Delivery of long-term-injectable agents for TB by lay carers: pragmatic randomised trial


Cohen, Danielle B, Mbendera, Kuzani, Maheswaran, Hendramoorthy ORCID: 0000-0002-7375-4845, Mukaka, Mavuto, Mangochi, Helen, Phiri, Linna, Madan, Jason, Davies, Geraint ORCID: 0000-0002-3819-490X, Corbett, Elizabeth and Squire, Bertel (2020) Delivery of long-term-injectable agents for TB by lay carers: pragmatic randomised trial. THORAX, 75 (1). pp. 64-71.

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Abstract

<h4>Background</h4>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.<h4>Methods</h4>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.<h4>Results</h4>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%.<h4>Conclusions</h4>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.<h4>Trial registration number</h4>ISRCTN05815615.

Item Type: Article
Uncontrolled Keywords: streptomycin, OPAT, community-based care, catastrophic household costs, drug-resistant TB, recurrent TB, retreatment TB
Depositing User: Symplectic Admin
Date Deposited: 10 Dec 2019 10:32
Last Modified: 19 Jan 2023 00:13
DOI: 10.1136/thoraxjnl-2018-212675
Open Access URL: http://doi.org/10.1136/thoraxjnl-2018-212675
Related URLs:
URI: https://livrepository.liverpool.ac.uk/id/eprint/3065585

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