Virus-HIVcoVIHd-19NCT04581746
Impact of the Epidemic of COVID-19 Infection Among People Living With HIV (SARS-CoV-2)
A study testing questionnaire in people with Virus-HIV and Covid19, run by Tourcoing Hospital at 3 sites in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- questionnaire
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,800 participants
- Where
- 3 sitesFrance
- Study dates
- 25 Nov 2020to Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Minor patient
- Refusal to participate
- Patient under guardianship
Trial locations and contacts
3 sites in 1 country.
About this study
Official title: Evaluation of the Impact of the Epidemic of COVID-19 Infection Among People Living With HIV (SARS-CoV-2)
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.
Read the 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.
- Being tested
- questionnaire
- Medical subject headings
- Acquired Immunodeficiency Syndrome, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
questionnaireOther
bi-monthly questionnaire and then one visit with questionnaire and covid-19 test
| Study group | Role | What they receive |
|---|---|---|
| experimental arm | Other | questionnaire and follow-up visit Receives: Other: questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Inclusion
Secondary outcomes (6)
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
Measured: through study completion, an average of 19 months
Determine the incidence rate of COVID 19 among PVVIH antiretroviral treatment
Percentage of patients who stopped their antiretroviral treatment
Measured: through study completion, an average of 19 months
Determine the incidence rate of COVID 19 among PVVIH discontinuing antiretroviral treatment
Reason for discontinuing antiretroviral treatment
Measured: through study completion, an average of 19 months
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
Measured: through study completion, an average of 19 months
Psychological consequences of this epidemic among PVVIH : HAD
Evaluation of the psychological scales HAD on PVVIH
Measured: through study completion, an average of 19 months
Psychological consequences of this epidemic among PVVIH : PROQOL-HIV
Evaluation of the psychological scales PROQOL-HIV on PVVIH
Measured: through study completion, an average of 19 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2020
- Study start25 Nov 2020
- Primary completionJun 2022 (estimated)
- Study completionDec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Virus-HIVStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1,800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tourcoing Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pauline THILL, MD, Principal investigator, CH TOURCOING
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04581746
- Sponsor's protocol ID
- RIPH_2020_7
- Acronym
- coVIHd-19
- Status last verified
- May 2022
- First submitted
- 22 Sep 2020
- Last updated
- 10 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Impact of the Epidemic of COVID-19 Infection Among People Living With HIV (SARS-CoV-2)
- ClinicalTrials.gov ID
- NCT04581746
- Acronym / sponsor ID
- coVIHd-19 / RIPH_2020_7
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,800 participants (estimated)
- Lead sponsor
- Tourcoing HospitalUniversity, hospital or other
- Study start
- 25 Nov 2020 (actual)
- Primary completion
- Jun 2022 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 9 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| experimental arm | Other | Other: questionnairequestionnaire and follow-up visit |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- Minor patient
- Refusal to participate
- Patient under guardianship
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| questionnairebi-monthly questionnaire and then one visit with questionnaire and covid-19 test | Other | experimental arm |
Primary outcome
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
6 secondary outcomes
Prevalence of SARS CoV2 infection in PVVIH in Hauts de France
Time frame: through study completion, an average of 19 months
Determine the incidence rate of COVID 19 among PVVIH antiretroviral treatment
Time frame: through study completion, an average of 19 months
Determine the incidence rate of COVID 19 among PVVIH discontinuing antiretroviral treatment
Time frame: through study completion, an average of 19 months
Determine the incidence rate of COVID 19 among PVVIH who stopped all follow-up
Time frame: through study completion, an average of 19 months
Psychological consequences of this epidemic among PVVIH : HAD
Time frame: through study completion, an average of 19 months
Psychological consequences of this epidemic among PVVIH : PROQOL-HIV
Time frame: through study completion, an average of 19 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2022.
- Individual participant dataSharing planned: No
Related trials for Virus-HIV
Not yet recruiting
HealthMpowerment Korea: Pilot Testing the Cultural Adaptation of a Digital HIV Intervention for Men Who Have Sex With Men in South Korea
HIV Infections, HIV Prevention and Care
Not yet recruiting
Prescribe to Prevent HIV: A Hybrid Trial Helping Addiction Clinics Prevent HIV & Infections Through Safer Drug Use Support
People Who Use Opioids/People With Opioid Use Disorder (OUD)
Recruiting
Evaluating the Impact of Using the B-OK Bottles for HIV and ART Literacy in South Africa
HIV, HIV Treatment
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
RecruitingObservational study
Olfactory Function and Model-Based Behavior in People Living With HIV and SUD
HIV, Substance Use Disorder
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pauline THILL, MD principal investigator
CH TOURCOING
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing questionnaire in people with Virus-HIV and Covid19, run by Tourcoing Hospital at 3 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of SARS CoV2 infection in PVVIH in Hauts de France (time frame: Inclusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 May 2022.