Monkey PoxMonVIPNCT05922735
Seroprevalence of Monkeypox Infection Among People Living With HIV and PrEP Users
An observational study of Monkey Pox and HIV Infections, run by ANRS, Emerging Infectious Diseases.
Trial summary
This is a cohort, non-health product, non-interventional biomedical research, multi-centric, to determine the seroprevalence of mpox infection in the population of people living with HIV and in PrEP users in Ile-de-France and in the province. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Monkey Pox, HIV Infections
- What is being tested?
- Questionnaire
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 5,000 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2023to 1 Feb 2025
- Phase
- Observational
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: The target population is the population of PLHIV (n=18,500) and PrEP users (n=4930) followed up in the infectious and tropical diseases departments (SMIT) in 9 centers in Ile de France and province.
Who may be able to join
- Age ≥ 18 years
- People Living with HIV or PrEP users with a blood test within 6 months before the start of the epidemic (i.e. between 1/11/2021 and 30/04/2022, D0) and with a blood test scheduled at M6 and/or at M12 of this collection depending on the care, in the centers participating in the study
- Having been informed about the study and not having expressed his opposition
- Affiliated to a social security system or entitled person, AME beneficiary
Who cannot join
- Refusal of participation by the patient
- Under legal protection (guardianship/guardianship)
- Not able to understand the information and/or express opposition and/or not speaking French
Trial locations and contacts
No sites are listed yet.
About this study
This is a cohort, non-health product, non-interventional biomedical research, multi-centric, to determine the seroprevalence of mpox infection in the population of people living with HIV and in PrEP users in Ile-de-France and in the province.
Read the detailed description
The target population is the population of people living with HIV (PLHIV) (n=18,500) and PrEP users (n=4930) followed up in Parisian infectious and tropical diseases departments (SMIT) of the Pitié-Salpêtrière, Tenon, Saint-Antoine, Bichat, Saint-Louis, Necker hospitals, the University Department of Infectious and Traveller Diseases of Hôpital Dron (Tourcoing), the 190 health center, and the Maison de santé du Chemin vert (Paris).
The principal objective is to determine the seroprevalence of Monkeypox infection in the population of PLHIV and PrEP users followed in the infectious and tropical disease departments in 9 centers.
In addition to the primary objective, there exist the following secondary objectives:
- To assess the level of anti-Mpox antibodies in PLHIV and PrEP users
- To assess the level of anti-Mpox antibodies in PLHIV and PrEP users with a previous confirmed diagnosis of Mpox or if they have been recently vaccinated
- Assess antibody levels in PLHIV in relation to CD4 cell count and HIV viral load
- Study antibody kinetics and persistence over time (D0 (between November 1, 2021 and April 30, 2022), M6, M12)
- Study the Mpox seroconversion rate over time
- Determine the neutralizing activity of anti-Mpox antibodies in individuals with positive anti-Mpox ELISA serology.
- Describe the natural history of the disease, the different forms of the disease, their clinical characterization
- Describe sexual behavior and the impact of this health crisis on different aspects of their lives using a self-administered questionnaire
- To determine the prevalence of asymptomatic infections
- Proportion of participants with positive Mpox serology without PCR confirmed diagnosis
- History of childhood or recent smallpox vaccination
During the patient's follow-up consultation, after information and in the absence of an expression of no objection, inclusion will consist of recovering a blood sample taken between November 2021 and April 2022 during the HIV infection assessment or PrEP follow-up (no additional sample) and possibly the blood sample taken at M6 and/or M12 if this follow-up consultation has already taken place.
An online self-questionnaire will also be proposed to the patient (male only). It will be constructed from questions already validated in other surveys (Rapport au Sexe, Prévenir, Parcours).
A check on the appearance or persistence of antibodies will be carried out at M6 +/- 8 weeks and/or M12 +/- 8 weeks on tube bottoms of samples always taken as part of the HIV infection assessment or PrEP follow-up.
