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Center for Advancing COVID-19 health Equity Research

Award Number: U01FD007571
ORGANIZATION: FOOD AND DRUG ADMINISTRATION
OPDIV: FDA
AWARD CLASS: COOPERATIVE AGREEMENT
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 04/01/2022
PERIOD OF PERFORMANCE END DATE: 03/07/2025

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Center for Advancing COVID-19 health Equity Research - PROJECT SUMMARY Minority enrollment in clinical trials is essential as it allows scientists to evaluate the safety and efficacy of medical products, including medications, vaccines, and devices within these genetically/ethnically diverse populations. Despite this, minority participation in clinical trials remains low. The overall goal of this grant proposal is to investigate possible causes of low enrollment of racial and ethnic minority populations in COVID-19/COVID-19 variant clinical trials and determine solutions to overcome low enrollment. Over the years, the College of Pharmacy and Pharmaceutical Sciences, Institute of Public Health has developed strong collaborative relationships with organizations such as Northeast Florida Medical Society, William Gunn’s Medical Society, Turner Alliance Consulting, and East Coast Research Institute. In this proposed investigation, we will partner with these organizations to focus on three specific aims 1) Identify the major gaps in the local communities that contribute to the low enrollment of racial and ethnic minority populations in COVID-19 clinical trials, 2) Develop, pilot, and evaluate a community- based targeted strategy to actively improve the enrollment of the racial and ethnic minority population in local COVID-19 clinical trials and 3) Provide Clinical Research Fastrack training for 30 minority healthcare providers and workers in three geographic areas (Jacksonville, Tampa, Tallahassee, FL). The investigators will conduct qualitative interviews with the community, healthcare providers, and community leaders to discuss strategies/education methods to increase enrollment for minority populations in clinical trials and identify health advisors/ambassadors to conduct educational sessions for the community focusing on COVID-19 clinical trials. A website containing clinical trial information and frequently asked questions will be developed along with billboards with website information. The expected outcome of this proposed study is to identify the possible causes of low enrollment of racial and ethnic minority populations in COVID- 19/COVID-19 variant clinical trials. Our major goal is to develop a workable model to increase awareness and participation of minorities in COVID-19/COVID-19 variant clinical research trials.


Issue Date FY	Funding FY	Legal Entity Name	Legal Entity Address	Legal Entity City	Legal Entity State	Legal Entity Zip Code	Legal Entity COUNTY	Legal Entity COUNTRY	Assistance Listing	Award Code	Budget Year	Action Date	Action Type	Action Amount

Issue Date FY: 2026 ( Subtotal = -$1,959 )
2026	2022	FLORIDA A & M UNIVERSITY	1700 LEE HALL DR #201	TALLAHASSEE	FL	32307	LEON	USA	Food and Drug Administration Research	000	1	12/30/2025	NEW	-$1,959
														Subtotal = -$1,959

Issue Date FY: 2024 ( Subtotal = $0 )
2024	2022	FLORIDA A & M UNIVERSITY	1700 LEE HALL DR #201	TALLAHASSEE	FL	32307	LEON	USA	Food and Drug Administration Research	001	1	9/18/2024	NEW	$0
2024	2022	FLORIDA A & M UNIVERSITY	1700 LEE HALL DR #201	TALLAHASSEE	FL	32307	LEON	USA	Food and Drug Administration Research	000	1	2/21/2024	NEW	$0
														Subtotal = $0

Issue Date FY: 2023 ( Subtotal = $0 )
2023	2022	FLORIDA A & M UNIVERSITY	1500 WAHNISH WAY	TALLAHASSEE	FL	32307	LEON	USA	Food and Drug Administration Research	000	1	6/21/2023	NEW	$0
2023	2022	FLORIDA A & M UNIVERSITY	1500 WAHNISH WAY	TALLAHASSEE	FL	32307	LEON	USA	Food and Drug Administration Research	001	1	6/29/2023	NEW	$0
														Subtotal = $0

Issue Date FY: 2022 ( Subtotal = $707,280 )
2022	2022	FLORIDA A & M UNIVERSITY	1500 WAHNISH WAY	TALLAHASSEE	FL	32307	LEON	USA	Food and Drug Administration Research	000	1	3/15/2022	NEW	$707,280
														Subtotal = $707,280

Grand Total All Awards = $705,321

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Center for Advancing COVID-19 health Equity Research

Award Number: U01FD007571

ORGANIZATION: FOOD AND DRUG ADMINISTRATION

OPDIV: FDA

AWARD CLASS: COOPERATIVE AGREEMENT

AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

PERIOD OF PERFORMANCE START DATE: 04/01/2022

PERIOD OF PERFORMANCE END DATE: 03/07/2025

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