HIV/COV in Ukraine-NL

Study Overview
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Brief Summary
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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.

Official Title
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COVID-19 in People Living With HIV in Light of the 90-90-90 Goals: A Netherlands/Ukraine Research Collaboration.

Conditions
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Hiv, Covid19

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: HIV infected No registered objection to use of data Exclusion Criteria: None

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| ATHENA<br>Cohort of people living with HIV in the Netherlands | |
| LUKCY<br>Cohort of people living with HIV in the Lviv area, Ukraine | |

What is the study measuring?
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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 |