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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT04581746
Other study ID # RIPH_2020_7
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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