Intervening with a Manualised Package to achieve treatment adherence in people with Tuberculosis

Not Applicable

Completed

• Conditions: Tuberculosis, improving adherence to treatment.; Infections and Infestations; Tuberculosis

• Registration Number: ISRCTN95243114
• Lead Sponsor: Joint Research Office

Brief Summary

2019 Protocol article in https://pubmed.ncbi.nlm.nih.gov/31852704/ protocol (added 12/11/2020) 2021 Interim results article in https://pubmed.ncbi.nlm.nih.gov/33898764/ Qualitative study (added 14/11/2022) 2021 Other publications in https://pubmed.ncbi.nlm.nih.gov/34049611/ Scoping review (added 14/11/2022) 2021 Other publications in https://pubmed.ncbi.nlm.nih.gov/34584407/ Scoping review (added 14/11/2022)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-02-14
• Study Completion: 2022-05-01
• Last Update Posted: 28 November 2022

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 79

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> Adherence is measured using:<br> 1.1. Pill counts, assessed at every visit for the duration of treatment<br> 1.2. Patient-reported drug administration, timely clinic attendance as planned<br> 1.3. Urine tests for anti-TB drug metabolites and<br> 1.4. If the patient is receiving either DOT or VOT, objective evidence of taking medication.<br><br> These are validated against the other adherence measures and the quality of each assessed.<br>