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Delivery of long-term-injectable agents for TB by lay carers : pragmatic randomised trial
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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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WRAP-delivery-long-term-injectable-agents-TB-lay-carers-pragmatic-randomised-trial-Madan-2020.pdf - Published Version - Requires a PDF viewer. Available under License Creative Commons Attribution 4.0. Download (313Kb) | Preview |
Official URL: http://dx.doi.org/10.1136/thoraxjnl-2018-212675
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 | ||||||||
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| Subjects: | R Medicine > RA Public aspects of medicine R Medicine > RC Internal medicine |
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| 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 |
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| 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: |
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| 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: |
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