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

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Covid19; Virus-HIV
• Intervention / Treatment: Other: questionnaire

Detailed Description

On 16 March 2020, an instruction to postpone "non-urgent" consultations was given to doctors. Thus, 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. This change in care can have an impact on follow-up and access to treatment for PVVIH. In addition, the epidemic itself may have consequences: PVVIH may be at greater risk because of their immunosuppression and associated co-morbidities.

• Study Type: Interventional
• Enrollment (Anticipated): 1800
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Amiens, France
    • CHU Amiens Picardie
  • Lens, France
    • CH LENS
  • Tourcoing, France
    • Ch Tourcoing

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• Minor patient
• Refusal to participate
• Patient under guardianship

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
OTHER: experimental arm; questionnaire and follow-up visit	Other: questionnaire; bi-monthly questionnaire and then one visit with questionnaire and covid-19 test

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 the end of the study	through study completion, an average of 19 months
Determine the incidence rate of COVID 19 among PVVIH antiretroviral treatment	Percentage of patients who stopped their antiretroviral treatment	through study completion, an average of 19 months
Determine the incidence rate of COVID 19 among PVVIH discontinuing antiretroviral treatment	Reason for 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	Percentage of patients who stopped all follow-up by an infectious disease specialist	through study completion, an average of 19 months
Psychological consequences of this epidemic among PVVIH : HAD	Evaluation of the psychological scales HAD on PVVIH	through study completion, an average of 19 months
Psychological consequences of this epidemic among PVVIH : PROQOL-HIV	Evaluation of the psychological scales PROQOL-HIV on PVVIH	through study completion, an average of 19 months

Collaborators and Investigators

• Sponsor: Tourcoing Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 25, 2020
• Primary Completion (ANTICIPATED): June 1, 2022
• Study Completion (ANTICIPATED): December 1, 2022

Study Registration Dates

• First Submitted: September 22, 2020
• First Submitted That Met QC Criteria: October 7, 2020
• First Posted (ACTUAL): October 9, 2020

Study Record Updates

• Last Update Posted (ACTUAL): May 10, 2022
• Last Update Submitted That Met QC Criteria: May 9, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: RIPH_2020_7

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No