Gondar

Researchers are evaluating patients with visceral leishmaniasis (VL) in Ethiopia to develop a tool that can predict relapse of the disease. This study focuses on understanding the factors that influence poor outcomes, including relapse, treatment failure, and mortality, especially since certain groups, such as those co-infected with HIV or sepsis, face higher risks. The goal is to improve patient care by identifying those at higher risk and providing more targeted monitoring and treatment. The study involves comprehensive clinical and laboratory evaluations of confirmed VL patients before and during treatment. Data collected will include clinical signs, laboratory results, immunological markers, and other relevant health parameters. No experimental treatment is given; instead, the study tracks and assesses patients to identify key factors that predict relapse and poor outcomes. Participants will undergo thorough assessments and follow-up visits to collect data on their health status, laboratory tests, and disease progression. Researchers will use this information to create a prognostic tool to help healthcare providers identify patients at risk of relapse and tailor care accordingly. The study aims to improve follow-up, reduce morbidity and mortality, and enhance overall management of VL through better prediction of relapse risk. The main outcome measures include identification of relapse risk factors and development of the prognostic tool by December 2026.

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 investigating the key factors that lead to relapse and parasite persistence in patients co-infected with visceral leishmaniasis (VL) and HIV in northern Ethiopia. The study aims to improve understanding of why some patients experience chronic or recurrent disease and to enhance treatment monitoring for this vulnerable group. This observational cohort study includes both prospective and retrospective data collection to analyze clinical and laboratory information related to VL/HIV co-infection. The study focuses on identifying host and pathogen factors contributing to active chronic disease by monitoring parasite presence in blood and tissue samples before, during, and after treatment as well as during follow-up. Researchers will use molecular diagnostics and genotyping to assess parasite behavior, drug resistance, and reinfection. The study also examines HIV co-infection characteristics, potential antiretroviral therapy resistance, additional co-infections like tuberculosis and malaria, immune system exhaustion, and quality of life through standardized questionnaires. Participants will undergo routine clinical and laboratory evaluations with molecular testing of parasites and assessment of immune markers. The study will measure parasite persistence in the skin and stool microbiome changes, and explore the impact of secondary prophylaxis on relapse patterns compared to historical data. Follow-up visits will monitor disease status and quality of life over a 12-month period, helping to identify factors linked to chronicity in VL/HIV patients.