[Observance during clinical trials in HIV infection. A discontinuity between patient history and trial logic]

Describe and analyze the processes which lead to patient compliance or non-compliance in HIV treatment trials and to develop a model for strategies aimed at improving compliance and facilitating inclusion (adherence) of these patients.

First, 12 members of the health care teams at two day care clinics (Internal medicine unit, Sainte-Marguerite Hospital, Marseille and Hematology unit, Cimiez Hospital, Nice) were interviewed. In addition, 40 patients involved in the Delta trial (known compliance in 22, non compliance in 7, trial refusal in 7 and eligibility in 5 who were not invited to participate) responded in semi-directive discussions.

The physicians found that the responses were a priori in agreement with patient compliance for those who had participated. Physicians tended to introduce "unofficial" criteria to select patients on the basis of "psychosociological" patterns. Patient agreement to begin the trial or to refuse inclusion and their compliance to medical prescriptions depended in part on their personal opinion concerning AIDS treatment. Patients who presevered in following medical prescriptions in the long-term trial adapted their lifestyle to the new care system (participation in the trial) and discussed their "adaptation" with the physician. The importance of the patient-physician relationship is of prime importance in the behavior of compliant patients.

A communication strategy, reinforcing patient adherence at inclusion and favoring compliance during the trial should be part of the "basic rules" for controlled regulation of compliance in clinical trials.