Pharmacist-led Digital Interventions to Improve Tuberculosis Treatment Adherence

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Malaya

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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

18 years old or older

Able to give consent and physically able to participate in the study

Own a video-recording device with internet connectivity

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

  • Standard Care

    Behavioral

    Directly observed therapy at any government healthcare facility (by nurses) or at home (by caretaker)

Treatment groups

160 Participants
are divided into 2 treatment groups
Group A: Standard care armActive comparator 1 intervention
Group B: CARE-TB armExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Medication adherence (Binary outcome)

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

Time frame
8 weeks following enrollment

Secondary outcomes

1

Adherence rate (Continuous outcome)

Proportion of doses observed over 8 weeks (Dose observed divided by total observable doses prescribed)

Time frame
8 weeks following enrolment
2

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

Proportion of patients completing TB treatment, died, are lost to follow-up or hospitalized during TB treatment

Time frame
From enrolment till 6 months or treatment completion/ termination
3

TB cure rate

Proportion of microbiological TB clearance (e.g. AFB smear/ MTB PCR/ MTB culture)

Time frame
At 6 months of treatment
4

Adverse event reporting

Number of adverse events or adverse drug reactions reported during TB treatment

Time frame
From enrolment till 6 months of treatment

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.