Protocol for a cluster randomised control trial evaluating the efficacy and safety of treatment for latent tuberculosis infection in recent migrants within primary care: The CATAPuLT trial

M. Burman*, A. Copas, Dominik Zenner, V. Hickson, L. Gosce, D. Trathen, R. Ashcroft, A. R. Martineau, Ibrahim Abubakar, C. Griffiths, H. Kunst

*Corresponding author for this work

Research output: Contribution to journalArticlepeer-review

Abstract

Background: The identification and treatment of LTBI is a key component of the WHO's strategy to eliminate TB. Recent migrants from high TB-incidence countries are recognised to be at risk TB reactivation, and many high-income countries have focused on LTBI screening and treatment programmes for this group. However, migrants are the group least likely to complete the LTBI cascade-of-care. This pragmatic cluster-randomised, parallel group, superiority trial investigates whether a model of care based entirely within a community setting (primary care) will improve treatment completion compared with treatment in specialist TB services (secondary care). Methods: The CATAPuLT trial (Completion and Acceptability of Treatment Across Primary Care and the community for Latent Tuberculosis) randomised 34 general practices in London, England, to evaluate the efficacy and safety of treatment for LBTI in recent migrants within primary care. GP practices were randomised to either provide management for LTBI entirely within primary care (GPs and community pharmacists) or to refer patients to secondary care. The target recruitment number for individuals is 576. The primary outcome is treatment completion (defined as taking at least 90% of antibiotic doses). The secondary outcomes assess adherence, acceptance of treatment, the incidence of adverse effects including drug-induced liver injury, the rates of active TB, patient satisfaction and cost-effectiveness of LTBI treatment. This protocol adheres to the SPIRIT Checklist. Discussion: The CATAPuLT trial seeks to provide implementation research evidence for a patient-centred intervention to improve treatment completion for LTBI amongst recent migrants to the UK. Trial registration: NCT03069807, March 2017, registered retrospectively.

Original languageEnglish
Article number1598
JournalBMC Public Health
Volume19
Issue number1
DOIs
Publication statusPublished - 29 Nov 2019
Externally publishedYes

Bibliographical note

Funding Information:
The study is funded by a grant from Barts Charity. The trial sponsor is Queen Mary University of London

Publisher Copyright:
© 2019 The Author(s).

Keywords

  • Primary care
  • Public health
  • Respiratory medicine
  • Tuberculosis

Fingerprint

Dive into the research topics of 'Protocol for a cluster randomised control trial evaluating the efficacy and safety of treatment for latent tuberculosis infection in recent migrants within primary care: The CATAPuLT trial'. Together they form a unique fingerprint.

Cite this