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.
