Abstract
Background: Anti-retro-viral therapy (ART) has changed human immunodeficiency virus/acquired immunodeficiency syndrome (HIV/AIDS) from fatal disease to chronic illness, it does however requires almost perfect adherence for the medication to be therapeutically effective. Methodology: A study will be conducted among people living with Human Immunodeficiency Virus (PLHIV) aged 18 years and above, who are on ART at the ART center of Kasturba Medical College Hospital (KMCH), Attavar, Mangalore, India. Study consists of two phases: Phase I cross sectional study: A cross sectional study (n=409), has already been done to find out the level of adherence to ART using Adult AIDS Clinical Trials Group adherence follow-up questionnaire and the pre-testing for HIV related knowledge of the participants was done using HIV Knowledge Questionnaire. We observed the prevalence of non-adherence to be 27.1% (n=121) and HIV related knowledge was high among 127 (31.1%) and low among 282 (68.9%) PLHIV. Among the 121 non-adherents, 110 PLHIV will be included in the 2nd phase of the study using block randomization. Phase II randomized controlled trial (RCT): A sample size of 110 will be included in this study, which was calculated based on the statistical formula. Randomization of the participants will be done using block randomization method into intervention and control groups. HIV educational intervention will be provided for six months to the intervention group along with the standard patient care available at the hospital, whereas the control group will receive only the standard patient care available at the hospital for duration of six months. This will be followed by conduction of the first post-test at the end of 6th months among both the groups. The participants will be followed up for next 6 months and second post-test will be done at the end of 12th month for the assessment of study outcomes.
Highlights
Introduction to the Proposed ResearchHuman Immunodeficiency virus/acquired immunodeficiency syndrome (HIV/AIDS) is a global health concern
According to the National AIDS Control Organization (NACO) report 2011, India has around 2.9 million people living with HIV (PLHIV) with a national prevalence of 0.27% [2] and among them about 0.25 million are living in the state of Karnataka with a prevalence of 0.69% [3]
Most commonly depression is strongly associated with non-compliance and decreased health related quality of life (HRQOL) among PLHIV [6]
Summary
Human Immunodeficiency virus/acquired immunodeficiency syndrome (HIV/AIDS) is a global health concern. PLHIV who were better aware of the HIV disease through HIV educational intervention had shown increase in adherence to ART, better quality of life and better therapeutic outcomes compared to the patients under standard care [9,10]. In this randomized controlled trial, we aim to assess the effectiveness of an educational intervention in improving the level of adherence to ART and change in CD4 count among PLHIV. Results of the studies conducted outside India may not be relevant/ extrapolated to the Indian scenario, the intervention strategies should be contextualized according to the cultural settings before implementation
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