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

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

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

Study Overview

• Status: Completed
• Conditions: Sexually Transmitted Diseases; HIV-1-infection
• Intervention / Treatment: Other: Description

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 Type: Observational
• Enrollment (Actual): 631

Contacts and Locations

Study Locations

• Spain
  • Madrid, Spain, 28031
    • Hospital Universitario Infanta Leonor

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

Latin American migrants infected with HIV

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
HIV viral control	Number of participants with plasma HIV-1 RNA level of more than 50 copies per mL	At inclusion

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Hospital Universitario Infanta Leonor
• Investigators: Principal Investigator: Pablo Ryan Murua, MD, PhD, Hospital Universitario Infanta Leonor

Study record dates

Study Major Dates

• Study Start (Actual): January 30, 2022
• Primary Completion (Actual): April 30, 2023
• Study Completion (Actual): July 15, 2023

Study Registration Dates

• First Submitted: August 10, 2023
• First Submitted That Met QC Criteria: August 16, 2023
• First Posted (Actual): August 21, 2023

Study Record Updates

• Last Update Posted (Actual): August 21, 2023
• Last Update Submitted That Met QC Criteria: August 16, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: Europe; Latin America; Migration; Asylum Seekers
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Communicable Diseases; Disease Attributes; Urogenital Diseases; Genital Diseases; Sexually Transmitted Diseases
• Other Study ID Numbers: HUIL_MI_VIH01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: IPD that underlie results in a publication
• IPD Sharing Time Frame: December, 2024
• IPD Sharing Access Criteria: IP email
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No