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Delivery of long-term-injectable agents for TB by lay carers: pragmatic randomised trial
  1. Danielle B Cohen1,2,3,
  2. Kuzani Mbendera4,
  3. Hendramoorthy Maheswaran2,5,6,
  4. Mavuto Mukaka2,7,8,
  5. Helen Mangochi2,
  6. Linna Phiri2,
  7. Jason Madan6,
  8. Geraint Davies2,9,
  9. Elizabeth Corbett2,10,
  10. Bertel Squire3
  1. 1 Infection, Immunity & Cardiovascular Disease, University of Sheffield, Sheffield, UK
  2. 2 Clinical Department, Malawi Liverpool Wellcome Clinical Research Programme, Blantyre, Malawi
  3. 3 Department of Clinical Sciences, Liverpool School of Tropical Medicine, Liverpool, UK
  4. 4 Malawi National TB Programme, Lilongwe, Malawi
  5. 5 Institute of Psychology, Health and Society, University of Liverpool, Liverpool, UK
  6. 6 Division of Health Sciences, University of Warwick, Warwick, UK
  7. 7 Mahidol Oxford Tropical Medicine Research Unit, Mahidol University, Bankok, Thailand
  8. 8 Centre for Tropical Medicine and Global Health, University of Oxford, Oxford, United Kingdom
  9. 9 Institute of Infection and Global Health, University of Liverpool, Liverpool, United Kingdom
  10. 10 Department of Clinical Research, LSHTM, London, UK
  1. Correspondence to Dr Danielle B Cohen, Infection, Immunity & Cardiovascular Disease, University of Sheffield, Sheffield S10 2TN, UK; Danielle.Cohen{at}sheffield.ac.uk

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.

Trial registration number ISRCTN05815615.

  • streptomycin
  • OPAT
  • community-based care
  • catastrophic household costs
  • drug-resistant TB
  • recurrent TB
  • retreatment TB

This is an open access article distributed in accordance with the Creative Commons Attribution 4.0 Unported (CC BY 4.0) license, which permits others to copy, redistribute, remix, transform and build upon this work for any purpose, provided the original work is properly cited, a link to the licence is given, and indication of whether changes were made. See: https://creativecommons.org/licenses/by/4.0/.

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Footnotes

  • Contributors DBC designed and implemented the study, analysed the data and wrote the first draft of the manuscript. KM coordinated implementation and data collection at the Lilongwe site. HM and JM advised on the collection and analysis of data for the health economic evaluation. HM provided additional data for the hospital costing. HM and LP were involved in overall study design, implemented the project, managed data collection and provided participant care at the Blantyre and Lilongwe sites, respectively. GD, EC and BS provided supervisory support throughout project design, data collection and analysis. All authors contributed to preparation of the final manuscript.

  • Funding This work was conducted using funding from a Wellcome Trust grant held by D.B. Cohen.

  • Disclaimer The Wellcome Trust had no role in the design of the study; collection, analysis and interpretation of data; or writing the manuscript.

  • Competing interests None declared.

  • Patient consent for publication Obtained.

  • Ethics approval The study received ethical approval from the ethics committees of The Liverpool School of Tropical Medicine and The University of Malawi College of Medicine.

  • Provenance and peer review Not commissioned; externally peer reviewed.

  • Data availability statement Data are available in a public, open access repository.

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