Thursday, November 21, 2024 11/21/2024

Statistical and Data Management Center (SDMC), Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections (ACTG)

Award Number: UM1AI068634
ORGANIZATION: NATIONAL INSTITUTE OF ALLERGY & INFECTIOUS DISEASES
OPDIV: NIH
AWARD CLASS: COOPERATIVE AGREEMENT
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

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Project Summary/Abstract This application requests renewal of funding to serve as the Statistical and Data Management Center of the AIDS Clinical Trials Group (ACTG). The ACTG is an international clinical trials network which is proposing to address objectives in NIAID high priority research areas for adults living with HIV. Specifically: to evaluate novel and durable interventions targeting HIV infection; to identify strategies to reduce HIV reservoirs and control HIV replication in the absence of ART (“ART-free remission”); to improve the diagnosis and treatment of tuberculosis, especially in those co-infected with HIV; and to improve the prevention and treatment of co-morbidities and co-infections, including curative strategies hepatitis B virus co-infection. The application's specific aims and long-term objectives are: to support the international research agenda of the ACTG by providing a group of highly-experienced statisticians, epidemiologists, data managers and other professionals who have a deep interest in research in HIV infection and its complications and co-infections; to support the development, conduct and analysis of ACTG studies with expert statistical and data management leadership and high quality clinical and laboratory data management and communications systems which comply with regulatory requirements, meet industry standards and are fully integrated into quality management system workflows; and to advance the mission of the ACTG through innovation in study design and analysis and the development of efficient methods and systems, that facilitate the work of the ACTG and promote harmonization and data sharing with collaborating organizations. The proposed SDMC consists of two components. One is a Statistical and Data Analysis Center at Harvard T.H. Chan School of Public Health which will provide biostatistical leadership, and includes a subcontract to University of California San Francisco to support additional tuberculosis trial design expertise. The second is a Data Management Center at Frontier Science & Technology Research Foundation which will provide expertise and leadership in data management systems, and has primary responsibility for data collection, quality and integrity.


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 = $3,119,632 )
2025	2025	HARVARD COLLEGE PRESIDENT & FELLOWS OF	677 HUNTINGTON AVE	BOSTON	MA	02115	SUFFOLK	USA	Allergy and Infectious Diseases Research	000	19	11/12/2024	NON-COMPETING CONTINUATION	$3,119,632
														Subtotal = $3,119,632

Issue Date FY: 2024 ( Subtotal = $20,646,124 )
2024	2024	HARVARD COLLEGE PRESIDENT & FELLOWS OF	677 HUNTINGTON AVE	BOSTON	MA	02115	SUFFOLK	USA	Allergy and Infectious Diseases Research	002	18	8/26/2024	NON-COMPETING CONTINUATION	$0
2024	2024	HARVARD COLLEGE PRESIDENT & FELLOWS OF	677 HUNTINGTON AVE	BOSTON	MA	02115	SUFFOLK	USA	Allergy and Infectious Diseases Research	000	18	11/7/2023	NON-COMPETING CONTINUATION	$10,523,061
2024	2024	HARVARD COLLEGE PRESIDENT & FELLOWS OF	677 HUNTINGTON AVE	BOSTON	MA	02115	SUFFOLK	USA	Allergy and Infectious Diseases Research	003	18	9/3/2024	NON-COMPETING CONTINUATION	$0
2024	2024	HARVARD COLLEGE PRESIDENT & FELLOWS OF	677 HUNTINGTON AVE	BOSTON	MA	02115	SUFFOLK	USA	Allergy and Infectious Diseases Research	001	18	3/7/2024	NON-COMPETING CONTINUATION	$10,123,063
														Subtotal = $20,646,124

