Ignite Creation Date:
2025-12-25 @ 4:05 AM
Ignite Modification Date:
2025-12-26 @ 3:01 AM
Study NCT ID:
NCT06296602
Status:
RECRUITING
Last Update Posted:
2024-03-08
First Post:
2024-02-29
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Screening Anal HPV Colonization in Men Sex Men Using Pre-exposure Prophylaxis for HIV (ANAPreP'HPV)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'A prelevement for HPV genotyping and anal cytology will be carried out in addition to the anal swabs taken quarterly to screen for other sexually transmitted infections.\n\nA questionnaire will be completed by the doctor to record the data of interest.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-03-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2024-11-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-03-07', 'studyFirstSubmitDate': '2024-02-29', 'studyFirstSubmitQcDate': '2024-02-29', 'lastUpdatePostDateStruct': {'date': '2024-03-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-03-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-11-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'prevalence HPV', 'timeFrame': 'day 1', 'description': 'prevalence HPV'}, {'measure': 'typing HPV', 'timeFrame': 'day 1', 'description': 'typing HPV'}], 'secondaryOutcomes': [{'measure': 'High risk HPV risk factors', 'timeFrame': 'day 1', 'description': 'High risk HPV risk factors'}, {'measure': 'Cytologist abnormalies', 'timeFrame': 'day 1', 'description': 'Cytologist abnormalies'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['PreP'], 'conditions': ['Pre-Exposure Prophylaxis']}, 'descriptionModule': {'briefSummary': 'This is an interventional study investigating HPV carriage and liquid-based cytology at anal level. It will be offered to all patients undergoing PreP consultations at Besançon University Hospital. The anal swab will be taken by the doctor using a cyto-brush during the consultation.', 'detailedDescription': 'The duration of participation in the study is 3 months for the submission of the results of the samples. A medical proctology consultation may also be offered, depending on the results of the screening.\n\nThis will be carried out in addition to the anal swabs taken quarterly to screen for other sexually transmitted infections.\n\nA questionnaire will be completed by the doctor to record the data of interest. From additional data already entered in the e-NADIS software will be included for study.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nMen sex Men Using Pre-exposure Prophylaxis for HIV Follow up au CHU de Besançon.\n\nExclusion Criteria:\n\n* Women\n* No MSM\n* Under 18\n* History of HPV related cancer'}, 'identificationModule': {'nctId': 'NCT06296602', 'acronym': "ANAPreP'HPV", 'briefTitle': "Screening Anal HPV Colonization in Men Sex Men Using Pre-exposure Prophylaxis for HIV (ANAPreP'HPV)", 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire de Besancon'}, 'officialTitle': 'Screening Anal HPV Colonization in Men Sex Men Using Pre-exposure Prophylaxis for HIV', 'orgStudyIdInfo': {'id': '2023/777'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ANAPreP-HPV', 'description': 'A prelevement for HPV genotyping and anal cytology will be carried out in addition to the anal swabs taken quarterly to screen for other sexually transmitted infections.\n\nA questionnaire will be completed by the doctor to record the data of interest.', 'interventionNames': ['Other: A prelevement for HPV genotyping and anal cytology will be carried out in addition to the anal swabs taken quarterly to screen for other sexually transmitted infections.']}], 'interventions': [{'name': 'A prelevement for HPV genotyping and anal cytology will be carried out in addition to the anal swabs taken quarterly to screen for other sexually transmitted infections.', 'type': 'OTHER', 'otherNames': ['A questionnaire will be completed by the doctor to record the data of interest'], 'description': 'A prelevement for HPV genotyping and anal cytology will be carried out in addition to the anal swabs taken quarterly to screen for other sexually transmitted infections. A questionnaire will be completed by the doctor to record the data of interest.', 'armGroupLabels': ['ANAPreP-HPV']}]}, 'contactsLocationsModule': {'locations': [{'zip': '25000', 'city': 'Besançon', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Cédric LEBRETON, Dr', 'role': 'CONTACT'}], 'facility': 'CHU Besançon', 'geoPoint': {'lat': 47.24878, 'lon': 6.01815}}], 'centralContacts': [{'name': 'Cedric LEBRETON, Dr', 'role': 'CONTACT', 'email': 'c1lebreton@chu-besancon.fr', 'phone': '03 81 21 88 98', 'phoneExt': '+33'}, {'name': 'Ingrid TISSOT', 'role': 'CONTACT', 'email': 'itissot@chu-besancon.fr', 'phone': '03 81 21 84 27', 'phoneExt': '+33'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire de Besancon', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}