Desafios éticos em relação ao processo de consentimento informado e testagem nas unidades sanitárias no contexto da seropositividade induzida pela vacina do HIV na cidade de Maputo

Abstract

Several countries have made efforts to develop an effective vaccine for HIV prevention and Mozambique is part of this group of countries that have carried out vaccine clinical trials for HIV prevention. (2) In these studies, participants receive active products that can develop seropositivity in the rapid tests used in health facilities, this phenomenon is called VISP. (3) As it is a new phenomenon in the context of the Mozambique National Health System and due to a lack of information about VISP, participants may suffer clinical and social harm. The informed consent process in this type of study is very important because it allows the participant to receive all the information necessary to make an informed and voluntary decision. The aim of the study was to evaluate the ethical challenges of VISP in clinical trials, taking into account the informed consent process and care in health units. A cross-sectional descriptive study was carried out with a qualitative component that followed a phenomenological study design, semi-structured interviews and in-depth interviews were carried out with all groups of volunteers in five health units and a research center in the city of Maputo. This study demonstrated that the majority of health professionals in health units still have gaps in their knowledge about VISP and HIV testing in health units for this group of participants. On the other hand, most participants in HIV vaccine clinical trials demonstrated solid knowledge of the subjects.