Mozambique Quarterly Report

The program aims to accelerate research for tuberculosis elimination in Mozambique. The program's geographic focus is Mozambique, with a specific emphasis on improving diagnostic accuracy and acceptability of novel point-of-care (POC) tuberculosis diagnostics in children. The ADAPT for Kids activity is a key component of the SMART4TB program, with the overall goal of evaluating the diagnostic accuracy and acceptability/usability of novel POC TB diagnostics in children with presumptive TB. In Year 2, the ADAPT for Kids protocol was continued, with ongoing evaluation of tongue swab-based Xpert Ultra and Truenat MTBplus, and initiation of evaluations of additional novel tests identified through Activity 1.1. Key achievements and deliverables submitted for the ADAPT for Kids activity include protocol adaptation/approvals, site preparation, study activation and participant enrollment, and study data quality and assurance activities. The study team successfully completed all training, procurement, and site preparation activities at the Mavalane clinical research unit, and new staff received initial training in the objectives and procedures of the study. The first ADAPT for Kids participant in Mozambique was enrolled on January 26, 2024, and by the end of Q2, 24 children had been screened and 12 enrolled in the study. The study team also conducted ongoing monitoring and quality control activities, including review of each participant file and data record by internal monitors on site, as well as data review by both in-country and US-based analysts. The site benefited from both an EGPAF monitoring trip and an INS quality assurance unit monitoring visit, which provided feedback for areas of correction or improvement. Weekly team meetings were held with PIs, study coordinators, and site staff, and additional quarterly meetings were held to discuss enrollment progress and challenges with study co-investigators. The program's implementation details include the use of novel POC TB diagnostics, such as Xpert Ultra and Truenat MTBplus, and the evaluation of additional novel tests identified through Activity 1.1. The program also involves collaboration with local partners, including the Instituto Nacional de Saude and the National TB Program, as well as international partners, such as Johns Hopkins University and the Elizabeth Glaser Pediatric AIDS Foundation. The program's geographic focus is Mozambique, with a specific emphasis on improving diagnostic accuracy and acceptability of novel POC TB diagnostics in children. The program's timeframes include Year 2 of the SMART4TB program, with ongoing evaluation and implementation of the ADAPT for Kids protocol. The program's recommendations include the continued evaluation and implementation of novel POC TB diagnostics, as well as the strengthening of local capacity and collaboration with international partners.