Design and protocol for a pragmatic randomised study to optimise screening, prevention and care for tuberculosis and HIV in Malawi (PROSPECT Study)

MacPherson, P. , Webb, E. L., Lalloo, D. G., Nliwasa, M., Maheswaran, H., Joekes, E., Phiri, D., Squire, B., Pai, M. and Corbett, E. L. (2018) Design and protocol for a pragmatic randomised study to optimise screening, prevention and care for tuberculosis and HIV in Malawi (PROSPECT Study). Wellcome Open Research, 3, 61. (doi: 10.12688/wellcomeopenres.14598.3) (PMID:30542662) (PMCID:PMC6259593)

Abstract

Background: Adults seeking diagnosis and treatment for tuberculosis (TB) and HIV in low-resource settings face considerable barriers and have high pre-treatment mortality. Efforts to improve access to prompt TB treatment have been hampered by limitations in TB diagnostics, with considerable uncertainty about how available and new tests can best be implemented. Design and methods: The PROSPECT Study is an open, three-arm pragmatic randomised study that will investigate the effectiveness and cost-effectiveness of optimised HIV and TB diagnosis and linkage to care interventions in reducing time to TB diagnosis and prevalence of undiagnosed TB and HIV in primary care in Blantyre, Malawi. Participants (≥ 18 years) attending a primary care clinic with TB symptoms (cough of any duration) will be randomly allocated to one of three groups: (i) standard of care; (ii) optimised HIV diagnosis and linkage; or (iii) optimised HIV and TB diagnosis and linkage. We will test two hypotheses: firstly, whether prompt linkage to HIV care should be prioritised for adults with TB symptoms; and secondly, whether an optimised TB triage testing algorithm comprised of digital chest x-ray evaluated by computer-aided diagnosis software and sputum GeneXpert MTB/Rif can outperform clinician-directed TB screening. The primary trial outcome will be time to TB treatment initiation by day 56, and secondary outcomes will include prevalence of undiagnosed TB and HIV, mortality, quality of life, and cost-effectiveness. Conclusions: The PROSPECT Study will provide urgently-needed evidence under "real-life" conditions to inform clinicians and policy makers on how best to improve TB/HIV diagnosis and treatment in Africa.

• Item Type: Articles
• Additional Information: This work was supported by the Wellcome Trust [206575 to PM, 200901 to ELC]. It was additional supported by the UK Medical Research Council (MRC) and the UK Department for International Development (DFID) under the MRC/DFID Concordat agreement [MR/K012126/1] to ELW. ELW is also part of the EDCTP2 programme supported by the European Union.
• Status: Published
• Refereed: Yes
• Glasgow Author(s) Enlighten ID: MacPherson, Professor Peter
• Authors: MacPherson, P., Webb, E. L., Lalloo, D. G., Nliwasa, M., Maheswaran, H., Joekes, E., Phiri, D., Squire, B., Pai, M., and Corbett, E. L.
• College/School: College of Medical Veterinary and Life Sciences > School of Health & Wellbeing > Public Health
• Journal Name: Wellcome Open Research
• Publisher: F1000Research
• ISSN: 2398-502X
• ISSN (Online): 2398-502X
• Copyright Holders: Copyright © 2018 MacPherson P et al.
• First Published: First published in Wellcome Open Research 3:61
• Publisher Policy: Reproduced under a Creative Commons licence