A clinical trial evaluating an improved treatment regimen for drug-sensitive tuberculosis - " OptiRiMox TB Project"

The OptiRiMox TB project, a modification of the Op6RiMox trial, is a comprehensive clinical trial designed to address tuberculosis (TB) through a combination of community engagement activities, clinical trials, and monitoring and evaluation efforts. 

The project whose full title is "A pragmatic trial with optimized dose of rifampicin and moxifloxacin for the treatment of drug-susceptible pulmonary tuberculosis" is funded by the Europe and Developing Countries Clinical Trials Partnership (EDCTP) and coordinated by The University Court of The University of St Andrews. It will be conducted across four project sites in Gabon, Malawi, Mozambique, and Tanzania.

In Tanzania, the project will be implemented across three study sites (in Dar, Bagamoyo and Mwanza), spearheaded by the Ifakara Health Institute in collaboration with Kibong'oto Infectious Diseases Hospital (KIDH), the technical sponsor for the OptiRiMox TB Trial, and National Institute for Medical Research (NIMR) Mwanza. The project's duration spans from February 24, 2024, to October 24, 2025.

Key components of the project include various community engagement activities such as Community Engagement Forums, TB Day events, dramas, and Community Advisory Board (CAB) meetings. These activities aim to foster community involvement and raise awareness about TB.

Additionally, the project will undertake rigorous monitoring and evaluation activities to ensure the effectiveness and integrity of the interventions. Engagement efforts with Ifakara Health Institute and KIDH will focus on prioritizing Clinical Trial Monitoring, ensuring the rights, safety, and well-being of study participants, alongside safeguarding the credibility of trial data. 

This multifaceted approach underscores the commitment to advancing TB research while fostering community involvement and maintaining the highest standards of ethical conduct throughout the project's implementation.

The project will be led by Dr Benno Mbeya who will oversee the project implementation as the Project Investigator and Dr. Alwissa Urassa also from will act as the Research Quality Assurance – both Ifakara Health Institute.