South Africa Quarterly Report: Supporting, Mobilizing, and Accelerating Research for Tuberculosis Elimination (SMART4TB)

The project aims to invest up to $200 million to achieve a decline in TB incidence and mortality and to help prepare priority countries for managing the disease. SMART4TB has planned to implement research studies with South Africa and in-country local partners to identify effective person-centered methods for finding, treating, and preventing TB; strengthen local capacity to conduct high-quality research; and engage communities to build demand for new interventions, to drive policy change, and improve implementation of new and existing interventions to reach the End TB targets. The project has planned to implement the following research studies: PRISM-TB, SMILE-TB, and the ESI Program. PRISM-TB is a randomized controlled trial to improve the treatment of rifampin-resistant TB by identifying both the right regimen and right duration which depends on a patient's own baseline risk of treatment failure and relapse. The trial will enroll adolescents and adults with confirmed rifampin-resistant TB, based on a GeneXpert result, where they will be randomized to receive either the standard of care control strategy or an intervention strategy. The standard of care will be defined by World Health Organization (WHO) guidelines, which currently recommend 6 months of BPaLM. The ESI Program is designed as an Early-Stage Investigator (ESI) Training and Mentorship Program with the long-term objective of supporting local and country leadership of SMART4TB scientific research, protocols, and outputs. The program aims to strengthen local capacity to conduct high-quality research and engage communities to build demand for new interventions, to drive policy change, and improve implementation of new and existing interventions to reach the End TB targets. In collaboration with USAID, the consortium developed the Year 1 workplan for the specified studies. With ongoing support from USAID Washington DC, a partnership was established with the South African USAID Country Mission to implement these studies throughout the duration of the project. After initiating communication with South Africa and engaging in discussions with both USAID South Africa Mission and USAID Washington DC, Mission Concurrence was obtained the week of May 8th, 2023. The PRISM-TB trial has been approved for the Isango Lethemba TB Research Unit, University of the Witwatersrand (in Eastern Cape), and the SMILE-TB trial has been approved for the Africa Health Research Institute (AHRI), King Edward VIII Hospital, and Somkele Clinical Trials Unit in KwaZulu-Natal. The ESI Program aims to support local and country leadership of SMART4TB scientific research, protocols, and outputs. The SMART4TB project has made significant progress in its first year, with the development of the Year 1 workplan and the establishment of a partnership with the South African USAID Country Mission. The project has also obtained Mission Concurrence and has approved trial sites for the PRISM-TB and SMILE-TB studies. The ESI Program aims to strengthen local capacity to conduct high-quality research and engage communities to build demand for new interventions, to drive policy change, and improve implementation of new and existing interventions to reach the End TB targets.