A randomized prospective study to assess health-related quality-of-life outcomes of antiretroviral therapy in human immunodeficiency virus-positive adults

INTRODUCTION: Health-related quality of life (HRQOL) in human immunodeficiency virus (HIV)-positive individuals is substantially challenged due to disease, opportunistic infections, lifelong commitment, and tolerability to antiretroviral therapy (ART) and various social, physical, and psychological domains. AIM: This study was conducted to assess the magnitude of the impact on HRQOL in HIV-positive people from early access to ART. SETTINGS AND DESIGN: This was a randomized, prospective, open-label study, conducted at the ART center attached to the Government Medical College, Amritsar. SUBJECTS AND METHODS: This study comprised 240 HIV-infected adults in the age group >18 years who presented to the ART center. Approval from the Institutional Ethics Committee was obtained. Informed consent was taken from all the enrolled participants after explaining the study therapy and its benefits and side effects. Patients who presented early in their course of disease and had baseline CD4 count ≥350/mm(3) were recruited in early arm and those with <350/mm(3) or the development of symptomatic HIV-related disease in the late arm. Following stratification, both groups were 1:1 randomized by permuted block randomization. The primary objective was to assess HRQOL using the World Health Organization Quality of Life-HIV brief instrument (WHOQOL-HIV). STATISTICAL ANALYSIS USED: The summary domain and total HRQOL scores were calculated using method developed by the WHOQOL-HIV group. Unpaired t-test was applied for statistical analysis, with level of significance expressed as P < 0.05. RESULTS: Out of the total 240 HIV-positive patients, 120 who met eligibility criteria were recruited for the final analysis. There was a significant difference between HRQOL score of Physical domains and Psychological domains, between early and late arms at baseline and at the end of 9 months. CONCLUSIONS: Quality of life is an important holistic measure for assessing the health of people living with HIV/AIDS.