Tuberculosis (TB)CARE-TBNCT07069387
Pharmacist-led Digital Interventions to Improve Tuberculosis Treatment Adherence
A study testing CARE-TB digital adherence package in people with Tuberculosis (TB), run by University of Malaya at 1 site in Malaysia.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tuberculosis (TB)
- What is being tested?
- CARE-TB digital adherence package
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 81 participants
- Where
- 1 siteMalaysia
- Study dates
- 7 Apr 2025to 31 Jul 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Microbiologically confirmed TB
- 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
Who cannot join
- 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
- Incarceration or other involuntary detention
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comprehensive Digital Adherence and Remote Engagement to Optimise Treatment Adherence for Tuberculosis Patients (CARE-TB Study) in Selangor, Malaysia: An Effectiveness-Implementation Science Study
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
- Tuberculosis (TB)
- Being tested
- CARE-TB digital adherence package, Standard Care
- Keywords
- tuberculosis, active tuberculosis, monitoring, video observed therapy, education, pharmacist, digital, implementation science, cost, motivational
- Medical subject headings
- Tuberculosis, Latent Tuberculosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CARE-TB digital adherence packageBehavioural
Also called video observed therapy, motivational interviewing, counselling, education
CARE-TB package includes pharmacist-led asynchronous video observed therapy, digital medication reminders, telecounselling and e-learning for patients.
Standard CareBehavioural
Also called Directly observed therapy, In-person dose monitoring
Directly observed therapy at any government healthcare facility (by nurses) or at home (by caretaker)
| Study group | Role | What they receive |
|---|---|---|
| Standard care arm | Active comparator | Directly observed therapy (healthcare or caretaker-based) Receives: Behavioral: Standard Care |
| CARE-TB arm | Experimental | CARE-TB package includes pharmacist-led asynchronous video observed therapy, digital medication reminders, telecounselling and e-learning for patients. Receives: Behavioral: CARE-TB digital adherence package |
What is being measured
The primary outcome is the main question the study is designed to answer.
Medication adherence (Binary outcome)
Completed ≥ 80% scheduled observations during the 8 weeks following enrolment.
Measured: 8 weeks following enrollment
Secondary outcomes (11)
Adherence rate (Continuous outcome)
Proportion of doses observed over 8 weeks (Dose observed divided by total observable doses prescribed)
Measured: 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
Measured: 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)
Measured: At 6 months of treatment
Adverse event reporting
Number of adverse events or adverse drug reactions reported during TB treatment
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 8 weeks following enrolment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2025
- Study start7 Apr 2025
- Primary completion31 Mar 2026
- Study completion31 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tuberculosis (TB)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 81 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Malaya
- Sponsor type
- University, hospital or other
- Collaborators
- Fogarty International Center of the National Institute of Health
- Responsible party
- Sponsor
- Investigators
- Reena Rajasuriar, Principal investigator, University of Malaya
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07069387
- Sponsor's protocol ID
- NMRR ID 23-03504-DLE (IIR)
- Acronym
- CARE-TB
- Status last verified
- Jul 2026
- First submitted
- 12 Jun 2025
- Last updated
- 7 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie the results reported following deidentification.
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comprehensive Digital Adherence and Remote Engagement to Optimise Treatment Adherence for Tuberculosis Patients (CARE-TB Study) in Selangor, Malaysia: An Effectiveness-Implementation Science Study
- ClinicalTrials.gov ID
- NCT07069387
- Acronym / sponsor ID
- CARE-TB / NMRR ID 23-03504-DLE (IIR)
- Conditions
- Tuberculosis (TB)
- Keywords
- tuberculosis, active tuberculosis, monitoring, video observed therapy, education, pharmacist, digital, implementation science
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 81 participants (actual)
- Lead sponsor
- University of MalayaUniversity, hospital or other
- Collaborators
- Fogarty International Center of the National Institute of Health
- Study start
- 7 Apr 2025 (actual)
- Primary completion
- 31 Mar 2026 (actual)
- Study completion
- 31 Jul 2026 (actual)
- First posted
- 16 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard care arm | Active comparator | Behavioral: Standard CareDirectly observed therapy (healthcare or caretaker-based) |
| CARE-TB arm | Experimental | Behavioral: CARE-TB digital adherence packageCARE-TB package includes pharmacist-led asynchronous video observed therapy, digital medication reminders, telecounselling and e-learning for patients. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Microbiologically confirmed TB
- 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
Key exclusion criteria (5 listed)
- 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
- Incarceration or other involuntary detention
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CARE-TB digital adherence packageAlso: video observed therapy, motivational interviewing, counselling, educationCARE-TB package includes pharmacist-led asynchronous video observed therapy, digital medication reminders, telecounselling and e-learning for patients. | Behavioural | CARE-TB arm |
| Standard CareAlso: Directly observed therapy, In-person dose monitoringDirectly observed therapy at any government healthcare facility (by nurses) or at home (by caretaker) | Behavioural | Standard care arm |
Primary outcome
Medication adherence (Binary outcome)
Time frame: 8 weeks following enrollment
Completed ≥ 80% scheduled observations during the 8 weeks following enrolment.
11 secondary outcomes
Adherence rate (Continuous outcome)
Time frame: 8 weeks following enrolment
Proportion of TB treatment completion, death, loss to follow up, and hospitalization
Time frame: From enrolment till 6 months or treatment completion/ termination
TB cure rate
Time frame: At 6 months of treatment
Adverse event reporting
Time frame: From enrolment till 6 months of treatment
EQ-5D-5L Health-related Quality of Life (HRQoL)
Time frame: At baseline, 2 months and 6 months of treatment
SF-12 Health-related Quality of Life (HRQoL)
Time frame: At baseline and 2 months of treatment
Implementation Outcomes: Acceptability, Feasibility, Appropriateness (Quantitative measure)
Time frame: At 2 months and 6 months of treatment
Perceived acceptability, feasibility, and fit of the intervention (Qualitative measure)
Time frame: After 6 months of implementation phase
Adoption rate
Time frame: Through study completion, an average of 1 year
Patient fidelity to intervention
Time frame: 8 weeks following enrolment
Healthcare providers (HCP) fidelity to intervention
Time frame: 8 weeks following enrolment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2026.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported following deidentification.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Reena Rajasuriar principal investigator
University of Malaya
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CARE-TB digital adherence package in people with Tuberculosis (TB), run by University of Malaya at 1 site in Malaysia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Malaysia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Medication adherence (Binary outcome) (time frame: 8 weeks following enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Oct 2026.