Ignite Creation Date:
2025-12-24 @ 2:14 PM
Ignite Modification Date:
2026-01-09 @ 4:25 AM
Study NCT ID:
NCT04938895
Status:
COMPLETED
Last Update Posted:
2023-05-19
First Post:
2021-06-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Willingness to Participate in Clinical Trials Among Black and African Americans
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 323}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-06-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-05', 'completionDateStruct': {'date': '2022-02-21', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-05-17', 'studyFirstSubmitDate': '2021-06-22', 'studyFirstSubmitQcDate': '2021-06-22', 'lastUpdatePostDateStruct': {'date': '2023-05-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-06-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-02-21', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Willingness to Participate in a Clinical Trial', 'timeFrame': 'February 17, 2022 - February 19, 2022', 'description': "Survey respondents' willingness to participate in a vaccine clinical trial led by the person in the photo."}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Researcher-Subject Relations']}, 'descriptionModule': {'briefSummary': "Despite significant racial disparities in health outcomes, racial minority groups in the United States are not adequately represented in clinical trials, and clinical trial results published in major medical journals often underreport racial demographic data of participants. Lack of diversity in clinical trials threatens the generalizability of study results and reduces the ability of minority groups to benefit from medical advancement and innovation. Prior studies show that Black men are more likely to engage in preventive services when there is racial concordance with their healthcare provider. There is minimal literature about how racial concordance or diversity in clinical trial leadership impacts study enrollment. This project examines whether patients' willingness to participate in randomized clinical trials differs based on the characteristics of the investigator.", 'detailedDescription': "We plan to recruit subjects and randomly assign them to one of four treatments. In each treatment arm, the subject will view a photograph of a real NIH investigator. We experimentally vary treatment along two dimensions: whether the sender is Black or white and whether the sender is male or female.\n\nOur primary aim is to assess whether the subject's stated willingness to participate in a clinical trial led by the investigator. Our secondary aim is to assess whether the subject is a more objective measure of interest in signing up for information on other clinical trials. To assess mechanisms, we will ask the respondent to rate the subject's perceived trustworthiness and quality of the investigator. In addition, we will also assess the subject's perceived attractiveness and age of the investigator as well as the subject's risk aversion, altruism, time preference, and general trust."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '64 Years', 'minimumAge': '25 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* participant identifies as Black or White\n\nExclusion Criteria:\n\n* participant doesn't identify as Black or White\n* younger than 25 years old, older than 64"}, 'identificationModule': {'nctId': 'NCT04938895', 'briefTitle': 'Willingness to Participate in Clinical Trials Among Black and African Americans', 'organization': {'class': 'OTHER', 'fullName': 'Harvard University'}, 'officialTitle': 'Willingness to Participate in Clinical Trials Among Black and African Americans', 'orgStudyIdInfo': {'id': 'IRB21-0864'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Black Woman Investigator', 'description': 'Survey respondents are exposed to a Black woman investigator.', 'interventionNames': ['Behavioral: Black Respondents Exposure to a Photo']}, {'type': 'EXPERIMENTAL', 'label': 'Black Man Investigator', 'description': 'Survey respondents are exposed to a Black man investigator.', 'interventionNames': ['Behavioral: Black Respondents Exposure to a Photo']}, {'type': 'EXPERIMENTAL', 'label': 'White Woman Investigator', 'description': 'Survey respondents are exposed to a white woman investigator.', 'interventionNames': ['Behavioral: Black Respondents Exposure to a Photo']}, {'type': 'EXPERIMENTAL', 'label': 'White Man Investigator', 'description': 'Survey respondents are exposed to a white man investigator.', 'interventionNames': ['Behavioral: Black Respondents Exposure to a Photo']}], 'interventions': [{'name': 'Black Respondents Exposure to a Photo', 'type': 'BEHAVIORAL', 'description': "Black survey respondents will be randomly assigned to one of four treatments. In each treatment arm, the subject will view a photo of an NIH investigator. We experimentally vary treatment along two dimensions: whether the investigator is a man v. woman and whether the man is white vs. black. We will survey participants' willingness to participate in a clinical trial and how their initial response is impacted by other characteristics such as perceived trustworthiness and quality.", 'armGroupLabels': ['Black Man Investigator', 'Black Woman Investigator', 'White Man Investigator', 'White Woman Investigator']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02138', 'city': 'Cambridge', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Harvard University', 'geoPoint': {'lat': 42.3751, 'lon': -71.10561}}], 'overallOfficials': [{'name': 'Marcella Alsan, MD,PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Harvard University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Harvard University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Public Policy', 'investigatorFullName': 'Marcella Alsan', 'investigatorAffiliation': 'Harvard University'}}}}