TY - JOUR
T1 - Exploring the Decision-Making Process of People Living with HIV Enrolled in Antiretroviral Clinical Trials
T2 - A Qualitative Study of Decisions Guided by Trust and Emotions
AU - Feijoo-Cid, Maria
AU - Arreciado Marañón, Antonia
AU - Huertas, Ariadna
AU - Rivero-Santana, Amado
AU - Cesar, Carina
AU - Fink, Valeria
AU - Fernández-Cano, María Isabel
AU - Sued, Omar
N1 - © 2023. The Author(s).
PY - 2023/12
Y1 - 2023/12
N2 - The informed consent is an ethical and legal requirement for potential participants to enroll in a study. There is ample of evidence that understanding consent information and enrollment is challenging for participants in clinical trials. On the other hand, the reasoning process behind decision-making in HIV clinical trials remains mostly unexplored. This study aims to examine the decision-making process of people living with HIV currently participating in antiretroviral clinical trials and their understanding of informed consent. We conducted a qualitative socio-constructivist study using semi-structured interviews. Eleven participants were selected by purposive sampling in Argentina until data saturation was reached. A content analysis was performed. The findings highlight the fact that some participants decided to enroll on the spot, while others made the decision a few days later. In all cases, the decision was based on different aspects of trust (in doctors, in the clinical research site, in the clinical trials system) but also on emotions associated with HIV and/or treatment. Moreover, while people living with HIV felt truly informed after the consent dialogue with a researcher, consent forms were unintelligible and unfriendly. The immediacy of patient decision-making has rarely been described before. Enrollment in an HIV clinical trial is mainly a trust-based decision but this does not contradict the ethical values of autonomy, voluntariness, non-manipulation, and non‐exploitation. Thus, trust is a key issue to be included in reshaping professional practices to ensure the integrity of the informed consent process.
AB - The informed consent is an ethical and legal requirement for potential participants to enroll in a study. There is ample of evidence that understanding consent information and enrollment is challenging for participants in clinical trials. On the other hand, the reasoning process behind decision-making in HIV clinical trials remains mostly unexplored. This study aims to examine the decision-making process of people living with HIV currently participating in antiretroviral clinical trials and their understanding of informed consent. We conducted a qualitative socio-constructivist study using semi-structured interviews. Eleven participants were selected by purposive sampling in Argentina until data saturation was reached. A content analysis was performed. The findings highlight the fact that some participants decided to enroll on the spot, while others made the decision a few days later. In all cases, the decision was based on different aspects of trust (in doctors, in the clinical research site, in the clinical trials system) but also on emotions associated with HIV and/or treatment. Moreover, while people living with HIV felt truly informed after the consent dialogue with a researcher, consent forms were unintelligible and unfriendly. The immediacy of patient decision-making has rarely been described before. Enrollment in an HIV clinical trial is mainly a trust-based decision but this does not contradict the ethical values of autonomy, voluntariness, non-manipulation, and non‐exploitation. Thus, trust is a key issue to be included in reshaping professional practices to ensure the integrity of the informed consent process.
KW - Antiretroviral
KW - Clinical trial
KW - Decision-making
KW - HIV
KW - Informed consent
KW - Trust
UR - http://www.scopus.com/inward/record.url?scp=85165382792&partnerID=8YFLogxK
UR - https://www.mendeley.com/catalogue/48bbcb3c-4922-3fd3-81a7-8a565a711acc/
U2 - 10.1007/s10728-023-00461-z
DO - 10.1007/s10728-023-00461-z
M3 - Article
C2 - 37479908
AN - SCOPUS:85165382792
SN - 1065-3058
VL - 31
SP - 135
EP - 155
JO - Health Care Analysis
JF - Health Care Analysis
IS - 3-4
ER -