NCT04636736

Brief Summary

According to the Polish governmental statistics migration of people from Ukraine to Poland is growing and only in year 2020 have come to Poland about a quarter of a million of Ukrainian migrants. As well, more than 40% of those diagnosed with HIV infection in the European Union (EU)/European Economic Area (EEA) in 2018 were also migrants, originating from countries with generalized HIV epidemics, such as Ukraine. Antiretroviral treatment should be started, based, among others, on epidemiological data and evidence of presence of drug resistance mutations in a the population.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2021

Typical duration for all trials

Geographic Reach
1 country

1 active site

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

First Submitted

Initial submission to the registry

November 13, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 19, 2020

Completed
1 month until next milestone

Study Start

First participant enrolled

January 1, 2021

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2023

Completed
Last Updated

November 23, 2020

Status Verified

November 1, 2020

Enrollment Period

2 years

First QC Date

November 13, 2020

Last Update Submit

November 20, 2020

Conditions

HIV InfectionsHIV-1-infectionResistant Infection

Keywords

HIV-infectionAIDSmigrationcARTdrug-resistance

Outcome Measures

Primary Outcomes (1)

  • Difference in HIV drug resistance pattern

    Differences between people originating from Poland and from Eastern Europe

    2 years

Study Arms (2)

HIV POLISH (PL)

HIV infected people with polish nationality, who most probably acquired infection in Poland

Diagnostic Test: HIV drug resistance testing

HIV MIGRANTS (M)

HIV infected people, originating from outside of Poland, where they were diagnosed with HIV infection

Diagnostic Test: HIV drug resistance testing

Interventions

HIV drug resistance testingDIAGNOSTIC_TEST

HIV drug resistance testing in people newly diagnosed in HIV in Poland

HIV MIGRANTS (M)HIV POLISH (PL)

Eligibility Criteria

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

People diagnosed with HIV infection in Poland, originating from Poland and other countries

You may qualify if:

  • recent diagnosis with HIV infection (\<6 months)
  • no history of antiretrovirals intake (PrEP, PEP)
  • age 18 years or olde

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Infectious Diseases, Tropical Diseases and Hepatology, Medical University of Warsaw

Warsaw, Mazowia, 01-201, Poland

Location

Related Publications (3)

  • Wensing AM, Calvez V, Ceccherini-Silberstein F, Charpentier C, Gunthard HF, Paredes R, Shafer RW, Richman DD. 2019 update of the drug resistance mutations in HIV-1. Top Antivir Med. 2019 Sep;27(3):111-121.

    PMID: 31634862BACKGROUND

  • Shafer RW, Rhee SY, Pillay D, Miller V, Sandstrom P, Schapiro JM, Kuritzkes DR, Bennett D. HIV-1 protease and reverse transcriptase mutations for drug resistance surveillance. AIDS. 2007 Jan 11;21(2):215-23. doi: 10.1097/QAD.0b013e328011e691.

    PMID: 17197813BACKGROUND

  • Zaleski A, Lembas A, Dyda T, Siwak E, Osinska J, Suchacz M, Stempkowska-Rejek J, Strycharz M, Orzechowska J, Wiercinska-Drapalo A. Changes in Primary HIV-1 Drug Resistance Due to War Migration from Eastern Europe. J Immigr Minor Health. 2024 Feb;26(1):15-22. doi: 10.1007/s10903-023-01559-1. Epub 2023 Nov 16.

    PMID: 37973713DERIVED

Related Links

Biospecimen

Retention: SAMPLES WITHOUT DNA

HIV- RNA and standard analysis of drug-resistance pattern

MeSH Terms

Conditions

HIV InfectionsAcquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesSlow Virus Diseases

Study Officials

  • Alicja Wiercińska-Drapało, PhD

    Department of Infectious Diseases,Tropical Diseases and Hepatology, Medical University of Warsaw

    STUDY CHAIR

Central Study Contacts

Andrzej Zaleski, PhD

CONTACT

048600982185andrzejzaleski84@wp.pl

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 13, 2020

First Posted

November 19, 2020

Study Start

January 1, 2021

Primary Completion

December 31, 2022

Study Completion

June 30, 2023

Last Updated

November 23, 2020

Record last verified: 2020-11

Data Sharing

IPD Sharing
Will not share

there is no plan to share the data

Locations

PL(1)