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Completed

NCT Number: NCT05998499

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

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

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Key information

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital Universitario Infanta Leonor

Madrid, 28031, Spain

About this study

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.

Data collection In this study, the REDCap application was utilized for the collection of data. The database was stored in a secure server, and only researchers and health personnel of the project had access to it.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Those who do not give their consent

Treatment and study plan

Description

Other

This study aimed to understand the situation of Latin American HIV-positive migrants seeking asylum in Spain and identify the challenges they encounter in getting HIV treatment. The main result measured was the proportion of participants with an HIV-1 RNA level of 50 copies/mL or higher at their first clinic visit

Primary outcomes

  1. HIV viral control

    Time frame: At inclusion

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

Secondary outcomes

  1. Resistance Pattern

    Time frame: At inclusion

    Number of participants with Drug Resistance

  2. Sexually transmited infections

    Time frame: At inclusion

    Number of participants with sexually transmited infections

  3. Number and Type of Barriers to Accessing Healthcare

    Time frame: At inclusion

    The outcome will assess the number and type of barriers faced by study participants when trying to access healthcare, based on the presence of any of the following barriers: administrative, geographical, financial, cultural, lack of knowledge, stigma, and organizational.

  4. HIV viral control at 6 months

    Time frame: 6 months

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

  5. Retention in care

    Time frame: 6 months

    Number of participants who maintain retention to healthcare

Sponsors and collaborators

Lead sponsor

Hospital Universitario Infanta Leonor

Other

Registry information

Official study title

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

Acronym: ELHC

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Aug 21, 2023
Registry last updated
Aug 21, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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