Evaluation and demonstration of a new tuberculosis diagnostic tool for Indonesia: Study protocol of the EVIDENT cluster randomised controlled trial
Abstract
Introduction: Most people with tuberculosis (TB) reside in countries with limited resources for prompt TB diagnosis, resulting in diagnosis and treatment delays and ongoing community transmission. Current TB diagnostics rely on sputum, while some people with presumptive TB cannot produce adequate sample. A new generation near-point-of-care (NPOC) tests using sputum or tongue swabs may provide more accessible TB diagnosis.
Methods: In this pragmatic cluster randomised controlled trial (cRCT) in Indonesia, a multi-component public health intervention will include: (a) introduction of NPOC MiniDock MTB test (Guangzhou Pluslife Biotech, China) on sputum, tongue swab, or both specimens, (b) optimisation of clinical algorithms incorporating the new test, (c) a promotional package to encourage patient attendance and test utilisation, and (d) TB household contact investigation, including the new test, by community health volunteers. We will randomly stratify 40 community health centre (CHC) areas into intervention and control arms (1:1) in Bandung District. The intervention will be administered in healthcare facilities (HCFs) and in the community of the intervention areas. The control areas will continue standard of care with no intervention, except TB notification refresher training, which will be delivered in both areas before intervention roll-out. The primary outcome is the number of TB cases diagnosed and notified by HCFs per population attending them. It will be measured by…
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Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design.
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