About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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 that will hinder video device use and lack assistance of a caretaker
Receiving injectable anti-TB drugs
Trial design
Parallel
Treatments tested in this trial
CARE-TB digital adherence package
BehavioralCARE-TB package includes pharmacist-led asynchronous video observed therapy, digital medication reminders, telecounselling and e-learning for patients.
Standard Care
BehavioralDirectly observed therapy at any government healthcare facility (by nurses) or at home (by caretaker)
Treatment groups
Trial outcomes
Primary outcomes
Medication adherence (Binary outcome)
Completed ≥ 80% scheduled observations during the 8 weeks following enrolment.
Secondary outcomes
Adherence rate (Continuous outcome)
Proportion of doses observed over 8 weeks (Dose observed divided by total observable doses prescribed)
Proportion of TB treatment completion, death, loss to follow up, and hospitalization
Proportion of patients completing TB treatment, died, are lost to follow-up or hospitalized during TB treatment
TB cure rate
Proportion of microbiological TB clearance (e.g. AFB smear/ MTB PCR/ MTB culture)
Adverse event reporting
Number of adverse events or adverse drug reactions reported during TB treatment
Sponsors and contacts
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