- Conditions
- Monkey Pox, HIV Infections
- Being tested
- Questionnaire
- Keywords
- Mpox, PrEP, HIV Infections, Mpox serology, Sexual behaviors
- Medical subject headings
- Mpox, Monkeypox, HIV Infections, Coitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnaireBehavioural
Serology from remaining blood sample Self-questionnaire about sexual behavior during the epidemy mpox
| Study group | Role | What they receive |
|---|---|---|
| Population living with HIV and PrEP users | Population of people living with HIV and PrEP users followed in the infectious disease departments in Ile de France and in the province. Receives: Behavioral: Questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mpox serology
The primary endpoint will be to determine the presence or not of anti-Mpox antibodies in the population of PLHIV or PrEP users
Measured: 12 months
Secondary outcomes (10)
Anti-Mpox antibodies
To determine the presence or not of anti-Mpox antibodies by ELISA in PLWHIV and PrEP users with a previous confirmed diagnosis of Mpox or with a recent vaccination
Measured: 12 months
Antibody level in PLWHIV
Comparison of Mpox serology with CD4 count and viral load of PLHIV
Measured: 12 months
Antibody kinetics
Comparison of Mpox antibody levels between D0, M6 and M12
Measured: 12 months
Mpox seroconversion
Comparison of anti-Mpox serology results between D0, M6 and M12
Measured: 12 months
Neutralizing activity
Observation of the number of serum-neutralization test results for all Mpox-positive samples
Measured: 12 months
Natural history of Mpox
Collect information on date of seropositivity, date of onset of symptoms, types of symptoms, clinical features of infection.
Measured: 12 months
Asymptomatic infections
Comparison of the proportion of asymptomatic vs. symptomatic in HIV-positive patients.
Measured: 12 months
Mpox serology and PCR
Comparison of the proportion of asymptomatic, the proportion with symptoms without PCR confirmation, proportion vaccinated in the past or recently
Measured: 12 months
Childhood or recent smallpox vaccination
Comparison of proportion with PCR-confirmed Mpox, proportion previously or recently vaccinated.
Measured: 12 months
Sexual behavior
To count and collection of sexual behavior and impact of health crisis among PLWHIV and PrEP users via self-questionnaire
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2023
- Study start1 Sep 2023 (estimated)
- Primary completion1 Feb 2025 (estimated)
- Study completion1 Feb 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Monkey PoxStudies of the same condition, open and under way.
- More trials run by ANRS, Emerging Infectious DiseasesThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 5,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ANRS, Emerging Infectious Diseases
- Sponsor type
- Other government
- Collaborators
- INSERM UMR S 1136, Institut de Recherche en Santé Publique, France, Institut Pasteur
- Responsible party
- Sponsor
- Investigators
- Valérie POURCHER, Pr, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05922735
- Sponsor's protocol ID
- ANRS 0297s MonVIP
- Acronym
- MonVIP
- Status last verified
- Jun 2023
- First submitted
- 20 Jun 2023
- Last updated
- 28 Jun 2023
- 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 28 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Seroprevalence of Monkeypox Infection Among People Living With HIV and PrEP Users
- ClinicalTrials.gov ID
- NCT05922735
- Acronym / sponsor ID
- MonVIP / ANRS 0297s MonVIP
- Conditions
- Monkey Pox, HIV Infections
- Keywords
- Mpox, PrEP, HIV Infections, Mpox serology, Sexual behaviors
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 5,000 participants (estimated)
- Lead sponsor
- ANRS, Emerging Infectious DiseasesOther government
- Collaborators
- INSERM UMR S 1136, Institut de Recherche en Santé Publique, France, Institut Pasteur
- Study start
- 1 Sep 2023 (estimated)
- Primary completion
- 1 Feb 2025 (estimated)
- Study completion
- 1 Feb 2025 (estimated)
- First posted
- 28 Jun 2023 (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.
This is a cohort, non-health product, non-interventional biomedical research, multi-centric, to determine the seroprevalence of mpox infection in the population of people living with HIV and in PrEP users in Ile-de-France and in the province.
Detailed description
The target population is the population of people living with HIV (PLHIV) (n=18,500) and PrEP users (n=4930) followed up in Parisian infectious and tropical diseases departments (SMIT) of the Pitié-Salpêtrière, Tenon, Saint-Antoine, Bichat, Saint-Louis, Necker hospitals, the University Department of Infectious and Traveller Diseases of Hôpital Dron (Tourcoing), the 190 health center, and the Maison de santé du Chemin vert (Paris).
