Prospective randomized two-arm controlled study to determine the efficacy of a specific intervention to improve long-term adherence to highly active antiretroviral therapy

Background: Nearly perfect compliance seems to be indispensable to obtain t he maximum benefit from highly active antiretroviral therapy (HAART). Inter ventions to ensure a high level of adherence during a relatively long-term period of therapy are necessary. Methods: This is a prospective, randomized, two-arm controlled study includ ing patients starting their first- or second-line HAART who were randomized to receive psychoeducative intervention to implement adherence (experiment al group [EG]) or a usual medical follow-up (control group [CG]). We aimed to study the efficacy of a psychoeducative intervention to ensure long-term adherence to HAART, its relation with the virologic efficacy of treatment, and to determine the variables related to long-term adherence. Visits were made at weeks 0, 4, 24, and 48 for data collection. Self-reported adherenc e was registered at each visit and its veracity was tested by randomized bl ood analyses performed without previous warning to 40% of patients. Appropr iate adherence was defined as the consumption of greater than or equal to 9 5% of medication prescribed. Statistical analyses were performed both by th e as treated (AT) and the intention to treat missing = failure (ITT) method s. Results: In all, 116 patients were included. At week 48, 94% of patients in the EG versus 69% controls achieved adherence greater than or equal to 95% (p = .008); 89% of patients in the EG versus 66% controls had HIV-1 RNA le vels <400 copies/ml (p = .026). Overall, 85% of patients with adherence <gr eater than or equal to>95% but only 45% of those with adherence <95% had vi ral load (VL) <400 copies/ml (p = .008). In multivariate analysis, variable s significantly related to adherence were having received a psychoeducative intervention (odds ratio [OR], 6.58; p = .04), poor effort to take medicat ion (OR, 5.38; p = .03), and high self-perceived capacity to follow the reg imen (OR, 13.76; p = .04). Self-reported adherence and drug plasma levels c oincided in 93% of cases. However, differences in adherence did not reach s tatistical significance in the ITT analysis although a clear tendency towar d benefit was observed in EG. Conclusions: Specific and maintained psychoeducative interventions based on excellence on clinical practice are useful to keep high levels of adherenc e as well as high levels of viral suppression. There is a clear relation be tween high adherence levels and virologic success. Assessment of certain sp ecific variables related to adherence may be helpful to monitor patient's c ompliance in the clinical setting.