Seroprevalence of Monkeypox Infection Among People Living With HIV and PrEP Users
MonVIP
1 other identifier
observational
5,000
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Sep 2023
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 20, 2023
CompletedFirst Posted
Study publicly available on registry
June 28, 2023
CompletedStudy Start
First participant enrolled
September 1, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2025
CompletedJune 28, 2023
June 1, 2023
1.4 years
June 20, 2023
June 20, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (10)
Anti-Mpox antibodies
12 months
Antibody level in PLWHIV
12 months
Antibody kinetics
12 months
Mpox seroconversion
12 months
Neutralizing activity
12 months
- +5 more secondary outcomes
Study Arms (1)
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.
Interventions
Serology from remaining blood sample Self-questionnaire about sexual behavior during the epidemy mpox
Eligibility Criteria
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.
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- ANRS, Emerging Infectious Diseaseslead
- INSERM UMR S 1136collaborator
- Institut de Recherche en Santé Publique, Francecollaborator
- Institut Pasteurcollaborator
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Valérie POURCHER, Pr
Assistance Publique - Hôpitaux de Paris
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 20, 2023
First Posted
June 28, 2023
Study Start
September 1, 2023
Primary Completion
February 1, 2025
Study Completion
February 1, 2025
Last Updated
June 28, 2023
Record last verified: 2023-06
Data Sharing
- IPD Sharing
- Will not share