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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 anti-retroviral 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 ≥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.

Effect of Individual Cognitive Behaviour Intervention on Adherence to Antiretroviral Therapy: Prospective Randomized Trial