Willingness to Participate in Clinical Trials Among Black and African Americans

Researcher-Subject Relations Clinical Trial

Official title:

Willingness to Participate in Clinical Trials Among Black and African Americans

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04938895
• Other study ID #: IRB21-0864
• Status: Completed
• Phase: N/A
• Start date: June 7, 2021
• Est. completion date: February 21, 2022

Study information

• Verified date: May 2023
• Source: Harvard University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 323
• Est. completion date: February 21, 2022
• Est. primary completion date: February 21, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 25 Years to 64 Years

Eligibility

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

Related Conditions & MeSH terms

• Researcher-Subject Relations

Intervention

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.

Locations

Country	Name	City	State
United States	Harvard University	Cambridge	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Harvard University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Willingness to Participate in a Clinical Trial	Survey respondents' willingness to participate in a vaccine clinical trial led by the person in the photo.	February 17, 2022 - February 19, 2022