Topic: Respiratory disorders
Conditions
Interventions
Participants requiring once a day tuberculosis treatment will be recruited over a two-year period and randomly allocated to either a DOT treatment observation arm organised by the TB clinic or VOT arm
b) community based working with a responsible professional such as a hostel worker or pharmacist
c) through a DOT worker outreaching DOT.
Follow Up Length: 6 month(s)
Sponsors
University College London
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Any TB patient aged 16 years or older seen at participating clinics who meets national or local guidance for DOT and are assessed to be eligible for DOT. Target Gender: Male & Female ; Lower Age Limit 16 years
Exclusion criteria
Exclusion criteria: 1. Patients who are eligible for DOT but not suitable for VOT due to: 1.1. Need for intravenous treatment 1.2. No access to the facilities to charge a smartphone 2. Patients in whom the primary outcome cannot be measured because they have less than 2 months of treatment remaining 3. MDRTB patients requiring more than once daily treatment who will be recruited into a non-randomised arm of the study where VOT is offered, with the same follow up as the other study arms. This represents small numbers of patients and is planned because DOT is highly difficult to organise in this group and VOT is therefore already considered the optimal arrangement
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of participants having more than 80% of scheduled VOT/DOT sessions successfully competed in the 2 months following randomisation (binary aggregation) | — |
Secondary
| Measure | Time frame |
|---|---|
| Assessment after recruitment will include: 1. Proportion of doses observed over 2 months and 6 months 2. Reported side effects 3. Culture conversion at 2 months 4. Quality of life 5. Participants' satisfaction 6. Treatment outcome at 12 months (completed, loss to follow up, transferred out, died); acquisition of new resistance; and membership of a transmission cluster - based on data linkage to the national surveillance data 7. Cost effectiveness measured using quality-adjusted life years, and including costs to NHS and participant | — |
Countries
United Kingdom
Outcome results
None listed