Pharmacist-led Digital Interventions to Improve Tuberculosis Treatment Adherence (CARE-TB)

University of Malaya

Status: Enrolling

Conditions: Tuberculosis (TB)

Treatments: Behavioral: Standard Care; Behavioral: CARE-TB digital adherence package

Study type: Interventional

Funder types: Other

Identifiers

NCT07069387

NMRR ID 23-03504-DLE (IIR)

Details and patient eligibility

About

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.

Enrollment: 160 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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160 participants in 2 patient groups

Standard care arm

Active Comparator group

Description:

Directly observed therapy (healthcare or caretaker-based)

Treatment:

Behavioral: Standard Care

CARE-TB arm

Experimental group

Description:

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

Treatment:

Behavioral: CARE-TB digital adherence package