HIV-1-infectionELHCNCT05998499
HIV-Infected Latin American Asylum Seekers in Europe: Insights From the EuroLatin HIV Cohort
An observational study of HIV-1-infection and Sexually Transmitted Diseases, run by Hospital Universitario Infanta Leonor at 1 site in Spain.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- HIV-1-infection, Sexually Transmitted Diseases
- What is being tested?
- Description
- How many people
- 631 participants
- Where
- 1 siteSpain
- Study dates
- 30 Jan 2022to 15 Jul 2023
- How long will I take part?
- 6 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Child, Adult, Older adult
Study population: Latin American migrants infected with HIV
Who may be able to join
- Latin American migrants infected with HIV who arrive in Spain with the intent to seek international protection and who lack access to healthcare.
Who cannot join
- Those who do not give their consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
Read the 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.
- Conditions
- HIV-1-infection, Sexually Transmitted Diseases
- Being tested
- Description
- Keywords
- Asylum Seekers, Migration, Europe, Latin America
- Medical subject headings
- Sexually Transmitted Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DescriptionOther
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
| Study group | Role | What they receive |
|---|---|---|
| EuroLatin HIV Cohort (ELHC) | Cohort of Latin American migrants living with HIV who were seeking international protection in Spain (Europe) Receives: Other: Description |
What is being measured
The primary outcome is the main question the study is designed to answer.
HIV viral control
Number of participants with plasma HIV-1 RNA level of more than 50 copies per mL
Measured: At inclusion
Secondary outcomes (5)
Resistance Pattern
Number of participants with Drug Resistance
Measured: At inclusion
Sexually transmited infections
Number of participants with sexually transmited infections
Measured: 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.
Measured: At inclusion
HIV viral control at 6 months
Number of participants with plasma HIV-1 RNA level of more than 50 copies per mL
Measured: 6 months
Retention in care
Number of participants who maintain retention to healthcare
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2023
- Study start30 Jan 2022
- Primary completion30 Apr 2023
- Study completion15 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV-1-infectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 631 participants (actual)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Hospital Universitario Infanta Leonor
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pablo Ryan, Hospital Universitario Infanta Leonor
- Investigators
- Pablo Ryan Murua, MD, PhD, Principal investigator, Hospital Universitario Infanta Leonor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05998499
- Sponsor's protocol ID
- HUIL_MI_VIH01
- Acronym
- ELHC
- Status last verified
- Aug 2023
- First submitted
- 10 Aug 2023
- Last updated
- 21 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: IPD that underlie results in a publication
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- HIV-Infected Latin American Asylum Seekers in Europe: Insights From the EuroLatin HIV Cohort (ELHC)
- ClinicalTrials.gov ID
- NCT05998499
- Acronym / sponsor ID
- ELHC / HUIL_MI_VIH01
- Conditions
- HIV-1-infection, Sexually Transmitted Diseases
- Keywords
- Asylum Seekers, Migration, Europe, Latin America
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 631 participants (actual)
- Lead sponsor
- Hospital Universitario Infanta LeonorUniversity, hospital or other
- Study start
- 30 Jan 2022 (actual)
- Primary completion
- 30 Apr 2023 (actual)
- Study completion
- 15 Jul 2023 (actual)
- First posted
- 21 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| EuroLatin HIV Cohort (ELHC) | – | Other: DescriptionCohort of Latin American migrants living with HIV who were seeking international protection in Spain (Europe) |
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- Latin American migrants infected with HIV
Key inclusion criteria (1 listed)
- Latin American migrants infected with HIV who arrive in Spain with the intent to seek international protection and who lack access to healthcare.
Key exclusion criteria (1 listed)
- Those who do not give their consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DescriptionThis 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 | Other | EuroLatin HIV Cohort (ELHC) |
Primary outcome
HIV viral control
Time frame: At inclusion
Number of participants with plasma HIV-1 RNA level of more than 50 copies per mL
5 secondary outcomes
Resistance Pattern
Time frame: At inclusion
Sexually transmited infections
Time frame: At inclusion
Number and Type of Barriers to Accessing Healthcare
Time frame: At inclusion
HIV viral control at 6 months
Time frame: 6 months
Retention in care
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2023.
- Individual participant dataSharing planned: Yes. IPD that underlie results in a publication
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pablo Ryan Murua, MD, PhD principal investigator
Hospital Universitario Infanta Leonor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV-1-infection and Sexually Transmitted Diseases, run by Hospital Universitario Infanta Leonor at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HIV viral control (time frame: At inclusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2023.