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A nurse-led intervention to extend the HIV treatment cascade for cardiovascular disease prevention (EXTRA-CVD)

Award Number: U01HL142099
ORGANIZATION: NATIONAL HEART, LUNG, & BLOOD INSTITUTE
OPDIV: NIH
AWARD CLASS: COOPERATIVE AGREEMENT
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

Group Awards By Issue Date FY or Funding FY:

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Social distancing in the context of the SARS-CoV-2 coronavirus and COVID-19 disease pandemic may amplify isolation and loneliness due to the requirement to limit in-person interactions with loved ones, friends, community members, healthcare providers, etc. Social isolation increases susceptibility to illness, stress, hypertension, depression, and mortality and decreases engagement in self-management and physical activity. People living with HIV (PLWH) are at increased risk for cardiovascular disease (CVD) and are particularly vulnerable to the stress and social isolation caused by the public health measures to combat COVID-19. Using mixed-methods and a human-centered design approach, we have developed and are currently testing in a randomized controlled trial a nurse-led intervention to EXtend the HIV/AIDS TReatment cAscade for CVD prevention (EXTRA-CVD). Racially and ethnically diverse participants on suppressive antiretroviral therapy (n=300 total; 64 enrolled to date) with high BP AND high cholesterol from 3 HIV-specialty clinics [University Hospitals, MetroHealth (both Cleveland, OH) and Duke Health (Durham, NC)] are randomized 1:1 to intervention vs. education control. In response to NOT-OD-20-757, we propose this administrative supplement to leverage the EXTRA-CVD platform to Assess and Adapt to the Impact of COVID-19 on CVD Self-Management and Prevention Care in Adults Living with HIV (AAIM-High). The proposed activities are IRB approved and ready to begin immediately if funded. In a formative Aim 1, we will assess the impact of COVID-19 related social distancing on HIV and CVD self-management behaviors among participants in EXTRA-CVD using well-validated instruments, NIH common data elements and a sequential mixed-methods design. In Aim 2, we will conduct a hybrid type 3 implementation study to evaluate the implementation of a virtually enhanced EXTRA-CVD intervention to improve BP control in PLWH. Using a human-centered design approach, we will convene our EXTRA-CVD stakeholder Design Team, to refine virtual enhancements to the intervention, such as virtual adherence support groups, cardiovascular prevention specialist remote consultation, and community health worker technology coaches. We will enroll adult PLWH participants (n=75) on suppressive ART with high BP whom are otherwise ineligible for the parent trial because they do not also have high cholesterol or because they are unwilling or unable to participate in the in-person trial. Thus, this supplemental study arm will not poach potentially eligible participants from the parent trial. Implementation outcomes based on a RE-AIM framework will be compared to parent trial participants: reach (% agreeing to participate), effectiveness (change in home systolic BP), adoption (frequency of home BP use), implementation (qualitative assessment of feasibility/acceptability), and maintenance (qualitative). This supplement will increase the impact and scalability of the EXTRA-CVD study without compromising the integrity or feasibility of the parent trial.


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: 2023 ( Subtotal = $0 )
2023	2021	UNIVERSITY OF WASHINGTON	4333 BROOKLYN AVE NE	SEATTLE	WA	98195	KING	USA	Translation and Implementation Science Research for Heart, Lung, Blood Diseases, and Sleep Disorders	002	5	4/27/2023	CHANGE OF GRANTEE / TRAINING INSTITUTION / AWARDING INSTITUTION	$0
2023	2021	UNIVERSITY OF WASHINGTON	4333 BROOKLYN AVE NE	SEATTLE	WA	98195	KING	USA	Translation and Implementation Science Research for Heart, Lung, Blood Diseases, and Sleep Disorders	001	5	10/20/2022	SUPPLEMENT FOR EXPANSION	$0
2023	2021	UNIVERSITY OF WASHINGTON	4333 BROOKLYN AVE NE	SEATTLE	WA	98195	KING	USA	Translation and Implementation Science Research for Heart, Lung, Blood Diseases, and Sleep Disorders	000	5	10/19/2022	CHANGE OF GRANTEE / TRAINING INSTITUTION / AWARDING INSTITUTION	$0
														Subtotal = $0

