Ignite Creation Date:
2025-12-25 @ 2:09 AM
Ignite Modification Date:
2025-12-28 @ 9:50 PM
Study NCT ID:
NCT04655560
Status:
COMPLETED
Last Update Posted:
2021-09-28
First Post:
2020-11-13
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Understanding Barriers and Facilitators to the Participation of Women Living With HIV in Clinical Trials : a Mixed-method Study (EVA)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2024-09-17', 'releaseDate': '2024-05-08'}, {'resetDate': '2025-01-22', 'releaseDate': '2024-12-04'}], 'estimatedResultsFirstSubmitDate': '2024-05-08'}}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-12-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-09', 'completionDateStruct': {'date': '2021-04-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-09-27', 'studyFirstSubmitDate': '2020-11-13', 'studyFirstSubmitQcDate': '2020-12-04', 'lastUpdatePostDateStruct': {'date': '2021-09-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-12-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-04-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Evaluation of barriers and facilitators to the participation of women in clinical trials (HIV) through a questionnaire', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'Specific questions will be asked during a face-to-face interview to identify factors favoring or barriers to the participation of women in clinical trials.'}, {'measure': 'Evaluation of mechanisms leading to refusal of trial participation through a questionnaire', 'timeFrame': 'through study completion, an average of 1 year', 'description': "Specific questions will be asked during a face-to-face interview to understand mechanisms leading to refusal of trial participation.\n\nSpecifically, psychosocial factors and/or cultural environments that enhance or undermine HIV-positive cisgender women's participation. These can include social inclusion, confidence in research, perceived personal vulnerability, cultural, familial and professional environment."}], 'secondaryOutcomes': [{'measure': 'Offering solutions for a better inclusion of HIV-women in clinical trials - qualitative study', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'Analysis of questionnaires allowing recommendations to be made'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['HIV', 'Clinical trials', 'Women', 'qualitative study'], 'conditions': ['HIV']}, 'descriptionModule': {'briefSummary': "To identify the most important barriers and facilitators to the participation of cisgender women living with HIV in clinical trials (perceived and real) and to establish possible mechanisms leading to refusal of trial participation. Specifically, psychosocial factors and/or cultural environments that enhance or undermine HIV-positive cisgender women's participation. These can include social inclusion, confidence in research, perceived personal vulnerability, cultural, familial and professional environment.\n\nThe investigators expect to propose pragmatic solutions to enhance participation of HIV-positive cisgender women in clinical trials."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': "Women living with HIV\n\nNote: ethnicity will not represent a selection's criteria. However, special care will be payed to assure a certain heterogeneity in the sample concerning this aspect.", 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Cisgender women\n* Adult (\\>18 years) HIV-infected\n* Informed consent documented by signature\n* Patients under stable antiretroviral therapy\n* French speaking (sufficient fluency for a conversation)\n\nExclusion Criteria:\n\n* Having participated in a previous qualitative study about Cure Trials acceptability among HIV patients\n* Incapable of discernment'}, 'identificationModule': {'nctId': 'NCT04655560', 'acronym': 'EVA', 'briefTitle': 'Understanding Barriers and Facilitators to the Participation of Women Living With HIV in Clinical Trials : a Mixed-method Study (EVA)', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Geneva'}, 'officialTitle': 'Understanding Barriers and Facilitators to the Participation of Women Living With HIV in Clinical Trials : a Mixed-method Study (EVA)', 'orgStudyIdInfo': {'id': '2020-02286'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Women living with HIV', 'interventionNames': ['Other: no intervention']}], 'interventions': [{'name': 'no intervention', 'type': 'OTHER', 'description': 'qualitative study', 'armGroupLabels': ['Women living with HIV']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1205', 'city': 'Geneva', 'country': 'Switzerland', 'facility': 'Hôpitaux Universitaires de Genève', 'geoPoint': {'lat': 46.20222, 'lon': 6.14569}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Geneva', 'class': 'OTHER'}, 'collaborators': [{'name': 'Merck Sharp & Dohme LLC', 'class': 'INDUSTRY'}, {'name': 'Center for Primary Care and Public Health (Unisante), University of Lausanne, Switzerland', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Calmy Alexandra', 'investigatorAffiliation': 'University Hospital, Geneva'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2024-05-08', 'type': 'RELEASE'}, {'date': '2024-09-17', 'type': 'RESET'}, {'date': '2024-12-04', 'type': 'RELEASE'}, {'date': '2025-01-22', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Calmy Alexandra, Professor, University Hospital, Geneva'}}}}