search
Back to results

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

Primary Purpose

Virus-HIV, Covid19

Status
Active
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
questionnaire
Sponsored by
Tourcoing Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Virus-HIV

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • CHU Amiens Picardie
  • CH Lens
  • CH Tourcoing

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

experimental arm

Arm Description

questionnaire and follow-up visit

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
Determine the incidence rate of COVID 19 among PVVIH antiretroviral treatment
Percentage of patients who stopped their antiretroviral treatment
Determine the incidence rate of COVID 19 among PVVIH discontinuing antiretroviral treatment
Reason for discontinuing antiretroviral treatment
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
Psychological consequences of this epidemic among PVVIH : HAD
Evaluation of the psychological scales HAD on PVVIH
Psychological consequences of this epidemic among PVVIH : PROQOL-HIV
Evaluation of the psychological scales PROQOL-HIV on PVVIH

Full Information

First Posted
September 22, 2020
Last Updated
May 9, 2022
Sponsor
Tourcoing Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT04581746
Brief Title
Impact of the Epidemic of COVID-19 Infection Among People Living With HIV (SARS-CoV-2)
Acronym
coVIHd-19
Official Title
Evaluation of the Impact of the Epidemic of COVID-19 Infection Among People Living With HIV (SARS-CoV-2)
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
November 25, 2020 (Actual)
Primary Completion Date
June 2022 (Anticipated)
Study Completion Date
December 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tourcoing Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Virus-HIV, Covid19

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
1800 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
experimental arm
Arm Type
Other
Arm Description
questionnaire and follow-up visit
Intervention Type
Other
Intervention Name(s)
questionnaire
Intervention Description
bi-monthly questionnaire and then one visit with questionnaire and covid-19 test
Primary Outcome Measure Information:
Title
Prevalence of SARS CoV2 infection in PVVIH in Hauts de France
Description
Determination of the number of patients with microbiologically or clinically-biologically proven SARS CoV2 infection at inclusion in the study
Time Frame
Inclusion
Secondary Outcome Measure Information:
Title
Prevalence of SARS CoV2 infection in PVVIH in Hauts de France
Description
Determination of the number of patients with microbiologically or clinically-biologically proven SARS CoV2 infection at the end of the study
Time Frame
through study completion, an average of 19 months
Title
Determine the incidence rate of COVID 19 among PVVIH antiretroviral treatment
Description
Percentage of patients who stopped their antiretroviral treatment
Time Frame
through study completion, an average of 19 months
Title
Determine the incidence rate of COVID 19 among PVVIH discontinuing antiretroviral treatment
Description
Reason for discontinuing antiretroviral treatment
Time Frame
through study completion, an average of 19 months
Title
Determine the incidence rate of COVID 19 among PVVIH who stopped all follow-up
Description
Percentage of patients who stopped all follow-up by an infectious disease specialist
Time Frame
through study completion, an average of 19 months
Title
Psychological consequences of this epidemic among PVVIH : HAD
Description
Evaluation of the psychological scales HAD on PVVIH
Time Frame
through study completion, an average of 19 months
Title
Psychological consequences of this epidemic among PVVIH : PROQOL-HIV
Description
Evaluation of the psychological scales PROQOL-HIV on PVVIH
Time Frame
through study completion, an average of 19 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pauline THILL, MD
Organizational Affiliation
CH Tourcoing
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU Amiens Picardie
City
Amiens
Country
France
Facility Name
CH Lens
City
Lens
Country
France
Facility Name
CH Tourcoing
City
Tourcoing
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

We'll reach out to this number within 24 hrs