Issue Date FY: 2022 ( Subtotal = -$24,045 )
2022	2021	CASE WESTERN RESERVE UNIVERSITY	10900 EUCLID AVE	CLEVELAND	OH	44106	CUYAHOGA	USA	Translation and Implementation Science Research for Heart, Lung, Blood Diseases, and Sleep Disorders	007	4	4/30/2022	SUPPLEMENT FOR EXPANSION	-$247,115
2022	2021	UNIVERSITY OF WASHINGTON	4333 BROOKLYN AVE NE	SEATTLE	WA	98195	KING	USA	Translation and Implementation Science Research for Heart, Lung, Blood Diseases, and Sleep Disorders	009	5	5/28/2022	SUPPLEMENT FOR EXPANSION	$0
2022	2021	UNIVERSITY OF WASHINGTON	4333 BROOKLYN AVE NE	SEATTLE	WA	98195	KING	USA	Translation and Implementation Science Research for Heart, Lung, Blood Diseases, and Sleep Disorders	003	5	4/20/2022	CHANGE OF GRANTEE / TRAINING INSTITUTION / AWARDING INSTITUTION	$399,936
2022	2021	UNIVERSITY OF WASHINGTON	4333 BROOKLYN AVE NE	SEATTLE	WA	98195	KING	USA	Translation and Implementation Science Research for Heart, Lung, Blood Diseases, and Sleep Disorders	013	5	7/11/2022	CHANGE OF GRANTEE / TRAINING INSTITUTION / AWARDING INSTITUTION	$331,617
2022	2021	CASE WESTERN RESERVE UNIVERSITY	10900 EUCLID AVE	CLEVELAND	OH	44106	CUYAHOGA	USA	Translation and Implementation Science Research for Heart, Lung, Blood Diseases, and Sleep Disorders	010	4	7/11/2022	NON-COMPETING CONTINUATION	-$167,489
2022	2021	CASE WESTERN RESERVE UNIVERSITY	10900 EUCLID AVE	CLEVELAND	OH	44106	CUYAHOGA	USA	Translation and Implementation Science Research for Heart, Lung, Blood Diseases, and Sleep Disorders	004	4	4/21/2022	SUPPLEMENT FOR EXPANSION	-$92,431
2022	2021	CASE WESTERN RESERVE UNIVERSITY	10900 EUCLID AVE	CLEVELAND	OH	44106	CUYAHOGA	USA	Translation and Implementation Science Research for Heart, Lung, Blood Diseases, and Sleep Disorders	000	4	10/16/2021	SUPPLEMENT FOR EXPANSION	$0
2022	2021	CASE WESTERN RESERVE UNIVERSITY	10900 EUCLID AVE	CLEVELAND	OH	44106	CUYAHOGA	USA	Translation and Implementation Science Research for Heart, Lung, Blood Diseases, and Sleep Disorders	001	4	2/18/2022	SUPPLEMENT FOR EXPANSION	-$24,045
2022	2021	CASE WESTERN RESERVE UNIVERSITY	10900 EUCLID AVE	CLEVELAND	OH	44106	CUYAHOGA	USA	Translation and Implementation Science Research for Heart, Lung, Blood Diseases, and Sleep Disorders	015	4	7/19/2022	SUPPLEMENT FOR EXPANSION	-$128,789
2022	2021	CASE WESTERN RESERVE UNIVERSITY	10900 EUCLID AVE	CLEVELAND	OH	44106	CUYAHOGA	USA	Translation and Implementation Science Research for Heart, Lung, Blood Diseases, and Sleep Disorders	011	4	7/11/2022	SUPPLEMENT FOR EXPANSION	-$69,100
2022	2021	UNIVERSITY OF WASHINGTON	4333 BROOKLYN AVE NE	SEATTLE	WA	98195	KING	USA	Translation and Implementation Science Research for Heart, Lung, Blood Diseases, and Sleep Disorders	008	5	4/30/2022	SUPPLEMENT FOR EXPANSION	$247,115
2022	2021	UNIVERSITY OF WASHINGTON	4333 BROOKLYN AVE NE	SEATTLE	WA	98195	KING	USA	Translation and Implementation Science Research for Heart, Lung, Blood Diseases, and Sleep Disorders	016	5	7/19/2022	SUPPLEMENT FOR EXPANSION	$176,298
2022	2021	CASE WESTERN RESERVE UNIVERSITY	10900 EUCLID AVE	CLEVELAND	OH	44106	CUYAHOGA	USA	Translation and Implementation Science Research for Heart, Lung, Blood Diseases, and Sleep Disorders	012	4	7/11/2022	SUPPLEMENT FOR EXPANSION	-$95,028
2022	2021	UNIVERSITY OF WASHINGTON	4333 BROOKLYN AVE NE	SEATTLE	WA	98195	KING	USA	Translation and Implementation Science Research for Heart, Lung, Blood Diseases, and Sleep Disorders	006	5	4/28/2022	SUPPLEMENT FOR EXPANSION	$92,431
2022	2021	CASE WESTERN RESERVE UNIVERSITY	10900 EUCLID AVE	CLEVELAND	OH	44106	CUYAHOGA	USA	Translation and Implementation Science Research for Heart, Lung, Blood Diseases, and Sleep Disorders	002	4	4/19/2022	NON-COMPETING CONTINUATION	-$399,936
2022	2021	CASE WESTERN RESERVE UNIVERSITY	10900 EUCLID AVE	CLEVELAND	OH	44106	CUYAHOGA	USA	Translation and Implementation Science Research for Heart, Lung, Blood Diseases, and Sleep Disorders	005	4	4/28/2022	SUPPLEMENT FOR EXPANSION	$0
2022	2020	CASE WESTERN RESERVE UNIVERSITY	10900 EUCLID AVE	CLEVELAND	OH	44106	CUYAHOGA	USA	Translation and Implementation Science Research for Heart, Lung, Blood Diseases, and Sleep Disorders	014	3	7/19/2022	SUPPLEMENT FOR EXPANSION	-$47,509
														Subtotal = -$24,045

