Willingness to Participate in Clinical Trials Among Black and African Americans

• ClinicalTrials.gov Identifier: NCT04938895
• Recruitment Status: Completed
• First Posted: June 24, 2021
• Last Update Posted: May 19, 2023
• Sponsor: Harvard University
• Information provided by (Responsible Party): Marcella Alsan, Harvard University

Study Description

Brief Summary:

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.

Condition or disease	Intervention/treatment	Phase
Researcher-Subject Relations	Behavioral: Black Respondents Exposure to a Photo	Not Applicable

Detailed Description:

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.

Our 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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 323 participants
• Allocation: Randomized
• Intervention Model: Sequential Assignment
• Masking: Single (Participant)
• Primary Purpose: Health Services Research
• Official Title: Willingness to Participate in Clinical Trials Among Black and African Americans
• Actual Study Start Date: June 7, 2021
• Actual Primary Completion Date: February 21, 2022
• Actual Study Completion Date: February 21, 2022

Arms and Interventions

Arm	Intervention/treatment
Experimental: Black Woman Investigator; Survey respondents are exposed to a Black woman investigator.	Behavioral: Black Respondents Exposure to a Photo; 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.
Experimental: Black Man Investigator; Survey respondents are exposed to a Black man investigator.	Behavioral: Black Respondents Exposure to a Photo; 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.
Experimental: White Woman Investigator; Survey respondents are exposed to a white woman investigator.	Behavioral: Black Respondents Exposure to a Photo; 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.
Experimental: White Man Investigator; Survey respondents are exposed to a white man investigator.	Behavioral: Black Respondents Exposure to a Photo; 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.

Outcome Measures

Primary Outcome Measures :

1. Willingness to Participate in a Clinical Trial [ Time Frame: February 17, 2022 - February 19, 2022 ]
   Survey respondents' willingness to participate in a vaccine clinical trial led by the person in the photo.

Eligibility Criteria

• Ages Eligible for Study: 25 Years to 64 Years (Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

Inclusion Criteria:

• participant identifies as Black or White

Exclusion Criteria:

• participant doesn't identify as Black or White
• younger than 25 years old, older than 64

Contacts and Locations

Locations

United States, Massachusetts

Harvard University

Cambridge, Massachusetts, United States, 02138

Sponsors and Collaborators

Harvard University

Investigators

• Principal Investigator: Marcella Alsan, MD,PhD; Harvard University

More Information

• Responsible Party: Marcella Alsan, Professor of Public Policy, Harvard University
• ClinicalTrials.gov Identifier: NCT04938895
• Other Study ID Numbers: IRB21-0864
• First Posted: June 24, 2021
• Last Update Posted: May 19, 2023
• Last Verified: May 2023

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No