Pharmacist-led Digital Interventions to Improve Tuberculosis Treatment Adherence

NCT07069387 | Recruiting

• 1 other identifier: NMRR ID 23-03504-DLE (IIR)
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

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)

Keywords

tuberculosis; active tuberculosis; monitoring; video observed therapy; education; pharmacist; digital; implementation science; cost; motivational

Outcome Measures

Primary Outcomes (1)

• Medication adherence (Binary outcome)

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

  8 weeks following enrollment

Secondary Outcomes (11)

• Adherence rate (Continuous outcome)

  8 weeks following enrolment

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

  From enrolment till 6 months or treatment completion/ termination

• TB cure rate

  At 6 months of treatment

• Adverse event reporting

  From enrolment till 6 months of treatment

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

  At baseline, 2 months and 6 months of treatment

Study Arms (2)

Standard care arm

ACTIVE COMPARATOR

Directly observed therapy (healthcare or caretaker-based)

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.

Behavioral: CARE-TB digital adherence package

Interventions

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.

Also known as: video observed therapy, motivational interviewing, counselling, education, reminder, digital intervention

CARE-TB arm

Standard Care BEHAVIORAL

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

Standard care arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Malaya: lead

Study Sites (1)

Sungai Buloh Hospital

Sungai Buloh, Selangor, 47000, Malaysia

RECRUITING

MeSH Terms

Conditions

Tuberculosis; Latent Tuberculosis

Interventions

Motivational Interviewing; Counseling; Educational Status; Standard of Care

Condition Hierarchy (Ancestors)

Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Latent Infection

Intervention Hierarchy (Ancestors)

Directive Counseling; Mental Health Services; Behavioral Disciplines and Activities; Health Services; Health Care Facilities Workforce and Services; Community Health Services; Socioeconomic Factors; Population Characteristics; Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Reena Rajasuriar

  University of Malaya

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hui Moon Koh

CONTACT

+60183926328; kohhuimoon@moh.gov.my

Reena Rajasuriar

CONTACT

reena@um.edu.my

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 12, 2025
• First Posted: July 16, 2025
• Study Start: April 7, 2025
• Primary Completion: December 1, 2025
• Study Completion (Estimated): June 1, 2026
• Last Updated: July 16, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• Time Frame: Beginning 3 months following publication and no end date.
• Access Criteria: Investigators whose proposed used of data has been approved by independent review. Proposals should be submitted to kohhuimoon@moh.gov.my. To gain access, a data sharing agreement must be signed.

Locations

MY (1)