Issue Date FY: 2021 ( Subtotal = $1,416,041 )
2021	2021	CASE WESTERN RESERVE UNIVERSITY	10900 EUCLID AVE	CLEVELAND	OH	44106	CUYAHOGA	USA	Translation and Implementation Science Research for Heart, Lung, Blood Diseases, and Sleep Disorders	006	4	7/11/2021	SUPPLEMENT FOR EXPANSION	$93,145
2021	2021	CASE WESTERN RESERVE UNIVERSITY	10900 EUCLID AVE	CLEVELAND	OH	44106	CUYAHOGA	USA	Translation and Implementation Science Research for Heart, Lung, Blood Diseases, and Sleep Disorders	005	4	7/10/2021	SUPPLEMENT FOR EXPANSION	$187,459
2021	2021	CASE WESTERN RESERVE UNIVERSITY	10900 EUCLID AVE	CLEVELAND	OH	44106	CUYAHOGA	USA	Translation and Implementation Science Research for Heart, Lung, Blood Diseases, and Sleep Disorders	003	4	6/11/2021	NON-COMPETING CONTINUATION	$759,533
2021	2021	CASE WESTERN RESERVE UNIVERSITY	10900 EUCLID AVE	CLEVELAND	OH	44106	CUYAHOGA	USA	Translation and Implementation Science Research for Heart, Lung, Blood Diseases, and Sleep Disorders	004	4	7/9/2021	NON-COMPETING CONTINUATION	$0
2021	2021	CASE WESTERN RESERVE UNIVERSITY	10900 EUCLID AVE	CLEVELAND	OH	44106	CUYAHOGA	USA	Translation and Implementation Science Research for Heart, Lung, Blood Diseases, and Sleep Disorders	007	4	8/20/2021	SUPPLEMENT FOR EXPANSION	$375,904
2021	2020	CASE WESTERN RESERVE UNIVERSITY	10900 EUCLID AVE	CLEVELAND	OH	44106	CUYAHOGA	USA	Translation and Implementation Science Research for Heart, Lung, Blood Diseases, and Sleep Disorders	002	3	5/20/2021	NON-COMPETING CONTINUATION	$0
2021	2020	CASE WESTERN RESERVE UNIVERSITY	10900 EUCLID AVE	CLEVELAND	OH	44106	CUYAHOGA	USA	Translation and Implementation Science Research for Heart, Lung, Blood Diseases, and Sleep Disorders	001	3	5/17/2021	NON-COMPETING CONTINUATION	$0
2021	2020	CASE WESTERN RESERVE UNIVERSITY	10900 EUCLID AVE	CLEVELAND	OH	44106	CUYAHOGA	USA	Translation and Implementation Science Research for Heart, Lung, Blood Diseases, and Sleep Disorders	000	3	10/24/2020	NON-COMPETING CONTINUATION	$0
														Subtotal = $1,416,041

