Willingness to Participate in Clinical Trials Among Black and African Americans

President and Fellows of Harvard College

Status: Completed

Conditions: Researcher-Subject Relations

Treatments: Behavioral: Black Respondents Exposure to a Photo

Study type: Interventional

Funder types: Other

Identifiers

NCT04938895

IRB21-0864

Details and patient eligibility

About

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.

Full 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.

Enrollment: 323 patients

Sex: All

Ages: 25 to 64 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Single Blind

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323 participants in 4 patient groups

Black Woman Investigator

Experimental group

Description:

Survey respondents are exposed to a Black woman investigator.

Treatment:

Behavioral: Black Respondents Exposure to a Photo

Black Man Investigator

Experimental group

Description:

Survey respondents are exposed to a Black man investigator.

Treatment:

Behavioral: Black Respondents Exposure to a Photo

White Woman Investigator

Experimental group

Description:

Survey respondents are exposed to a white woman investigator.

Treatment:

Behavioral: Black Respondents Exposure to a Photo

White Man Investigator

Experimental group

Description:

Survey respondents are exposed to a white man investigator.

Treatment:

Behavioral: Black Respondents Exposure to a Photo