The principal objective is to determine the seroprevalence of Monkeypox infection in the population of PLHIV and PrEP users followed in the infectious and tropical disease departments in 9 centers.
In addition to the primary objective, there exist the following secondary objectives:
- To assess the level of anti-Mpox antibodies in PLHIV and PrEP users
- To assess the level of anti-Mpox antibodies in PLHIV and PrEP users with a previous confirmed diagnosis of Mpox or if they have been recently vaccinated
- Assess antibody levels in PLHIV in relation to CD4 cell count and HIV viral load
- Study antibody kinetics and persistence over time (D0 (between November 1, 2021 and April 30, 2022), M6, M12)
- Study the Mpox seroconversion rate over time
- Determine the neutralizing activity of anti-Mpox antibodies in individuals with positive anti-Mpox ELISA serology.
- Describe the natural history of the disease, the different forms of the disease, their clinical characterization
- Describe sexual behavior and the impact of this health crisis on different aspects of their lives using a self-administered questionnaire
- To determine the prevalence of asymptomatic infections
- Proportion of participants with positive Mpox serology without PCR confirmed diagnosis
- History of childhood or recent smallpox vaccination
During the patient's follow-up consultation, after information and in the absence of an expression of no objection, inclusion will consist of recovering a blood sample taken between November 2021 and April 2022 during the HIV infection assessment or PrEP follow-up (no additional sample) and possibly the blood sample taken at M6 and/or M12 if this follow-up consultation has already taken place.
An online self-questionnaire will also be proposed to the patient (male only). It will be constructed from questions already validated in other surveys (Rapport au Sexe, Prévenir, Parcours).
A check on the appearance or persistence of antibodies will be carried out at M6 +/- 8 weeks and/or M12 +/- 8 weeks on tube bottoms of samples always taken as part of the HIV infection assessment or PrEP follow-up.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Population living with HIV and PrEP users | – | Behavioral: QuestionnairePopulation of people living with HIV and PrEP users followed in the infectious disease departments in Ile de France and in the province. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The target population is the population of PLHIV (n=18,500) and PrEP users (n=4930) followed up in the infectious and tropical diseases departments (SMIT) in 9 centers in Ile de France and province.
Key inclusion criteria (4 listed)
- Age ≥ 18 years
- People Living with HIV or PrEP users with a blood test within 6 months before the start of the epidemic (i.e. between 1/11/2021 and 30/04/2022, D0) and with a blood test scheduled at M6 and/or at M12 of this collection depending on the care, in the centers participating in the study
- Having been informed about the study and not having expressed his opposition
- Affiliated to a social security system or entitled person, AME beneficiary
Key exclusion criteria (3 listed)
- Refusal of participation by the patient
- Under legal protection (guardianship/guardianship)
- Not able to understand the information and/or express opposition and/or not speaking French
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 |
|---|---|---|
| QuestionnaireSerology from remaining blood sample Self-questionnaire about sexual behavior during the epidemy mpox | Behavioural | Population living with HIV and PrEP users |
Primary outcome
Mpox serology
Time frame: 12 months
The primary endpoint will be to determine the presence or not of anti-Mpox antibodies in the population of PLHIV or PrEP users
10 secondary outcomes
Anti-Mpox antibodies
Time frame: 12 months
Antibody level in PLWHIV
Time frame: 12 months
Antibody kinetics
Time frame: 12 months
Mpox seroconversion
Time frame: 12 months
Neutralizing activity
Time frame: 12 months
Natural history of Mpox
Time frame: 12 months
Asymptomatic infections
Time frame: 12 months
Mpox serology and PCR
Time frame: 12 months
Childhood or recent smallpox vaccination
Time frame: 12 months
Sexual behavior
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2023.
- Individual participant dataSharing planned: No
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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.
Valérie POURCHER, Pr principal investigator
Assistance Publique - Hôpitaux de Paris
Questions about this trial
What is this clinical trial studying?
An observational study of Monkey Pox and HIV Infections, run by ANRS, Emerging Infectious Diseases.
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 28 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
Contact Simon AMADOR PAZ (01 53 94 80 78, simon.amador-paz@anrs.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mpox serology (time frame: 12 months). 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 28 Jun 2023.