Randomized Controlled Trial to Evaluate the Impact of Pharmaceutical Care on Therapeutic Success in HIV-Infected Patients in Southern Brazil

Abstract

A non-blinded randomized controlled trial evaluated efficacy of pharmaceutical care (PC) (Dáder method) on self-reported antiretroviral adherence and undetectable plasma viral load (UPVL), compared with usual care (UC) in HIV-positive patients in Brazil. Most were male (63 %), mean age 40.3 years (SD = 10). After 12 months, 79.8 % of those receiving PC versus 73.8 % in UC were adherent (RR 1.05, 95 % CI 0.95-1.15, P = 0.35), and 50.3 versus 49.8 % (PC vs. UC, respectively) had UPVL (RR 1.08, 95 % CI 0.97-1.20, P = 0.15). Factors associated with self-reported adherence were regular employment, UPVL, no depressive symptoms, and lower pill load in the treatment regimen. Older age, education, CD4 count <200 cells/mm(3), and shorter treatment duration were associated with UPVL. Of 94 reported drug-related problems, 43 % resolved. In subgroup analyses of patients who experienced therapeutic failure and who were non-adherent at the beginning of the trial (N = 50), no differences were found in UPVL (HR 1.35, 95 % CI 0.57-3.19). Only education level (>12 years) was independently predictive of viral suppression (HR 7.47, 95 % CI 1.69-32.91). In conclusion, PC was not associated with increased self-reported adherence to ART or UPVL in patients treated at a health care facility in southern Brazil. The study suggests, however, that PC could be effective for the subgroup of patients with poor adherence.

Pharmaceutical interventions in antiretroviral therapy: systematic review and meta-analysis of randomized clinical trials

“…All four studies assessed the outcome adherence to ART; the results are described in Table . Adherence was measured in two studies via electronic monitoring using the Medication Event Monitoring System (MEMS), one applied a semi‐structured questionnaire, and one used patient self‐reporting . The cut‐off points selected to define patients as adherent were 80%, 95% and 90 and 95% …”

“…The lack of effect of pharmaceutical intervention might have been related to the sample used in that study. Because the authors selected individuals at various stages of disease with different sociodemographic characteristics and differences in their adherence to treatment, it is quite difficult to assess the impact of intervention on the outcomes related to ART …”

“…The samples of the studies included in the present review differed in their characteristics, as they included patients starting or switching to a new protease inhibitor regimen; patients assisted at an indigent‐care clinic; patients undergoing treatment for depression; and patients assisted at a specialized outpatient clinic without any relevant specific characteristics …”

Considerations and guidance in designing equity-relevant clinical trials

“…In a trial of pharmaceutical care to improve treatment success in people living with HIV in Brazil, higher level of education was found to be predictive of virological success [42]. …”

The Influence of Psychological Predictors and Cognitive Behavioral Stress Management Intervention on Antiretroviral Therapy (ART) Adherence Among HIV-Positive Female Haitian Alcohol Users

“…The importance of the role of health professionals in educating on the purpose of the treatment, which may lead to increased confidence in medication (Silveira et al, 2014;Nachega et al, 2012;Garvie et al, 2011), and developing symptom-management interventions for individuals were also significant factors related to adherence (Garvie et al, 2011;Campos et al, 2008;Sumari-deBoer et al, 2012).…”