Tuberculosis, improving adherence to treatment. Infections and Infestations Tuberculosis
Conditions
Interventions
This study is a mixed-methods work programme comprising of the following:
1. Scoping review of the social sciences and health literature
2. Refinement of a conceptual framework based on qualitative an
Sponsors
Joint Research Office
Eligibility
Sex/Gender
All
Age
18 Years to 120 Years
Inclusion criteria
Inclusion criteria: 1. Individuals aged over 18 being started on treatment for TB affecting any site. 2. Migrants newly arrived in the UK 3. People whose first language is not English 4. Woman who are pregnant 5. People with a mental health disorder 6. People taking immunosuppressive therapy or known to have immunodeficiency 7. Those with a previous history of treatment for TB or non-adherence with anti-TB medication 8. People with a current or previous history of drug or alcohol misuse
Exclusion criteria
Exclusion criteria: 1. Patients already on treatment for TB at the point they attend the TB services in the study 2. If the patient is not expected to live for the duration of treatment (that is a minimum of six months from starting treatment) 3. Age under 16
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adherence is measured using: 1.1. Pill counts, assessed at every visit for the duration of treatment 1.2. Patient-reported drug administration, timely clinic attendance as planned 1.3. Urine tests for anti-TB drug metabolites and 1.4. If the patient is receiving either DOT or VOT, objective evidence of taking medication. These are validated against the other adherence measures and the quality of each assessed. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. The number of patients who give consent as a proportion of those who were approached and asked if they would participate are assessed using consent logs and consent rate at the end of recruitment. 2. Completeness of data for measures of adherence and treatment completion is measured as the proportion of patients who have pill counts entered at each visit and the proportion of patient visits with a recorded pill count. These measures of completeness will be monitored throughout the study and finally determined at the end of the study. 3. The number and proportion of patients who were identified by the application of the manual as likely to benefit from at least one of the menu of interventions available to support adherence at any point during their treatment. It will be assessed at 6 months after treatment commences. 4. The number and proportion of patients who were offered and the number and proportion of patients accepting at least one of the menu of interventions available to support adherence at any point during their treatment. It will be assessed at 6 months after treatment commences. 5. Adherence and treatment completion rates: 5.1. Proportion of patients completing treatment 5.2. Proportion of patients still on treatment after 9 months | — |
Countries
England, Scotland, United Kingdom
Outcome results
None listed