NCT04711954

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.

Trial Health

47
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,100

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2020

Geographic Reach
2 countries

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2020

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 12, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 15, 2021

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2021

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2022

Completed
Last Updated

July 28, 2022

Status Verified

July 1, 2022

Enrollment Period

1 year

First QC Date

January 12, 2021

Last Update Submit

July 26, 2022

Conditions

HivCovid19

Outcome Measures

Primary Outcomes (1)

  • Prevalence COVID19

    Prevalence (percent) of clinical COVID-19 in PWH cohorts from Ukraine and in the Netherlands.

    Up to 2 years

Secondary Outcomes (9)

  • Incidence COVID-19

    Up to 2 years

  • WHO categories COVID-19

    Up to 2 years

  • WHO categories COVID-19

    Up to 2 years

  • WHO disease severity COVID-19

    Up to 2 years

  • Seroprevalence

    Up to 2 years

  • +4 more secondary outcomes

Other Outcomes (6)

  • HIV vs non-HIV

    Up to 2 years

  • PPV/NPV WHO categories COVID-19

    Up to 2 years

  • Effect of socio-economic status by questionnaire on COVID-19 incidence

    Up to 2 years

  • +3 more other outcomes

Study Arms (2)

ATHENA

Cohort of people living with HIV in the Netherlands

LUKCY

Cohort of people living with HIV in the Lviv area, Ukraine

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • HIV infected No registered objection to use of data

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Erasmus MC

Rotterdam, 3015 CN, Netherlands

Location

Lviv Regional AIDS Health Center

Lviv, Ukraine

Location

Related Publications (1)

  • 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.

    PMID: 38318789DERIVED

MeSH Terms

Conditions

Acquired Immunodeficiency SyndromeCOVID-19

Condition Hierarchy (Ancestors)

HIV InfectionsBlood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesSlow Virus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesPneumonia, ViralPneumoniaRespiratory Tract InfectionsCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsLung DiseasesRespiratory Tract Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Target Duration
2 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD PhD

Study Record Dates

First Submitted

January 12, 2021

First Posted

January 15, 2021

Study Start

November 1, 2020

Primary Completion

November 1, 2021

Study Completion

November 1, 2022

Last Updated

July 28, 2022

Record last verified: 2022-07

Data Sharing

IPD Sharing
Will share

Other research group can contact the PI with a research question to gain access to IPD.

Shared Documents
STUDY PROTOCOL, SAP, CSR, ANALYTIC CODE
Time Frame
Data will be kept up to 15 years

Locations

NL(1)UA(1)