Exploring the Decision-Making Process of People Living with HIV Enrolled in Antiretroviral Clinical Trials : A Qualitative Study of Decisions Guided by Trust and Emotions
Feijoo Cid, Maria (Universitat Autònoma de Barcelona. Departament d'Infermeria)
Arreciado Marañón, Antonia (Universitat Autònoma de Barcelona. Departament d'Infermeria)
Huertas-Zurriaga, Ariadna (Institut Germans Trias i Pujol. Hospital Universitari Germans Trias i Pujol)
Rivero-Santana, Amado (Fundación Canaria de Investigación Sanitaria)
Cesar, Carina (Fundación Huésped, Buenos Aires)
Fink, Valeria (Fundación Huésped, Buenos Aires)
Fernández-Cano, María Isabel (Universitat Autònoma de Barcelona. Departament d'Infermeria)
Sued, Omar (Fundación Huésped, Buenos Aires)

Data:	2023
Descripció:	21 pàg.
Resum:	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 clinicaltrials 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.
Nota:	Altres ajuts: acords transformatius de la UAB
Drets:	Aquest document està subjecte a una llicència d'ús Creative Commons. Es permet la reproducció total o parcial, la distribució, la comunicació pública de l'obra i la creació d'obres derivades, fins i tot amb finalitats comercials, sempre i quan es reconegui l'autoria de l'obra original.
Llengua:	Anglès
Document:	Article ; recerca ; Versió publicada
Matèria:	Antiretroviral ; Clinical trial ; Decision-making ; HIV ; Informed consent ; Trust ; SDG 3 - Good Health and Well-being
Publicat a:	Health Care Analysis, Vol. 31, N. 3-4 (2023) , p. 135-155, ISSN 1573-3394

DOI: 10.1007/s10728-023-00461-z
PMID: 37479908

21 p, 670.7 KB

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Documents de recerca > Documents dels grups de recerca de la UAB > Centres i grups de recerca (producció científica) > Ciències de la salut i biociències > Institut d'Investigació en Ciencies de la Salut Germans Trias i Pujol (IGTP)
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