Thursday, November 21, 2024 11/21/2024

SDMC: HIV Prevention Trials Network

Award Number: UM1AI068617
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 to RFA-AI-19-002 is to continue as the statistical and data management center (SDMC) for the HIV Prevention Trials Network (HPTN). The overarching goal of the HPTN is to identify acceptable, feasible, safe, effective, and scalable interventions for HIV prevention that address the needs of populations at risk in the US and around the world. The HPTN will address this goal through identifying: 1) new biomedical products and tools for HIV prevention that have unique characteristics, such as longer duration of action, new targets of HIV inhibition or as multi-purpose technologies; 2) integrated strategies that optimize use of proven efficacious prevention interventions tailored to specific populations at risk to achieve maximal public health impact. The HPTN SDMC is housed at the Fred Hutchinson Cancer Research Center in Seattle and takes advantage of the particular strengths of the institution, which also includes the HVTN SDMC, and data and coordinating centers for several other research networks. The HPTN SDMC has faculty biostatisticians experienced in the design, conduct and analysis of global HIV prevention studies, who support the goals of HPTN research through leadership in statistical design, trial conduct and analysis, and development and implementation of innovative statistical methods as needed and motivated by HPTN scientific goals. The SDMC provides regulatory compliant data management functions for all HPTN trials, including electronic data capture directly from research sites, integration of laboratory specimens and assay results, and electronic participant reported outcomes. During the grant period, the SDMC will design and analyze Phase 1-3 trials of both antiretroviral and broadly neutralizing monoclonal antibody (bNAb) products, including completion of two Phase 3 active-controlled randomized clinical trials (RCTs) of long-acting cabotegravir (CAB LA) and two Phase 3 placebo-controlled RCTs of the bNAb VRC-01. The SDMC will fully support the development pathway for multi-purpose technologies, encompassing both acceptability and user-based design. If CAB LA proves efficacious, it will be incorporated into integrated strategy trials for populations at risk. Trial designs for integrated strategies will range from individual-randomized, to cluster-randomized (either parallel or step-wedge), to non-randomized trials, depending on the context and population. Mathematical modeling will estimate the population impact and cost- effectiveness of successful HPTN interventions in specific populations at risk. The SDMC will continue to deliver high-quality, timely, cost-efficient, and secure data management and safety monitoring functions for HPTN trials. State-of-the-art systems for data acquisition, storage, quality control, curation, and annotation, will be compliant with Clinical Data Interchange Standards Consortium (CDISC) and maintained using a continuous quality improvement strategy. HPTN socio-behavioral research is supported through flexible data interface processes with external data sources including mobile apps, SMS, tablets, and electronic Patient Reported Outcomes.


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 = -$490,841 )
2025	2020	FRED HUTCHINSON CANCER RESEARCH CENTER	1100 FAIRVIEW AVE N J6-300	SEATTLE	WA	98109	KING	USA	Allergy and Infectious Diseases Research	000	14	10/1/2024	NON-COMPETING CONTINUATION	-$490,841
														Subtotal = -$490,841

Issue Date FY: 2024 ( Subtotal = $22,081,371 )
2024	2024	FRED HUTCHINSON CANCER CENTER	1100 FAIRVIEW AVE N	SEATTLE	WA	98109	KING	USA	Allergy and Infectious Diseases Research	002	19	4/2/2024	NON-COMPETING CONTINUATION	$9,959,956
2024	2024	FRED HUTCHINSON CANCER CENTER	1100 FAIRVIEW AVE N	SEATTLE	WA	98109	KING	USA	Allergy and Infectious Diseases Research	001	19	3/5/2024	SUPPLEMENT FOR EXPANSION	$1,195,111
2024	2024	FRED HUTCHINSON CANCER CENTER	1100 FAIRVIEW AVE N	SEATTLE	WA	98109	KING	USA	Allergy and Infectious Diseases Research	000	19	11/14/2023	NON-COMPETING CONTINUATION	$10,926,304
														Subtotal = $22,081,371

