A trial comparing digital tools to help tuberculosis patients complete their treatment in India

INTERVENTION: This is a three‐arm non‐blinded, parallel‐grouped, patient randomised trial with individual‐level randomisation and a 1:1:1 allocation ratio, stratified by HCW and facility type (public vs private). Participants are randomised to one of three adherence management strategies: (1) toll‐free calling (99DLite), (2) smart pillboxes (MERM), or (3) control group refill monitoring. All participants receive counselling at treatment initiation. Free first‐line fixed‐dose combination (FDC) therapy treatment is supplied at the diagnosing facility, per prescribed refill frequency. Intervention arm 1 – 99DLite: Participants receive a medication container labelled with a toll‐free number and are oriented to call daily to confirm dose intake. Missed calls for 3 consecutive days trigger a follow‐up phone call; 7 consecutive days trigger a home visit. Intervention arm 2 – MERM: Participants receive an electronic pillbo Xwith an audio‐visual alarm set to their preferred dose time; opening the lid automatically logs the dose daily. A missed signal for 3 consecutive days triggers a follow‐up call; 7 consecutive days triggers a home visit. Control arm – Refill Monitoring: Participants receive a toll‐free number on their initial prescription and are oriented to call at time of prescription refill (expected monthly). A missed call within 3 days of the refill due date triggers a follow‐up call; 7 days triggers a home visit. Follow‐ups for all three arms include adherence counselling, personalised counselling on treatment challenges, and troubleshooting, if any. CONDITION: Tuberculosis (TB) ; Infections and Infestations PRIMARY OUTCOME: Unfavourable treatment outcome measured using a binary variable (1 = unfavourable, else 0), defined per Indian National TB Elimination Programme as any of: treatment failure, death, loss to follow‐up, switch to drug resistant regimen, or not evaluated, measured using culture results and patient interviews at the end of the 6‐month treatment SECONDARY OUTCOME: Medication non‐adherence measured using a binary variable (1 = negative, else 0) based on the proportion of urine tests negative for isoniazid metabolites using the Arkansas colorimetric method at up to three randomly assigned urine tests during 6‐month treatment regimen INCLUSION CRITERIA: 1. Notified in the national TB platform, Nikshay, in participating study sites 2. Aged 18 years or older 3. Diagnosed with pulmonary tuberculosis 4. Microbiologically confirmed by a nucleic acid amplification test (NAAT) with rifampicin sensitivity 5. Initiated on free first‐line treatment with fixed‐dose combination (FDC) therapy 6. Plans to reside in the study district for the treatment duration period 7. Has daily access to a mobile phone (own or a family member's)