Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05998499 |
| Other study ID # |
HUIL_MI_VIH01 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
January 30, 2022 |
| Est. completion date |
July 15, 2023 |
Study information
| Verified date |
August 2023 |
| Source |
Hospital Universitario Infanta Leonor |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational [Patient Registry]
|
Clinical Trial 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
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.
