Ignite Creation Date:
2025-12-24 @ 10:13 PM
Ignite Modification Date:
2026-01-02 @ 10:50 AM
Study NCT ID:
NCT05922735
Status:
UNKNOWN
Last Update Posted:
2023-06-28
First Post:
2023-06-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Seroprevalence of Monkeypox Infection Among People Living With HIV and PrEP Users
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D045908', 'term': 'Mpox, Monkeypox'}, {'id': 'D015658', 'term': 'HIV Infections'}, {'id': 'D003075', 'term': 'Coitus'}], 'ancestors': [{'id': 'D011213', 'term': 'Poxviridae Infections'}, {'id': 'D004266', 'term': 'DNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D018419', 'term': 'Primate Diseases'}, {'id': 'D000820', 'term': 'Animal Diseases'}, {'id': 'D012376', 'term': 'Rodent Diseases'}, {'id': 'D000086982', 'term': 'Blood-Borne Infections'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D015229', 'term': 'Sexually Transmitted Diseases, Viral'}, {'id': 'D012749', 'term': 'Sexually Transmitted Diseases'}, {'id': 'D016180', 'term': 'Lentivirus Infections'}, {'id': 'D012192', 'term': 'Retroviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D007153', 'term': 'Immunologic Deficiency Syndromes'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D012725', 'term': 'Sexual Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D011795', 'term': 'Surveys and Questionnaires'}], 'ancestors': [{'id': 'D003625', 'term': 'Data Collection'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 5000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2023-09-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-06', 'completionDateStruct': {'date': '2025-02-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-06-20', 'studyFirstSubmitDate': '2023-06-20', 'studyFirstSubmitQcDate': '2023-06-20', 'lastUpdatePostDateStruct': {'date': '2023-06-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-06-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-02-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mpox serology', 'timeFrame': '12 months', 'description': 'The primary endpoint will be to determine the presence or not of anti-Mpox antibodies in the population of PLHIV or PrEP users'}], 'secondaryOutcomes': [{'measure': 'Anti-Mpox antibodies', 'timeFrame': '12 months', 'description': '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'}, {'measure': 'Antibody level in PLWHIV', 'timeFrame': '12 months', 'description': 'Comparison of Mpox serology with CD4 count and viral load of PLHIV'}, {'measure': 'Antibody kinetics', 'timeFrame': '12 months', 'description': 'Comparison of Mpox antibody levels between D0, M6 and M12'}, {'measure': 'Mpox seroconversion', 'timeFrame': '12 months', 'description': 'Comparison of anti-Mpox serology results between D0, M6 and M12'}, {'measure': 'Neutralizing activity', 'timeFrame': '12 months', 'description': 'Observation of the number of serum-neutralization test results for all Mpox-positive samples'}, {'measure': 'Natural history of Mpox', 'timeFrame': '12 months', 'description': 'Collect information on date of seropositivity, date of onset of symptoms, types of symptoms, clinical features of infection.'}, {'measure': 'Asymptomatic infections', 'timeFrame': '12 months', 'description': 'Comparison of the proportion of asymptomatic vs. symptomatic in HIV-positive patients.'}, {'measure': 'Mpox serology and PCR', 'timeFrame': '12 months', 'description': 'Comparison of the proportion of asymptomatic, the proportion with symptoms without PCR confirmation, proportion vaccinated in the past or recently'}, {'measure': 'Childhood or recent smallpox vaccination', 'timeFrame': '12 months', 'description': 'Comparison of proportion with PCR-confirmed Mpox, proportion previously or recently vaccinated.'}, {'measure': 'Sexual behavior', 'timeFrame': '12 months', 'description': 'To count and collection of sexual behavior and impact of health crisis among PLWHIV and PrEP users via self-questionnaire'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Mpox', 'PrEP', 'HIV Infections', 'Mpox serology', 'Sexual behaviors'], 'conditions': ['Monkey Pox', 'HIV Infections']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': "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).\n\nThe 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.\n\nIn addition to the primary objective, there exist the following secondary objectives:\n\n* To assess the level of anti-Mpox antibodies in PLHIV and PrEP users\n* 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\n* Assess antibody levels in PLHIV in relation to CD4 cell count and HIV viral load\n* Study antibody kinetics and persistence over time (D0 (between November 1, 2021 and April 30, 2022), M6, M12)\n* Study the Mpox seroconversion rate over time\n* Determine the neutralizing activity of anti-Mpox antibodies in individuals with positive anti-Mpox ELISA serology.\n* Describe the natural history of the disease, the different forms of the disease, their clinical characterization\n* Describe sexual behavior and the impact of this health crisis on different aspects of their lives using a self-administered questionnaire\n* To determine the prevalence of asymptomatic infections\n* Proportion of participants with positive Mpox serology without PCR confirmed diagnosis\n* History of childhood or recent smallpox vaccination\n\nDuring 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.\n\nAn 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).\n\nA 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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '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.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥ 18 years\n* 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\n* Having been informed about the study and not having expressed his opposition\n* Affiliated to a social security system or entitled person, AME beneficiary\n\nExclusion Criteria:\n\n* Refusal of participation by the patient\n* Under legal protection (guardianship/guardianship)\n* Not able to understand the information and/or express opposition and/or not speaking French'}, 'identificationModule': {'nctId': 'NCT05922735', 'acronym': 'MonVIP', 'briefTitle': 'Seroprevalence of Monkeypox Infection Among People Living With HIV and PrEP Users', 'organization': {'class': 'OTHER_GOV', 'fullName': 'ANRS, Emerging Infectious Diseases'}, 'officialTitle': 'Seroprevalence of Monkeypox Infection Among People Living With HIV and PrEP Users', 'orgStudyIdInfo': {'id': 'ANRS 0297s MonVIP'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Population living with HIV and PrEP users', 'description': 'Population of people living with HIV and PrEP users followed in the infectious disease departments in Ile de France and in the province.', 'interventionNames': ['Behavioral: Questionnaire']}], 'interventions': [{'name': 'Questionnaire', 'type': 'BEHAVIORAL', 'description': 'Serology from remaining blood sample Self-questionnaire about sexual behavior during the epidemy mpox', 'armGroupLabels': ['Population living with HIV and PrEP users']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Simon AMADOR PAZ', 'role': 'CONTACT', 'email': 'simon.amador-paz@anrs.fr', 'phone': '01 53 94 80 78'}, {'name': 'Alexia PAUCARD', 'role': 'CONTACT', 'email': 'alexia.paucard@iplesp.upmc.fr', 'phone': '01 42 16 42 55'}], 'overallOfficials': [{'name': 'Valérie POURCHER, Pr', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Assistance Publique - Hôpitaux de Paris'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'ANRS, Emerging Infectious Diseases', 'class': 'OTHER_GOV'}, 'collaborators': [{'name': 'INSERM UMR S 1136', 'class': 'OTHER'}, {'name': 'Institut de Recherche en Santé Publique, France', 'class': 'OTHER'}, {'name': 'Institut Pasteur', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}