Diepstra Karen L, Barr Liz, Palm David, Hogg Evelyn, Mollan Katie R, Henley Laney, Stover Angela M, Simoni Jane M, Sugarman Jeremy, Brown Brandon, Sauceda John A, Deeks Steven, Fox Lawrence, Gandhi Rajesh T, Smith Davey, Li Jonathan Z, Dubé Karine
UNC Gillings School of Global Public Health, Chapel Hill, North Carolina, USA.
AIDS Clinical Trials Group (ACTG) Community Scientific Sub-Committee, Baltimore, Maryland, USA.
AIDS Res Hum Retroviruses. 2021 Jun;37(6):489-501. doi: 10.1089/AID.2020.0222. Epub 2021 Feb 16.
The AIDS Clinical Trials Group (ACTG) A5345 study included an intensively monitored antiretroviral pause (IMAP), during which a cohort of participants temporarily stopped antiretroviral treatment during chronic HIV infection. We surveyed participant perceptions and understanding of A5345 using a cross-sectional sociobehavioral questionnaire. Participants completed the baseline questionnaire either before or after initiating the study's IMAP. Questionnaire responses were linked to existing demographic data. Quantitative responses were analyzed overall and stratified by IMAP status. Open-ended responses were analyzed using conventional content analysis. Thirty-two participants completed the baseline sociobehavioral questionnaire. Half ( = 16) completed it before (i.e., pre-IMAP initiation group) and half ( = 16) after IMAP initiation (i.e., post-IMAP initiation group). Eight pre-IMAP initiation respondents (50%) and 11 post-IMAP respondents (69%) responded "yes" when asked if they perceived any direct benefits from participating in A5345. Perceived societal-level benefits included furthering HIV cure-related research and helping the HIV community. Perceived personal-level benefits included the opportunity to learn about the body's response to IMAP and financial compensation. The majority of respondents-13 from each group (81% of each)-reported risks from participation, for example, viral load becoming detectable. A5345 participants perceived both societal- and personal-level benefits of study participation. While the majority of survey respondents perceived participatory risks, nearly one in five did not. Key messages pertaining to study-related risks and benefits may need to be clarified or reiterated periodically throughout follow-up in HIV cure-related studies with IMAPs. Clinical Trail Registration Number: NCT03001128.
艾滋病临床试验组（ACTG）A5345研究包括一个强化监测的抗逆转录病毒治疗中断期（IMAP），在此期间，一组参与者在慢性HIV感染期间暂时停止抗逆转录病毒治疗。我们使用横断面社会行为问卷对参与者对A5345研究的认知和理解进行了调查。参与者在启动研究的IMAP之前或之后完成了基线问卷。问卷回答与现有人口统计学数据相关联。对定量回答进行了总体分析，并按IMAP状态进行了分层。对开放式回答使用传统内容分析法进行了分析。32名参与者完成了基线社会行为问卷。一半（=16名）在IMAP启动之前（即IMAP启动前组）完成，另一半（=16名）在IMAP启动之后（即IMAP启动后组）完成。当被问及是否认为参与A5345研究有任何直接益处时，8名IMAP启动前的受访者（50%）和11名IMAP启动后的受访者（69%）回答“是”。感知到的社会层面益处包括推进与HIV治愈相关的研究以及帮助HIV群体。感知到的个人层面益处包括有机会了解身体对IMAP的反应以及获得经济补偿。每组中的大多数受访者——每组13名（每组的81%）——报告了参与的风险，例如病毒载量变得可检测到。A5345研究的参与者感知到了参与研究在社会和个人层面的益处。虽然大多数调查受访者感知到了参与的风险，但近五分之一的受访者没有。在涉及IMAP的HIV治愈相关研究的整个随访过程中，可能需要定期澄清或重申与研究相关的风险和益处的关键信息。临床试验注册号：NCT03001128。
