Can treatment outcomes in drug-resistant tuberculosis (TB) patients be improved with mHealth: The V-SMART trial

Not Applicable

• Conditions: Tuberculosis; Respiratory - Other respiratory disorders / diseases; Public Health - Health service research; Infection - Other infectious diseases

• Registration Number: ACTRN12620000681954
• Lead Sponsor: niversity of Sydney

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-06-15
• Last Update Posted: 22 June 2020

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 902

Inclusion Criteria

Aged greater than or equal to 15 years
- Have a diagnosis of bacteriologically confirmed pulmonary and/or extrapulmonary rifampicin resistant (RR) or multidrug-resistant (MDR)-TB
- Have commenced MDR-TB treatment within the previous 30 days
- Demonstrate the ability to operate simple functions on a smartphone (including entering a passcode, opening an application and making a phone call)

Exclusion Criteria

- Inability to provide written informed consent (e.g. due to a significant communication impairment)
- Do not intend to receive treatment within participating provinces over the subsequent 12 month period
- Another person residing within the same household, at least one day per week, has already been enrolled and randomized within this study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Treatment success - proportion of randomized patients with treatment success (defined as treatment completion and/or bacteriological cure) after 24 months.<br><br>Treatment success is a standard WHO programmatic indicator of treatment outcome, obtained from routine PMDT registries, comprising the sum of treatment completion and<br>bacteriological cure.[24 month post-enrolment]