Effectiveness of gamified real-time video-observed therapy for adherence in drug-susceptible tuberculosis: Non-inferiority randomized trial protocol

Tuberculosis (TB) treatment adherence remains challenging despite directly observed treatment, short-course (DOTS). This study will evaluate gamified real-time video-observed therapy (GRVOTS), a smartphone-based adherence intervention, against standard DOTS care among adults with newly diagnosed drug-susceptible pulmonary tuberculosis in Malaysia. In this two-arm, parallel-group, open-label, non-inferiority randomized controlled trial, 70 participants will be allocated 1:1 to GRVOTS or standard DOTS care for six months. A non-inferiority design was selected to determine whether GRVOTS can maintain medication adherence while offering a more flexible treatment-support option rather than universally replacing standard DOTS care. The protocol follows the standard protocol items: recommendations for interventional trials 2025 statement. The primary outcome is medication adherence rate (%), with a prespecified non-inferiority margin of -15 percentage points. Secondary outcomes include medication-adherence behavior, sputum acid-fast bacilli conversion, TB treatment outcomes and intrinsic motivation. Trial registration: Thai clinical trials registry (TCTR20260411006).