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Racial & Ethnic minority Acceleration Consortium for Health Equity (REACH) Response from Indigenous Innovators Collaborative

Award Number: U01FD007981
ORGANIZATION: FOOD AND DRUG ADMINISTRATION
OPDIV: FDA
AWARD CLASS: COOPERATIVE AGREEMENT
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 06/05/2023
PERIOD OF PERFORMANCE END DATE: 05/31/2028

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Racial & Ethnic minority Acceleration Consortium for Health Equity (REACH) Response from Indigenous Innovators Collaborative - Project Summary/Abstract 30 lines of text With a collaborative approach grounded in Indigenous core cultural values, the Indigenous Innovators Collaborative (IIC) team will engage in community-based participatory research study to address the FDA priorities as outlined in FDA OMHHE Health Equity Innovation Award: Racial and Ethnic Minority Acceleration Consortium for Health Equity (REACH) funding opportunity. The IIC seeks to engage American Indian and Alaska Native (AIAN) communities, stakeholders, researchers in an exploration of clinical trials and promote cultural knowledge in understanding clinical trials in Indian Country. The IIC consists of core partners that form the Administrative Core (AC) of this project, including: (1) Americans for Indian Opportunity (AIO), which serves as the fiscal agent/grant administrator; (2) Co-Investigator 1: Dr. Myra Parker (Three Affiliated Tribes), University of Washington; (3) Co-Investigator 2: Dr. Billie Jo Kipp (Blackfeet), Natives in Philanthropy; (4) Principle Investigator: Stephine Poston (Pueblo of Sandia), Poston & Associates, LLC; and, (5) the United Tribes Technical College (UTTC), an accredited, land-grant tribal college located in Bismarck, North Dakota, that serves the five reservations in ND and tribal members across the U.S. UTTC has provided higher education support to over 10,000 AI students from over 75 tribes. We propose to expand this effort to implement an exploratory study that would employ a mixed methods approach to improve understandings of AIAN perceptions of clinical trials and gene therapy across multiple regions of the U.S. Our aims include: 1. Specific Aim 1 – Partner with local tribal colleges to assess AIAN community knowledge, concerns, and beliefs about clinical trials and gene therapy within the 12 IHS regions using a mixed methods approach. a. Hypothesis 1 – AIAN community knowledge, concerns, and beliefs about clinical trials and gene therapy will vary across IHS regions and will reflect local tribal cultural understandings. 2. Specific Aim 2 – Identify barriers and supports for clinical trials and gene therapy among AIAN within the 12 IHS regions by collecting qualitative data from AIAN providers, researchers, and public health experts. a. Hypothesis 2 – Barriers and supports for clinical trials and gene therapy among AIAN will vary by IHS Region and tribal cultures.


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	AMERICANS FOR INDIAN OPPORTUNITY, INC.	1001 MARQUETTE AVE NW	ALBUQUERQUE	NM	87102	BERNALILLO	USA	Food and Drug Administration Research	001	2	11/29/2024	SUPPLEMENT FOR EXPANSION	$100,000
2025	2024	AMERICANS FOR INDIAN OPPORTUNITY, INC.	1001 MARQUETTE AVE NW	ALBUQUERQUE	NM	87102	BERNALILLO	USA	Food and Drug Administration Research	000	2	11/26/2024	NON-COMPETING CONTINUATION	$0
														Subtotal = $100,000

Issue Date FY: 2024 ( Subtotal = $450,000 )
2024	2024	AMERICANS FOR INDIAN OPPORTUNITY, INC.	1001 MARQUETTE AVE NW	ALBUQUERQUE	NM	87102	BERNALILLO	USA	Food and Drug Administration Research	002	2	5/20/2024	NON-COMPETING CONTINUATION	$50,000
2024	2024	AMERICANS FOR INDIAN OPPORTUNITY, INC.	1001 MARQUETTE AVE NW	ALBUQUERQUE	NM	87102	BERNALILLO	USA	Food and Drug Administration Research	003	2	7/11/2024	SUPPLEMENT FOR EXPANSION	$250,000
2024	2024	AMERICANS FOR INDIAN OPPORTUNITY, INC.	1001 MARQUETTE AVE NW	ALBUQUERQUE	NM	87102	BERNALILLO	USA	Food and Drug Administration Research	001	1	5/10/2024	SUPPLEMENT FOR EXPANSION	$50,000
2024	2024	AMERICANS FOR INDIAN OPPORTUNITY, INC.	1001 MARQUETTE AVE NW	ALBUQUERQUE	NM	87102	BERNALILLO	USA	Food and Drug Administration Research	005	2	9/19/2024	SUPPLEMENT FOR EXPANSION	$0
2024	2024	AMERICANS FOR INDIAN OPPORTUNITY, INC.	1001 MARQUETTE AVE NW	ALBUQUERQUE	NM	87102	BERNALILLO	USA	Food and Drug Administration Research	004	2	9/14/2024	SUPPLEMENT FOR EXPANSION	$100,000
2024	2023	AMERICANS INDIAN OPPORTUNITY	1001 MARQUETTE AVE NW	ALBUQUERQUE	NM	87102	BERNALILLO	USA	Food and Drug Administration Research	000	1	11/20/2023	NEW	$0
														Subtotal = $450,000

Issue Date FY: 2023 ( Subtotal = $825,000 )
2023	2023	AMERICANS INDIAN OPPORTUNITY	1001 MARQUETTE AVE NW	ALBUQUERQUE	NM	87102	BERNALILLO	USA	Food and Drug Administration Research	001	1	8/1/2023	SUPPLEMENT FOR EXPANSION	$325,000
2023	2023	AMERICANS INDIAN OPPORTUNITY	1001 MARQUETTE AVE NW	ALBUQUERQUE	NM	87102	BERNALILLO	USA	Food and Drug Administration Research	002	1	8/28/2023	SUPPLEMENT FOR EXPANSION	$0
2023	2023	AMERICANS INDIAN OPPORTUNITY	1001 MARQUETTE AVE NW	ALBUQUERQUE	NM	87102	BERNALILLO	USA	Food and Drug Administration Research	000	1	6/13/2023	NEW	$500,000
														Subtotal = $825,000

Grand Total All Awards = $1,375,000

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Racial & Ethnic minority Acceleration Consortium for Health Equity (REACH) Response from Indigenous Innovators Collaborative

Award Number: U01FD007981

ORGANIZATION: FOOD AND DRUG ADMINISTRATION

OPDIV: FDA

AWARD CLASS: COOPERATIVE AGREEMENT

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

PERIOD OF PERFORMANCE START DATE: 06/05/2023

PERIOD OF PERFORMANCE END DATE: 05/31/2028

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