Computer Aided Screening for Tuberculosis in Low Resource Environments (CASTLE)
Tuberculosis Infection, HIV Infections
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About this trial
This is an interventional diagnostic trial for Tuberculosis Infection
Eligibility Criteria
Inclusion Criteria:
- Requires acute admission to a hospital medical ward at Zomba Central Hospital for any reason
- Is living with HIV (existing or new diagnosis, irrespective of ART status)
- Willing and able to give informed consent
Exclusion Criteria:
- Aged <18 years
- Has been admitted to a medical ward for longer than 18 hours
- Taking TB treatment before admission or has received treatment for TB within the preceding 6 months.
- Has already been in the study during an earlier hospital admission.
Sites / Locations
- Zomba Central Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
No Intervention
Experimental
Other
Usual Care
DCXR-CAD and FujiLAM and usual care
Diagnostic cohort
Participants in the usual care arm will receive no specific trial intervention. Usual care includes tests routinely available at Zomba Central Hospital, including (but not limited to) conventional (plain film) chest X-ray, urine Alere LAM and sputum Xpert Mtb/Rif on treating clinician request.
Participants randomized to the intervention arm will receive TB screening using DCXR-CAD and urine FujiLAM. The CAD score and FujLAM results will be appended into their medical notes for treating clinicians to see. If patients have a CAD score above a pre-determined threshold the study team will attempt to collect sputum for Xpert Mtb/Rif. Chest X-ray images will be available for clinicians to view. This is in addition to usual care (detailed above).
Patients in the observational enhanced diagnostic arm will receive an enhanced package of diagnostics. This is a smaller arm (1 in 9 of all clusters) and is observational only - participants in this arm do not contribute to trial outcomes.