Virtually Observed Treatment (VOT) for Tuberculosis Patients in Moldova

The Behavioural Insights Team

Status: Unknown

Conditions: Tuberculosis

Treatments: Behavioral: Virtually Observed Treatment; Other: Directly Observed Treatment

Study type: Interventional

Funder types: Other

Identifiers

NCT02331732

201405*

Details and patient eligibility

About

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.

Enrollment: 400 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Consent to being part of the trial
2. Live in Chisinau and no plans to move away from Chisinau during the four months
3. Aged 18 or over
4. At least four months of care remaining

Exclusion criteria

1. Having MDR-TB
2. Homeless
3. Is not homeless
4. Suffer from alcoholism or drug misuse
5. In prison
6. Has a treatment regimen with injections

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

400 participants in 2 patient groups

Control

Active Comparator group

Description:

Patients receive DOT as normal - involves patient going to polyclinic to be observed taking treatment every day

Treatment:

Other: Directly Observed Treatment

Treatment

Experimental group

Description:

Patients receive VOT - involves patient sending a video of themselves taking their treatment over M-health app which will be reviewed remotely by observers

Treatment:

Behavioral: Virtually Observed Treatment