Pharmacist-led digital support to improve TB treatment adherence
Comprehensive Digital Adherence and Remote Engagement to Optimise Treatment Adherence for Tuberculosis Patients (CARE-TB Study) in Selangor, Malaysia: An Effectiveness-Implementation Science Study
This project will test whether a pharmacist-led digital package featuring asynchronous video-observed therapy and education helps adults with active pulmonary TB stay on their medication.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 160 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Malaya Academic / other |
| Locations | 1 site (Sungai Buloh, Selangor) |
| Trial ID | NCT07069387 on ClinicalTrials.gov |
What this trial studies
Investigators will implement CARE-TB, a pharmacist-led digital adherence package that combines asynchronous video-observed therapy, medication reminders, and targeted education delivered via patients' smartphones. Adult patients with microbiologically confirmed pulmonary TB within the first three weeks of intensive treatment and who own an internet-connected video device will be enrolled at Sungai Buloh Hospital in Malaysia. Participants will be assigned to CARE-TB or standard care and followed to measure medication adherence, loss-to-follow-up, and treatment completion. Outcomes will compare adherence and retention between the digital intervention and standard care to determine whether the package improves treatment support in this setting.
Who should consider this trial
Good fit: Adults (≥18 years) with microbiologically confirmed pulmonary TB who are within the first three weeks of intensive phase treatment, able to consent, physically able to participate, and who own an internet-connected video-recording device are eligible.
Not a fit: Patients with complicated or disseminated TB requiring extended treatment, confirmed or suspected drug-resistant TB, those receiving injectable anti-TB drugs, incarcerated individuals, or those without a usable video device are unlikely to benefit from this intervention.
Why it matters
Potential benefit: If successful, CARE-TB could increase medication adherence, reduce loss-to-follow-up, and lower the risk of treatment failure, relapse, and onward transmission.
How similar studies have performed: Video-observed therapy programs in other countries have shown adherence comparable to directly observed therapy, but pharmacist-led digital adherence packages remain less tested in Malaysia.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Sungai Buloh, Selangor
- Sungai Buloh Hospital — Sungai Buloh, Selangor, Malaysia (Recruiting)
Study contacts
- Principal investigator: Reena Rajasuriar — University of Malaya
- Study coordinator: Hui Moon Koh
- Email: kohhuimoon@moh.gov.my
- Phone: +60183926328
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.