OBJECTIVE: The HIV vaccine attempts in developing countries have underlined many ethical questions on the informed consent of the participants. These problems have already been encountered in the context of studies on the prevention of mother-child transmission (MCT) of HIV in Africa. This study is aimed at describing the level of understanding and interpretations that these women have of the clinical trial, randomisation and placebo, as well as their motivations for participating in the study. METHODS: This was a qualitative study conducted in 1997 by a sociologist in the form of in-depth, structured interviews among 57 women participating in a clinical trial on the prevention of MCT of HIV. The interview included a section on the representation of MCT then questions on the eventual sharing of information concerning the HIV-infection status, the motivations for participating in the study and the understanding of the randomIsation and the placebo. RESULTS: Nearly half of the women had not shared the result of their blood test with anyone. Their isolation enhanced the difficulties in getting information on the study. The notion of a probability of transmission was not easy to explain in terms adapted to the level of education of the women. The randomisation was understood as a number pulled out of a hat during a lucky draw. The women did not really understand the pictures used to describe the placebo. They claimed that they wanted to participate in the study essentially to protect their child and to have access to treatment. CONCLUSION: The correct information of patients participating in clinical trials requires repeated interventions throughout the research period. When there is no social protection, the notion of freedom of choice itself, including the idea of informed consent, is relative and the pragmatic choices made by the women clearly show this. These elements must be taken into consideration in the projects of vaccination trials.
RCT Entities:
OBJECTIVE: The HIV vaccine attempts in developing countries have underlined many ethical questions on the informed consent of the participants. These problems have already been encountered in the context of studies on the prevention of mother-child transmission (MCT) of HIV in Africa. This study is aimed at describing the level of understanding and interpretations that these women have of the clinical trial, randomisation and placebo, as well as their motivations for participating in the study. METHODS: This was a qualitative study conducted in 1997 by a sociologist in the form of in-depth, structured interviews among 57 women participating in a clinical trial on the prevention of MCT of HIV. The interview included a section on the representation of MCT then questions on the eventual sharing of information concerning the HIV-infection status, the motivations for participating in the study and the understanding of the randomIsation and the placebo. RESULTS: Nearly half of the women had not shared the result of their blood test with anyone. Their isolation enhanced the difficulties in getting information on the study. The notion of a probability of transmission was not easy to explain in terms adapted to the level of education of the women. The randomisation was understood as a number pulled out of a hat during a lucky draw. The women did not really understand the pictures used to describe the placebo. They claimed that they wanted to participate in the study essentially to protect their child and to have access to treatment. CONCLUSION: The correct information of patients participating in clinical trials requires repeated interventions throughout the research period. When there is no social protection, the notion of freedom of choice itself, including the idea of informed consent, is relative and the pragmatic choices made by the women clearly show this. These elements must be taken into consideration in the projects of vaccination trials.