Effects of Counselling on Adherence to Antiretroviral Treatment Among People with HIV in Estonia: A Randomized Controlled Trial

To assess the efficacy of an education- and strengths-based counselling programme to promote antiretroviral therapy (ART) adherence in a cohort of HIV-infected individuals with high prevalence of injection drug use in Estonia. Parallel-group randomized (1:1) controlled trial (RCT). Adults receiving ART in two clinics were followed for 12 months. The trial compared: (i) an intervention (three sessions) incorporated into routine clinic visits, providing education about HIV, ART, the role of adherence, and tailoring regimen to daily routines using problem-solving skills to address adherence barriers versus (ii) usual care (control). Primary and secondary outcomes were self-reported ART adherence (3-day recall) and viral load (respectively). 519 patients were randomized and 82% completed the study. Recent optimal ART adherence (3-day recall >= 95%) was reported by 75.6% in the intervention group and 72.9% of controls at baseline and 76.7% and 67.5%, respectively, at 12 months (RR 1.14, 95% CI 1.00-1.28; adjusted RR 1.13, 95% CI 1.00-1.27). There was no difference in the proportion of patients with undetectable viral load. At 12 months the intervention group reported significantly higher perceptions of ART necessity versus ART concerns [mean ART necessity-concerns differential: intervention group 1.32 (SD 1.22) vs control group 1.08 (SD 1.12); p = 0.048]. All-cause mortality among study participants was 27.7 per 1000 person years (95% CI 15.6-44.8). A brief, clinic-based adherence intervention alone may assist with adherence but lacks impact on viral load at 12 months.