An interventional study of CARE-TB digital adherence package and Standard Care in Tuberculosis (TB), sponsored by University of Malaya. Completed at 1 site in Malaysia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-07.
Sponsored by University of Malaya · Not applicable, Interventional, and Supportive care
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.
1,417 studies on the registry are indexed under Tuberculosis; 208 are open to participants now.
This study's enrollment of 81 is below the median of 150 across 952 interventional studies indexed under Tuberculosis.
Browse Tuberculosis studies →University of Malaya is the lead sponsor of 280 studies on the registry; 55 are open to participants now.
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Exclusion Criteria:
Directly observed therapy (healthcare or caretaker-based)
Behavioral: Standard Care
CARE-TB package includes pharmacist-led asynchronous video observed therapy, digital medication reminders, telecounselling and e-learning for patients.
Behavioral: CARE-TB digital adherence package
CARE-TB package includes pharmacist-led asynchronous video observed therapy, digital medication reminders, telecounselling and e-learning for patients.
Also known as: video observed therapy, motivational interviewing, counselling, education, reminder, digital intervention
Directly observed therapy at any government healthcare facility (by nurses) or at home (by caretaker)
Also known as: Directly observed therapy, In-person dose monitoring
Medication adherence (Binary outcome)
Completed ≥ 80% scheduled observations during the 8 weeks following enrolment.
Time frame: 8 weeks following enrollment
Adherence rate (Continuous outcome)
Proportion of doses observed over 8 weeks (Dose observed divided by total observable doses prescribed)
Time frame: 8 weeks following enrolment
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
Time frame: From enrolment till 6 months or treatment completion/ termination
TB cure rate
Proportion of microbiological TB clearance (e.g. AFB smear/ MTB PCR/ MTB culture)
Time frame: At 6 months of treatment
Adverse event reporting
Number of adverse events or adverse drug reactions reported during TB treatment
Time frame: From enrolment till 6 months of treatment
EQ-5D-5L Health-related Quality of Life (HRQoL)
HRQoL will be assessed using the EuroQol 5-Dimension 5-Level (EQ-5D-5L) questionnaire. Unit of Measure: EQ-5D index score (range: -0.281 to 1.000 based on country-specific value set) Interpretation: Higher scores indicate better health-related quality of life.
Time frame: At baseline, 2 months and 6 months of treatment
SF-12 Health-related Quality of Life (HRQoL)
The 12-Item Short Form Survey (SF-12) will be used to assess participants' health-related quality of life. Two summary scores will be generated: the Physical Component Summary (PCS) and the Mental Component Summary (MCS). The scoring scale is from 0 to 100, the higher the score the better the health related quality of life.
Time frame: At baseline and 2 months of treatment
Implementation Outcomes: Acceptability, Feasibility, Appropriateness (Quantitative measure)
Implementation outcomes will be assessed using the combined Acceptability of Intervention Measure (AIM), Feasibility of Intervention Measure (FIM), and Intervention Appropriateness Measure (IAM) questionnaire. Unit of Measure: Total and individual mean scores on 5-point Likert scale (1 = completely disagree, 5 = completely agree) Scoring: Each subscale consists of 4 items; subscale scores range from 4 to 20 Interpretation: Higher scores indicate greater perceived acceptability, feasibility, or appropriateness of the intervention
Time frame: At 2 months and 6 months of treatment
Perceived acceptability, feasibility, and fit of the intervention (Qualitative measure)
Semi-structured qualitative interviews and focus group discussions will explore participants' perceptions of the intervention's acceptability, feasibility, and fit. Unit of Measure: Thematic findings from qualitative analysis Interpretation: Interview data will be thematically coded and analyzed to identify key barriers, facilitators, and contextual factors.
Time frame: After 6 months of implementation phase
Adoption rate
Rate of uptake (number of participants who agree to use the CARE TB strategy divided by total number offered)
Time frame: Through study completion, an average of 1 year
Patient fidelity to intervention
Rate of drop-out (count of individuals who fulfill any of the following: withdraw from the study, switch arms, appointment no-show)
Time frame: 8 weeks following enrolment
Healthcare providers (HCP) fidelity to intervention
Rate of reengagement attempt (count of reminders sent to reestablish VOT over total number of missed VOT appointments)
Time frame: 8 weeks following enrolment
Documents are hosted by the registry — open the source record to download them.
Plan to share: Yes — Individual participant data that underlie the results reported following deidentification.
Supporting information: Study protocol, Sap, Icf, Analytic code
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is completed, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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University of Malaya