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

NCT07687121 | Not Yet Recruiting

• 1 other identifier: 2024.15908.PEX
• Study Type: observational
• Target: 200
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Tuberculosis; Tuberculosis (TB); Tuberculosis Active; Tuberculosis Infection, Latent

Keywords

Immigrants; Migrants; Tuberculosis; Surveillance; Screening; Care pathway

Outcome Measures

Primary Outcomes (2)

• Incidence of TB

  Number of TB positive immigrants / Total immigrants screened

  Baseline

• Incidence of TB infection

  Number of participants positive for TB infection / All participants screened

  Baseline

Secondary Outcomes (1)

• Immigrant profile

  Baseline

Study Arms (1)

Immigrants

Immigrants in Portugal that have started migration journey less than 5 years before the data collcetion for the study, originated from Angola, Mozambique, Guinea Bissau, Cape Verde, Bangladesh, India or Nepal

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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.

You may qualify if:

• \- adult immigrants, aged 18 years or older, from Angola, Cape Verde, Guinea-Bissau, Mozambique, India, Bangladesh, or Nepal, who began their migration journey less than five years ago, who attend or are identified through community services or associated community networks, and who agree to participate by signing an informed consent form.

You may not qualify if:

• 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

Sponsors & Collaborators

• NOVA National School of Public Health: collaborator
• Universidade Nova de Lisboa: lead

Related Publications (2)

• Direção Geral da Saúde. (2023). Guia Cuidados de Saúde em Tuberculose para Populações Vulneráveis . Direção Geral da Saúde. https:// www.dgs.pt/tuberculose/ficheiro-de-registos-folhetos/guia-tb-populacoes-vulneraveis_mar2023-pdf.aspx

  BACKGROUND

• Direção Geral da Saúde. (2022). Recomendações de rastreio de Tuberculose em cidadãos provenientes de paises de alta incidência de TB . https://www.chporto.pt/images/noticias/2022/ Recomendac__o__es_de_rastreio_de_Tuberculose_em_cidada__os_provenientes_de_paises_de_alta_incide__ncia_de_TB.pdf

  BACKGROUND

MeSH Terms

Conditions

Tuberculosis; Latent Tuberculosis

Condition Hierarchy (Ancestors)

Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Latent Infection

Study Officials

• Ines Fronteira, PhD

  NOVA National School of Public Health

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ines Fronteira, PhD

CONTACT

+351215712100; ines.fronteira@ensp.unl.pt

Study Design

• Study Type: observational
• Observational Model: ECOLOGIC OR COMMUNITY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 12, 2026
• First Posted: July 7, 2026
• Study Start (Estimated): December 1, 2026
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): May 1, 2027
• Last Updated: July 7, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR