EFFECTS OF 2 FORMATS OF INFORMED CONSENT ON KNOWLEDGE AMONGST PERSONSWITH ADVANCED HIV-DISEASE IN A CLINICAL-TRIAL OF DIDANOSINE

To determine subjects' perception of the purpose of informed consent, 113 subjects were recruited from a dose-controlled clinical trial of d idanosine (ddI), Subjects were surveyed regarding how they made decisi ons regarding their medical care in general, about how they obtained i nformation about this trial in particular, and several aspects of the informed consent procedure, Subjects were then randomly allocated to r eceive information about the trial by either a written only format or a written and verbal format 1 week before commencement of the trial. A n eight-item instrument assessed knowledge of ddI prior to and subsequ ent to receiving information, Most subjects obtained information about HIV-related issues from their specialist (70%) or general (51%) medic al practitioner, A large proportion of subjects (88%) reported that th ey believed their specialist medical practitioner always acted in thei r best interest. The majority of subjects (79%) believed that subjects should be allowed the choice between participating in the clinical tr ial and receiving the drug outside the trial mechanism, Of the subject s, 96% believed that informed consent was necessary in clinical trials ; however, their opinions of the purpose of informed consent varied wi dely. Although they signed the informed consent, 44% of the subjects s tated that they did not understand 'all' of the information that was p rovided. We found that the provision of information by written mode al one, or written and verbal modes were both associated with significant increases in knowledge levels and that there was a significant intera ction in the degree of change between the two methods, with the writte n plus verbal method showing the most improvement over time. There was an interaction between degree of improvement in knowledge of didanosi ne in subjects who received written information versus those who recei ved written and verbal knowledge and time (pre- versus post-consent) a nd a significant main effect for time, All subjects were relatively we ll-informed about the drug and stated that specialist and general medi cal practitioners were their major source of knowledge for all aspects of their HIV health care.