Role of yoga therapy against tuberculosis in people living with HIV infection

INTERVENTION: Eligible People Living with HIV (PLHIV) are allocated to the interventional group and the control group by a simple random allocation. This is done by an independent statistician with the help of a computer‐generated random number table. The random allocation sequence is concealed from the independent statistician enrolling the participants. Masking is not possible due to a strong PLHIV network and patient staying in the same locality or job place. The outcome assessor will be blind for assessing the study outcome. Intervention group: PLHIV in the intervention group are provided with a yoga therapy intervention. This consists of a joint loosening exercise (5 min), asana (yogic postures, 10 min), pranayama (yogic breathing exercise, 10 min) and yoga nidra (guided meditational sleep, 15 min). A 40‐minute session is given to the PLHIV once a month for 3 months, followed by high definition video, audio and booklet. Participants are asked to practice yoga therapy at home. The total duration of intervention is 3 months followed by first follow up at 6 months from enrolment and then six‐monthly until 2 years. The yoga therapy intervention is given by a trained and qualified (graduate degree holder) yoga trainer. Control group: PLHIV in the control group are not given yoga therapy intervention and are given the usual care and support. CONDITION: Prevention of tuberculosis in people living with HIV infection ; Infections and Infestations ; Tuberculosis PRIMARY OUTCOME: ; 1. Occurrence of tuberculosis among PLHIV, diagnosed by Nucleic Acid Amplification test (NAAT), or sputum smear microscopy or chest X‐ray when a PLHIV has a presumptive TB as evident by positive 4S symptom screening consisting of cough, fever, weight loss or night sweat, presence of any one irrespective of duration.; 2. CD4 T cell count measured by flow cytometry methods at baseline, 6, 12, 18, and 24 months; 3. Viral load measured using real time PCR at baseline, 6, 12, 18, and 24 months; SECONDARY OUTCOME: ; 1. Proportion of opportunistic infections other than tuberculosis, measured by taking clinical history at baseline, 6,12, 18 and 24 months; 2. Treatment outcome of the diagnosed TB cases amongst PLHIV, measured by sputum smear microscopy at the end of the intensive phase of anti TB treatment and at the end of continuation phase of anti TB treatment; INCLUSION CRITERIA: 1. Age 18 ‐ 65 years irrespective of gender 2. Documented HIV diagnosis 3. PLHIV on antiretroviral treatment and stable 4. Received or completed isoniazid prophylaxis therapy 5. Physically fit to perform yoga therapy as self‐assessed 6. Written informed consent