NCT04938895

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
323

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 7, 2021

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

June 22, 2021

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 24, 2021

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 21, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 21, 2022

Completed
Last Updated

May 19, 2023

Status Verified

May 1, 2023

Enrollment Period

9 months

First QC Date

June 22, 2021

Last Update Submit

May 17, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (4)

Black Woman Investigator

EXPERIMENTAL

Survey respondents are exposed to a Black woman investigator.

Behavioral: Black Respondents Exposure to a Photo

Black Man Investigator

EXPERIMENTAL

Survey respondents are exposed to a Black man investigator.

Behavioral: Black Respondents Exposure to a Photo

White Woman Investigator

EXPERIMENTAL

Survey respondents are exposed to a white woman investigator.

Behavioral: Black Respondents Exposure to a Photo

White Man Investigator

EXPERIMENTAL

Survey respondents are exposed to a white man investigator.

Behavioral: Black Respondents Exposure to a Photo

Interventions

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.

Black Man InvestigatorBlack Woman InvestigatorWhite Man InvestigatorWhite Woman Investigator

Eligibility Criteria

Age25 Years - 64 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • participant identifies as Black or White

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Harvard University

Cambridge, Massachusetts, 02138, United States

Location

Study Officials

  • Marcella Alsan, MD,PhD

    Harvard University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SEQUENTIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Public Policy

Study Record Dates

First Submitted

June 22, 2021

First Posted

June 24, 2021

Study Start

June 7, 2021

Primary Completion

February 21, 2022

Study Completion

February 21, 2022

Last Updated

May 19, 2023

Record last verified: 2023-05

Locations