Bissau

Tuberculosis TB remains a major global health challenge, with many cases going undetected and untreated, particularly in low-resource settings such as Guinea-Bissau and Ethiopia. This trial evaluates whether improving current point-of-care diagnostic methods can increase TB case detection rates and enable earlier treatment, potentially reducing transmission and improving outcomes. The study compares an Enhanced Usual Diagnostic Procedure EUDP with an Optimized Diagnostic Procedure ODP that incorporates novel strategies like computer-aided detection CAD of chest X-rays and non-sputum sample testing. The study uses a stepped-wedge cluster-randomized design, where participating health centers start with the standard diagnostic approach EUDP and later switch to the intervention ODP. The ODP includes oral and mobile phone-guided sputum sampling instructions, pooling of sputum samples for improved microscopy and molecular testing, and additional non-sputum sample collection buccaltongue swabs, saliva, and fecal samples analyzed by GeneXpert Ultra PCR. Smear-negative patients undergo chest X-ray evaluation with CAD software to identify active TB cases. Participants presenting with TB symptoms such as cough, sputum production, or weight loss will be assessed using the Bandim TBscore to determine diagnostic referral. Follow-up visits will occur one week after initial evaluation to ensure treatment initiation or reassessment. Researchers will measure diagnostic yields comparing EUDP and ODP over 1.5 years, tracking smear, PCR, and chest X-ray positivity, treatment numbers, and follow-up rates. The study also evaluates the feasibility of advanced sequencing techniques for resistance detection and supports capacity building in the participating countries.

Researchers are investigating the effects of measles vaccine MV and Bacille Calmette-Gurin vaccine BCG given to women of fertile age before pregnancy, and the impact of providing early measles vaccination to their children. The study aims to understand both measles-specific and general immune benefits in mothers and children, focusing on antibody responses, viral loads after yellow fever vaccination, and overall health outcomes. This is a phase 4 randomized, triple-blind trial conducted in Guinea-Bissau, exploring the novel concept that vaccinating mothers with live vaccines may enhance protection for their children. In this trial, 2400 non-pregnant, HIV-negative women aged 15 to 35 will be randomly assigned to receive either the measles vaccine, BCG vaccine, or a saline placebo. Their children, all receiving BCG at birth as per local recommendations, will be further randomized at 20 weeks of age to receive either an early measles vaccine or placebo. All children will then receive the standard measles and yellow fever vaccines at 9 months. The study will create six groups combining maternal and child vaccination schedules to compare outcomes. Participants will be followed through regular home visits and health center monitoring. Women will have blood samples taken before and after vaccination to measure antibody levels. Children will be closely monitored monthly and have blood samples taken at specified ages to assess immune responses and viral loads. The study tracks morbidity and mortality data for both mothers and children over time, using interviews, hospital records, and vaccination documentation. The trial will continue until 2027, assessing which vaccination schedules best support health and immunity.