Effect of individual cognitive behaviour intervention on adherence to antiretroviral therapy: prospective randomized trial.

Objective: A high level of adherence to antiretroviral therapy is required for complete suppression of HIV replication, immunological and clinical effectiveness. We investigated whether cognitive behaviour therapy can improve medication adherence.

Design: Prospective randomized 1-year trial.

Setting: Collaboration of HIV university outpatient clinic and psychotherapists in private practice.

Participants: 60 HIV-infected persons on stable antiretroviral combination therapy and viral load below 50 copies/ml.

Intervention: Cognitive behaviour intervention in individual patients, in addition to standard of care.

Main Outcome Measures: Feasibility and acceptance of intervention; adherence to therapy assessed using medication event monitoring system (MEMS) and self-report questionnaire; virological failure; psychosocial measures.

Results: The median number of sessions for cognitive behaviour intervention per patient during the 1-year trial was 11 (range 2-25). At months 10-12, mean adherence to therapy as assessed using MEMS was 92.8% in the intervention and 88.9% in the control group (P=0.2); the proportion of patients with adherence > or = 95% was 70 and 50.0% (P=0.014), respectively. While there was no significant deterioration of adherence during the study in the intervention arm, adherence decreased by 8.7% per year (P=0.006) in the control arm. No differences between the intervention group and standard of care group were found regarding virological outcome. Compared with the control group, participants in the intervention group perceived a significant improvement of their mental health during the study period.

Conclusions: Cognitive behavioural support in addition to standard of care of HIV-infected persons is feasible in routine practice, and can improve medication adherence and mental health.