NCT02331732

Virtually Observed Treatment (VOT) for Tuberculosis Patients in Moldova

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 400 (estimated)
• Sponsor: The Behavioural Insights Team · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

This trial aims to increase the wellbeing of tuberculosis patients and their adherence to medication in Chisinau, The Republic of Moldova. The design is an individually randomised controlled trial (RCT) and will involve 400 TB patients during their 'continuation phase' of treatment. The trial will have two arms; 200 patients will form the control group and receive the standard provision of Directly Observed Treatment (DOT) and 200 will receive Virtually Observed Treatment (VOT). VOT differs from DOT in that the daily observation of patients taking their medication will be observed via internet video messages rather than in-person. Based on a small sample of patient interviews we think that for some patients DOT may be a hindrance rather than a help. VOT allows patients to take their treatment in the comfort of their home and means they don't have to travel to their polyclinic every day. There will be a central VOT observation centre where VOT observers will view and respond to video messages sent in by patients in the VOT arm. The messages will be sent via an M-Health app. The VOT observers will also respond to the patients by sending feedback to the patients. The trial duration will depend on the recruitment rate of eligible patients but is expected to take 16 months.

Conditions

• Tuberculosis

Interventions

Type	Name	Description
BEHAVIORAL	Virtually Observed Treatment
OTHER	Directly Observed Treatment

Timeline

• Start date: 2015-10-01
• Primary completion: 2017-02-01
• Completion: 2017-03-01
• First posted: 2015-01-06
• Last updated: 2015-09-25