Issue Date FY: 2023 ( Subtotal = $20,338,729 )
2023	2023	HARVARD COLLEGE PRESIDENT & FELLOWS OF	677 HUNTINGTON AVE	BOSTON	MA	02115	SUFFOLK	USA	Allergy and Infectious Diseases Research	004	17	3/22/2023	NON-COMPETING CONTINUATION	$9,315,648
2023	2023	HARVARD COLLEGE PRESIDENT & FELLOWS OF	677 HUNTINGTON AVE	BOSTON	MA	02115	SUFFOLK	USA	Allergy and Infectious Diseases Research	005	17	5/1/2023	SUPPLEMENT FOR EXPANSION	$250,000
2023	2023	HARVARD COLLEGE PRESIDENT & FELLOWS OF	677 HUNTINGTON AVE	BOSTON	MA	02115	SUFFOLK	USA	Allergy and Infectious Diseases Research	002	17	1/18/2023	SUPPLEMENT FOR EXPANSION	$1
2023	2023	HARVARD COLLEGE PRESIDENT & FELLOWS OF	677 HUNTINGTON AVE	BOSTON	MA	02115	SUFFOLK	USA	Allergy and Infectious Diseases Research	001	17	12/7/2022	NON-COMPETING CONTINUATION	$9,315,645
2023	2023	HARVARD COLLEGE PRESIDENT & FELLOWS OF	677 HUNTINGTON AVE	BOSTON	MA	02115	SUFFOLK	USA	Allergy and Infectious Diseases Research	006	17	7/21/2023	NON-COMPETING CONTINUATION	$1,457,472
2023	2021	HARVARD COLLEGE PRESIDENT & FELLOWS OF	677 HUNTINGTON AVE	BOSTON	MA	02115	SUFFOLK	USA	Allergy and Infectious Diseases Research	000	15	10/28/2022	SUPPLEMENT FOR EXPANSION	$0
2023	2020	HARVARD COLLEGE PRESIDENT & FELLOWS OF	677 HUNTINGTON AVE	BOSTON	MA	02115	SUFFOLK	USA	Allergy and Infectious Diseases Research	003	14	2/2/2023	SUPPLEMENT FOR EXPANSION	-$37
														Subtotal = $20,338,729

Issue Date FY: 2022 ( Subtotal = $19,575,670 )
2022	2022	HARVARD COLLEGE PRESIDENT & FELLOWS OF	677 HUNTINGTON AVE	BOSTON	MA	02115	SUFFOLK	USA	Allergy and Infectious Diseases Research	007	16	9/8/2022	SUPPLEMENT FOR EXPANSION	$944,359
2022	2022	PRESIDENT AND FELLOWS OF HARVARD COLLEGE	677 HUNTINGTON AVE	BOSTON	MA	02115	SUFFOLK	USA	Allergy and Infectious Diseases Research	000	16	11/29/2021	NON-COMPETING CONTINUATION	$11,178,776
2022	2022	HARVARD COLLEGE PRESIDENT & FELLOWS OF	677 HUNTINGTON AVE	BOSTON	MA	02115	SUFFOLK	USA	Allergy and Infectious Diseases Research	004	16	6/17/2022	NON-COMPETING CONTINUATION	$7,452,517
2022	2021	PRESIDENT AND FELLOWS OF HARVARD COLLEGE	677 HUNTINGTON AVE	BOSTON	MA	02115	SUFFOLK	USA	Allergy and Infectious Diseases Research	001	15	12/16/2021	SUPPLEMENT FOR EXPANSION	$0
2022	2021	HARVARD COLLEGE PRESIDENT & FELLOWS OF	677 HUNTINGTON AVE	BOSTON	MA	02115	SUFFOLK	USA	Allergy and Infectious Diseases Research	003	15	5/19/2022	COMPETING CONTINUATION	$795
2022	2020	HARVARD COLLEGE PRESIDENT & FELLOWS OF	677 HUNTINGTON AVE	BOSTON	MA	02115	SUFFOLK	USA	Allergy and Infectious Diseases Research	002	14	5/19/2022	NON-COMPETING CONTINUATION	-$795
2022	2020	HARVARD COLLEGE PRESIDENT & FELLOWS OF	677 HUNTINGTON AVE	BOSTON	MA	02115	SUFFOLK	USA	Allergy and Infectious Diseases Research	008	14	9/26/2022	SUPPLEMENT FOR EXPANSION	$18
2022	2020	HARVARD COLLEGE PRESIDENT & FELLOWS OF	677 HUNTINGTON AVE	BOSTON	MA	02115	SUFFOLK	USA	Allergy and Infectious Diseases Research	006	14	6/21/2022	SUPPLEMENT FOR EXPANSION	$18
2022	2020	HARVARD COLLEGE PRESIDENT & FELLOWS OF	677 HUNTINGTON AVE	BOSTON	MA	02115	SUFFOLK	USA	Allergy and Infectious Diseases Research	005	14	6/21/2022	SUPPLEMENT FOR EXPANSION	-$18
														Subtotal = $19,575,670

