[The Ditrame (ANRS 049) clinical trial aimed at reducing the mother-child transmission of HIV in Abidjan. Participants' understanding of the trial principles].
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.


CONCLUSIONS
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.
Coulibaly-Traoré
D
D
Université de Cocody, Abidjan, Côte d'Ivoire.
Msellati
P
P
Vidal
L
L
Ekra
C Welffens
CW
Dabis
F
F
D016915:AIDS Vaccines; D000293:Adolescent; D000328:Adult; D005260:Female; D015658:HIV Infections / Q000517:prevention & control* / Q000635:transmission*; D006801:Humans; D018445:Infectious Disease Transmission, Vertical / Q000517:prevention & control*; D007258:Informed Consent; D019359:Knowledge; D009042:Motivation; D009549:Nigeria; D010353:Patient Education as Topic; D010358:Patient Participation; D010919:Placebos; D011247:Pregnancy; D016032:Randomized Controlled Trials as Topic
D016915:AIDS Vaccines; D010919:Placebos
Essai clinique ditrame (ANRS 049) visant à réduire la transmission mère-enfant du VIH à Abidjan. Compréhension des principes par les participantes.