的研究结果强调了参与涉及ART中断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实现持续无ART病毒学抑制的未来研究设计提供信息非常宝贵。
