Impact of the Epidemic of COVID-19 Infection Among People... | NCT04581746

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

NCT04581746

Sponsor

Tourcoing Hospital

Status

Unknown status

Last Update Posted

May 10, 2022Actual

Enrollment

1,800Estimated

Phase

Not Applicable

Conditions

Virus-HIV
Covid19

Interventions

questionnaire

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2022

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 25, 2020Actual

Primary Completion Date

Jun 2022Estimated

Completion Date

Dec 2022Estimated

First Submitted Date

Sep 22, 2020

First Submission Date that Met QC Criteria

Oct 7, 2020

First Posted Date

Oct 9, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 9, 2022

Last Update Posted Date

May 10, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

1,800Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
experimental arm	Other	questionnaire and follow-up visit	Other: questionnaire

Interventions

Name	Type	Description	Arm Group Labels	Other Names
questionnaire	Other	bi-monthly questionnaire and then one visit with questionnaire and covid-19 test	experimental arm

Outcomes Module

Primary Outcomes

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 Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Pauline THILL, MD	CH TOURCOING	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
CHU Amiens Picardie		Amiens			France
CH Lens

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D000163	Acquired Immunodeficiency Syndrome
D000086382	COVID-19

Ancestor Terms

ID	Term
D015658	HIV Infections
D000086982	Blood-Borne Infections
D003141	Communicable Diseases
D007239	Infections

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D011795	Surveys and Questionnaires

Ancestor Terms

ID	Term
D003625	Data Collection
D004812	Epidemiologic Methods
D008919	Investigative Techniques
D017531	Health Care Evaluation Mechanisms

Browse Leaves

Not provided

Browse Branches

Not provided