NCT05998499

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
631

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 30, 2022

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2023

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 15, 2023

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

August 10, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

August 21, 2023

Completed
Last Updated

August 21, 2023

Status Verified

August 1, 2023

Enrollment Period

1.2 years

First QC Date

August 10, 2023

Last Update Submit

August 16, 2023

Conditions

Keywords

Asylum SeekersMigrationEuropeLatin America

Outcome Measures

Primary Outcomes (1)

  • HIV viral control

    Number of participants with plasma HIV-1 RNA level of more than 50 copies per mL

    At inclusion

Secondary Outcomes (5)

  • Resistance Pattern

    At inclusion

  • Sexually transmited infections

    At inclusion

  • Number and Type of Barriers to Accessing Healthcare

    At inclusion

  • HIV viral control at 6 months

    6 months

  • Retention in care

    6 months

Study Arms (1)

EuroLatin HIV Cohort (ELHC)

Cohort of Latin American migrants living with HIV who were seeking international protection in Spain (Europe)

Other: Description

Interventions

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

EuroLatin HIV Cohort (ELHC)

Eligibility Criteria

Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Latin American migrants infected with HIV

You may qualify if:

  • Latin American migrants infected with HIV who arrive in Spain with the intent to seek international protection and who lack access to healthcare.

You may not qualify if:

  • Those who do not give their consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Universitario Infanta Leonor

Madrid, 28031, Spain

Location

MeSH Terms

Conditions

Sexually Transmitted Diseases

Condition Hierarchy (Ancestors)

Communicable DiseasesInfectionsGenital DiseasesUrogenital DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Pablo Ryan Murua, MD, PhD

    Hospital Universitario Infanta Leonor

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
6 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 10, 2023

First Posted

August 21, 2023

Study Start

January 30, 2022

Primary Completion

April 30, 2023

Study Completion

July 15, 2023

Last Updated

August 21, 2023

Record last verified: 2023-08

Data Sharing

IPD Sharing
Will share

IPD that underlie results in a publication

Shared Documents
STUDY PROTOCOL
Time Frame
December, 2024
Access Criteria
IP email

Locations