Pharmacist-led Digital Interventions to Improve Tuberculosis Treatment Adherence

NCT ID: NCT07069387

Last Updated: 2025-07-16

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 160 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-04-07
• Study Completion Date: 2026-06-30

Brief 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. 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)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Standard care arm

Directly observed therapy (healthcare or caretaker-based)

Group Type: ACTIVE_COMPARATOR

Standard Care

Intervention Type: BEHAVIORAL

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

CARE-TB arm

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

Group Type: EXPERIMENTAL

CARE-TB digital adherence package

Intervention Type: BEHAVIORAL

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

Interventions

CARE-TB digital adherence package

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

Intervention Type: BEHAVIORAL

Standard Care

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

Intervention Type: BEHAVIORAL

Other Intervention Names

video observed therapy; motivational interviewing; counselling; education; reminder; digital intervention; Directly observed therapy; In-person dose monitoring

Eligibility Criteria

Inclusion Criteria

1. Microbiologically confirmed pulmonary TB (smear- or culture-positive PTB)

2. 18 years old or older

3. Able to give consent and physically able to participate in the study

4. Own a video-recording device with internet connectivity

5. Within the first 3 weeks of intensive phase TB treatment

Exclusion Criteria

1. Complicated TB disease including TB meningitis, TB bone/joint, and disseminated TB with planned treatment duration of 9 to 12 months.

2. Confirmed or suspected drug-resistant (DR)-TB

3. Documented cognitive, motor, or visual disability that will hinder video device use and lack assistance of a caretaker

4. Receiving injectable anti-TB drugs

5. Incarceration or other involuntary detention

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Malaya

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Reena Rajasuriar

Role: PRINCIPAL_INVESTIGATOR

University of Malaya

Locations

Sungai Buloh Hospital

Sungai Buloh, Selangor, Malaysia

Site Status: RECRUITING

Countries

Malaysia

Central Contacts

Hui Moon Koh

Role: CONTACT

kohhuimoon@moh.gov.my

+60183926328

Reena Rajasuriar

Role: CONTACT

reena@um.edu.my

Facility Contacts

Nor Arisah Misnan

Role: primary

drnorarisah@moh.gov.my

+60361454333

Farah Syakirah Ahmad

Role: backup

farahsyakirah@moh.gov.my

Other Identifiers

NMRR ID 23-03504-DLE (IIR)

Identifier Type: -

Identifier Source: org_study_id