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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.

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04711954
Enrollment
1100
Registered
2021-01-15
Start date
2020-11-01
Completion date
2022-11-01
Last updated
2022-07-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Covid19, Hiv

Brief 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.

Interventions

None listed

Sponsors

Lviv Regional AIDS Health Center
CollaboratorUNKNOWN
Erasmus Medical Center
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum

Inclusion criteria

HIV infected No registered objection to use of data

Exclusion criteria

None

Design outcomes

Primary

MeasureTime frameDescription
Prevalence COVID19Up to 2 yearsPrevalence (percent) of clinical COVID-19 in PWH cohorts from Ukraine and in the Netherlands.

Secondary

MeasureTime frameDescription
WHO categories COVID-19Up to 2 yearsPrevalence of no suspicion, possible, probable and proven COVID-19 cases in the past 6 months PWH cohorts from Ukraine and the Netherlands.
WHO disease severity COVID-19Up to 2 yearsProportion 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.
SeroprevalenceUp to 2 yearsAnti-SARSCOV2 seroprevalence in PWH cohorts from Ukraine and the Netherlands
NPV/PPV WHO categories COVID19Up to 2 yearsPositive and negative predictive value of the WHO COVID-19 case probability categories on anti-SARSCOV2 serology in PWH cohort from Ukraine
TreatmentUp to 2 yearsDescription of COVID-19 therapeutic management in PWH cohorts from Ukraine and the Netherlands
Predictors for COVID-19Up to 2 yearsPredictor 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).
Predictors for COVID-19 severityUp to 2 yearsPredictor 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)
Incidence COVID-19Up to 2 yearsIncidence (nr cases/person years) of clinical COVID-19 cases in PWH cohorts from Ukraine and in the Netherlands

Other

MeasureTime frameDescription
Effect of socio-economic status by questionnaire on COVID-19 incidenceUp to 2 yearsEvaluate the impact of social economic status on COVID-19 incidence.
Effect of socio-economic status on COVID-19 severityUp to 2 yearsEvaluate 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)
SymptomsUp to 2 yearsDescribe symptoms associated with COVID probability in PWH cohorts from Ukraine and the Netherlands
Rapid Ag testUp to 2 yearsEvaluate the PPV/NPV of the rapid antigen test in PWH with symptoms suspected of COVID-19 in Ukraine and the Netherlands
PPV/NPV WHO categories COVID-19Up to 2 yearsPositive 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
HIV vs non-HIVUp to 2 yearsCorrelation 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.

Countries

Netherlands, Ukraine

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 7, 2026