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Pharmacist-led Digital Interventions to Improve Tuberculosis Treatment Adherence

Study acronym: CARE-TB
StatusCompleted
PhaseNot applicable
Started
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Record History

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  1. Eligibility criteria shortened, about 5 words
  2. Trial completed
    • Eligibility criteria expanded, about 10 words
    • Secondary endpoints: details revised at 6 of 11 entries
    • Collaborators expanded, about 9 words
  3. Trial status: Recruiting to Active, Not Recruitingv2 Show 4 more changesShow less
    • Enrollment target: estimated 160 to confirmed 81
    • Primary completion date changed from estimate of Dec 2025 to Mar 31, 2026
    • Study completion date: Jun 2026 to Jul 31, 2026
    • Site details revised
  4. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07069387
Lead Sponsor University of Malaya
Collaborators: Fogarty International Center of the National Institute of Health
Conditions
(from sponsor)		 Tuberculosis (TB)
Related terms Latent Tuberculosis, Tuberculosis
Enrollment 81 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov