Ignite Creation Date:
2025-12-25 @ 12:45 AM
Ignite Modification Date:
2026-03-08 @ 11:00 PM
Study NCT ID:
NCT03986567
Status:
UNKNOWN
Last Update Posted:
2019-06-14
First Post:
2018-11-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The "Notijoves" Randomised Controlled
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012749', 'term': 'Sexually Transmitted Diseases'}], 'ancestors': [{'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 416}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-10', 'completionDateStruct': {'date': '2019-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-06-13', 'studyFirstSubmitDate': '2018-11-15', 'studyFirstSubmitQcDate': '2019-06-13', 'lastUpdatePostDateStruct': {'date': '2019-06-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-06-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Effectiveness of partner notification: number of partners notified out of number of cases diagnosed', 'timeFrame': '2 months after diagnose', 'description': 'number of partners notified out of number of cases diagnosed'}], 'secondaryOutcomes': [{'measure': 'yield of early diagnosis and treatment of those exposed and infected;', 'timeFrame': '3 months', 'description': 'number of partners exposed out of number of cases diagnosed'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Mobile Applications', 'Contact Tracing', 'Game Theory', 'Adolescent'], 'conditions': ['Sexually Transmitted Diseases']}, 'descriptionModule': {'briefSummary': 'Background:\n\nIncrease of sexually transmitted infections (STIs) as well as increased use of new information and communication technologies (ICTs) among young people in Catalonia triggers the idea of designing a mobile phone application to promote partner notification.\n\nObjective:\n\nDesign a web based tool adapted to Mobile phones for partner notification of STI among youngsters 16 to 24 years old and evaluate its role in increasing the "patient referral" partner notification.\n\nMethods:\n\nThis is a multicentre randomised controlled trial with a proportional stratification of the sample by centre and random allocation of participants to the three arms of the study (simple web based intervention, game web based intervention and control). This study is conducted by midwives, gynaecologists and physicians in the sexual and reproductive areas of the primary health care centres.\n\nThe study population is: 1- All youngsters 16 to 24 years old diagnosed with one of the three curable STIs, (Syphilis, gonococcus and chlamydia). 2- All partners of those diagnosed with the previous STIs, independently of their state of infection.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '24 Years', 'minimumAge': '16 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 16 to 24 years old diagnosed with one of the three curable STIs, (Syphilis, gonococcus and chlamydia).\n* All partners of those diagnosed with the previous STIs, independently of their state of infection.\n\nExclusion Criteria:\n\n* Already participated in the study within its length'}, 'identificationModule': {'nctId': 'NCT03986567', 'acronym': 'notijoves', 'briefTitle': 'The "Notijoves" Randomised Controlled', 'organization': {'class': 'OTHER', 'fullName': "Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina"}, 'officialTitle': 'Impact of New Communication Technologies and Gamification in the Promotion of Partner Notification of Sexually Transmitted Infections Among Young People: The "Notijoves" Randomised Controlled', 'orgStudyIdInfo': {'id': '40547236'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'control', 'description': 'Providing with a paper notification card to the STI diagnosed young person', 'interventionNames': ['Behavioral: gamification for partner notification among youngsters']}, {'type': 'EXPERIMENTAL', 'label': 'intervention web app', 'description': 'providing to the STI diagnosed young person, with a code number to enter into the app to notify sexual partners', 'interventionNames': ['Behavioral: gamification for partner notification among youngsters']}, {'type': 'EXPERIMENTAL', 'label': 'intervention game', 'description': 'providing to the STI diagnosed young person, with a code number to enter into the app and play a game to get motivated to notify sexual partners', 'interventionNames': ['Behavioral: gamification for partner notification among youngsters']}], 'interventions': [{'name': 'gamification for partner notification among youngsters', 'type': 'BEHAVIORAL', 'description': 'Design a web based tool adapted to Mobile phones for partner notification of STI among youngsters 16 to 24 years old and evaluate its role in increasing the "patient referral" partner notification', 'armGroupLabels': ['control', 'intervention game', 'intervention web app']}]}, 'contactsLocationsModule': {'locations': [{'zip': '08202', 'city': 'Sabadell', 'state': 'Barcelona', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Gemma Falguera-Puig, PhD', 'role': 'CONTACT', 'email': 'gfalguera.mn.ics@gencat.cat', 'phone': '+34 936932732'}], 'facility': 'Catalan Institute of Health (Ics)', 'geoPoint': {'lat': 41.54329, 'lon': 2.10942}}], 'centralContacts': [{'name': 'DOLORS CARNICER-PONT, PhD', 'role': 'CONTACT', 'email': 'dcarnicer@iconcologia.net', 'phone': '+34616688195'}, {'name': 'JOSEP M MANRESA DOMINGUEZ, BIOLOGIST', 'role': 'CONTACT', 'email': 'jmanresa@idiap.cat', 'phone': '+34934824124'}], 'overallOfficials': [{'name': 'GEMMA FALGUERA PUIG, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CATALAN INSTITUTE OF HEALTH (ICS)'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina", 'class': 'OTHER'}, 'collaborators': [{'name': "Institut Català d'Oncologia", 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}