Hospital Universitario Infanta Leonor
Madrid, 28031, Spain
NCT Number: NCT05998499
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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Observational
Madrid, 28031, Spain
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.
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
Time frame: At inclusion
Number of participants with plasma HIV-1 RNA level of more than 50 copies per mL
Time frame: At inclusion
Number of participants with Drug Resistance
Time frame: At inclusion
Number of participants with sexually transmited infections
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.
Time frame: 6 months
Number of participants with plasma HIV-1 RNA level of more than 50 copies per mL
Time frame: 6 months
Number of participants who maintain retention to healthcare
Hospital Universitario Infanta Leonor
Other
HIV-Infected Latin American Asylum Seekers in Europe: Insights From the EuroLatin HIV Cohort (ELHC)
Acronym: ELHC
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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