Ignite Creation Date:
2025-12-25 @ 4:33 AM
Ignite Modification Date:
2025-12-26 @ 3:35 AM
Study NCT ID:
NCT04921618
Status:
UNKNOWN
Last Update Posted:
2022-07-25
First Post:
2021-04-27
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Partner Notification of Sexually Transmitted Infections (STIs) in Testing Centers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012749', 'term': 'Sexually Transmitted Diseases'}, {'id': 'D000163', 'term': 'Acquired Immunodeficiency Syndrome'}], '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'}, {'id': 'D015658', 'term': 'HIV Infections'}, {'id': 'D000086982', 'term': 'Blood-Borne Infections'}, {'id': 'D015229', 'term': 'Sexually Transmitted Diseases, Viral'}, {'id': 'D016180', 'term': 'Lentivirus Infections'}, {'id': 'D012192', 'term': 'Retroviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D012897', 'term': 'Slow Virus Diseases'}, {'id': 'D007153', 'term': 'Immunologic Deficiency Syndromes'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 2200}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-07-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-07', 'completionDateStruct': {'date': '2022-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-07-22', 'studyFirstSubmitDate': '2021-04-27', 'studyFirstSubmitQcDate': '2021-06-08', 'lastUpdatePostDateStruct': {'date': '2022-07-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-06-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Partner notification by index patients', 'timeFrame': 'One month after STI diagnosis', 'description': 'Proportion of index patients who notified at least one sexual partner one month after their STI diagnosis'}], 'secondaryOutcomes': [{'measure': 'Partners notified by index patients', 'timeFrame': 'One month after STI diagnosis', 'description': 'Mean proportion of notified partners among partners reported by index patients'}, {'measure': 'Notified partners tested positive', 'timeFrame': 'At notified partners inclusion', 'description': 'Proportion of notified partners tested positive among notified partners attending STI testing'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['partner notification', 'STI', 'HIV', 'testing center', 'intervention design'], 'conditions': ['STI', 'Hiv']}, 'descriptionModule': {'briefSummary': 'Since the 2000s, the incidence of bacterial STIs increases, mainly among men who have sex with men but also among heterosexual men and women with multiple sexual partners. A partner notification (PN) approach could break transmission chains and curb STI epidemics. PN brings together a set of interventions to help people diagnosed with STIs to inform their partners, encourage them to get tested, so that they can access treatment or prevention. A PN approach, systematically offered at STI diagnosis, has not yet been implemented in France and needs to be evaluated. In 2018, the Conseil National du Sida (French National AIDS Council) stated in favor of a formalized PN approach, particularly in testing centers, which carry out a large part of STI diagnoses.\n\nThe aim of our research project is to build interventions facilitating information, testing and treatment of partners of people diagnosed with STIs in testing centers and sexual health clinics.\n\nStep 1: A cross-sectional study\n\nPrimary objective\n\nTo describe the PN practices of people diagnosed with an STI in testing centers and sexual health clinics without any intervention\n\nSecondary objectives\n\n* To describe the profiles of people diagnosed with an STI in testing centers or sexual health clinics and therefore likely to receive an intervention to help them notify their partners;\n* To describe the profiles of people notified by their partners and who attend testing centers or sexual health clinics for STI testing;\n* To describe the notification received by these notified partners and identify the facilitators of testing use following notification.\n\nStep 2: A qualitative study\n\nObjectives\n\n* To evaluate the acceptability of testing center staff for an STI notification program in general and discuss the feasibility of interventions pre-identified by a literature review;\n* In a collaborative (researchers and staffs) approach, to adapt these interventions to (1) the testing centers working and (2) the needs of their users identified in the cross-sectional study.\n\nExpected results\n\nThis study is the first step in implementation of a PN program as part of a comprehensive management of STI diagnoses in France.', 'detailedDescription': 'Methods\n\nStep 1: A cross-sectional study\n\nCross-sectional study conducted in testing centers and sexual health clinics (6 centers, 6 months of enrollment), targeting two populations:\n\n* People aged 18 years or more diagnosed for at least one STI: the index patients;\n* People aged 18 years or more attending the same centers for STI testing after being notified by a sexual partner: the notified partners.\n\nThis study is based on 3 online self-administered questionnaires:\n\n* A questionnaire, the same for index patients and notified partners, collecting socio-demographic profile, health care and testing use, STI history and sexual behavior;\n* A questionnaire for index patient on spontaneous PN practices of index patients one month after STI diagnosis, including types of partners notified, methods used to notify, and reasons for not notifying partners (this questionnaire will be sent one month after STI diagnosis to give participants the time to inform their partners);\n* A questionnaire for notified partner on their experience of PN, such as the type of notifying partner, the methods and information transmitted during notification, their feelings and what led them to get testing after being notified.\n\nA notified partner diagnosed with an STI will receive also the questionnaire on spontaneous practices of index patients at M1. This will allow us to observe whether people who had already been notified for an STI are more likely to notify their partners.