Issue Date FY: 2021 ( Subtotal = $21,066,217 )
2021	2021	PRESIDENT AND FELLOWS OF HARVARD COLLEGE	677 HUNTINGTON AVE	BOSTON	MA	02115	SUFFOLK	USA	Allergy and Infectious Diseases Research	004	15	4/26/2021	SUPPLEMENT FOR EXPANSION	$55,171
2021	2021	PRESIDENT AND FELLOWS OF HARVARD COLLEGE	677 HUNTINGTON AVE	BOSTON	MA	02115	SUFFOLK	USA	Allergy and Infectious Diseases Research	002	15	2/22/2021	COMPETING CONTINUATION	$933,052
2021	2021	PRESIDENT AND FELLOWS OF HARVARD COLLEGE	677 HUNTINGTON AVE	BOSTON	MA	02115	SUFFOLK	USA	Allergy and Infectious Diseases Research	007	15	7/23/2021	COMPETING CONTINUATION	$4,717,974
2021	2021	PRESIDENT AND FELLOWS OF HARVARD COLLEGE	677 HUNTINGTON AVE	BOSTON	MA	02115	SUFFOLK	USA	Allergy and Infectious Diseases Research	000	15	11/20/2020	COMPETING CONTINUATION	$8,397,468
2021	2021	PRESIDENT AND FELLOWS OF HARVARD COLLEGE	677 HUNTINGTON AVE	BOSTON	MA	02115	SUFFOLK	USA	Allergy and Infectious Diseases Research	009	15	9/3/2021	COMPETING CONTINUATION	$2,000,000
2021	2021	PRESIDENT AND FELLOWS OF HARVARD COLLEGE	677 HUNTINGTON AVE	BOSTON	MA	02115	SUFFOLK	USA	Allergy and Infectious Diseases Research	006	15	7/14/2021	COMPETING CONTINUATION	$3,509,735
2021	2021	PRESIDENT AND FELLOWS OF HARVARD COLLEGE	677 HUNTINGTON AVE	BOSTON	MA	02115	SUFFOLK	USA	Allergy and Infectious Diseases Research	003	15	4/2/2021	SUPPLEMENT FOR EXPANSION	$2,350,006
2021	2021	PRESIDENT AND FELLOWS OF HARVARD COLLEGE	677 HUNTINGTON AVE	BOSTON	MA	02115	SUFFOLK	USA	Allergy and Infectious Diseases Research	008	15	8/25/2021	COMPETING CONTINUATION	$2,612,546
2021	2020	PRESIDENT AND FELLOWS OF HARVARD COLLEGE	677 HUNTINGTON AVE	BOSTON	MA	02115	SUFFOLK	USA	Allergy and Infectious Diseases Research	001	14	2/5/2021	SUPPLEMENT FOR EXPANSION	$0
2021	2020	PRESIDENT AND FELLOWS OF HARVARD COLLEGE	677 HUNTINGTON AVE	BOSTON	MA	02115	SUFFOLK	USA	Allergy and Infectious Diseases Research	005	14	7/14/2021	NON-COMPETING CONTINUATION	-$3,509,735
														Subtotal = $21,066,217

