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临床试验/NCT05998499
NCT05998499已完成不适用

HIV-Infected Latin American Asylum Seekers in Europe: Insights From the EuroLatin HIV Cohort (ELHC)

Hospital Universitario Infanta Leonor1 个研究点 分布在 1 个国家目标入组 631 人开始时间: 2022年1月30日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
631
试验地点
1
主要终点
HIV viral control

研究概览

简要总结

This is a longitudinal observational study conducted in Europe that describes migrants infected with HIV from Latin America who come to Europe with the intention of seeking asylum or international protection. The aim of the study is to identify the barriers this population faces in accessing the healthcare system and to assess disease control

详细描述

Study Design and Setting This observational study was conducted between 2022 and 2023 in Madrid, Spain. Participants were recruited at the HIV outpatient clinic of Infanta Leonor University Hospital (HUIL) for the study and were monitored for a period of 6 months from their enrollment in the study.

Participant Recruitment Participants were primarily identified and referred by various non-governmental organizations (NGOs) working with migrants living with HIV. These NGOs, which included gTt-VIH, Apoyo Positivo, Cogam, Acción Triangulo, Kif-Kif, Salud Entre Culturas, and the Spanish Red Cross, played an essential role by establishing a crucial link and provided a vital bridge, facilitating the patients' integration into the healthcare system through an unconventional circuit.

Medical Evaluation In the HIV unit, assessments were conducted by experienced infectious disease specialists and a unit-specific nurse. The care protocol comprised a meticulous collection of medical history, an exhaustive physical examination, along with a series of tests. Furthermore, appointments were scheduled for a one-month and six-month follow-up to ensure continuous care and monitor the effectiveness of the treatment regimen.

Social and Psychological Evaluation An experienced social worker with a background in vulnerable populations was hired to perform a social assessment. Six months post the initial hospital visit, the social worker re-established contact with the patients to reassess their social circumstances and their continued engagement with the HIV consultation services.

Ethical Considerations This study adhered to the ethical principles outlined in the Declaration of Helsinki and received the necessary approvals from the ethics committee at Infanta Leonor Hospital. Informed consent was provided by every participant.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

性别
All
接受健康志愿者

入选标准

  • Latin American migrants infected with HIV who arrive in Spain with the intent to seek international protection and who lack access to healthcare.

排除标准

  • Those who do not give their consent

结局指标

主要结局

HIV viral control

时间窗: At inclusion

Number of participants with plasma HIV-1 RNA level of more than 50 copies per mL

次要结局

  • HIV viral control at 6 months(6 months)
  • Sexually transmited infections(At inclusion)
  • Retention in care(6 months)
  • Resistance Pattern(At inclusion)
  • Number and Type of Barriers to Accessing Healthcare(At inclusion)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Pablo Ryan

Principal Investigator

Hospital Universitario Infanta Leonor

研究点 (1)

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