Date of Award

2025

Thesis Type

PhD

Document Type

Thesis

Divisions

Faculty of Medicine

Department

Department of Social and Preventive Medicine

Institution

Universiti Malaya

Abstract

Introduction: Tuberculosis (TB) remains the leading public health threat. In 2023, an estimated 10.8 million people developed the disease and 1.25 million died, making TB the world’s leading killer from a single treatable infection. In Malaysia, the notification rate of TB is 80.2 per 100,000 population and a rise of 5.5% from the previous year. Since its introduction in the early 1990s, Direct Observed Treatment, Short-course (DOTS) has been the standard of approach for TB treatment. While effective, DOTS is often logistically challenging for both patients and service providers. Daily clinic visits place significant time, travel, and staffing demands on the system. As an alternative, the World Health Organisation (WHO) has conditionally endorsed Video-Observed Therapy (VOT). VOT addresses these barriers by using secure smartphone or web platforms to record or live-stream dose ingestion, either synchronously (real-time) or asynchronously (patient-recorded, staff-reviewed later), thereby preserving the “observed” element while essentially eliminating in-person attendance. Our study investigates whether VOT improves clinical outcomes and treatment adherence in Malaysian TB patients to the level of or better than conventional DOTS. Methods: A multicentre, open-label randomised controlled trial (RCT) was conducted in Terengganu among adult TB patients. Participants were randomly assigned in a 1:1 ratio to receive either DOTS or VOT. Simple randomisation was performed using a computergenerated sequence prepared by an independent statistician, with allocation concealed in sealed, opaque envelopes. Both groups were followed for two months. The primary outcome was treatment adherence. Secondary and tertiary outcomes include sputum conversion, early detection of side effects, patient satisfaction, and cost and time savings. Data were analysed using the intention-to-treat ( ITT ) approach. Descriptive statistics, chi-square tests, and independent t-tests were used, with significance set at p < 0.05. Data collection instruments included a demographic form, TBIS10E (healthcare record form), TBIS10D (patient record form), and a patient satisfaction questionnaire adapted from TB REACH. Results: A total of 110 participants were enrolled, with 55 assigned to the VOT VOT arm and 55 to the DOTS arm. Most participants were Malay (95.2%), female (67.3%), resided in rural areas (94.2%), and belonged to the B40 income group (66.3%). In the ITT analysis, no statistically significant difference was observed in treatment adherence between the two groups. However, VOT demonstrated potential advantages over DOTS in secondary outcomes, including earlier detection of side effects, reduced costs, and time savings. These findings warrant further investigation through more comprehensive research. Conclusion: Our study in rural Malaysia demonstrated that VOT maintained adherence to TB treatment as well as conventional DOTS while providing operational benefits: cutting patient and provider costs, travel, and clinic time, and flagging adverse reaction sooner. VOT can support patient-centred care and help sustain high adherence rates without overstretching clinic resources. These gains are relevant to public health because they address well-known barriers, distance, workforce constraints, and financial burden that undermine TB control in Malaysia’s primarily rural, lower-income populations. Future research should test VOT in larger, more diverse cohorts and over complete treatment courses, include economic evaluations to measure cost-effectiveness, and embed qualitative studies to record user experience to guide policy adoption.

Initial

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Additional Information

Thesis (PhD) – Faculty of Medicine, Universiti Malaya, 2025.

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