Issue Date FY: 2020 ( Subtotal = $1,576,172 )
2020	2020	CASE WESTERN RESERVE UNIVERSITY	10900 EUCLID AVE	CLEVELAND	OH	44106	CUYAHOGA	USA	Translation and Implementation Science Research for Heart, Lung, Blood Diseases, and Sleep Disorders	003	3	8/14/2020	SUPPLEMENT FOR EXPANSION	$446,517
2020	2020	CASE WESTERN RESERVE UNIVERSITY	10900 EUCLID AVE	CLEVELAND	OH	44106	CUYAHOGA	USA	Translation and Implementation Science Research for Heart, Lung, Blood Diseases, and Sleep Disorders	002	3	6/25/2020	SUPPLEMENT FOR EXPANSION	$187,362
2020	2020	CASE WESTERN RESERVE UNIVERSITY	10900 EUCLID AVE	CLEVELAND	OH	44106	CUYAHOGA	USA	Translation and Implementation Science Research for Heart, Lung, Blood Diseases, and Sleep Disorders	001	3	6/3/2020	NON-COMPETING CONTINUATION	$942,293
2020	2019	CASE WESTERN RESERVE UNIVERSITY	10900 EUCLID AVE	CLEVELAND	OH	44106	CUYAHOGA	USA	Translation and Implementation Science Research for Heart, Lung, Blood Diseases, and Sleep Disorders	000	2	3/27/2020	NON-COMPETING CONTINUATION	$0
														Subtotal = $1,576,172

Issue Date FY: 2019 ( Subtotal = $1,056,027 )
2019	2019	CASE WESTERN RESERVE UNIVERSITY	10900 EUCLID AVE	CLEVELAND	OH	44106	CUYAHOGA	USA	Translation and Implementation Science Research for Heart, Lung, Blood Diseases, and Sleep Disorders	001	2	7/15/2019	NON-COMPETING CONTINUATION	$963,461
2019	2019	CASE WESTERN RESERVE UNIVERSITY	10900 EUCLID AVE	CLEVELAND	OH	44106	CUYAHOGA	USA	Translation and Implementation Science Research for Heart, Lung, Blood Diseases, and Sleep Disorders	000	1	1/11/2019	SUPPLEMENT FOR EXPANSION	$92,566
														Subtotal = $1,056,027

Issue Date FY: 2018 ( Subtotal = $749,510 )
2018	2018	CASE WESTERN RESERVE UNIVERSITY	10900 EUCLID AVE	CLEVELAND	OH	44106	CUYAHOGA	USA	Translation and Implementation Science Research for Heart, Lung, Blood Diseases, and Sleep Disorders	000	1	6/25/2018	NEW	$749,510
														Subtotal = $749,510

Grand Total All Awards = $4,773,705

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A nurse-led intervention to extend the HIV treatment cascade for cardiovascular disease prevention (EXTRA-CVD)

Award Number: U01HL142099

ORGANIZATION: NATIONAL HEART, LUNG, & BLOOD INSTITUTE

OPDIV: NIH

AWARD CLASS: COOPERATIVE AGREEMENT

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

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