The authors conducted a prospective, randomized, clinical trial to evaluate the impact of an educational intervention on adherence to antiretroviral therapy, knowledge, quality of life (QOL) and therapeutic response in a large cohort of chronic HIV-infected outpatients. The Ciel Bleu study took place in France between May 1999 and June 2001 in three hospital-, university-based centers. Three hundred twenty-six patients participated in the experiment, which compared two groups of HIV-1 infected outpatients receiving a stable antiretroviral regimen with at least three drugs for at least three months. The experimental group (168 patients) was given an educational program, and the control group (158 patients) received standard care over a 12-month period. All patients from the control group were given the chance to participate in the educational sessions after month 12, and the last evaluation occurred at month 18.

The researchers collected data on HIV diagnosis, therapeutic history and clinical and laboratory characteristics, and patients completed a sociodemographic and lifestyle questionnaire when they were included in the study (T0). Then, investigators recorded clinical data, therapeutic changes, standard laboratory data, CD4 cell count and plasma viral load every 6 months (T6, T12, T18). Patients completed a questionnaire assessing their QOL, adherence, and knowledge about HIV infection at each visit.

The educational program was individualized and took place at each center. Patients received a personalized educational diagnosis based on adherence problems, a planning card with self-adhesive stickers, pillboxes and at least three one-hour educational sessions during the first 12 months. Control patients received a therapeutic planning card at inclusion.

Eighty percent of study participants were male, with a mean age of 40.5 years. Forty-four percent of patients reported tobacco consumption, and 20 percent reported alcohol consumption. Thirty-three percent had AIDS. The mean duration of treatment was 4.0 years, and 80 percent of patients had a protease inhibitor in their drug regimen. CD4 cell count was <200/mm³ in 17 percent of patients, 200-500/mm³ in 49 percent, and =500/mm³ in 34 percent. Plasma viral load was <200 copies/mL in 55 percent of patients, 200-5000 copies/mL in 22.5 percent, and =5000 copies/mL in 22.5 percent. A high percentage of patients had already achieved a maximum score for adherence (46 percent) or for some QOL dimensions: daily living (62 percent), physical role (57 percent), social functioning (47 percent) and emotional role (45 percent). There was no significant difference between the two groups at inclusion.

The researchers found that patients who were older, had higher incomes, and were nonsmokers reported better adherence. They also correlated a high level of adherence with a higher CD4 cell count and a lower plasma viral load.

"The educational intervention had an impact on adherence and knowledge in the experimental group at 6 months, which was maintained at 12 and 18 months," the study stated. "A delayed increase in adherence was observed in the control group at 12 months. No significant impact on quality of life was observed over time. The patients' health status improved in 56 percent of the experimental group subjects and 50 percent of the control subjects. However, no significant impact was shown on CD4 cell count and plasma viral load. This study shows that an educational intervention improves adherence to antiretroviral regimens and health status and suggests that it should be initiated early in therapy."

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