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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: HIV Infections; Monkey Pox
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Estimated): 5000

Contacts and Locations

• Study Contact: Name: Simon AMADOR PAZ; Phone Number: 01 53 94 80 78; Email: simon.amador-paz@anrs.fr
• Study Contact Backup: Name: Alexia PAUCARD; Phone Number: 01 42 16 42 55; Email: alexia.paucard@iplesp.upmc.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	12 months
Antibody level in PLWHIV	Comparison of Mpox serology with CD4 count and viral load of PLHIV	12 months
Antibody kinetics	Comparison of Mpox antibody levels between D0, M6 and M12	12 months
Mpox seroconversion	Comparison of anti-Mpox serology results between D0, M6 and M12	12 months
Neutralizing activity	Observation of the number of serum-neutralization test results for all Mpox-positive samples	12 months
Natural history of Mpox	Collect information on date of seropositivity, date of onset of symptoms, types of symptoms, clinical features of infection.	12 months
Asymptomatic infections	Comparison of the proportion of asymptomatic vs. symptomatic in HIV-positive patients.	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	12 months
Childhood or recent smallpox vaccination	Comparison of proportion with PCR-confirmed Mpox, proportion previously or recently vaccinated.	12 months
Sexual behavior	To count and collection of sexual behavior and impact of health crisis among PLWHIV and PrEP users via self-questionnaire	12 months

Collaborators and Investigators

• Sponsor: ANRS, Emerging Infectious Diseases
• Collaborators: Institut Pasteur; Institut de Recherche en Santé Publique, France; INSERM UMR S 1136
• Investigators: Principal Investigator: Valérie POURCHER, Pr, Assistance Publique - Hôpitaux de Paris

Study record dates

Study Major Dates

• Study Start (Estimated): September 1, 2023
• Primary Completion (Estimated): February 1, 2025
• Study Completion (Estimated): February 1, 2025

Study Registration Dates

• First Submitted: June 20, 2023
• First Submitted That Met QC Criteria: June 20, 2023
• First Posted (Actual): June 28, 2023

Study Record Updates

• Last Update Posted (Actual): June 28, 2023
• Last Update Submitted That Met QC Criteria: June 20, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: PrEP; HIV Infections; Mpox; Sexual behaviors; Mpox serology
• Additional Relevant MeSH Terms: Pathologic Processes; RNA Virus Infections; Virus Diseases; Blood-Borne Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; Immune System Diseases; Disease Attributes; DNA Virus Infections; Poxviridae Infections; Urogenital Diseases; Genital Diseases; HIV Infections; Infections; Communicable Diseases; Monkeypox
• Other Study ID Numbers: ANRS 0297s MonVIP

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No