NCT07069387 Pharmacist-led Digital Interventions to Improve Tuberculosis Treatment Adherence
| NCT ID | NCT07069387 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Malaya |
| Condition | Tuberculosis (TB) |
| Study Type | INTERVENTIONAL |
| Enrollment | 160 participants |
| Start Date | 2025-04-07 |
| Primary Completion | 2025-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 160 participants in total. It began in 2025-04-07 with a primary completion date of 2025-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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
Contact & Investigator
Reena Rajasuriar
PRINCIPAL INVESTIGATOR
University of Malaya
Frequently Asked Questions
Who can join the NCT07069387 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Tuberculosis (TB). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07069387 currently recruiting?
Yes, NCT07069387 is actively recruiting participants. Contact the research team at kohhuimoon@moh.gov.my for enrollment information.
Where is the NCT07069387 trial being conducted?
This trial is being conducted at Sungai Buloh, Malaysia.
Who is sponsoring the NCT07069387 clinical trial?
NCT07069387 is sponsored by University of Malaya. The principal investigator is Reena Rajasuriar at University of Malaya. The trial plans to enroll 160 participants.