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Please use this identifier to cite or link to this item: http://repository.li.mahidol.ac.th/dspace/handle/123456789/49669
Title: Delivery of long-term-injectable agents for TB by lay carers: Pragmatic randomised trial
Authors: Danielle B. Cohen
Kuzani Mbendera
Hendramoorthy Maheswaran
Mavuto Mukaka
Helen Mangochi
Linna Phiri
Jason Madan
Geraint Davies
Elizabeth Corbett
Bertel Squire
Malawi-Liverpool-Wellcome Trust Clinical Research Programme
London School of Hygiene & Tropical Medicine
University of Oxford
The University of Warwick
Liverpool School of Tropical Medicine
University of Liverpool
Mahidol University
University of Sheffield
National TB Control Programme
Keywords: Medicine
Issue Date: 1-Jan-2020
Citation: Thorax. Vol.75, No.1 (2020), 64-71
Abstract: © 2020 Author(s) (or their employer(s)). Re-use permitted under CC BY. Published by BMJ. 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. Trial registration number ISRCTN05815615.
URI: http://repository.li.mahidol.ac.th/dspace/handle/123456789/49669
metadata.dc.identifier.url: https://www.scopus.com/inward/record.uri?partnerID=HzOxMe3b&scp=85074491840&origin=inward
ISSN: 14683296
00406376
Appears in Collections:Scopus 2020

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