Issue Date FY: 2020 ( Subtotal = $15,649,579 )
2020	2020	PRESIDENT AND FELLOWS OF HARVARD COLLEGE	677 HUNTINGTON AVE	BOSTON	MA	02115	SUFFOLK	USA	Allergy and Infectious Diseases Research	004	14	8/7/2020	SUPPLEMENT FOR EXPANSION	$71,413
2020	2020	PRESIDENT AND FELLOWS OF HARVARD COLLEGE	677 HUNTINGTON AVE	BOSTON	MA	02115	SUFFOLK	USA	Allergy and Infectious Diseases Research	001	14	3/3/2020	NON-COMPETING CONTINUATION	$2,724,247
2020	2020	PRESIDENT AND FELLOWS OF HARVARD COLLEGE	677 HUNTINGTON AVE	BOSTON	MA	02115	SUFFOLK	USA	Allergy and Infectious Diseases Research	000	14	11/15/2019	NON-COMPETING CONTINUATION	$6,328,066
2020	2020	PRESIDENT AND FELLOWS OF HARVARD COLLEGE	677 HUNTINGTON AVE	BOSTON	MA	02115	SUFFOLK	USA	Allergy and Infectious Diseases Research	003	14	7/10/2020	SUPPLEMENT FOR EXPANSION	$584,051
2020	2020	PRESIDENT AND FELLOWS OF HARVARD COLLEGE	677 HUNTINGTON AVE	BOSTON	MA	02115	SUFFOLK	USA	Allergy and Infectious Diseases Research	002	14	6/3/2020	NON-COMPETING CONTINUATION	$5,941,802
														Subtotal = $15,649,579

Issue Date FY: 2019 ( Subtotal = $17,038,975 )
2019	2019	PRESIDENT AND FELLOWS OF HARVARD COLLEGE	677 HUNTINGTON AVE	BOSTON	MA	02115	SUFFOLK	USA	Allergy and Infectious Diseases Research	000	13	11/21/2018	NON-COMPETING CONTINUATION	$4,724,625
2019	2019	PRESIDENT AND FELLOWS OF HARVARD COLLEGE	677 HUNTINGTON AVE	BOSTON	MA	02115	SUFFOLK	USA	Allergy and Infectious Diseases Research	001	13	2/27/2019	NON-COMPETING CONTINUATION	$3,712,205
2019	2019	PRESIDENT AND FELLOWS OF HARVARD COLLEGE	677 HUNTINGTON AVE	BOSTON	MA	02115	SUFFOLK	USA	Allergy and Infectious Diseases Research	003	13	8/26/2019	NON-COMPETING CONTINUATION	$2,443,261
2019	2019	PRESIDENT AND FELLOWS OF HARVARD COLLEGE	677 HUNTINGTON AVE	BOSTON	MA	02115	SUFFOLK	USA	Allergy and Infectious Diseases Research	002	13	5/17/2019	NON-COMPETING CONTINUATION	$6,158,884
														Subtotal = $17,038,975

Issue Date FY: 2018 ( Subtotal = $15,607,936 ) (Continued on the next page)
2018	2018	PRESIDENT AND FELLOWS OF HARVARD COLLEGE	677 HUNTINGTON AVE	BOSTON	MA	02115	SUFFOLK	USA	Allergy and Infectious Diseases Research	002	12	5/25/2018	NON-COMPETING CONTINUATION	$6,810,617
2018	2018	PRESIDENT AND FELLOWS OF HARVARD COLLEGE	677 HUNTINGTON AVE	BOSTON	MA	02115	SUFFOLK	USA	Allergy and Infectious Diseases Research	001	12	2/27/2018	NON-COMPETING CONTINUATION	$2,909,954
Grand Total All Awards = $226,287,150

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Statistical and Data Management Center (SDMC), Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections (ACTG)

Award Number: UM1AI068634

ORGANIZATION: NATIONAL INSTITUTE OF ALLERGY & INFECTIOUS DISEASES

OPDIV: NIH

AWARD CLASS: COOPERATIVE AGREEMENT

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

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