HivNCT04711954
HIV/COV in Ukraine-NL
An observational study of Hiv and Covid19, run by Erasmus Medical Center at 2 sites in 2 countries.
Trial summary
Contradicting preliminary results are available on the impact of COVID-19 in people with HIV (PWH). How achieving goals of the HIV 90-90-90 cascade of care influences the risk of COVID-19 in PWH is unclear. The primary objective is to determine the impact of COVID-19 in PWH cohorts from Ukraine and the Netherlands. Read more about this study
- Who is it for?
- Ages 18 years and older
- How many people
- 1,100 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 1 Nov 2020to 1 Nov 2022
- How long will I take part?
- 2 Years
- 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 18 years and older
- All sexes
- Adult, Older adult
Study population: People with HIV from patient cohorts in the Netherlands and Ukraine. All participants will be systematically included consecutively.
Who may be able to join
- HIV infected No registered objection to use of data
Who cannot join
- None
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
Official title: COVID-19 in People Living With HIV in Light of the 90-90-90 Goals: A Netherlands/Ukraine Research Collaboration.
Contradicting preliminary results are available on the impact of COVID-19 in people with HIV (PWH). How achieving goals of the HIV 90-90-90 cascade of care influences the risk of COVID-19 in PWH is unclear. The primary objective is to determine the impact of COVID-19 in PWH cohorts from Ukraine and the Netherlands.
- Medical subject headings
- Acquired Immunodeficiency Syndrome, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| ATHENA | Cohort of people living with HIV in the Netherlands | |
| LUKCY | Cohort of people living with HIV in the Lviv area, Ukraine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence COVID19
Prevalence (percent) of clinical COVID-19 in PWH cohorts from Ukraine and in the Netherlands.
Measured: Up to 2 years
Secondary outcomes (9)
Incidence COVID-19
Incidence (nr cases/person years) of clinical COVID-19 cases in PWH cohorts from Ukraine and in the Netherlands
Measured: Up to 2 years
WHO categories COVID-19
Prevalence of no suspicion, possible, probable and proven COVID-19 cases in the past 6 months PWH cohorts from Ukraine and the Netherlands.
Measured: Up to 2 years
WHO categories COVID-19
Incidence of no suspicion, possible, probable and proven COVID-19 cases in the past 6 months PWH cohorts from Ukraine and the Netherlands.
Measured: Up to 2 years
WHO disease severity COVID-19
Proportion of COVID-19 patients according to the severity of COVID-19 on an adapted World Health Organisation 5 point disease severity scale (where 1=no symptoms, 2=symptoms but outpatient, 3=admitted to hospital, 4=admitted to ICU, 5=fatal) in people with HIV cohorts from Ukraine and the Netherlands.
Measured: Up to 2 years
Seroprevalence
Anti-SARSCOV2 seroprevalence in PWH cohorts from Ukraine and the Netherlands
Measured: Up to 2 years
NPV/PPV WHO categories COVID19
Positive and negative predictive value of the WHO COVID-19 case probability categories on anti-SARSCOV2 serology in PWH cohort from Ukraine
Measured: Up to 2 years
Treatment
Description of COVID-19 therapeutic management in PWH cohorts from Ukraine and the Netherlands
Measured: Up to 2 years
Predictors for COVID-19
Predictor variables for having clinical COVID-19 in PWH cohorts from Ukraine and the Netherlands according to 1) sex, 2) age categories (<50, 50-70, >70), 3) ART (LPV/r vs other and TDF containing vs non-TDF containing regimens), 4) most recent CD4+T-cell 5) HIV-RNA suppressed (<=50 / >50), 6) prior TB, 7) prior BCG, 8) HIV transmission group, 9) comorbidities (0 vs 1 vs >1).
Measured: Up to 2 years
Predictors for COVID-19 severity
Predictor variables for the highest score on an ordinal scale for COVID-19 severity according to the adapted 5point WHO severity scale (where 1=no symptoms, 2=symptoms but outpatient, 3=admitted to hospital, 4=admitted to ICU, 5=fatal) in PWH cohorts from Ukraine and the Netherlands according to 1) sex, 2) age categories (<50, 50-70, >70), 3) ART (LPV/r vs other and TDF containing vs non-TDF containing regimens), 4) most recent CD4+T-cell 5) HIV-RNA suppressed (<=50 / >50), 6) prior TB, 7) prior BCG, 8) HIV transmission group, 9) comorbidities (0 vs 1 vs >1)
Measured: Up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2021
- Study start1 Nov 2020
- Primary completion1 Nov 2021
- Study completion1 Nov 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HivStudies of the same condition, open and under way.
