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

HIV Infections Clinical Trial

— MonVIP  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05922735
• Other study ID #: ANRS 0297s MonVIP
• Status: Not yet recruiting
• Start date: September 1, 2023
• Est. completion date: February 1, 2025

Study information

• Verified date: June 2023
• Source: ANRS, Emerging Infectious Diseases
• Contact: Simon AMADOR PAZ
• Phone: 01 53 94 80 78
• Email: simon.amador-paz[@]anrs.fr
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 5000
• Est. completion date: February 1, 2025
• Est. primary completion date: February 1, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Communicable Diseases
• HIV Infections
• Infections
• Monkey Pox
• Monkeypox

Intervention

Behavioral:
• Questionnaire
Serology from remaining blood sample Self-questionnaire about sexual behavior during the epidemy mpox

Locations

Country	Name	City	State
n/a

Sponsors (4)

Lead Sponsor	Collaborator
ANRS, Emerging Infectious Diseases	INSERM UMR S 1136, Institut de Recherche en Santé Publique, France, Institut Pasteur

Outcome

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