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Integrating Genomic Risk Assessment for Chronic Disease Management in a Diverse Population

Award Number: U01HG011167
ORGANIZATION: NATIONAL HUMAN GENOME RESEARCH INSTITUTE
OPDIV: NIH
AWARD CLASS: COOPERATIVE AGREEMENT
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 07/01/2020
PERIOD OF PERFORMANCE END DATE: 04/30/2025

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Integrating Genomic Risk Assessment for Chronic Disease Management in a Diverse Population - Abstract In the United States, 60% of adults have a chronic disease and 40% have two or more. Collectively these diseases are the leading causes of death and disability accounting for >90% of our nation’s $3.3 trillion annual health care costs. Genome-wide association studies (GWAS) have identified genetic underpiinings of disease and enabled the development of polygenic risk scores (PRS) that may help to predict the occurrence and progression of common dieases. Working with the eMERGE team, we will select the fifteen diseases of public health impact. For these diseases, we will finalize the PRS to be adopted including adaptations (if any) for minority race groups, the genotyping array, the family history (FHx) tool and key clinical variables to be used in calculating genomic risk estimates (GRE). We will identify GRE thresholds at which genomic risk assessment (GRA) with risk reduction recommendations (RRR) in concordance with practice guidelines. To strengthen the evaluation of race-specific PRS, we bring an additional cohort of 30,0000 AAs. We will conduct a pilot ethical legal social implications study, to explore patient perspectives on use of FHx and PRS for estimating disease risk among Alabama Genomic Health Initiative (a state wide cohort) participants. The results will inform the development of consent, educational materials and a communication strategy to enhance recruitment and retention of eMERGE participants. We will prospectively recruit 2,500 patients with >75% patients from medically underserved communities, incorporate PRS, FHX and clinical data to compute GRE for the selected fifteen diseases for all patients. For high-risk patients, where GRE exceeds pre-specified thresholds (n~ 5000 of the 20,000 recruited across the network), deploy clinical decision support (CDS) and present the GRA and RRR. We expect ≥50% uptake of RRRs. We will assess whether the uptake of GRA-RRR improve outcomes. We will assess three outcomes: uptake of GRA-RRR (implementation outcome), adherence to clinic visits (engagement outcome), and surrogates of disease / control (clinical outcome; e.g. blood sugar, cholesterol). Although research has identified genomic signatures of common diseases, genomic risk assessments to identify, and if appropriate, pre-treat at-risk patients have not been implemented in clinical care. This is the vital first step to leverage the power of genomics to prevent disease. We bring our expertise and experience to collaborate with the eMERGE investigative team to take this vital first step.


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: 2024 ( Subtotal = $1,082,151 )
2024	2024	UNIVERSITY OF ALABAMA AT BIRMINGHAM	701 S 20TH STREET	BIRMINGHAM	AL	35294	JEFFERSON	USA	Human Genome Research	003	5	6/14/2024	NON-COMPETING CONTINUATION	$0
2024	2024	UNIVERSITY OF ALABAMA AT BIRMINGHAM	701 S 20TH STREET	BIRMINGHAM	AL	35294	JEFFERSON	USA	Human Genome Research	002	5	5/29/2024	NON-COMPETING CONTINUATION	$88,337
2024	2024	UNIVERSITY OF ALABAMA AT BIRMINGHAM	701 S 20TH STREET	BIRMINGHAM	AL	35294	JEFFERSON	USA	Human Genome Research	001	5	4/24/2024	NON-COMPETING CONTINUATION	$993,814
2024	2023	UNIVERSITY OF ALABAMA AT BIRMINGHAM	701 S 20TH STREET	BIRMINGHAM	AL	35294	JEFFERSON	USA	Human Genome Research	000	4	4/12/2024	NON-COMPETING CONTINUATION	$0
														Subtotal = $1,082,151

