Project Info
About Stool4TB
Stool4TB is an EDCTP funded project that aims to evaluate an innovative stool-based qPCR diagnostic platform (with the capacity to become a POC diagnostic tool) in the high TB and HIV burden settings of Mozambique, Eswatini and Uganda, under the hypothesis that it will narrow the extremely large TB case detection gap by improving TB confirmation rates in children and PLHIV.
Project Objectives
This project (Stool4TB) aims to validate an innovative stool homogenization and DNA isolation method that yields a highly sensitive and specific Mtb qPCR-based diagnostic. We aim to create a TB diagnostic network among African high TB burden countries with the capacity to conduct clinical studies of novel diagnostics and new drugs with a focus on children and PLHIV.
Project objectives include:
Assess the feasibility, tolerability and acceptability of such specimen collection from both the patient and the health system perspective.
Create a biobank of comparative specimens provided by pediatric and HIV-positive suspected TB patients at different time points during treatment to facilitate the future evaluation of novel assays for TB diagnosis or drug resistance detection among pediatric populations and PLHIV.
Create a TB diagnostic network among African high TB burden countries with the capacity to conduct clinical studies of novel diagnostics and new drugs with a focus on children and PLHIV. This will be achieved by strengthening collaboration and sustaining capacity-building activities among participating African institutions.
Study Population: Children less than 8 years of age and adults living with HIV (>15 years of age) who present with TB compatible symptoms.
Expected recruitment: Around 1500 pediatric TB presumptive children and 650 HIV-positive TB presumptive adults.
Timeline: The project implementation will run for 2 years starting from June-July 2021. One year and a half of recruitment plus 6 months to allow for the follow up of the participants.
Study Sites
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