Impact of the Epidemic of COVID-19 Infection Among People Living With HIV (SARS-CoV-2)

NCT04581746 | Unknown

• 1 other identifier: RIPH_2020_7
• Study Type: interventional
• Target: 1,800
• Locations: 1 country
• Sites: 3

Brief Summary

The non-essential and non-urgent follow-up consultations of patients living with HIV were postponed or transformed into "teleconsultation" or exchanges of e-mails between practitioners and patients during COVID-19 epidemic. This change in care can have an impact on follow-up and access to treatment for PVVIH.

Conditions

Virus-HIV; Covid19

Outcome Measures

Primary Outcomes (1)

• Prevalence of SARS CoV2 infection in PVVIH in Hauts de France

  Determination of the number of patients with microbiologically or clinically-biologically proven SARS CoV2 infection at inclusion in the study

  Inclusion

Secondary Outcomes (6)

• Prevalence of SARS CoV2 infection in PVVIH in Hauts de France

  through study completion, an average of 19 months

• Determine the incidence rate of COVID 19 among PVVIH antiretroviral treatment

  through study completion, an average of 19 months

• Determine the incidence rate of COVID 19 among PVVIH discontinuing antiretroviral treatment

  through study completion, an average of 19 months

• Determine the incidence rate of COVID 19 among PVVIH who stopped all follow-up

  through study completion, an average of 19 months

• Psychological consequences of this epidemic among PVVIH : HAD

  through study completion, an average of 19 months

Study Arms (1)

experimental arm

OTHER

questionnaire and follow-up visit

Other: questionnaire

Interventions

questionnaire OTHER

bi-monthly questionnaire and then one visit with questionnaire and covid-19 test

experimental arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient followed up for HIV infection in one of the COREVIH Hauts de France centres participating in the study
• Having communicated an email address
• Having given their consent to participate in this study
• Beneficiary subject affiliated or entitled to a social security scheme

You may not qualify if:

• Minor patient
• Refusal to participate
• Patient under guardianship

Sponsors & Collaborators

• Tourcoing Hospital: lead

Study Sites (3)

CHU Amiens Picardie

Amiens, France

Location

CH Lens

Lens, France

Location

CH Tourcoing

Tourcoing, France

Location

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome; COVID-19

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Pauline THILL, MD

  CH TOURCOING

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 22, 2020
• First Posted: October 9, 2020
• Study Start: November 25, 2020
• Primary Completion: June 1, 2022
• Study Completion: December 1, 2022
• Last Updated: May 10, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

FR (3)