Issue Date FY: 2023 ( Subtotal = $1,824,589 )
2023	2023	UNIVERSITY OF ALABAMA AT BIRMINGHAM	701 S 20TH ST	BIRMINGHAM	AL	35294	JEFFERSON	USA	Human Genome Research	002	4	5/26/2023	NON-COMPETING CONTINUATION	$1,484,587
2023	2023	UNIVERSITY OF ALABAMA AT BIRMINGHAM	701 S 20TH ST	BIRMINGHAM	AL	35294	JEFFERSON	USA	Human Genome Research	003	4	8/3/2023	NON-COMPETING CONTINUATION	$0
2023	2023	UNIVERSITY OF ALABAMA AT BIRMINGHAM	701 S 20TH ST	BIRMINGHAM	AL	35294	JEFFERSON	USA	Human Genome Research	004	4	8/3/2023	SUPPLEMENT FOR EXPANSION	$340,002
2023	2022	UNIVERSITY OF ALABAMA AT BIRMINGHAM	701 S 20TH ST	BIRMINGHAM	AL	35294	JEFFERSON	USA	Human Genome Research	001	3	12/15/2022	NON-COMPETING CONTINUATION	$0
2023	2022	UNIVERSITY OF ALABAMA AT BIRMINGHAM	701 S 20TH ST	BIRMINGHAM	AL	35294	JEFFERSON	USA	Human Genome Research	000	3	11/18/2022	SUPPLEMENT FOR EXPANSION	$0
														Subtotal = $1,824,589

Issue Date FY: 2022 ( Subtotal = $1,747,535 )
2022	2022	UNIVERSITY OF ALABAMA AT BIRMINGHAM	701 S 20TH ST	BIRMINGHAM	AL	35294	JEFFERSON	USA	Human Genome Research	002	3	9/23/2022	SUPPLEMENT FOR EXPANSION	$144,382
2022	2022	UNIVERSITY OF ALABAMA AT BIRMINGHAM	701 S 20TH ST	BIRMINGHAM	AL	35294	JEFFERSON	USA	Human Genome Research	001	3	6/21/2022	NON-COMPETING CONTINUATION	$1,603,153
2022	2021	UNIVERSITY OF ALABAMA AT BIRMINGHAM	701 S 20TH ST	BIRMINGHAM	AL	35294	JEFFERSON	USA	Human Genome Research	000	2	2/18/2022	NON-COMPETING CONTINUATION	$0
														Subtotal = $1,747,535

Issue Date FY: 2021 ( Subtotal = $1,633,230 )
2021	2021	UNIVERSITY OF ALABAMA AT BIRMINGHAM	701 S 20TH ST	BIRMINGHAM	AL	35294	JEFFERSON	USA	Human Genome Research	001	2	7/8/2021	NON-COMPETING CONTINUATION	$1,633,230
2021	2020	UNIVERSITY OF ALABAMA AT BIRMINGHAM	701 S 20TH ST	BIRMINGHAM	AL	35294	JEFFERSON	USA	Human Genome Research	000	1	3/25/2021	NEW	$0
														Subtotal = $1,633,230

Issue Date FY: 2020 ( Subtotal = $1,258,787 )
2020	2020	UNIVERSITY OF ALABAMA AT BIRMINGHAM	701 S 20TH ST	BIRMINGHAM	AL	35294	JEFFERSON	USA	Human Genome Research	000	1	7/1/2020	NEW	$1,258,787
														Subtotal = $1,258,787

Grand Total All Awards = $7,546,292

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Integrating Genomic Risk Assessment for Chronic Disease Management in a Diverse Population

Award Number: U01HG011167

ORGANIZATION: NATIONAL HUMAN GENOME RESEARCH INSTITUTE

OPDIV: NIH

AWARD CLASS: COOPERATIVE AGREEMENT

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

PERIOD OF PERFORMANCE START DATE: 07/01/2020

PERIOD OF PERFORMANCE END DATE: 04/30/2025

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