Participant Perspectives and Experiences Entering an Intensively Monitored Antiretroviral Pause (IMAP): Results from the AIDS Clinical Trials Group (ACTG) A5345 Biomarker Study.

Abstract

BACKGROUND\nThe 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 socio-behavioral questionnaire.\n\n\nMETHODS\nParticipants 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.\n\n\nRESULTS\nThirty-two participants completed the baseline socio-behavioral 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, e.g., viral load becoming detectable.\n\n\nCONCLUSIONS\nA5345 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.