Issue Date FY: 2023 ( Subtotal = $14,385,924 )
2023	2023	FRED HUTCHINSON CANCER CENTER	1100 FAIRVIEW AVE N	SEATTLE	WA	98109	KING	USA	Allergy and Infectious Diseases Research	001	18	3/10/2023	NON-COMPETING CONTINUATION	$6,071,580
2023	2023	FRED HUTCHINSON CANCER CENTER	1100 FAIRVIEW AVE N	SEATTLE	WA	98109	KING	USA	Allergy and Infectious Diseases Research	000	18	12/7/2022	NON-COMPETING CONTINUATION	$6,634,301
2023	2023	FRED HUTCHINSON CANCER CENTER	1100 FAIRVIEW AVE N	SEATTLE	WA	98109	KING	USA	Allergy and Infectious Diseases Research	003	18	6/6/2023	NON-COMPETING CONTINUATION	$1,680,043
2023	2022	FRED HUTCHINSON CANCER CENTER	1100 FAIRVIEW AVE N	SEATTLE	WA	98109	KING	USA	Allergy and Infectious Diseases Research	002	17	4/6/2023	SUPPLEMENT FOR EXPANSION	$0
2023	2021	FRED HUTCHINSON CANCER RESEARCH CENTER	1100 FAIRVIEW AVE N J6-300	SEATTLE	WA	98109	KING	USA	Allergy and Infectious Diseases Research	004	15	6/21/2023	SUPPLEMENT FOR EXPANSION	$0
														Subtotal = $14,385,924

Issue Date FY: 2022 ( Subtotal = $14,598,797 )
2022	2022	FRED HUTCHINSON CANCER CENTER	1100 FAIRVIEW AVE N	SEATTLE	WA	98109	KING	USA	Allergy and Infectious Diseases Research	008	17	8/29/2022	CHANGE OF GRANTEE / TRAINING INSTITUTION / AWARDING INSTITUTION	$8,472,297
2022	2022	FRED HUTCHINSON CANCER RESEARCH CENTER	1100 FAIRVIEW AVE N J6-300	SEATTLE	WA	98109	KING	USA	Allergy and Infectious Diseases Research	003	16	5/27/2022	NON-COMPETING CONTINUATION	$0
2022	2022	FRED HUTCHINSON CANCER RESEARCH CENTER	1100 FAIRVIEW AVE N J6-300	SEATTLE	WA	98109	KING	USA	Allergy and Infectious Diseases Research	000	16	11/30/2021	NON-COMPETING CONTINUATION	$2,949,235
2022	2022	FRED HUTCHINSON CANCER CENTER	1100 FAIRVIEW AVE N	SEATTLE	WA	98109	KING	USA	Allergy and Infectious Diseases Research	010	17	8/31/2022	CHANGE OF GRANTEE / TRAINING INSTITUTION / AWARDING INSTITUTION	$3,384,794
2022	2022	FRED HUTCHINSON CANCER CENTER	1100 FAIRVIEW AVE N	SEATTLE	WA	98109	KING	USA	Allergy and Infectious Diseases Research	004	17	5/27/2022	CHANGE OF GRANTEE / TRAINING INSTITUTION / AWARDING INSTITUTION	$5,773,385
2022	2022	FRED HUTCHINSON CANCER RESEARCH CENTER	1100 FAIRVIEW AVE N J6-300	SEATTLE	WA	98109	KING	USA	Allergy and Infectious Diseases Research	002	16	2/28/2022	NON-COMPETING CONTINUATION	$1,853,211
2022	2022	FRED HUTCHINSON CANCER CENTER	1100 FAIRVIEW AVE N	SEATTLE	WA	98109	KING	USA	Allergy and Infectious Diseases Research	005	17	5/31/2022	SUPPLEMENT FOR EXPANSION	$389,142
2022	2022	FRED HUTCHINSON CANCER CENTER	1100 FAIRVIEW AVE N	SEATTLE	WA	98109	KING	USA	Allergy and Infectious Diseases Research	011	17	9/16/2022	CHANGE OF GRANTEE / TRAINING INSTITUTION / AWARDING INSTITUTION	$3,633,824
2022	2022	FRED HUTCHINSON CANCER CENTER	1100 FAIRVIEW AVE N	SEATTLE	WA	98109	KING	USA	Allergy and Infectious Diseases Research	009	17	8/31/2022	CHANGE OF GRANTEE / TRAINING INSTITUTION / AWARDING INSTITUTION	-$8,472,297
2022	2022	FRED HUTCHINSON CANCER RESEARCH CENTER	1100 FAIRVIEW AVE N J6-300	SEATTLE	WA	98109	KING	USA	Allergy and Infectious Diseases Research	007	16	8/29/2022	NON-COMPETING CONTINUATION	-$3,384,794
2022	2021	FRED HUTCHINSON CANCER RESEARCH CENTER	1100 FAIRVIEW AVE N J6-300	SEATTLE	WA	98109	KING	USA	Allergy and Infectious Diseases Research	006	15	7/14/2022	SUPPLEMENT FOR EXPANSION	$0
2022	2021	FRED HUTCHINSON CANCER RESEARCH CENTER	1100 FAIRVIEW AVE N J6-300	SEATTLE	WA	98109	KING	USA	Allergy and Infectious Diseases Research	001	15	12/17/2021	SUPPLEMENT FOR EXPANSION	$0
														Subtotal = $14,598,797

