Ignite Creation Date:
2025-12-25 @ 12:04 AM
Ignite Modification Date:
2026-03-14 @ 4:11 AM
Study NCT ID:
NCT06847958
Status:
COMPLETED
Last Update Posted:
2025-02-26
First Post:
2025-02-21
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
HepC Micro-elimination on MSM and TGW Population.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006526', 'term': 'Hepatitis C'}, {'id': 'D019966', 'term': 'Substance-Related Disorders'}], 'ancestors': [{'id': 'D000086982', 'term': 'Blood-Borne Infections'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D006525', 'term': 'Hepatitis, Viral, Human'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D018178', 'term': 'Flaviviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D006505', 'term': 'Hepatitis'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-07-22', 'size': 489390, 'label': 'Study Protocol, Statistical Analysis Plan, and Informed Consent Form', 'hasIcf': True, 'hasSap': True, 'filename': 'Prot_SAP_ICF_000.pdf', 'typeAbbrev': 'Prot_SAP_ICF', 'uploadDate': '2025-02-21T16:17', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 13161}, 'targetDuration': '2 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-08-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2023-09-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-02-21', 'studyFirstSubmitDate': '2025-02-21', 'studyFirstSubmitQcDate': '2025-02-21', 'lastUpdatePostDateStruct': {'date': '2025-02-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-02-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-09-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Hepatitis C active infection', 'timeFrame': 'August 2021 o September 2023', 'description': 'Confirmed Hepatitis C active infection'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['MSM', 'TGW', 'PrEP', 'Hepatitis C Transmision', 'micro-elimination'], 'conditions': ['Hepatitis C', 'PrEP', 'Drugs of Abuse']}, 'referencesModule': {'references': [{'pmid': '41380408', 'type': 'DERIVED', 'citation': 'Rivero A, Dalmau-Bueno A, Perez F, Coll P, Cabrera JM, Lucejko M, Fernandez J, Reguant J, Calderon J, Romero J, Caballero F, Marazzi G, Oro C, Michael Jacobs D, Vicioso H, Moises L, Taboada H, Saz J, Pujol F, Meulbroek M, Paredes R. HCV infection, risk factors and PrEP use among HIV-negative MSM and TW at a community health centre. J Infect Public Health. 2025 Dec 4;19(2):103086. doi: 10.1016/j.jiph.2025.103086. Online ahead of print.'}]}, 'descriptionModule': {'briefSummary': 'This is an observational study, in which a single visit will be carried out, which includes a questionnaire on sexual habits and in which the possibility of carrying out a screening for Hepatitis C will be offered. Depending on the score obtained in the questionnaire, the screening will be carried out using a rapid serology test or viral load. During the first year, a SCORE will be developed to classify the risk of positive results. This SCORE will be used during phase 2 to offer users of the centres a targeted screening based on the Pre-test score.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'genderBased': True, 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Men who have sex with other men or transgender women, that are HIV negative and comes to get tested in our center or are under controls in our center. Estimated enrollment first Phase 6000-7000 participants. Second phase 2000-3000 participants.', 'genderDescription': 'Male and TGW', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. All BCN Checkpoint and BCN PreP·Point clients.\n2. 18 years and older.\n3. HIV uninfected or diagnosticated in the center in the last 7 days prior to the study inclusion.\n4. Men that have sex with men or transgender women.\n5. Signature of written consent form.\n6. Ability to comply with the requirements of the study protocol.\n\nExclusion Criteria:\n\n1. Knowledge of HIV infection from more than 7 days\n2. Knowledge of active HCV infection'}, 'identificationModule': {'nctId': 'NCT06847958', 'briefTitle': 'HepC Micro-elimination on MSM and TGW Population.', 'organization': {'class': 'OTHER', 'fullName': 'Projecte dels NOMS Hispanosida'}, 'officialTitle': 'HepC Micro-elimination on MSM Comunity', 'orgStudyIdInfo': {'id': 'MSM-HCV-MicroElimination'}, 'secondaryIdInfos': [{'id': 'IN-ES-987-5997', 'type': 'OTHER_GRANT', 'domain': 'Gilead Sciences, S.L.U'}, {'id': 'PI-21-206', 'type': 'REGISTRY', 'domain': 'IEC Germans Trias i Pujol'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'MSM and TGW HIV negative PrEP User.'}, {'label': 'MSM and TGW HIV negative non PrEP User.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '08015', 'city': 'Barcelona', 'country': 'Spain', 'facility': 'BCN checkpoint', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR', 'ANALYTIC_CODE'], 'timeFrame': 'IPD will be availeble up to 5 years after Data publication', 'ipdSharing': 'YES', 'description': 'Data requisition will be individually evaluated. After that IEC will be required to evaluate data sharing.', 'accessCriteria': 'Data acces under private requisition and after individual evaluation.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Projecte dels NOMS Hispanosida', 'class': 'OTHER'}, 'collaborators': [{'name': 'Fundació Lluita contra les Infeccions', 'class': 'UNKNOWN'}, {'name': 'Germans Trias i Pujol Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}