Ignite Creation Date:
2025-12-25 @ 12:24 AM
Ignite Modification Date:
2025-12-28 @ 7:33 PM
Study NCT ID:
NCT05505058
Status:
COMPLETED
Last Update Posted:
2022-08-17
First Post:
2022-08-12
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
One-time Informed Consent for Research in Prison
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Cross-sectional study with parallel randomized design (allocation 1:1)'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 290}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-08', 'completionDateStruct': {'date': '2022-06-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-08-15', 'studyFirstSubmitDate': '2022-08-12', 'studyFirstSubmitQcDate': '2022-08-15', 'lastUpdatePostDateStruct': {'date': '2022-08-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-08-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-09-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Acceptance to sign the informed consent', 'timeFrame': 'Assessed immediately after intervention', 'description': 'Binary outcome, legal Swiss document'}], 'secondaryOutcomes': [{'measure': 'Understanding of the informed consent', 'timeFrame': 'Assessed immediately after intervention', 'description': 'Eight self-developed questions assessed as true/false and combined in a 0-8 points score'}, {'measure': 'Evaluation of the informed consent', 'timeFrame': 'Assessed immediately after intervention', 'description': 'Nine self-developed question assessed on a six-point Likert scale and averaged'}, {'measure': 'Time to read/watch', 'timeFrame': 'Assessed immediately after intervention', 'description': 'Time in minutes for reading the booklet (the video has a unique duration of 4 min)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Prison', 'Research ethics', 'Audio-visual intervention', 'Bioethics', 'Human rights'], 'conditions': ['Informed Consent']}, 'referencesModule': {'references': [{'pmid': '36219446', 'type': 'DERIVED', 'citation': 'Baggio S, Getaz L, Giraudier L, Tirode L, Urrutxi M, Carboni S, Britan A, Price RL, Wolff H, Heller P. Comparison of Audiovisual and Paper-Based Materials for 1-Time Informed Consent for Research in Prison: A Randomized Clinical Trial. JAMA Netw Open. 2022 Oct 3;5(10):e2235888. doi: 10.1001/jamanetworkopen.2022.35888.'}]}, 'descriptionModule': {'briefSummary': 'Ethical research on detained persons remains limited, including research on informed consent. This study aimed to fill in this research gap and compared audio-visual and paper-based materials for a one-time general informed consent for research in prison, using a randomized design. The primary outcome was whether participants sign the inform consent. Secondary outcomes included understanding, evaluation, and time to read/watch the informed consent.', 'detailedDescription': 'Detained persons constitute a very vulnerable and perhaps reluctant to share their medical data. In particular, it is crucial to ensure that these persons, deprived of their liberty, understand that their consent is voluntary and that a refusal will not have any consequence on their treatment or care. In other words, it is necessary to ensure that consent is informed. In a historical context of non-ethical research using detained persons, this is a crucial issue. However, while detained persons are now protected from various forms of abuse, this may have had the consequence of reducing research involving them, to the detriment of understanding their characteristics and vulnerabilities.\n\nA general consent for research will encourage research on prison populations by facilitating access to their medical data in order to study and reduce health disparities, for this population with multiple somatic and psychiatric comorbidities.\n\nOur main questions are:\n\nQ1. What is the acceptability rate of general consent for research in detained persons? Q2. What are the characteristics (socio-demographic and medical) of detained person who refuse to give their consent? Q3. Which material (paper-based or video) is more effective?\n\nTo answer these research question, we will use an exploratory randomized cross-sectional trial, conducted in an adult pre-trial prison and a juvenile detention center. Participants will be randomly assigned to read or watch information about informed consent, stratified on the prison. In both prisons, the study will take place in the prison medical unit.\n\nThis project is aimed to improve general consent, which contributes to reducing inequalities in documentation on health status, and ultimately, health inequalities.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '14 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* to be18 years old or more in the adult prison and 14 years old or more in the juvenile detention center\n* to be able to communicate in one of the languages of the study material\n* to agree to participate in this study.\n\nExclusion Criteria:\n\n* presence of an acute psychiatric problem preventing the person from participating in the study'}, 'identificationModule': {'nctId': 'NCT05505058', 'briefTitle': 'One-time Informed Consent for Research in Prison', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Geneva'}, 'officialTitle': 'One-time Informed Consent for Research in Prison: A Randomized Comparison Between Audio-visual and Written Materials', 'orgStudyIdInfo': {'id': '2019-01797'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Audio-visual material', 'description': "The video for informed consent was developed by a science filmmaker (https://www.lostlikebeesinrain.comhttps://betomation.space/) for the project's purposes.", 'interventionNames': ['Behavioral: Audio-visual material']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Paper-based conventional material', 'description': 'The written material for informed consent was developed by the Swiss Association of Research Ethic Committees and the booklet was designed by the Clinical Research Center of the Geneva University Hospitals.', 'interventionNames': ['Behavioral: Audio-visual material']}], 'interventions': [{'name': 'Audio-visual material', 'type': 'BEHAVIORAL', 'otherNames': ['Paper-based conventional material'], 'description': 'Participants were randomized to receive a paper-based conventional material or to watch a 4-min video. Materials both included legal information required by the Swiss Federal Act on Research involving Human Beings.', 'armGroupLabels': ['Audio-visual material', 'Paper-based conventional material']}]}, 'contactsLocationsModule': {'locations': [{'zip': '126', 'city': 'Geneva', 'country': 'Switzerland', 'facility': 'Division of prison health', 'geoPoint': {'lat': 46.20222, 'lon': 6.14569}}], 'overallOfficials': [{'name': 'Hans Wolff, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Division of Prison Health, Geneva University Hospitals'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'The datasets are not publicly available due their sensitive nature (detained persons) but are available from the corresponding author on reasonable request.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Geneva', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PD Dr.', 'investigatorFullName': 'Stéphanie Baggio', 'investigatorAffiliation': 'University Hospital, Geneva'}}}}