MonVIP: Seroprevalence of Monkeypox Infection Among People Living With HIV and PrEP Users

Sponsor

ANRS, Emerging Infectious Diseases (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05922735

Collaborator

INSERM UMR S 1136 (Other), Institut de Recherche en Santé Publique, France (Other), Institut Pasteur (Industry)

5,000

Enrollment

17.1

Anticipated Duration (Months)

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Monkey Pox HIV Infections	Behavioral: Questionnaire

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

Study Type:

Observational

Anticipated Enrollment :

5000 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

Official Title:

Seroprevalence of Monkeypox Infection Among People Living With HIV and PrEP Users

Anticipated Study Start Date :

Sep 1, 2023

Anticipated Primary Completion Date :

Feb 1, 2025

Anticipated Study Completion Date :

Feb 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
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.	Behavioral: Questionnaire Serology from remaining blood sample Self-questionnaire about sexual behavior during the epidemy mpox

Arm

Intervention/Treatment

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.

Behavioral: Questionnaire

Serology from remaining blood sample Self-questionnaire about sexual behavior during the epidemy mpox

Outcome Measures

Primary Outcome Measures

Mpox serology [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

Secondary Outcome Measures

Anti-Mpox antibodies [12 months]
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
Antibody level in PLWHIV [12 months]
Comparison of Mpox serology with CD4 count and viral load of PLHIV
Antibody kinetics [12 months]
Comparison of Mpox antibody levels between D0, M6 and M12
Mpox seroconversion [12 months]
Comparison of anti-Mpox serology results between D0, M6 and M12
Neutralizing activity [12 months]
Observation of the number of serum-neutralization test results for all Mpox-positive samples
Natural history of Mpox [12 months]
Collect information on date of seropositivity, date of onset of symptoms, types of symptoms, clinical features of infection.
Asymptomatic infections [12 months]
Comparison of the proportion of asymptomatic vs. symptomatic in HIV-positive patients.
Mpox serology and PCR [12 months]
Comparison of the proportion of asymptomatic, the proportion with symptoms without PCR confirmation, proportion vaccinated in the past or recently
Childhood or recent smallpox vaccination [12 months]
Comparison of proportion with PCR-confirmed Mpox, proportion previously or recently vaccinated.
Sexual behavior [12 months]
To count and collection of sexual behavior and impact of health crisis among PLWHIV and PrEP users via self-questionnaire

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

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

Exclusion Criteria:

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