Ignite Creation Date:
2025-12-24 @ 7:24 PM
Ignite Modification Date:
2026-03-04 @ 7:03 AM
Study NCT ID:
NCT03661203
Status:
UNKNOWN
Last Update Posted:
2020-07-08
First Post:
2018-09-05
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Investigation of the Psychosocial Factors Responsible for the Late Recourse to HIV Testing Within MSM
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000163', 'term': 'Acquired Immunodeficiency Syndrome'}, {'id': 'D006679', 'term': 'HIV Seropositivity'}], 'ancestors': [{'id': 'D015658', 'term': 'HIV Infections'}, {'id': 'D000086982', 'term': 'Blood-Borne Infections'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'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': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D012897', 'term': 'Slow Virus Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D007153', 'term': 'Immunologic Deficiency Syndromes'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D017144', 'term': 'Focus Groups'}], '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': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1190}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2020-09', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-01', 'completionDateStruct': {'date': '2022-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-07-07', 'studyFirstSubmitDate': '2018-09-05', 'studyFirstSubmitQcDate': '2018-09-05', 'lastUpdatePostDateStruct': {'date': '2020-07-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-09-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Socio-representational elements associated with the very late use of the HIV test', 'timeFrame': '3 years', 'description': 'Imbrication of representations and tests related to HIV'}], 'secondaryOutcomes': [{'measure': 'Means of risk management', 'timeFrame': '3 years', 'description': 'Use of screening in the management of the risk of seroconversion'}, {'measure': 'Representation and Knowledge of prevention methods', 'timeFrame': '3 years', 'description': 'To understand the links between the different uses or non-uses of the biomedical prevention methods TasP (Treatment as Prevention), PrEP (Pre-Exposure Prohylaxis) and the methods of recourse to the screening test.'}, {'measure': 'Sense of community belonging', 'timeFrame': '3 years', 'description': 'Understand the interaction links between community belonging and the use of the screening test.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['MSM population', 'Hindrances HIV screening', 'Late recourse HIV test', 'Healt social psychology'], 'conditions': ['AIDS', 'HIV Seropositivity']}, 'referencesModule': {'references': [{'pmid': '36798044', 'type': 'DERIVED', 'citation': 'Mabire-Yon R, Di Ciaccio M, Picard H, Palich R, Supervie V, Preau M. Psychosocial factors involved in the very infrequent use of HIV testing among French MSM: a cross-sectional study. Int J STD AIDS. 2023 Aug;34(9):603-607. doi: 10.1177/09564624231155762. Epub 2023 Feb 16.'}]}, 'descriptionModule': {'briefSummary': 'The present study will try to investigate and analyze the psycho-social hindrances and levers concerning the recourse to late HIV testing among the MSM population.\n\nThis study is divided in two parts. The first one will consist of individual and groups interviews. Then, depending on the items that will rise from the first part of the study, groups interview will take place based on theses items. Finally, a questionnaire build from the collected information will be sent to MSM community in order to obtain quantitative results.', 'detailedDescription': 'The late recourse to HIV testing, among the population in general way and among MSM population in a more specific way, participates in the dissemination of the HIV epidemic. Actually, there is no cure for HIV infection, but treatments that reduce viral charge to undetectable level exists. When diagnosed and treated earlier, seropositive people will be less communicating the virus because of the reduction of their viral charge.\n\nThis study aims to uncover the reasons behind the late recourse to HIV testing in MSM population facing a high risk of contamination.\n\nThe study hypothesis, is that late recourse to HIV testing is probably related to social and economics factors like age, social standing, accessibility to the diagnosis or even to a traditional beliefs or a fear of stigma etc. To shed the light on these factors, the main objectives of the investigator will try to investigate and analyze the psycho-social hindrances and levers through a quantitative and qualitative approach. This plurality of approaches is a part of a methodological triangulation method described by Kalampalikis \\& Apostolidis, 2016.