Clinical trial NCT05998499: HIV-Infected Latin American Asylum Seekers in Europe: Insights From the EuroLatin HIV Cohort
Official title: HIV-Infected Latin American Asylum Seekers in Europe: Insights From the EuroLatin HIV Cohort (ELHC)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: HIV-1-infection
Sexually Transmitted Diseases
Keywords: Asylum Seekers
Migration
Europe
Latin America
Lead sponsor: Hospital Universitario Infanta Leonor
Sponsor class: OTHER
First posted: 2023-08-21
Enrollment: 631
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Latin American migrants infected with HIV

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.

Eligibility criteria: 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

Primary outcomes:
measure: HIV viral control
timeFrame: At inclusion
Secondary outcomes:
measure: Resistance Pattern
timeFrame: At inclusion
measure: Sexually transmited infections
timeFrame: At inclusion
measure: Number and Type of Barriers to Accessing Healthcare
timeFrame: At inclusion
measure: HIV viral control at 6 months
timeFrame: 6 months
measure: Retention in care
timeFrame: 6 months
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Hospital Universitario Infanta Leonor
Study officials:
affiliation: Hospital Universitario Infanta Leonor
name: Pablo Ryan Murua, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: