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临床试验/NCT07687121
NCT07687121尚未招募不适用

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

Universidade Nova de Lisboa0 个研究点目标入组 200 人开始时间: 2026年12月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
200
主要终点
Incidence of TB

研究概览

简要总结

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.

详细描述

Tuberculosis (TB) is an infectious disease primarily affecting the lungs but capable of spreading to other organs. Following infection, around 5% of those infected develop the disease in the first 2 years, while the others carry the bacteria but remain asymptomatic. TB infection (TBI) occurs when individuals are infected but do not show symptoms and are not contagious. In 2022, there were 10.6 million cases of TB, 1.3 million deaths due to TB worldwide and approximately 1.7 billion people globally were estimated to have TBI, representing a significant pool of potential future TB cases. Preventive treatment for TBI is crucial to reducing the risk of progression to active TB and is a key component of the World Health Organization's (WHO) End TB Strategy. Early diagnosis, effective treatment, and targeted interventions for groups at increased risk are essential to controlling both TB and TBI globally.

The number of TB cases in Portugal has been gradually decreasing. In 2016 the country was considered a low-incidence country (<20 TB cases per 100,000 inhab). Immigrants are among the groups experiencing higher TB burden, especially in low-incidence countries, dure to factors such as overcrowding, poor living conditions, and limited healthcare access during migration trajectory and in refugee camps. Immigrants accounted for 30.1% of TB cases in Portugal in 2022, with a notification rate 4 times higher than the national average (58.5 cases/100,000 inhab). The majority of TB cases in immigrants were from Angola, Brazil, Guinea-Bissau, and Cape Verde. In 2023, the number of immigrants increased by 34% compared to 2022 with more than a million documented immigrants living in the country and an estimated number of undocumented immigrants between 30,000 and 50,000. Seven of the nine most common nationalities of newly arrived immigrants are from high TB burden regions like Africa and Hindustan, i.e., Angola, Cape Verde, India, Guinea Bissau, Bangladesh and Nepal.

In Portugal, the current guidelines for TB surveillance and management identify immigrants as one of the key populations for targeted intervention and establish those from high incidence countries (i.e., Angola, Guinea-Bissau, Cabo Verde, Mozambique, Ukraine, Romania and Russia) should be screened. However, immigrants from Hindustan countries are not included despite growing significance in current immigration trends.

The overall aims of this project are to develop a community based, participatory, co-created TB/ TBI screening care path, to estimate the incidence of TB and TBI in African and Hindustan immigrants in Portugal and to understand how some of their social, health and economic vulnerabilities may influence TB risk and adherence to a cascade of TB/TBI screening care.

Aim: to develop a co-created TB/TBI screening care path to ensure immigrants are not left behind and that no one is left untreated.

研究设计

研究类型
Observational
观察模型
Ecologic Or Community
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • - 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.

排除标准

  • 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

结局指标

主要结局

Incidence of TB

时间窗: Baseline

Number of TB positive immigrants / Total immigrants screened

Incidence of TB infection

时间窗: Baseline

Number of participants positive for TB infection / All participants screened

次要结局

  • Immigrant profile(Baseline)

研究者

申办方类型
Other
责任方
Sponsor

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