Issue Date FY: 2021 ( Subtotal = $18,762,698 )
2021	2021	FRED HUTCHINSON CANCER RESEARCH CENTER	1100 FAIRVIEW AVE N J6-300	SEATTLE	WA	98109	KING	USA	Allergy and Infectious Diseases Research	001	15	3/24/2021	COMPETING CONTINUATION	$862,744
2021	2021	FRED HUTCHINSON CANCER RESEARCH CENTER	1100 FAIRVIEW AVE N J6-300	SEATTLE	WA	98109	KING	USA	Allergy and Infectious Diseases Research	000	15	11/20/2020	COMPETING CONTINUATION	$7,764,698
2021	2021	FRED HUTCHINSON CANCER RESEARCH CENTER	1100 FAIRVIEW AVE N J6-300	SEATTLE	WA	98109	KING	USA	Allergy and Infectious Diseases Research	005	15	7/12/2021	SUPPLEMENT FOR EXPANSION	$492,189
2021	2021	FRED HUTCHINSON CANCER RESEARCH CENTER	1100 FAIRVIEW AVE N J6-300	SEATTLE	WA	98109	KING	USA	Allergy and Infectious Diseases Research	002	15	4/2/2021	SUPPLEMENT FOR EXPANSION	$486,494
2021	2021	FRED HUTCHINSON CANCER RESEARCH CENTER	1100 FAIRVIEW AVE N J6-300	SEATTLE	WA	98109	KING	USA	Allergy and Infectious Diseases Research	009	15	8/24/2021	COMPETING CONTINUATION	$2,842,278
2021	2021	FRED HUTCHINSON CANCER RESEARCH CENTER	1100 FAIRVIEW AVE N J6-300	SEATTLE	WA	98109	KING	USA	Allergy and Infectious Diseases Research	007	15	8/10/2021	COMPETING CONTINUATION	$502,788
2021	2021	FRED HUTCHINSON CANCER RESEARCH CENTER	1100 FAIRVIEW AVE N J6-300	SEATTLE	WA	98109	KING	USA	Allergy and Infectious Diseases Research	004	15	6/9/2021	COMPETING CONTINUATION	$6,314,295
2021	2021	FRED HUTCHINSON CANCER RESEARCH CENTER	1100 FAIRVIEW AVE N J6-300	SEATTLE	WA	98109	KING	USA	Allergy and Infectious Diseases Research	003	15	5/27/2021	SUPPLEMENT FOR EXPANSION	$0
2021	2020	FRED HUTCHINSON CANCER RESEARCH CENTER	1100 FAIRVIEW AVE N J6-300	SEATTLE	WA	98109	KING	USA	Allergy and Infectious Diseases Research	006	14	8/10/2021	NON-COMPETING CONTINUATION	-$502,788
2021	2020	FRED HUTCHINSON CANCER RESEARCH CENTER	1100 FAIRVIEW AVE N J6-300	SEATTLE	WA	98109	KING	USA	Allergy and Infectious Diseases Research	008	14	8/10/2021	SUPPLEMENT FOR EXPANSION	$0
														Subtotal = $18,762,698

