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Design and protocol for a cluster randomised trial of enhanced diagnostics for tuberculosis screening among people living with HIV in hospital in Malawi (CASTLE study)

Burke, Rachael M., Nyirenda, Saulos, Twabi, Hussein H., Nliwasa, Marriott, Joekes, Elizabeth, Walker, Naomi ORCID: https://orcid.org/0000-0002-3345-7694, Nyirenda, Rose, Gupta-Wright, Ankur, Fielding, Katherine, MacPherson, Peter ORCID: https://orcid.org/0000-0002-0329-9613 and Corbett, Elizabeth L. (2022) 'Design and protocol for a cluster randomised trial of enhanced diagnostics for tuberculosis screening among people living with HIV in hospital in Malawi (CASTLE study)'. PLoS ONE, Vol 17, Issue 1, e0261877.

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Abstract

Background: People living with HIV (PLHIV) have a high risk of death if hospitalised in low-income countries. Tuberculosis has long been the leading cause of admission and death, in part due to suboptimal diagnostics. Two promising new diagnostic tools are digital chest Xray with computer-aided diagnosis (DCXR-CAD) and urine testing with Fujifilm SILVAMP LAM (FujiLAM). Neither test has been rigorously evaluated among inpatients. Test characteristics may be complementary, with FujiLAM especially sensitive for disseminated tuberculosis and DCXR-CAD especially sensitive for pulmonary tuberculosis, making combined interventions of interest.
Design and methods: An exploratory unblinded, single site, two-arm cluster randomised controlled trial, with day of admission as the unit of randomisation. A third, smaller, integrated cohort arm (4:4:1 random allocation) contributes to understanding case-mix, but not trial outcomes. Participants are adults living with HIV not currently on TB treatment. The intervention (DCXR-CAD plus urine FujiLAM plus usual care) is compared to usual care alone. The primary outcome is proportion of participants started on tuberculosis treatment by day 56, with secondary outcomes of mortality (time to event) measured to to 56 days from enrolment, proportions with undiagnosed tuberculosis at death or hospital discharge and comparing proportions with enrolment-day tuberculosis treatment initiation.
Discussion: Both DCXR-CAD and FujiLAM have potential clinical utility and may have complementary diagnostic performance. To our knowledge, this is the first randomised trial to evaluate these tests among hospitalised PLHIV.

Item Type: Article
Subjects: WC Communicable Diseases > Virus Diseases > Acquired Immunodeficiency Syndrome. HIV Infections > WC 503 Acquired immunodeficiency syndrome. HIV infections
WF Respiratory System > Tuberculosis > WF 200 Tuberculosis (General)
WF Respiratory System > Tuberculosis > WF 220 Diagnosis. Prognosis
Faculty: Department: Clinical Sciences & International Health > Clinical Sciences Department
Education
Digital Object Identifer (DOI): https://doi.org/10.1371/journal.pone.0261877
SWORD Depositor: JISC Pubrouter
Depositing User: JISC Pubrouter
Date Deposited: 22 Mar 2022 13:29
Last Modified: 22 Mar 2022 13:29
URI: https://archive.lstmed.ac.uk/id/eprint/19793

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