Project: Research Capacity Strengthening Programme for Emerging and Re emerging Infectious Diseases Control in Tanzania

Acronym	REMODEL-TZ (Reference Number: TMA2016SF-1463)
Duration	01/04/2018 - 31/03/2023
Project Topic	Background: Tanzania, one of the sub-Saharan African countries with endemic tuberculosis (TB) and Human Immunodeficiency Virus (HIV) is confronting emerging and re-emerging infectious disease threats such as multidrug resistant tuberculosis (MDR-TB), dengue, chikungunya amidst the shortage of health care workers including medical researchers. Health research capacity strengthening (HRCS) has been recommended as one of the best approaches for the developing world in improving the ability to tackle epidemics. Aims and objectives: To conduct a clinical trial focused in TB/HIV patients that will not only answer an important scientific question of direct patient benefit, but with additional components of establishing a clinical trial unit with capacity for laboratory scientists, research trialists and a rapid response infrastructure. Methods: Through research aims proposed in the programme, the Senior Fellow will conduct a phase 2b double blind randomized controlled trial to evaluate the otoprotective efficacy, safety and tolerability of N-acetylcysteine in combination in adult subjects treated with kanamycin containing regimens for MDR-TB in Tanzania. In addition, trial participants will provide sequential sputum specimens to determine elimination of MTB in sputum using the molecular bacterial load (MBL) assay. The effect of second-line susceptibility will be determined by rt-PCR of MTB resistance determining regions as identified by the MTB specific TaqMan Array Card (TAC) platform on elimination of MTB on the sputum. In addition, TAC results will be compared to conventional phenotypic drug susceptibility results and isolates with discordant results between TAC and the phenotypic tests will be interrogated by Whole Genome Sequencing (WGS) (on the Illumina MiSeq) platform. In the research described, next generation of scientists will be mentored at Master and PhD levels. Likewise, mentees will acquire hands-on research skills on clinical trials and cutting edge molecular diagnostic research. This will create a critical mass of experts and a functional clinical trial unit (CTU). Relevancy to EDCTP scope: The proposed programme will support capacity strengthening of the Senior Fellow as an African research leader using the train-the-trainer model. Two young investigators and two junior researchers at PhD and Master degree levels respectively will be mentored during the conduct of proposed clinical trial activities. Expected impact: Researchers in this project will be designing and conducting clinical trials ( meeting the International Conference on Harmonisation – Good Clinical Practice (ICH-GCP) standards) and investigating infectious diseases pathogens using cutting edge molecular diagnostics. The team will continuously thrive and address the challenges of infectious diseases threats in the country.
Network	EDCTP2
Call	Senior Fellowships 2016

Project partner

Number	Name	Role	Country
1	Kibong'oto Infectious Diseases Hospital	Coordinator	Tanzania