Issue Date FY: 2020 ( Subtotal = $11,827,895 )
2020	2020	FRED HUTCHINSON CANCER RESEARCH CENTER	1100 FAIRVIEW AVE N J6-300	SEATTLE	WA	98109	KING	USA	Allergy and Infectious Diseases Research	002	14	5/20/2020	NON-COMPETING CONTINUATION	$2,477,810
2020	2020	FRED HUTCHINSON CANCER RESEARCH CENTER	1100 FAIRVIEW AVE N J6-300	SEATTLE	WA	98109	KING	USA	Allergy and Infectious Diseases Research	000	14	11/21/2019	NON-COMPETING CONTINUATION	$3,675,010
2020	2020	FRED HUTCHINSON CANCER RESEARCH CENTER	1100 FAIRVIEW AVE N J6-300	SEATTLE	WA	98109	KING	USA	Allergy and Infectious Diseases Research	006	14	9/23/2020	SUPPLEMENT FOR EXPANSION	$0
2020	2020	FRED HUTCHINSON CANCER RESEARCH CENTER	1100 FAIRVIEW AVE N J6-300	SEATTLE	WA	98109	KING	USA	Allergy and Infectious Diseases Research	003	14	5/28/2020	NON-COMPETING CONTINUATION	$0
2020	2020	FRED HUTCHINSON CANCER RESEARCH CENTER	1100 FAIRVIEW AVE N J6-300	SEATTLE	WA	98109	KING	USA	Allergy and Infectious Diseases Research	001	14	2/14/2020	NON-COMPETING CONTINUATION	$2,705,543
2020	2020	FRED HUTCHINSON CANCER RESEARCH CENTER	1100 FAIRVIEW AVE N J6-300	SEATTLE	WA	98109	KING	USA	Allergy and Infectious Diseases Research	004	14	8/24/2020	NON-COMPETING CONTINUATION	$2,673,539
2020	2020	FRED HUTCHINSON CANCER RESEARCH CENTER	1100 FAIRVIEW AVE N J6-300	SEATTLE	WA	98109	KING	USA	Allergy and Infectious Diseases Research	005	14	9/15/2020	SUPPLEMENT FOR EXPANSION	$295,993
														Subtotal = $11,827,895

Issue Date FY: 2019 ( Subtotal = $12,822,234 )
2019	2019	FRED HUTCHINSON CANCER RESEARCH CENTER	1100 FAIRVIEW AVE N J6-300	SEATTLE	WA	98109	KING	USA	Allergy and Infectious Diseases Research	000	13	11/21/2018	NON-COMPETING CONTINUATION	$3,543,260
2019	2019	FRED HUTCHINSON CANCER RESEARCH CENTER	1100 FAIRVIEW AVE N J6-300	SEATTLE	WA	98109	KING	USA	Allergy and Infectious Diseases Research	002	13	5/17/2019	NON-COMPETING CONTINUATION	$4,328,596
2019	2019	FRED HUTCHINSON CANCER RESEARCH CENTER	1100 FAIRVIEW AVE N J6-300	SEATTLE	WA	98109	KING	USA	Allergy and Infectious Diseases Research	003	13	8/28/2019	NON-COMPETING CONTINUATION	$1,614,220
2019	2019	FRED HUTCHINSON CANCER RESEARCH CENTER	1100 FAIRVIEW AVE N J6-300	SEATTLE	WA	98109	KING	USA	Allergy and Infectious Diseases Research	001	13	2/28/2019	NON-COMPETING CONTINUATION	$3,336,158
														Subtotal = $12,822,234

Issue Date FY: 2018 ( Subtotal = $11,597,790 ) (Continued on the next page)
Grand Total All Awards = $156,355,365

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SDMC: HIV Prevention Trials Network

Award Number: UM1AI068617

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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