Clinical Research Directory

SCAF-TB - Saving Children and Their Families From Tuberculosis: Implementation Research to Improve TB Preventive Treatment Initiation and Completion Rates Among Contact Persons in Tajikistan and Tanzania

The SCAF-TB study aims to evaluate how the WHO-endorsed SIILTIBCY skin test can be best implemented to test close contacts for tuberculosis infection (TBI) in Tajikistan and Tanzania, either facility-based or home-based delivered by community health workers (CHWs) with or without AI-facilitated diagnostic tools. The overall goal of this study is to improve access to innovative tuberculosis (TB) preventive services among children and their families in Tanzania and Tajikistan, both settings with a high burden of TB. Persons in close contact with people diagnosed with bacteriologically confirmed TB disease will be identified through the index patient and home visits. They will decide the preferred location for TBI testing, either at home or at the facility. Community health workers will be trained to implement home-based TB prevention services, including TBI testing and AI-assisted reading, and ruling out TB disease using a cough app (along traditional screening practices). The main objectives of the study are: 1. To assess whether CHWs can reliably measure SIILTIBCY results in TB contact persons at their homes, with or without the support of AI-assisted reading tools. 2. To determine how feasible and acceptable it is for CHWs to perform home-based SIILTIBCY testing, both with and without AI assistance. 3. To assess the added value, feasibility, and acceptability of using a mobile cough screening application, administered by CHWs, to help rule out TB disease. 4. To evaluate the impact of these home-based TBI testing strategies on improving uptake and completion of TB preventive treatment (TPT), as well as their budget implications for both the health care system and affected households. The study will be conducted in primary health care facilities in Tajikistan and Tanzania, which have access to short-course TPT regimens. The study population is composed of persons in close contact with people diagnosed with bacteriologically confirmed TB disease, and eligible for TPT as per national guidelines. The main outcomes of interest are: 1. SIILTIBCY inter-reader agreement CHW (home-based) and HCW (facility-based) 2. SIILTIBCY inter-reader agreement CHW with AI reading and without AI reading 3. Proportion tested for TBI out of those eligible for TBI testing 4. Proportion tested positive for TBI, stratified by demographic characteristics and mode of delivery 5. Diagnostic agreement between a cough application and symptom screening 6. Proportion initiated on TPT out of those eligible for TPT, stratified by regimen and mode of testing 7. Proportion completing TPT out of those initiated on TPT, stratified by regimen and mode of testing. 8. Interest-holders' perspectives on home-based TBI testing and cough app screening. 9. Budgetary impact scaling-up home-based TBI testing and cough app screening

Shaping a Community-based Pathway to Improve TB Surveillance Among African and Hindustan Immigrants Experiencing Vulnerabilities

This two-phase, mixed-methods approach project aims to develop a community-based, participatory, and co-created TB/TB infection (TBI) screening care pathway for African and Hindustan immigrants, who often face socioeconomic vulnerabilities and barriers to healthcare access, including TB/TBI screening. The first phase involves the co-design of a TB/TBI screening care pathway through four thematic workshops using the Double-Diamond theoretical framework. These workshops will engage key stakeholders, including immigrants, community leaders, healthcare professionals, and academics, to identify barriers, define needs, and develop actionable measures to improve TB/TBI screening care. The second phase involves a community-based study to implement the care pathway and estimate the incidence of TB and TBI among 200 immigrants from Angola, Cabo Verde, Guinea-Bissau, Mozambique, India, Bangladesh, and Nepal. Participants will be recruited through Grupcommunity services, and data will be collected on demographic, socioeconomic, health, and migration-related factors. The screening pathway will be implemented and evaluated, with patient-related outcomes measured to assess its effectiveness. The primary outcomes include the development of a culturally sensitive TB/TBI screening care pathway and the estimation of TB and TBI incidence among high-risk immigrant populations. Secondary outcomes include the profiling of immigrant populations, the identification of social vulnerabilities, and the establishment of eligibility criteria for TB/TBI screening in similar populations. We expected to advance knowledge on the specific needs of vulnerable immigrants regarding TB/TBI screening and care and to empower communities, improve access to healthcare, and inform policymakers on tailored prevention and control strategies. The findings will contribute to the global effort to eliminate TB by addressing the unique challenges faced by immigrant populations in low-incidence countries like Portugal.

Artificial Intelligence-driven Tuberculosis Landscape Analysis & Stratification Research

The goal of this observational study is to establish and validate a comprehensive AI-driven clinical decision support system (AI-CDSS) in whole-chain management for pulmonary tuberculosis (TB) patients. The main question it aims to answer is: How is the predictive performance of this system in terms of multiple key links during TB diagnosis and treatment? Can real-world benefits be derived from this system? This AI framework supports clinicians in making smarter decisions, ultimately improving cure rates and ensuring that every patient receives the most effective, personalized care possible.

Pharmacokinetics of Drugs Used to Treat Drug Sensitive Tuberculosis in Breastfeeding Mother-infant Pairs

Pregnant or lactating women requiring treatment for drug sensitive-TB will be identified and invited for sampling. If they are pregnant when identified, they will be invited for sampling after delivery. Plasma and breastmilk samples will be obtained pre-dose and at 2, 4, 6, and 8 hours post-dose. If logistics permit (for example living close to the research unit), the participant will be invited for a further sample at 24 hours post-dose. A heelprick sample will also be obtained from their breastfed infants at maternal trough (prior to maternal dose) and at a random timepoint (once per infant) over the 8-hour pharmacokinetic sampling visit in order to characterize concentrations of these drugs over an 8-hour dosing interval. Total concentrations of plasma and breastmilk Isoniazid, Rifampicin, Pyrazinamide and Ethambutol will be determined. If a participant has her first pharmacokinetic profile in the intensive phase of TB treatment (whilst on all four of isoniazid, rifampicin, pyrazinamide and ethambutol), she will be invited for a subsequent sampling day with the same time points when she is on the continuation phase of therapy (rifampicin and isoniazid).