Revista de SIDA e investigación clínica

Evaluating the Impact of Educational Interventions on Use of Highly Active Antiretroviral Therapy and Adherence Behavior in Indian Human Immunodeficiency Virus Positive Patients: Prospective Randomized Controlled Study

Abstract

Radhakrishnan Rajesh, Sudha Vidyasagar, Danturulu Muralidhar Varma, Vasudeva Guddattu and Ansar Hameed

Background: In India, there is a lack of awareness and inadequate knowledge about use of Highly Active Antiretroviral Therapy (HAART) due to social stigma leading to intentional non-adherence among Human Immunodeficiency Virus (HIV) infected patients thus, Educational Intervention (EI) must be sought. Need for the study: There is a need for an EI program for HIV-infected patients for improving adherence to Antiretroviral Therapy (ART). Aim: The aim of the study was to evaluate the impact of an EI on use of HAART and its effect on adherence behavior in Intervention Care Group (ICG) in comparison with Standard Care Group (SCG) in HIV infected patients. Methods: A prospective, randomized, controlled study was conducted at Kasturba hospital Manipal from August 2009 to May 2012 in HIV infected patients. The baseline response for Knowledge, Attitude, Belief, and Practice (KABP) questionnaire was assessed. Block randomization was used to assign the patients to the SCG and ICG. In ICG group, patients are educated every 4 weeks for a total of 16 weeks with Patient Information Leaflet (PIL), adherence counseling and awareness to Adverse Drug Reactions (ADRs) to ART by a clinical pharmacist. In ISG group, patients are given standard care for ART treatment by a clinician. Post KABP response was documented in both groups at 16th week and adherence rate was measured. Repeated-measures Analysis of Variance (RANOVA) was used for the comparison of pre and post total KABP responses between ICG and SCG. Results: A total of 256 HIV positive patients were enrolled. Out of which 16 patients were excluded because they were on traditional medicines and 240 HIV-infected patients with HAART were finally included in the study, of whom 120 (89 [74.2%] men, 31[25.8%] women) were randomly assigned to the ICG and 120 (99 [82.5%] men, 21[17.5%] women) to the SCG. Pre and post KABP responses significantly increased with mean ± standard deviation (SD) (p<0.001) and greater than 95% of adherence (p<0.001) was reported in ICG after EI in comparison with SCG. Conclusion: The EI program on use of HAART in this study changed their intentional non-adherence behavior, negative beliefs and social stigma.