Virtually Observed Treatment (VOT) for TB Patients in The Republic of Moldova

The Republic of Moldova has one of the highest documented levels of MDR-TB in the world (WHO, 2013) . The Ministry of Health has followed the WHO-recommended DOT (Directly Observed Treatment) during 2000-2004 and has used the Stop TB Strategy which includes DOT since 2006 (WHO, 2013). DOT is recommended by WHO as the best curative method for TB. Based on a small sample of patient interviews we think that for some patients DOT may be a hindrance rather than a help. The way that DOT is currently implemented in Moldova means that patients have to visit a doctor or nurse every day in order to be observed taking treatment. This is time consuming, can cost patients money, and adds a significant friction cost for patients. The alternative, for DOTs to be administered at home by roving personnel, is resource intensive and currently only available to a small number of patients in Moldova. VOT differs from DOT in that the daily observation of patients taking their medication will be observed via internet video calling rather than in-person. This should save patients a huge amount of time and money. Given the prevalence of side effects of medication, being able to take medication at home may also increase patient wellbeing.

2015-02-02

2015-11-02

For the trial there will be three outcome measures;
1) The number of days per month that each patient fails to adhere to treatment (continuous)
2) If a patient achieves 80% adherence for a given month (binary). This is the target adherence rate used for a forthcoming trial of VOT by the NHS
3) Patient wellbeing. Whether a patient gives a positive response about their treatment on a likert scale (binary).

Adherence is regularly recorded on patient TB-01 record sheets at TB cabinets. The time dimension of this data will give us additional power to detect results. The trial will run for one year, collecting nine months of adherence data collected for each patient every month. Trial duration is longer than data collection for each patient since patients are recorded from the start of their continuation phase, and different patients will be starting at different times. The patient wellbeing questionnaire will be conducted during the ninth month. Additionally this questionnaire will include questions on the cost of patient travel in order to quantify the money by patients receiving VOT.

VOT will initially be trialled on TB patients in the continuation phase with access to Skype in their home. The trial will work as a consent-randomise model. Initially the universe of MDR-TB patients in the intensive phase in Chisinau will be given a short questionnaire. The baseline patient questionnaire will include questions on patient characteristics, and whether patients would consent to being part of a trial of VOT for their treatment in the continuation phase . From the results of this questionnaire all patients that consent to be a part of the trial and are authorised by the relevant medical officials will be eligible to be a part of the trial .
The first 194 TB patients to consent to trial VOT will form our sample. Out of these 188 patients, 94 will be randomly chosen to form the treatment group. These 94 will all be observed from one VOT centre set up in one polyclinic. The 94 patients that from the control group will be sent to one of the 13 other TB polyclinics in Chisinau for the normal DOT treatment regimen.

Randomisation will be conducted at the individual level. Once the list of 188 potential participants is compiled, each patient will be randomly assigned to a control group (n = 94) or the treatment arm (n = 94). An online randomisation tool will be set up for the implementing partner.

Individual

No

No clusters

3384 biweekly adherence

188 Individuals

0.75 day shift in patient adherence (per 2 weeks of treatment). 0.41 st deviations