Improving Tuberculosis Detection Using Enhanced and Novel Diagnostic Methods in High-Burden Areas of Guinea-Bissau and Ethiopia

What this Trial Is About

Tuberculosis TB remains a major global health challenge, with many cases going undetected and untreated, particularly in low-resource settings such as Guinea-Bissau and Ethiopia. This trial evaluates whether improving current point-of-care diagnostic methods can increase TB case detection rates and enable earlier treatment, potentially reducing transmission and improving outcomes. The study compares an Enhanced Usual Diagnostic Procedure EUDP with an Optimized Diagnostic Procedure ODP that incorporates novel strategies like computer-aided detection CAD of chest X-rays and non-sputum sample testing. The study uses a stepped-wedge cluster-randomized design, where participating health centers start with the standard diagnostic approach EUDP and later switch to the intervention ODP. The ODP includes oral and mobile phone-guided sputum sampling instructions, pooling of sputum samples for improved microscopy and molecular testing, and additional non-sputum sample collection buccaltongue swabs, saliva, and fecal samples analyzed by GeneXpert Ultra PCR. Smear-negative patients undergo chest X-ray evaluation with CAD software to identify active TB cases. Participants presenting with TB symptoms such as cough, sputum production, or weight loss will be assessed using the Bandim TBscore to determine diagnostic referral. Follow-up visits will occur one week after initial evaluation to ensure treatment initiation or reassessment. Researchers will measure diagnostic yields comparing EUDP and ODP over 1.5 years, tracking smear, PCR, and chest X-ray positivity, treatment numbers, and follow-up rates. The study also evaluates the feasibility of advanced sequencing techniques for resistance detection and supports capacity building in the participating countries.

Increased Tuberculosis Case Detection - DiOpTB