Effectiveness of gamified real-time video-observed therapy for adherence in drug-susceptible tuberculosis: Non-inferiority randomized trial protocol
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Nurul Amirah Abdul Manab 1 , Siti Aishah Abas 2 , Mohamad Rodi Isa 1 , Suzana Mohd Hashim 3 , Zamzurina Abu Bakar 4 , Hakimah Yusop 3 , Khalid Ibrahim 1 , Siti Munira Yasin 1 , Nurhuda Ismail 1 *
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1 Department of Public Health Medicine, Faculty of Medicine, Universiti Teknologi MARA, Sungai Buloh Campus, Selangor, MALAYSIA2 Division of Medical Development, Ministry of Health Malaysia, Putrajaya, MALAYSIA3 Sector of TB and Leprosy, Division of Disease Control, Ministry of Health Malaysia, Putrajaya, MALAYSIA4 Institute of Respiratory Medicine, Hospital Kuala Lumpur, Kuala Lumpur, MALAYSIA* Corresponding Author

Abstract

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).

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This is an open access article distributed under the Creative Commons Attribution License which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

Article Type: Study Protocol

ELECTRON J GEN MED, Volume 23, Issue 6, December 2026, Article No: em763

https://doi.org/10.29333/ejgm/19774

Publication date: 04 Nov 2026

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