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Published in: BMC Public Health 1/2019

Open Access 01-12-2019 | Tuberculosis | Study protocol

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

Authors: M. Burman, A. Copas, D. Zenner, V. Hickson, L. Gosce, D. Trathen, R. Ashcroft, A. R. Martineau, I. Abubakar, C. Griffiths, H. Kunst

Published in: BMC Public Health | Issue 1/2019

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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.
Literature
1.
2.
Lönnroth K, Migliori GB, Abubakar I, D'Ambrosio L, de Vries G, Diel R, Douglas P, Falzon D, Gaudreau M-A, Goletti D, et al. Towards tuberculosis elimination: an action framework for low-incidence countries. Eur Respir J. 2015;45(4):928–52.CrossRef
3.
Houben RMGJ, Dodd PJ. The global burden of Latent tuberculosis infection: a re-estimation using mathematical Modelling. PLoS Med. 2016;13(10):e1002152–13.CrossRef
4.
Dye C, Glaziou P, Floyd K, Raviglione M. Prospects for tuberculosis elimination. Annu Rev Public Health. 2013;34(1):271–86.CrossRef
5.
Abubakar I, Drobniewski F, Southern J, Sitch AJ, Jackson C, Lipman M, Deeks JJ, Griffiths C, Bothamley G, Lynn W, et al. Prognostic value of interferon-γ release assays and tuberculin skin test in predicting the development of active tuberculosis (UK PREDICT TB): a prospective cohort study. Lancet Infect Dis. 2018;18(10):1–14.CrossRef
6.
7.
Alsdurf H, Hill PC, Matteelli A, Getahun H, Menzies D. The cascade of care in diagnosis and treatment of latent tuberculosis infection: a systematic review and meta-analysis. Lancet Infect Dis. 2016;16(11):1269–78.CrossRef
8.
Loutet MG, Burman M, Jayasekera N, Trathen D, Dart S, Kunst H, Zenner D. National roll-out of latent tuberculosis testing and treatment for new migrants in England: a retrospective evaluation in a high-incidence area. Eur Respir J. 2018;51(1):1701226.CrossRef
9.
10.
Chan A-W, Tetzlaff JM, Gøtzsche PC, Altman DG, Mann H, Berlin JA, Dickersin K, Hróbjartsson A, Schulz KF, Parulekar WR, et al. SPIRIT 2013 explanation and elaboration: guidance for protocols of clinical trials. BMJ. 2013;346(jan08 15):e7586.CrossRef
11.
Tommelein E, Mehuys E, Van Tongelen I, Brusselle G, Boussery K. Accuracy of the medication adherence report scale (MARS-5) as a quantitative measure of adherence to inhalation medication in patients with COPD. Ann Pharmacother. 2014;48(5):589–95.CrossRef
12.
Griffiths C, Sturdy P, Brewin P, Bothamley G, Eldridge S, Martineau A, MacDonald M, Ramsay J, Tibrewal S, Levi S, et al. Educational outreach to promote screening for tuberculosis in primary care: a cluster randomised controlled trial. Lancet (London, England). 2007;369(9572):1528–34.CrossRef
13.
Leber W, McMullen H, Marlin N, Bremner S, Santos AC, Terris-Prestholt F, Boomla K, Ashcroft R, Kerry S, Martineau A, et al. Point-of-care HIV testing in primary care and early detection of HIV (RHIVA2): a cluster randomised controlled trial. Lancet. 2013;382:S7.CrossRef
14.
Butcher K, Biggs B-A, Leder K, Lemoh C, O'Brien D, Marshall C. Understanding of latent tuberculosis, its treatment and treatment side effects in immigrant and refugee patients. BMC Res Notes. 2013;6:342.CrossRef
15.
Goswami ND, Gadkowski LB, Piedrahita C, Bissette D, Ahearn MA, Blain MLM, Østbye T, Saukkonen J, Stout JE. Predictors of latent tuberculosis treatment initiation and completion at a U.S. public health clinic: a prospective cohort study. BMC Public Health. 2012;12(1):468–8.
16.
Nicolau I, Tian L, Menzies D, Ostiguy G, Pai M. Point-of-care urine tests for smoking status and isoniazid treatment monitoring in adult patients. PLoS One. 2012;7(9):e45913–1.CrossRef
17.
Guerra RL, Conde MB, Efron A, Loredo C, Bastos G, Chaisson RE, Golub JE. Point-of-care Arkansas method for measuring adherence to treatment with isoniazid. Respir Med. 2010;104(5):754–7.CrossRef
18.
Whitfield R, Cope GF. Point-of-care test to monitor adherence to anti-tuberculous treatment. Ann Clin Biochem. 2004;41(5):411–3.CrossRef
19.
20.
21.
22.
23.
Reid MJA, Arinaminpathy N, Bloom A, Bloom BR, Boehme C, Chaisson R, Chin DP, Churchyard G, Cox H, Ditiu L, et al. Building a tuberculosis-free world: the lancet commission on tuberculosis. Lancet. 2019;393(10178):1331–84.CrossRef
24.
Shete PB, Boccia D, Dhavan P, Gebreselassie N, Lonnroth K, Marks S, Matteelli A, Posey DL, van der Werf MJ, Winston CA, et al. Defining a migrant-inclusive tuberculosis research agenda to end TB. Int J Tuberc Lung Dis. 2018;22(8):835–43.CrossRef
Metadata
Title
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
Authors
M. Burman
A. Copas
D. Zenner
V. Hickson
L. Gosce
D. Trathen
R. Ashcroft
A. R. Martineau
I. Abubakar
C. Griffiths
H. Kunst
Publication date
01-12-2019
Publisher
BioMed Central
Published in
BMC Public Health / Issue 1/2019
Electronic ISSN: 1471-2458
DOI
https://doi.org/10.1186/s12889-019-7983-7

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