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Elevating Community Voices by Developing a User-centered Approach to Enable Self-testing and Remote Data Collection among Under-represented Populations (Project Elevate)

Award Number: U01FD007976
ORGANIZATION: FOOD AND DRUG ADMINISTRATION
OPDIV: FDA
AWARD CLASS: COOPERATIVE AGREEMENT
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 06/01/2023
PERIOD OF PERFORMANCE END DATE: 05/31/2028

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Elevating Community Voices by Developing a User-centered Approach to Enable Self-testing and Remote Data Collection among Under-represented Populations (Project Elevate) - PROJECT SUMMARY The advent of remote technologies such as video conferencing and secure web-portals have revolutionized approaches to health data collection and access to healthcare. For example, these technologies can be deployed in fully remote and hybrid approaches for clinical trials which could help promoting more participation among under-represented groups as well as by bridging geographic distance and reducing participant burden (e.g., less travel time, more flexibility and confidentiality). Remote or online approaches can also increase access to critical services (e.g., mental health counseling, sexually transmitted testing [STI] prevention) that are scarce or geographically dispersed. However, these approaches have yet to be optimized for all possible beneficiaries of technological advances in clinical trials and healthcare, especially targeting under-represented populations that are disproportionately experiencing social and geographic isolation. Groups like Asian American and Pacific Islander (AAPI – including Native Hawaiian), American Indian (AI) and Hispanic/Latino populations are often under-represented in clinical trials, so much so that they often occupy the racial/ethnic category of “other” in research studies. Notably, their under-representation not only leads to this literal “othering,” but also prevents scientists from identifying their unique concerns which in turn diminishing the relevance and effectiveness of technologies and distribution campaigns among them. Sexual and gender minorities (SGM) such as gay, lesbian, bisexual, and transgender populations are also often not strategically sampled for clinical trials, and SGM identities are often not even measured in clinical trials. But many health concerns addressed in clinical trials are over-represented in SGM populations compared to general populations (e.g., HIV, STIs, mental health concerns), thus, making many novel health technologies (vaccines, antibiotics, hormonal therapies) disproportionately relevant to these populations. SGM populations may experience social isolation at increased rates relative to the general population, which can be further exacerbated by medical mistrust and stigmatizing experiences in healthcare and research contexts. To address these concerns, the current proposal seeks to leverage the team’s existing community connections in states across 4 different regions of the U.S. among the aforementioned groups to: (1) (a) co- create and maintain 4 virtual and hybrid advisory groups to address health issues and (b) develop materials for the conduct of remote advisory groups; (2) co-develop and administer a national needs assessment survey for the referenced 4 groups (N = 800) addressing the use of home self-testing technology (up to 3 types) and remote data collection for healthcare research and healthcare provision; and (3) pilot a community driven approach to introducing home self-testing technology and remote data collection to potential participants from these groups to assess feasibility and acceptability.


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 = $100,000 )
2025	2025	FLORIDA STATE UNIVERSITY	874 TRADITIONS WAY	TALLAHASSEE	FL	32306	LEON	USA	Food and Drug Administration Research	000	2	11/25/2024	SUPPLEMENT FOR EXPANSION	$100,000
2025	2024	FLORIDA STATE UNIVERSITY	874 TRADITIONS WAY	TALLAHASSEE	FL	32306	LEON	USA	Food and Drug Administration Research	001	2	11/26/2024	NON-COMPETING CONTINUATION	$0
2025	2024	FLORIDA STATE UNIVERSITY	874 TRADITIONS WAY	TALLAHASSEE	FL	32306	LEON	USA	Food and Drug Administration Research	002	2	9/17/2025	NON-COMPETING CONTINUATION	$0
														Subtotal = $100,000

Issue Date FY: 2024 ( Subtotal = $450,000 )
2024	2024	FLORIDA STATE UNIVERSITY	874 TRADITIONS WAY	TALLAHASSEE	FL	32306	LEON	USA	Food and Drug Administration Research	002	2	8/13/2024	SUPPLEMENT FOR EXPANSION	$0
2024	2024	FLORIDA STATE UNIVERSITY	874 TRADITIONS WAY	TALLAHASSEE	FL	32306	LEON	USA	Food and Drug Administration Research	001	2	6/27/2024	SUPPLEMENT FOR EXPANSION	$300,000
2024	2024	FLORIDA STATE UNIVERSITY	874 TRADITIONS WAY	TALLAHASSEE	FL	32306	LEON	USA	Food and Drug Administration Research	000	2	12/29/2023	NON-COMPETING CONTINUATION	$50,000
2024	2024	FLORIDA STATE UNIVERSITY	874 TRADITIONS WAY	TALLAHASSEE	FL	32306	LEON	USA	Food and Drug Administration Research	003	2	9/14/2024	SUPPLEMENT FOR EXPANSION	$100,000
														Subtotal = $450,000

Issue Date FY: 2023 ( Subtotal = $500,000 )
2023	2023	FLORIDA STATE UNIVERSITY	874 TRADITIONS WAY	TALLAHASSEE	FL	32306	LEON	USA	Food and Drug Administration Research	000	1	5/19/2023	NEW	$500,000
														Subtotal = $500,000

Grand Total All Awards = $1,050,000

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Elevating Community Voices by Developing a User-centered Approach to Enable Self-testing and Remote Data Collection among Under-represented Populations (Project Elevate)

Award Number: U01FD007976

ORGANIZATION: FOOD AND DRUG ADMINISTRATION

OPDIV: FDA

AWARD CLASS: COOPERATIVE AGREEMENT

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

PERIOD OF PERFORMANCE START DATE: 06/01/2023

PERIOD OF PERFORMANCE END DATE: 05/31/2028

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