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Optimizing the use of GeneXpert MTB/RIF assay for the diagnosis and clinical management of adult and childhood TB and MDR TB suspects in Ethiopia

Tuberculosis (TB) is one of the leading causes of morbidity and mortality in Ethiopia. Ethiopia ranks third in Africa and 8th among the 22 highest TB burdened countries in the world. Ethiopia also has the world’s 15th highest burden of MDR-TB. Despite the increased burden of TB and MDR-TB in Ethiopia, the diagnosis remains a challenge. In December 2010 WHO endorsed the new GeneXpert MTB/RIF® to TB laboratories. WHO strongly recommends the widespread use of GeneXpert for individuals suspected of MDR-TB or HIV-associated TB in adults, but many further studies assessing the performance of GeneXpert in vulnerable and/or difficult to diagnose groups (paediatric and extra-pulmonary TB) are still needed. Likewise, the diagnostic yield of GeneXpert for intensified TB case findings and its role in ruling out active TB to increase isoniazid preventive therapy (IPT) for HIV-positive patients in HIV and TB -endemic countries is not clearly addressed. The overall goal of this research project is to improve the diagnosis and clinical management of adult and childhood TB by maximizing use of the GeneXpert in Ethiopia. We also aim to evaluate whether sputum pre-treatment with propidium monoazide (PMA) in conjunction with GeneXpert might permit distinction between live and dead bacilli and helps to monitor the therapeutic response of TB patients. TB suspected adults and children visiting different health facilities in Jimma Southwest Ethiopia will be enrolled. Rapid HIV testing will be done for all consented study subjects. About 513 pulmonary TB suspected children and 270 extra-pulmonary TB suspected adults will be enrolled and tested for TB with conventional methods and GeneXpert. Data collection on EPTB was partly started, about 90 adult patients suspected of having EPTB were already recruited and enrolled. Likewise, 1250 diagnosed smear-positive adults will be put on anti- TB treatment and those patients that still remains smear positive at the end of 2nd month will be followed and monitored by using conventional methods, GeneXpert with and without PMA and fluorescein diacetate (FDA) staining. Finally, HIV-positive patients (n=812) visiting Jimma University Specialized Hospital (ART clinic) will be screened for active symptoms of TB. Patients with any symptom of TB will be tested with GeneXpert with and without pooling sputum sample to evaluate the efficiency of GeneXpert as a screening tool to exclude active TB and hence increase IPT on one hand, and for intensified TB case finding on the other hands. The project work was partly started in April, 2014 and ends in December, 2017. Funding for this project work is obtained from interuniversity cooperation between Jimma University and Flemish Universities (VLIR-UOS project).
Date:27 Oct 2014  →  15 Jun 2018
Project type:PhD project