Effectiveness of yoga therapy as an adjunct on mental health status, quality of life, and medication adherence among people living with HIV on antiretroviral therapy: A randomized controlled trial (ART YOGA)

IntroductionHIV, the retrovirus that causes AIDS, is a major global public health threat. This chronic viral infection diminishes the immune system by attacking CD4 cells. The principal treatment is antiretroviral medication (ART), which greatly increases the life expectancy of HIV patients. However, ART does not address psychological issues including depression, anxiety, and stress. These mental health issues are significant predictors of poor medication adherence, which can compromise treatment success. Depression and anxiety are associated with lower quality of life (QoL) and poor physical health because of diminished immunity. This trial aims to assess the effectiveness of yoga as an adjunct therapy on psychologic parameters (depression, anxiety and stress), quality of life, and medication adherence of people living with HIV on antiretroviral therapy at a tertiary care hospital in AIIMS New Delhi, India. Materials and methodsThis study is a two-arm, parallel-group, open-label blinded end-point trial, single-center, randomized controlled trial investigating the effects of Yoga Intervention as adjunct in People living with HIV (PLHIV). Participants (n=192) will be randomized to either 12 weeks of Yoga therapy program (n=96) or Active control group i.e., prescribed brisk walk (n=96). Both groups will receive standard treatment. The primary outcome is anxiety and depression scores (HADS-A and HADS-D), and the secondary outcomes are Stress (PSS), quality of life (WHOQOL-HIV BREF and SF-36 QoL) and medication adherence. The study is approved by Institute Research Board Ethics (AIIMSA2969/03.01.2025, RP-46/25, OP-16/02.05.25) and is registered at Clinicaltrials.gov (CTRI/2025/03/081645). CTRI Link-https://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?EncHid=MTIyNjUx&Enc=&userName=HIV,%20Yoga