HIV/COV in Ukraine-NL

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Covid19; Hiv

• Study Type: Observational
• Enrollment (Actual): 1100

Contacts and Locations

Study Locations

• Netherlands
  • Rotterdam, Netherlands, 3015 CN
    • Erasmus MC
• Ukraine
  • Lviv, Ukraine
    • Lviv Regional AIDS Health Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

People with HIV from patient cohorts in the Netherlands and Ukraine. All participants will be systematically included consecutively.

Description

Inclusion Criteria:

HIV infected No registered objection to use of data

Exclusion Criteria:

None

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
ATHENA; Cohort of people living with HIV in the Netherlands
LUKCY; Cohort of people living with HIV in the Lviv area, Ukraine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Prevalence COVID19	Prevalence (percent) of clinical COVID-19 in PWH cohorts from Ukraine and in the Netherlands.	Up to 2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence COVID-19	Incidence (nr cases/person years) of clinical COVID-19 cases in PWH cohorts from Ukraine and in the Netherlands	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.	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.	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.	Up to 2 years
Seroprevalence	Anti-SARSCOV2 seroprevalence in PWH cohorts from Ukraine and the Netherlands	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	Up to 2 years
Treatment	Description of COVID-19 therapeutic management in PWH cohorts from Ukraine and the Netherlands	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).	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)	Up to 2 years

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
HIV vs non-HIV	Correlation of HIV status with 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 matched PWH cases with HIV uninfected controls by age, sex and comorbidities.	Up to 2 years
PPV/NPV WHO categories COVID-19	Positive and negative predictive value of the WHO COVID-19 case probability categories in the prior 3 months on anti-SARSCOV2 serology in PWH cohort from Ukraine	Up to 2 years
Effect of socio-economic status by questionnaire on COVID-19 incidence	Evaluate the impact of social economic status on COVID-19 incidence.	Up to 2 years
Effect of socio-economic status on COVID-19 severity	Evaluate the impact of social economic status on COVID-19 severity according to WHO 5 point scale (where 1=no symptoms, 2=symptoms but outpatient, 3=admitted to hospital, 4=admitted to ICU, 5=fatal)	Up to 2 years
Symptoms	Describe symptoms associated with COVID probability in PWH cohorts from Ukraine and the Netherlands	Up to 2 years
Rapid Ag test	Evaluate the PPV/NPV of the rapid antigen test in PWH with symptoms suspected of COVID-19 in Ukraine and the Netherlands	Up to 2 years

Collaborators and Investigators

• Sponsor: Erasmus Medical Center
• Collaborators: Lviv Regional AIDS Health Center

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2020
• Primary Completion (Actual): November 1, 2021
• Study Completion (Anticipated): November 1, 2022

Study Registration Dates

• First Submitted: January 12, 2021
• First Submitted That Met QC Criteria: January 13, 2021
• First Posted (Actual): January 15, 2021

Study Record Updates

• Last Update Posted (Actual): July 28, 2022
• Last Update Submitted That Met QC Criteria: July 26, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: 1990 Study

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Other research group can contact the PI with a research question to gain access to IPD.
• IPD Sharing Time Frame: Data will be kept up to 15 years
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No