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Active, Not Recruiting

NCT Number: NCT07069387

Pharmacist-led Digital Interventions to Improve Tuberculosis Treatment Adherence

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Tuberculosis (TB) Actinomycetales Infections Bacterial Infections Bacterial Infections and Mycoses Gram-Positive Bacterial Infections Infections Latent Infection Latent Tuberculosis Mycobacterium Infections Tuberculosis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sungai Buloh Hospital

Sungai Buloh, Selangor, 47000, Malaysia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

CARE-TB digital adherence package

Behavioral

CARE-TB package includes pharmacist-led asynchronous video observed therapy, digital medication reminders, telecounselling and e-learning for patients.

Other names: video observed therapy, motivational interviewing, counselling, education, reminder, digital intervention

Standard Care

Behavioral

Directly observed therapy at any government healthcare facility (by nurses) or at home (by caretaker)

Other names: Directly observed therapy, In-person dose monitoring

Primary outcomes

  1. Medication adherence (Binary outcome)

    Time frame: 8 weeks following enrollment

    Completed ≥ 80% scheduled observations during the 8 weeks following enrolment.

Secondary outcomes

  1. Adherence rate (Continuous outcome)

    Time frame: 8 weeks following enrolment

    Proportion of doses observed over 8 weeks (Dose observed divided by total observable doses prescribed)

  2. Proportion of TB treatment completion, death, loss to follow up, and hospitalization

    Time frame: From enrolment till 6 months or treatment completion/ termination

    Proportion of patients completing TB treatment, died, are lost to follow-up or hospitalized during TB treatment

  3. TB cure rate

    Time frame: At 6 months of treatment

    Proportion of microbiological TB clearance (e.g. AFB smear/ MTB PCR/ MTB culture)

  4. Adverse event reporting

    Time frame: From enrolment till 6 months of treatment

    Number of adverse events or adverse drug reactions reported during TB treatment

  5. EQ-5D-5L Health-related Quality of Life (HRQoL)

    Time frame: At baseline, 2 months and 6 months of treatment

    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.

  6. SF-12 Health-related Quality of Life (HRQoL)

    Time frame: At baseline and 2 months of treatment

    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.

  7. Implementation Outcomes: Acceptability, Feasibility, Appropriateness (Quantitative measure)

    Time frame: At 2 months and 6 months of treatment

    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

  8. Perceived acceptability, feasibility, and fit of the intervention (Qualitative measure)

    Time frame: After 6 months of implementation phase

    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.

  9. Adoption rate

    Time frame: Through study completion, an average of 1 year

    Rate of uptake (number of participants who agree to use the CARE TB strategy divided by total number offered)

  10. Patient fidelity to intervention

    Time frame: 8 weeks following enrolment

    Rate of drop-out (count of individuals who fulfill any of the following: withdraw from the study, switch arms, appointment no-show)

  11. Healthcare providers (HCP) fidelity to intervention

    Time frame: 8 weeks following enrolment

    Rate of reengagement attempt (count of reminders sent to reestablish VOT over total number of missed VOT appointments)

Sponsors and collaborators

Lead sponsor

University of Malaya

Other

Registry information

Official study 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

Acronym: CARE-TB

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jul 16, 2025
Registry last updated
Jul 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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