About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
None
Disqualifiers
Participants with a legally appointed representative
Participants incapable of understanding essential study information, even with linguistic or cultural mediation support and with any clinical condition that prevents the interview, informed consent, or screening process
Trial population
We will use a sequential non-probability sampling method. Eligible participants will be recruited consecutively from community services in Lisbon and associated community networks during the defined data collection period, until the planned sample size is reached or until the end of the recruitment period (6 months after the first workshop). We plan to include approximately 200 participants. This sample size was determined by the operational capacity of the services involved, specifically capacity for community recruitment and participant follow-up, and the capacity of the TB community services for clinical evaluation, diagnosis, treatment decisions, and follow-up when necessary.
Trial design
Ecologic or community
Cross-sectional
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
Incidence of TB
Number of TB positive immigrants / Total immigrants screened
Incidence of TB infection
Number of participants positive for TB infection / All participants screened
Secondary outcomes
Immigrant profile
SE and demographic characteristics of immigrants, migration journey, general health and wellbeing, prevalence of social vulneraibilities
Locations
Sponsors and contacts
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Universidade Nova de Lisboa
Lead sponsor
NOVA National School of Public Health
Collaborator
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