\n\nPeople among MSM community having had a late or very late HIV test (as defined by biological parameters :CD4≤200/mm3 or having been diagnosed with AIDS), will be recruited in this study. During the first phase of the study, the eligible population will participate to individual or group interview . This qualitative part of the project will allow the set up of a questionnaire that will be diffused widely to the MSM community to have quantitative results.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'genderBased': True, 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'MSM: men who have sex with men.', 'genderDescription': 'Self-determination', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* HIV-positive\n* Self-reported homo-or bisexual contamination mode\n* TCD4 + / mm3 200 200 lymphocyte count or Have an AIDS classifying event\n* Diagnosis of HIV positive for at least two months and for a maximum of 24 months\n\nExclusion Criteria:\n\n* Primary infection'}, 'identificationModule': {'nctId': 'NCT03661203', 'acronym': 'ReTarD', 'briefTitle': 'Investigation of the Psychosocial Factors Responsible for the Late Recourse to HIV Testing Within MSM', 'organization': {'class': 'OTHER_GOV', 'fullName': 'ANRS, Emerging Infectious Diseases'}, 'officialTitle': 'The Issue of Late Recourse to HIV Testing. A Study of the Psychosocial Factors at Play Within Men Who Have Sex With Men in France.', 'orgStudyIdInfo': {'id': 'ANRS ReTarD VIH'}, 'secondaryIdInfos': [{'id': '2018-A00825-50', 'type': 'OTHER', 'domain': 'French FDA Registration Number (ANSM)'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Qualitative cohort', 'description': 'The cohort consists of MSM with late HIV diagnosis. The person from this cohort will participate to round table called also focus group or individual interview.', 'interventionNames': ['Behavioral: Focus group', 'Behavioral: Individual interview', 'Behavioral: self questionnaire']}, {'label': 'Quantitative cohort', 'description': 'MSM community will be invited to participate to an online self questionnaire established from the information gathered from the previous cohort.', 'interventionNames': ['Behavioral: online self questionnaire']}], 'interventions': [{'name': 'Focus group', 'type': 'BEHAVIORAL', 'description': 'Focus group for qualitative group only', 'armGroupLabels': ['Qualitative cohort']}, {'name': 'Individual interview', 'type': 'BEHAVIORAL', 'description': 'Individual interview for qualitative group only', 'armGroupLabels': ['Qualitative cohort']}, {'name': 'online self questionnaire', 'type': 'BEHAVIORAL', 'description': 'online self questionnaire', 'armGroupLabels': ['Quantitative cohort']}, {'name': 'self questionnaire', 'type': 'BEHAVIORAL', 'description': 'online self questionnaire following focus group or individual interview For qualitative group only', 'armGroupLabels': ['Qualitative cohort']}]}, 'contactsLocationsModule': {'locations': [{'zip': '75003', 'city': 'Paris', 'country': 'France', 'contacts': [{'name': 'Michel Ohayon, DM', 'role': 'CONTACT', 'email': 'mohayon@le190.fr', 'phone': '+331 48 04 30 34'}], 'facility': 'Le 190', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '75012', 'city': 'Paris', 'country': 'France', 'contacts': [{'name': 'Jessica Krause, DM', 'role': 'CONTACT', 'email': 'jessica.krause@aphp.fr', 'phone': '+331 71 97 07 83'}], 'facility': 'Hopital Saint-Antoine', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '75651', 'city': 'Paris', 'country': 'France', 'contacts': [{'name': 'Romain Palich, DM', 'role': 'CONTACT', 'email': 'romain.palich@aphp.fr', 'phone': '+331.42.16.01.19'}], 'facility': 'Hôpital Pitié-Salpêtrière', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '75876', 'city': 'Paris', 'country': 'France', 'contacts': [{'name': 'Roland Landman, DM', 'role': 'CONTACT', 'email': 'landman.roland@gmail.com', 'phone': '+331 40 25 88 93'}], 'facility': 'Hôpital Bichat Claude-Bernard', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}], 'centralContacts': [{'name': 'Marie Préau, PR', 'role': 'CONTACT', 'email': 'marie.preau@univ-lyon2.fr', 'phone': '+33 4 78 77 31 63'}], 'overallOfficials': [{'name': 'Marie Préau, PR', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Université Lumière Lyon 2'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'French National Agency for Research on AIDS and Viral Hepatitis', 'class': 'OTHER_GOV'}, 'collaborators': [{'name': 'University of Lyon', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}