Cohen, Danielle B., Mbendera, Kuzani, Maheswaran, Hendramoorthy, Mukaka, Mavuto, Mangochi, Helen, Phiri, Linna, Madan, Jason, Davies, Geraint, Corbett, Elizabeth L. and Squire, Bertel (2019) Delivery of long-term-injectable agents for TB by lay carers : pragmatic randomised trial. Thorax, 75 (1). pp. 64-71. doi:10.1136/thoraxjnl-2018-212675

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Abstract

Background: People with recurrent or drug-resistant TB require long courses of intramuscular injections. We evaluate a novel system in which patient-nominated lay carers were trained to deliver intramuscular injections to patients in their own homes.

Methods: A pragmatic, individually randomised non-inferiority trial was conducted at two hospitals in Malawi. Adults starting TB retreatment were recruited. Patients randomised to the intervention received home-based care from patient-nominated lay people trained to deliver intramuscular streptomycin. Patients receiving standard care were admitted to hospital for 2 months of streptomycin. The primary outcome was successful treatment (alive and on treatment) at the end of the intervention.

Results: Of 456 patients screened, 204 participants were randomised. The trial was terminated early due to futility. At the end of the intervention, 97/101 (96.0%) in the hospital arm were still alive and on treatment compared with 96/103 (93.2%) in the home-based arm (risk difference −0.03 (95% CI −0.09 to 0.03); p value 0.538). There were no differences in the proportion completing 8 months of anti-TB treatment; or the proportion experiencing 2-month sputum culture conversion. The mean cost of hospital-based management was US$1546.3 per person, compared to US$729.2 for home-based management. Home-based care reduced risk of catastrophic household costs by 84%.

Conclusions: Although this trial failed to meet target recruitment, the available data demonstrate that training patient-nominated lay people has potential to provide a feasible solution to the operational challenges associated with delivering long-term-injectable drugs to people with recurrent or drug-resistant TB in resource-limited settings, and substantially reduce costs. Further data under operational conditions are required.

Item Type:	Journal Article
Subjects:	R Medicine > RA Public aspects of medicine R Medicine > RC Internal medicine
Divisions:	Faculty of Medicine > Warwick Medical School > Health Sciences > Clinical Trials Unit Faculty of Medicine > Warwick Medical School > Health Sciences Faculty of Medicine > Warwick Medical School
Library of Congress Subject Headings (LCSH):	Tuberculosis, Tuberculosis -- Patients, Tuberculosis -- Patients -- Home care , Tuberculosis -- Patients -- Treatment, Tuberculosis -- Patients -- Treatment -- Cost effectiveness, Injections, Intramuscular , Multidrug-resistant tuberculosis , Multidrug-resistant tuberculosis -- Patients, Multidrug-resistant tuberculosis -- Patients -- Home care , Multidrug-resistant tuberculosis -- Patients -- Treatment , Multidrug-resistant tuberculosis -- Patients -- Treatment -- Cost effectiveness
Journal or Publication Title:	Thorax
Publisher:	BMJ
ISSN:	0040-6376
Official Date:	1 November 2019
Dates:	Date Event 13 December 2019 Available 1 November 2019 Published 20 September 2019 Accepted
Date of first compliant deposit:	15 April 2020
Date of first compliant Open Access:	16 April 2020
Volume:	75
Number:	1
Page Range:	pp. 64-71
DOI:	10.1136/thoraxjnl-2018-212675
Status:	Peer Reviewed
Publication Status:	Published
Access rights to Published version:	Open Access
RIOXX Funder/Project Grant:	Project/Grant ID RIOXX Funder Name Funder ID UNSPECIFIED Wellcome Trust http://dx.doi.org/10.13039/100010269

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