Bissau

Tuberculosis (TB) remains a major global health challenge, with over 10 million new cases estimated by the WHO in 2022 and more than three million cases going undetected and untreated. This trial evaluates whether improving existing point-of-care diagnostics in primary healthcare centers in Guinea-Bissau and Ethiopia can increase TB detection rates. The study compares the current Enhanced Usual Diagnostic Procedure (EUDP) with an Optimized Diagnostic Procedure (ODP) that includes advanced sampling techniques and computer-aided chest X-ray analysis. The ODP involves instructing patients on effective sputum collection, pooling spot sputum samples for fluorescence microscopy, and adding non-sputum samples like saliva and buccal/tongue swabs for GeneXpert Ultra PCR testing. Chest X-rays are analyzed using AI-based software to detect TB signs in smear-negative cases. The study uses a stepped-wedge cluster-randomized design where healthcare centers switch from EUDP to ODP at set times. Training and capacity building for local staff are integral parts of the study. Participants are adults presenting with cough, sputum production, or weight loss, assessed using the Bandim TBscore to determine TB likelihood. Follow-up visits occur one week after initial evaluation to monitor treatment start or reassess symptoms. Researchers measure the number of confirmed TB cases diagnosed within 1.5 years, comparing detection rates between EUDP and ODP. The study also tracks treatment initiation within two weeks and evaluates the feasibility of advanced molecular testing. The trial runs from June 2024 to September 2025, with follow-up ending in April 2026.

Researchers are studying the effects of measles vaccine (MV) and Bacille Calmette-Gue9rin vaccine (BCG) on women of fertile age and their children in Guinea-Bissau. This phase 4 trial explores how vaccinating mothers before pregnancy and providing an early measles vaccine to infants impacts measles-specific immunity, viral response to yellow fever vaccination, and overall health. The study investigates whether maternal vaccination strengthens children's resistance to infections and improves health outcomes. The trial will randomly assign 2400 HIV-negative, non-pregnant women aged 15 to 35 years to receive either BCG vaccine, measles vaccine, or a placebo. Their children will all receive BCG at birth as recommended and will be further randomized to receive an early measles vaccine or placebo at 20 weeks. At 9 months, all children will receive the standard measles vaccine and yellow fever (YF) vaccine, with some children receiving YF vaccine followed by measles vaccine 5 days later to assess viral load. Participants will be closely monitored through regular home visits, health center assessments, and hospital records for infections, hospitalizations, and vaccinations. Blood samples will be collected from mothers and children at various time points to measure measles antibodies and yellow fever viral load. The study will evaluate the six different vaccine schedules for their impact on immune response, child protection, and maternal and child health over time.