Actively Recruiting
Pharmacist-led Digital Interventions to Improve Tuberculosis Treatment Adherence
Led by University of Malaya · Updated on 2025-07-16
160
Participants Needed
1
Research Sites
60 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The gold standard for tuberculosis (TB) treatment support requires directly observed therapy (DOT), which means a trained health worker observes the patient swallow each dose of medication every day for 2 months. Despite the practice of DOT in Malaysia, 1 in 20 patients are loss-to-follow-up and non-adherent to treatment. Sub-optimal adherence due to poor treatment acceptability and social desirability promotes TB treatment failure, disease relapse, on-going transmission, drug resistance, and death. Telemedicine offers a flexible and less invasive option to support TB treatment adherence. Despite 97% internet and smartphone penetration rates, the practical implementation of digital adherence strategies to support and monitor TB treatment remains untested in Malaysia. The investigators propose to design, implement, and measure the effectiveness of a comprehensive, pharmacist-led digital solution for TB treatment support called CARE-TB which combines a package of asynchronous video-observed therapy, digital reminders, telecounselling and e-learning. In this multi-method effectiveness-implementation (Type 2) study using the Exploration, Preparation, Implementation and Sustainment (EPIS) framework, the investigators aim 1) To identify patient and provider-level facilitators and barriers to CARE-TB adoption via qualitative evaluation and to design a stakeholder-informed implementation strategy, (2) To assess effectiveness of CARE-TB strategy by evaluating (i) implementation outcomes, (ii) patient health outcomes, and (iii) service outcomes, and (3) To evaluate the cost-effectiveness of CARE-TB compared to standard of care from a societal perspective. This study will leverage digital platforms to expand the reach of TB adherence support, enhance adherence to TB treatment and improve treatment completion rates, while utilising existing personnel and resources in among the busiest TB treatment centres in the country.
CONDITIONS
Official Title
Pharmacist-led Digital Interventions to Improve Tuberculosis Treatment Adherence
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Microbiologically confirmed pulmonary TB (smear- or culture-positive PTB)
- 18 years old or older
- Able to give consent and physically able to participate in the study
- Own a video-recording device with internet connectivity
- Within the first 3 weeks of intensive phase TB treatment
You will not qualify if you...
- Complicated TB disease including TB meningitis, TB bone/joint, and disseminated TB with planned treatment duration of 9 to 12 months
- Confirmed or suspected drug-resistant (DR)-TB
- Documented cognitive, motor, or visual disability hindering video device use without caretaker assistance
- Receiving injectable anti-TB drugs
- Incarceration or other involuntary detention
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Sungai Buloh Hospital
Sungai Buloh, Selangor, Malaysia, 47000
Actively Recruiting
Research Team
H
Hui Moon Koh
CONTACT
R
Reena Rajasuriar
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
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