HIV/COV in Ukraine-NL

• Conditions: Hiv; Covid19

• Registration Number: NCT04711954
• Lead Sponsor: Erasmus Medical Center

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-11-01
• Study First Submitted: 2021-01-12
• Study First Submitted QC: 2021-01-13
• Study First Posted: 2021-01-15
• Primary Completion: 2021-11-01
• Status Verified: 2022-07
• Last Update Submitted: 2022-07-26
• Last Update Posted: 2022-07-28
• Study Completion: 2022-11-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1100

Inclusion Criteria

HIV infected No registered objection to use of data

Exclusion Criteria

None

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
WHO categories COVID-19	Up to 2 years	Incidence 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-19	Up to 2 years	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.
Seroprevalence	Up to 2 years	Anti-SARSCOV2 seroprevalence in PWH cohorts from Ukraine and the Netherlands
NPV/PPV WHO categories COVID19	Up to 2 years	Positive and negative predictive value of the WHO COVID-19 case probability categories on anti-SARSCOV2 serology in PWH cohort from Ukraine
Treatment	Up to 2 years	Description of COVID-19 therapeutic management in PWH cohorts from Ukraine and the Netherlands
Predictors for COVID-19 severity	Up to 2 years	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)
Incidence COVID-19	Up to 2 years	Incidence (nr cases/person years) of clinical COVID-19 cases in PWH cohorts from Ukraine and in the Netherlands
Predictors for COVID-19	Up to 2 years	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).

Trial Locations

Locations (2)

Erasmus MC; 🇳🇱 Rotterdam, Netherlands

Lviv Regional AIDS Health Center; 🇺🇦 Lviv, Ukraine