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

Completed

• Conditions: HIV-1-infection; Sexually Transmitted Diseases
• Interventions: Other: Description

• Registration Number: NCT05998499
• Lead Sponsor: Hospital Universitario Infanta Leonor

Brief Summary

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

Detailed Description

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.

Study Timeline

• Study Start: 2022-01-30
• Primary Completion: 2023-04-30
• Study Completion: 2023-07-15
• Status Verified: 2023-08
• Study First Submitted: 2023-08-10
• Study First Submitted QC: 2023-08-16
• Last Update Submitted: 2023-08-16
• Study First Posted: 2023-08-21
• Last Update Posted: 2023-08-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 631

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.

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Exclusion Criteria

• Those who do not give their consent

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
EuroLatin HIV Cohort (ELHC)	Description	Cohort of Latin American migrants living with HIV who were seeking international protection in Spain (Europe)

Primary Outcome Measures

Name	Time	Method
HIV viral control	At inclusion	Number of participants with plasma HIV-1 RNA level of more than 50 copies per mL

Secondary Outcome Measures

Name	Time	Method
Sexually transmited infections	At inclusion	Number of participants with sexually transmited infections
HIV viral control at 6 months	6 months	Number of participants with plasma HIV-1 RNA level of more than 50 copies per mL
Retention in care	6 months	Number of participants who maintain retention to healthcare
Resistance Pattern	At inclusion	Number of participants with Drug Resistance
Number and Type of Barriers to Accessing Healthcare	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.

Trial Locations

Locations (1)

Hospital Universitario Infanta Leonor; 🇪🇸 Madrid, Spain