Participant Perspectives and Experiences Entering an Intensively Monitored Antiretroviral Pause: Results from the AIDS Clinical Trials Group A5345 Biomarker Study
Karen L Diepstra, Liz Barr, David Palm, Evelyn Hogg, Katie R Mollan, Laney Henley, Angela M Stover, Jane M Simoni, Jeremy Sugarman, Brandon Brown, John A Sauceda, Steven Deeks, Lawrence Fox, Rajesh T Gandhi, Davey Smith, Jonathan Z Li, Karine Dubé, Karen L Diepstra, Liz Barr, David Palm, Evelyn Hogg, Katie R Mollan, Laney Henley, Angela M Stover, Jane M Simoni, Jeremy Sugarman, Brandon Brown, John A Sauceda, Steven Deeks, Lawrence Fox, Rajesh T Gandhi, Davey Smith, Jonathan Z Li, Karine Dubé
Abstract
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 (n = 16) completed it before (i.e., pre-IMAP initiation group) and half (n = 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.
Keywords: HIV cure-related research; analytical treatment interruption; behavioral sciences; intensively monitored antiretroviral pause; persons living with HIV; social sciences.
Conflict of interest statement
Jeremy Sugarman is a member of Merck KGaA's Bioethics Advisory Panel and Stem Cell Research Oversight Committee; a member of IQVIA's Ethics Advisory Panel; a member of Aspen Neurosciences Scientific Advisory Board; a consultant to Biogen; and a consultant to Portola Pharmaceuticals, Inc. None of these activities is related to the material discussed in this article. No other authors have outside interests to declare.
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Source: PubMed