Virtually Observed Treatment (VOT) for Tuberculosis Patients in Moldova

Study Overview
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Brief Summary
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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
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Tuberculosis

Intervention / Treatment
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* Behavioral: Virtually Observed Treatment
* Other: Directly Observed Treatment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Consent to being part of the trial Live in Chisinau and no plans to move away from Chisinau during the four months Aged 18 or over At least four months of care remaining Exclusion Criteria: Having MDR-TB Homeless Is not homeless Suffer from alcoholism or drug misuse In prison Has a treatment regimen with injections

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Control<br>Patients receive DOT as normal - involves patient going to polyclinic to be observed taking treatment every day | Other: Directly Observed Treatment<br> <br> |
| Experimental: Treatment<br>Patients receive VOT - involves patient sending a video of themselves taking their treatment over M-health app which will be reviewed remotely by observers | Behavioral: Virtually Observed Treatment<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adherence to medication | Number of days per two week period that each patient fails to adhere to treatment, continuous. Panel data collected from TB-01 record sheets for duration of patient continuation phase of treatment - on average 5 months | 2 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adherence 80% | Proportion of patients having more than 80% of scheduled medication sessions per two week period (binary). Panel data collected for duration of patient continuation phase of treatment - on average 5 months | 2 weeks | 
| Patient wellbeing | Self reported using a short form version (5 questions) of the WEMWBS questionnaire for measuring mental wellbeing was developed by researchers at Warwick and Edinburgh Universities | Collected at 4 months | 
| Patient satisfaction | Binary variable equal to 1 if a patient gives a positive response about their treatment on a likert scale (questionnaire, self-reported) | Collected at 4 months | 
| Travel and time cost of treatment borne by patient, self reported. | Total travel time and cost over 4 months (derived from questionnaire, self-reported) | Collected at 4 months | 
| Employment, self reported | Binary variable equal to 1 if patient currently does any work for pay or profit (questionnaire, self-reported) | Collected at 4 months | 
| Treatment success | Binary variable equal to 1 if treatment recorded a success on TB-01 patient record at 4 months | Collected at 4 months | 
| Body mass index (BMI) | Body mass index (BMI), measured at 4 months | Collected at 4 months | 
| Side effects reported during treatment | Binary variable equal to 1 if patient reported any side effects during treatment (questionnaire, self-reported) | Collected at 4 months |