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Co-creation of digital tools to enhance young adult minority participation in COVID-19 trials

Award Number: U01FD007558
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: 12/31/2024

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Co-creation of digital tools to enhance young adult minority participation in COVID-19 trials - PROJECT SUMMARY/ABSTRACT Increasing young adult racial and ethnic minorities’ participation in COVID-19 clinical trials is an essential component of reducing health disparities in the uptake of COVID-19 vaccinations and treatment burden. Yet, several obstacles hinder racial/ethnic minority participation in trials, including structural barriers associated with lack of financial resources, access and transportation issues, and group-specific issues such as mistrust of the medical/research community or concerns about medical experimentation. Although extensive research has focused on addressing the low participation of minority and underrepresented communities in clinical research, meeting 21st century goals of creating inclusive clinical trials that are representative of rapidly changing and increasingly diverse patient demographics in the United States remains a significant challenge. The proposed project is novel and fills a critical research and innovation gap by directly addressing the complex intersectionality of COVID-19 clinical trials and health equity using several interdisciplinary methods of inquiry. The objective of the proposed project is to utilize novel approaches involving big data, machine learning, data science, and community-driven qualitative research to develop and evaluate a digital tool to encourage young minority adults to participate in the clinical trial process. Through data mining and geospatial analysis of ClinicalTrials.gov, insights into which communities in the United States are underrepresented in the context of access to COVID- 19 clinical trials will be developed (Aim 1), while big data and machine learning approaches will be used to characterize user self-reported knowledge, attitudes, and lived experiences related to COVID-19 on social media platforms (Aim 2). Focus group discussions will be used to engage in deep exploration of specific rationalities, cultural norms, and historical influences related to COVID-19 clinical research engagement with minority young adults (Aim 3). Data collected from these multiple sources will serve as the basis of a protocol to ideate, co- create, and jointly design a digital health tool to encourage clinical trial participation among young adult minority populations through co-design sessions and pilot testing held with racial/ethnic minority young adults (Aim 4). The efficacy of the digital health tool will be evaluated by conducting a controlled before-and-after study among a population of young adult college students at a university designated as a Minority Serving Institution (Aim 5). The proposed project will result in a digital health tool designed to increase young adult participation in COVID- 19 clinical 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: 2025 ( Subtotal = -$63 )
2025	2022	CSU FULLERTON AUXILIARY SERVICES CORPORATION	1121 N STATE COLLEGE BLVD	FULLERTON	CA	92831	ORANGE	USA	Food and Drug Administration Research	000	1	10/30/2024	NEW	$0
2025	2022	CSU FULLERTON AUXILIARY SERVICES CORPORATION	1121 N STATE COLLEGE BLVD	FULLERTON	CA	92831	ORANGE	USA	Food and Drug Administration Research	001	1	7/8/2025	NEW	-$63
														Subtotal = -$63

Issue Date FY: 2024 ( Subtotal = $0 )
2024	2022	CSU FULLERTON AUXILIARY SERVICES CORPORATION	1121 N STATE COLLEGE BLVD	FULLERTON	CA	92831	ORANGE	USA	Food and Drug Administration Research	000	1	3/18/2024	NEW	$0
														Subtotal = $0

Issue Date FY: 2022 ( Subtotal = $968,302 )
2022	2022	CSU FULLERTON AUXILIARY SERVICES CORPORATION	1121 NORTH STATE COLLEGE BOULEVARD	FULLERTON	CA	92831	ORANGE	USA	Food and Drug Administration Research	000	1	3/15/2022	NEW	$968,302
														Subtotal = $968,302

Grand Total All Awards = $968,239

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Co-creation of digital tools to enhance young adult minority participation in COVID-19 trials

Award Number: U01FD007558

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: 12/31/2024

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