- More trials run by Erasmus Medical CenterThe sponsor's other registered studies.
- 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
- Cross-sectional
- Enrolment
- 1,100 participants (actual)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Erasmus Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Lviv Regional AIDS Health Center
- Responsible party
- Principal investigator, Casper Rokx, Erasmus Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04711954
- Sponsor's protocol ID
- 1990 Study
- Status last verified
- Jul 2022
- First submitted
- 12 Jan 2021
- Last updated
- 28 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Other research group can contact the PI with a research question to gain access to IPD.
Publications
Vasylyev M, Buhiichyk V, Buhiichyck N, Groenendijk A, Ben I, Ostapiuk L, Sluzhynska M, Bierman WFW, van Kampen JJA, Wit FWNM, Reiss P, Rijnders BJA, Sluzhynska O, Rokx C. COVID-19 epidemiology and performance of the WHO clinical algorithm to diagnose COVID-19 in people with HIV from Ukraine. Int J STD AIDS. 2024 Jun;35(7):510-515. doi: 10.1177/09564624241231016. Epub 2024 Feb 6.
PubMed 38318789
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- COVID-19 in People Living With HIV in Light of the 90-90-90 Goals: A Netherlands/Ukraine Research Collaboration.
- ClinicalTrials.gov ID
- NCT04711954
- Acronym / sponsor ID
- 1990 Study
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,100 participants (actual)
- Lead sponsor
- Erasmus Medical CenterUniversity, hospital or other
- Collaborators
- Lviv Regional AIDS Health Center
- Study start
- 1 Nov 2020 (actual)
- Primary completion
- 1 Nov 2021 (actual)
- Study completion
- 1 Nov 2022 (estimated)
- First posted
- 15 Jan 2021 (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.
Contradicting preliminary results are available on the impact of COVID-19 in people with HIV (PWH). How achieving goals of the HIV 90-90-90 cascade of care influences the risk of COVID-19 in PWH is unclear. The primary objective is to determine the impact of COVID-19 in PWH cohorts from Ukraine and the Netherlands.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Target follow-up
- 2 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ATHENA | – | –Cohort of people living with HIV in the Netherlands |
| LUKCY | – | –Cohort of people living with HIV in the Lviv area, Ukraine |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- People with HIV from patient cohorts in the Netherlands and Ukraine. All participants will be systematically included consecutively.
Key inclusion criteria (1 listed)
- HIV infected No registered objection to use of data
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Prevalence COVID19
Time frame: Up to 2 years
Prevalence (percent) of clinical COVID-19 in PWH cohorts from Ukraine and in the Netherlands.
9 secondary outcomes
Incidence COVID-19
Time frame: Up to 2 years
WHO categories COVID-19
Time frame: Up to 2 years
WHO categories COVID-19
Time frame: Up to 2 years
WHO disease severity COVID-19
Time frame: Up to 2 years
Seroprevalence
Time frame: Up to 2 years
NPV/PPV WHO categories COVID19
Time frame: Up to 2 years
Treatment
Time frame: Up to 2 years
Predictors for COVID-19
Time frame: Up to 2 years
Predictors for COVID-19 severity
Time frame: Up to 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2022.
- Derived from this study: PubMed 38318789Vasylyev M, Buhiichyk V, Buhiichyck N, Groenendijk A, Ben I, Ostapiuk L, Sluzhynska M, Bierman WFW, van Kampen JJA, Wit FWNM, Reiss P, Rijnders BJA, Sluzhynska O, Rokx C. COVID-19 epidemiology and performance of the WHO clinical algorithm to diagnose COVID-19 in people with HIV from Ukraine. Int J STD AIDS. 2024 Jun;35(7):510-515. doi: 10.1177/09564624241231016. Epub 2024 Feb 6.
- Individual participant dataSharing planned: Yes. Other research group can contact the PI with a research question to gain access to IPD.
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hiv and Covid19, run by Erasmus Medical Center at 2 sites in 2 countries.
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: status not confirmed, as of the sponsor's last update on 28 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Netherlands, Ukraine. 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?
Results are not available in the source record.
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?
Prevalence COVID19 (time frame: Up to 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04711954, which also lists 1 linked publication.
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 28 Jul 2022.