\n\nStep 2: A qualitative study\n\nFocus-groups of 6-8 volunteers involved in STI testing in testing centers and sexual health clinics will be conducted based on an interview guide. Doctors and other staffs will be interviewed separately.\n\nThematic analysis'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Two distinct populations will be studied\n\n* People diagnosed with \\>= 1 STI in testing centers or sexual health clinics: index patients,\n* People attenting testing centers or sexual health clinics for STI testing and/or access to treatment following notification of possible exposure to an STI by one of their partners: notified partners.\n\nIndex patients and notified partners will be included on a voluntary basis. The study will be offered to all eligible individuals during the study period.', 'eligibilityCriteria': 'Inclusion Criteria:\n\nFor index patients\n\n* Diagnosed with at least one bacterial STI, and/or HIV and/or acute HCV at one of the participating centers during the study period,\n* Aged \\>= 18,\n* Agree to participate in the study after oral and written information.\n\nFor notified partners\n\n* Attend one of the participating centers during the study period, within 6 months of being notified of their exposure to an STI (bacterial STI, and/or HIV and/or acute HCV) by one of their partners, who is infected with one or more of these STIs,\n* Aged \\>= 18,\n* Agree to participate in the study after oral and written information.\n\nNon-Inclusion Criteria:\n\nFor index patients and notified partners\n\n* People who do not read or speak French,\n* Wardship or curatorship adults.'}, 'identificationModule': {'nctId': 'NCT04921618', 'acronym': "Not'IST", 'briefTitle': 'Partner Notification of Sexually Transmitted Infections (STIs) in Testing Centers', 'organization': {'class': 'OTHER_GOV', 'fullName': 'ANRS, Emerging Infectious Diseases'}, 'officialTitle': "Towards Improving Information, Testing and Treatment for Partners of People Diagnosed With STIs in Testing Centres and Sexual Health Clinics, the Not'IST Study", 'orgStudyIdInfo': {'id': "ANRS MIE Not'IST"}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Index patients', 'description': 'People aged 18 or more diagnosed with \\>= 1 STI in testing centers.\n\n\\[STI = bacterial STIs and/or HIV and/or acute hepatitis C virus (HCV)\\]', 'interventionNames': ['Other: 2 online self-administered questionnaires on']}, {'label': 'Notified partners', 'description': 'People aged 18 or more getting STI testing in testing centers after being notified by a sexual partner.\n\n\\[STI = bacterial STIs and/or HIV and/or acute HCV\\]', 'interventionNames': ['Other: 2 online self-administered questionnaires on']}], 'interventions': [{'name': '2 online self-administered questionnaires on', 'type': 'OTHER', 'description': '1. Participant profile\n2. Spontaneous partner notification practices collected one month after STIs diagnosis', 'armGroupLabels': ['Index patients']}, {'name': '2 online self-administered questionnaires on', 'type': 'OTHER', 'description': '1. Participant profile\n2. Experiences with partner notification and use of STI testing following notification', 'armGroupLabels': ['Notified partners']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Aix-en-Provence', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Dominique AYMAR-MOULENE, Dr', 'role': 'CONTACT', 'email': 'dominique.aymarmoulene@departement13.fr', 'phone': '04 13 31 84 69'}], 'facility': "CeGIDD d'Aix-en-Provence", 'geoPoint': {'lat': 43.5283, 'lon': 5.44973}}, {'city': 'Caen', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Caroline GALIMARD, Dr', 'role': 'CONTACT', 'email': 'cpmi@fondation-misericorde.fr', 'phone': '02 31 38 51 58'}], 'facility': 'CeGIDD de Caen', 'geoPoint': {'lat': 49.18585, 'lon': -0.35912}}, {'city': 'Lille', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Laetitia RANDOUX, Dr', 'role': 'CONTACT', 'email': 'laetitia.randoux@lenord.fr', 'phone': '03 59 73 69 80'}], 'facility': 'CeGIDD de Lille', 'geoPoint': {'lat': 50.63391, 'lon': 3.05512}}, {'city': 'Marseille', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Julie SAULE, Dr', 'role': 'CONTACT', 'email': 'julie.saule@departement13.fr', 'phone': '04 13 31 69 14'}], 'facility': 'CeGIDD - La Joliette', 'geoPoint': {'lat': 43.29695, 'lon': 5.38107}}, {'city': 'Marseille', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Jean-Luc ROBERT, Dr', 'role': 'CONTACT', 'email': 'jeanluc.robert@departement13.fr', 'phone': '04 13 31 56 78'}], 'facility': 'CeGIDD - Saint Adrien', 'geoPoint': {'lat': 43.29695, 'lon': 5.38107}}, {'city': 'Paris', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Jade GHOSN, Pr', 'role': 'CONTACT', 'email': 'jade.ghosn@aphp.fr', 'phone': '01 40 25 84 34'}], 'facility': 'CeGIDD de Bichât', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'city': 'Paris', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Gentiane MONSEL, Dr', 'role': 'CONTACT', 'email': 'gentiane.monsel@aphp.fr', 'phone': '01 42 17 70 12'}], 'facility': 'CeGIDD de La Pitié Salpêtrière', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'city': 'Paris', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Michel OHAYON, Dr', 'role': 'CONTACT', 'email': 'mohayon@le190.fr', 'phone': '01 55 25 32 72'}], 'facility': 'Centre de santé sexuelle - LE 190', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'city': 'Paris', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'William TOSINI, Dr', 'role': 'CONTACT', 'email': 'william.tosini@institutfournier.org', 'phone': '01 40 78 26 00'}], 'facility': 'Institut Alfred Fournier', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}], 'overallOfficials': [{'name': 'Jade Ghosn, Pr', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'IAME, Inserm UMR1137, Paris and Infectious diseases department, Bichat Hospital, Paris'}, {'name': 'Karen Champenois', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'IAME, Inserm UMR1137, Paris'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'ANRS, Emerging Infectious Diseases', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'SPONSOR'}}}}