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

Covid19 Clinical Trial

— coVIHd-19  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04581746
• Other study ID #: RIPH_2020_7
• Status: Active, not recruiting
• Phase: N/A
• Start date: November 25, 2020
• Est. completion date: December 2022

Study information

• Verified date: May 2022
• Source: Tourcoing Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1800
• Est. completion date: December 2022
• Est. primary completion date: June 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• COVID-19
• Covid19
• Virus-HIV

Intervention

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

Locations

Country	Name	City	State
France	CHU Amiens Picardie	Amiens
France	CH Lens	Lens
France	CH Tourcoing	Tourcoing

Sponsors (1)

Lead Sponsor	Collaborator
Tourcoing Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Psychological consequences of this epidemic among PVVIH : HAD	Evaluation of the psychological scales HAD on PVVIH	through study completion, an average of 19 months
Secondary	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