Pharmacist-led Digital Interventions to Improve Tuberculosis Treatment Adherence

• CARE-TB digital adherence package (Behavioral), also known as video observed therapy, motivational interviewing, counselling, education, reminder, digital intervention: CARE-TB package includes pharmacist-led asynchronous video observed therapy, digital medication reminders, telecounselling and e-learning for patients.
• Standard Care (Behavioral), also known as Directly observed therapy, In-person dose monitoring: Directly observed therapy at any government healthcare facility (by nurses) or at home (by caretaker)

Primary outcomes

• Medication adherence (Binary outcome) [8 weeks following enrollment]: Completed ≥ 80% scheduled observations during the 8 weeks following enrolment.

Secondary outcomes

• Adherence rate (Continuous outcome) [8 weeks following enrolment]: Proportion of doses observed over 8 weeks (Dose observed divided by total observable doses prescribed)
• Proportion of TB treatment completion, death, loss to follow up, and hospitalization [From enrolment till 6 months or treatment completion/ termination]: Proportion of patients completing TB treatment, died, are lost to follow-up or hospitalized during TB treatment
• TB cure rate [At 6 months of treatment]: Proportion of microbiological TB clearance (e.g. AFB smear/ MTB PCR/ MTB culture)
• Adverse event reporting [From enrolment till 6 months of treatment]: Number of adverse events or adverse drug reactions reported during TB treatment
• EQ-5D-5L Health-related Quality of Life (HRQoL) [At baseline, 2 months and 6 months of treatment]: HRQoL will be assessed using the EuroQol 5-Dimension 5-Level (EQ-5D-5L) questionnaire. Unit of Measure: EQ-5D index score (range: -0.281 to 1.000 based on country-specific value set) Interpretation: Higher scores indicate better health-related quality of life.
• SF-12 Health-related Quality of Life (HRQoL) [At baseline and 2 months of treatment]: The 12-Item Short Form Survey (SF-12) will be used to assess participants' health-related quality of life. Two summary scores will be generated: the Physical Component Summary (PCS) and the Mental Component Summary (MCS). The scoring scale is from 0 to 100, the higher the score the better the health related quality of life.
• Implementation Outcomes: Acceptability, Feasibility, Appropriateness (Quantitative measure) [At 2 months and 6 months of treatment]: Implementation outcomes will be assessed using the combined Acceptability of Intervention Measure (AIM), Feasibility of Intervention Measure (FIM), and Intervention Appropriateness Measure (IAM) questionnaire. Unit of Measure: Total and individual mean scores on 5-point Likert scale (1 = completely disagree, 5 = completely agree) Scoring: Each subscale consists of 4 items; subscale scores range from 4 to 20 Interpretation: Higher scores indicate greater perceived acceptability, feasibility, or appropriateness of the intervention
• Perceived acceptability, feasibility, and fit of the intervention (Qualitative measure) [After 6 months of implementation phase]: Semi-structured qualitative interviews and focus group discussions will explore participants' perceptions of the intervention's acceptability, feasibility, and fit. Unit of Measure: Thematic findings from qualitative analysis Interpretation: Interview data will be thematically coded and analyzed to identify key barriers, facilitators, and contextual factors.
• Adoption rate [Through study completion, an average of 1 year]: Rate of uptake (number of participants who agree to use the CARE TB strategy divided by total number offered)
• Patient fidelity to intervention [8 weeks following enrolment]: Rate of drop-out (count of individuals who fulfill any of the following: withdraw from the study, switch arms, appointment no-show)
• Healthcare providers (HCP) fidelity to intervention [8 weeks following enrolment]: Rate of reengagement attempt (count of reminders sent to reestablish VOT over total number of missed VOT appointments)

Sex: All, ages: 18 Years to any

Inclusion Criteria:

1. Microbiologically confirmed TB
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

• Study Protocol, Statistical Analysis Plan, and Informed Consent Form (PDF, 2025-08-20)

• Reena Rajasuriar, Principal investigator, University of Malaya