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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04581746
Recruitment Status : Recruiting
First Posted : October 9, 2020
Last Update Posted : January 26, 2021
Sponsor:
Information provided by (Responsible Party):
Tourcoing Hospital

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.

Condition or disease Intervention/treatment Phase
Virus-HIV Covid19 Other: questionnaire Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1800 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Evaluation of the Impact of the Epidemic of COVID-19 Infection Among People Living With HIV (SARS-CoV-2)
Actual Study Start Date : November 25, 2020
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
experimental arm
questionnaire and follow-up visit
Other: questionnaire
bi-monthly questionnaire and then one visit with questionnaire and covid-19 test




Primary Outcome Measures :
  1. Prevalence of SARS CoV2 infection in PVVIH in Hauts de France [ Time Frame: Inclusion ]
    Determination of the number of patients with microbiologically or clinically-biologically proven SARS CoV2 infection at inclusion in the study


Secondary Outcome Measures :
  1. Prevalence of SARS CoV2 infection in PVVIH in Hauts de France [ Time Frame: through study completion, an average of 19 months ]
    Determination of the number of patients with microbiologically or clinically-biologically proven SARS CoV2 infection at the end of the study

  2. Determine the incidence rate of COVID 19 among PVVIH antiretroviral treatment [ Time Frame: through study completion, an average of 19 months ]
    Percentage of patients who stopped their antiretroviral treatment

  3. Determine the incidence rate of COVID 19 among PVVIH discontinuing antiretroviral treatment [ Time Frame: through study completion, an average of 19 months ]
    Reason for discontinuing antiretroviral treatment

  4. Determine the incidence rate of COVID 19 among PVVIH who stopped all follow-up [ Time Frame: through study completion, an average of 19 months ]
    Percentage of patients who stopped all follow-up by an infectious disease specialist

  5. Psychological consequences of this epidemic among PVVIH : HAD [ Time Frame: through study completion, an average of 19 months ]
    Evaluation of the psychological scales HAD on PVVIH

  6. Psychological consequences of this epidemic among PVVIH : PROQOL-HIV [ Time Frame: through study completion, an average of 19 months ]
    Evaluation of the psychological scales PROQOL-HIV on PVVIH



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04581746


Contacts
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Contact: Pauline THILL, MD 0320694949 pthill@ch-tourcoing.fr
Contact: Solange TREHOUX, PhD 0320694280 strehoux@ch-tourcoing.fr

Locations
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France
CHU Amiens Picardie Not yet recruiting
Amiens, France
CH Lens Not yet recruiting
Lens, France
CH Tourcoing Recruiting
Tourcoing, France
Sponsors and Collaborators
Tourcoing Hospital
Investigators
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Principal Investigator: Pauline THILL, MD CH Tourcoing
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Responsible Party: Tourcoing Hospital
ClinicalTrials.gov Identifier: NCT04581746    
Other Study ID Numbers: RIPH_2020_7
First Posted: October 9, 2020    Key Record Dates
Last Update Posted: January 26, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Infection
Acquired Immunodeficiency Syndrome
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Slow Virus Diseases
Immunologic Deficiency Syndromes
Immune System Diseases