Thursday, November 21, 2024 11/21/2024

PHRU-Setshaba Clinical Trials Unit

Award Number: UM1AI069453
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 HIV is the epidemic of our time; South Africa is its epicenter. Current interventions are denting the epidemic but are unlikely to achieve the UNAIDS goal of ending HIV by 2030. In South Africa, new infections continue: in 2018, 240 000 new infections added to the 7.7 million South Africans living with HIV. South Africa has the largest ARV program in the world, but treatment as prevention has not stalled new infections. Although progress has been made in controlling pediatric HIV, we have yet to meet the Joint United Nations Programme on HIV/AIDS (UNAIDS) elimination targets. The significant TB burden amongst people living with HIV destabilizes TB control efforts. Taken together, these realities underscore the need to find effective biomedical interventions to prevent HIV, address the long-term management of HIV throughout the age spectrum, and investigate HIV remission. Ongoing research investment is vital to our attempt to achieve epidemic control. NIH-sponsored research has led to vital advances in both treatment and prevention. Our proposed PHRU- Setshaba Clinical Trials Unit (CTU), with seven Clinical Research Sites (CRS), is strategically positioned in high HIV prevalence and incidence geographic hotspots. Our access to informal settlements, maternity units, TB clinics and hospitals enables the CTU to investigate the prevention and control of HIV and TB. Our PHRU- Setshaba CTU has the long-term objective to support the scientific agenda of the four NIH HIV/AIDS Clinical Trials Networks to reduce the impact of HIV and TB on infants, children, adolescents and adults. Our CTU comprises of internationally renowned scientists, based in South Africa, predominantly women, from diverse racial and ethnic backgrounds, with a track record of capacity development. To contribute to the scientific agenda of the NIH HIV/AIDS Clinical Trials Networks, the CTU intends to: 1) evaluate novel active HIV vaccination strategies that may be efficacious by inducing non-neutralizing vaccine immune responses; 2) evaluate passive neutralization utilizing one or more monoclonal antibodies for biomedical prevention; 3) investigate the role of alternatives to oral pre-exposure prophylaxis such as long-acting antiretrovirals and multi-purpose prevention technologies; 4) assess HIV vaccines to prevent breastmilk transmission of HIV; 5) contribute to finding HIV treatment options that reduce long-term side-effects in both adults and children; 6) support research into HIV remission and 7) to contribute to the TB research agenda for TB prevention and therapeutics. We aim to achieve this by operating an efficient CTU that will oversee the execution of quality clinical research which is regulatory and ethically compliant, in partnership with our communities, as well as by developing a successor generation of diverse scientists.


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 = -$126,039 )
2025	2020	WITS HEALTH CONSORTIUM (PTY) LTD	31 PRINCESS OF WALES TERRACE	JOHANNESBURG				ZAF	Allergy and Infectious Diseases Research	000	14	10/1/2024	NON-COMPETING CONTINUATION	-$126,039
														Subtotal = -$126,039

Issue Date FY: 2024 ( Subtotal = $2,756,588 )
2024	2024	WITS HEALTH CONSORTIUM (PTY) LTD	31 PRINCESS OF WALES TERRACE	JOHANNESBURG				ZAF	Allergy and Infectious Diseases Research	003	18	7/1/2024	SUPPLEMENT FOR EXPANSION	$0
2024	2024	WITS HEALTH CONSORTIUM (PTY) LTD	31 PRINCESS OF WALES TERRACE	JOHANNESBURG				ZAF	Allergy and Infectious Diseases Research	002	18	6/20/2024	NON-COMPETING CONTINUATION	$1,303,619
2024	2024	WITS HEALTH CONSORTIUM (PTY) LTD	31 PRINCESS OF WALES TERRACE	JOHANNESBURG				ZAF	Allergy and Infectious Diseases Research	001	18	6/12/2024	SUPPLEMENT FOR EXPANSION	$149,350
2024	2024	WITS HEALTH CONSORTIUM (PTY) LTD	31 PRINCESS OF WALES TERRACE PARKTOWN	JOHANNESBURG				ZAF	Allergy and Infectious Diseases Research	000	18	11/13/2023	NON-COMPETING CONTINUATION	$1,303,619
														Subtotal = $2,756,588

Issue Date FY: 2023 ( Subtotal = $2,404,119 )
2023	2023	WITS HEALTH CONSORTIUM (PTY) LTD	31 PRINCESS OF WALES TERRACE PARKTOWN	JOHANNESBURG				ZAF	Allergy and Infectious Diseases Research	000	17	11/22/2022	NON-COMPETING CONTINUATION	$742,834
2023	2023	WITS HEALTH CONSORTIUM (PTY) LTD	31 PRINCESS OF WALES TERRACE PARKTOWN	JOHANNESBURG				ZAF	Allergy and Infectious Diseases Research	001	17	6/6/2023	NON-COMPETING CONTINUATION	$1,661,285
														Subtotal = $2,404,119

Issue Date FY: 2022 ( Subtotal = $3,297,099 )
2022	2022	WITS HEALTH CONSORTIUM (PTY) LTD	31 PRINCESS OF WALES TERRACE PARKTOWN	JOHANNESBURG				ZAF	Allergy and Infectious Diseases Research	001	16	6/1/2022	NON-COMPETING CONTINUATION	$1,201,718
2022	2022	WITS HEALTH CONSORTIUM (PTY) LTD	31 PRINCESS OF WALES TERRACE PARKTOWN	JOHANNESBURG				ZAF	Allergy and Infectious Diseases Research	002	16	7/5/2022	NON-COMPETING CONTINUATION	$215,770
2022	2022	WITS HEALTH CONSORTIUM (PTY) LTD	31 PRINCESS OF WALES TERRACE PARKTOWN	JOHANNESBURG				ZAF	Allergy and Infectious Diseases Research	000	16	11/29/2021	NON-COMPETING CONTINUATION	$1,879,611
														Subtotal = $3,297,099

Issue Date FY: 2021 ( Subtotal = $3,532,996 )
2021	2021	WITS HEALTH CONSORTIUM (PTY) LTD	31 PRINCESS OF WALES TERRACE PARKTOWN	JOHANNESBURG				ZAF	Allergy and Infectious Diseases Research	003	15	8/10/2021	COMPETING CONTINUATION	$619,012
2021	2021	WITS HEALTH CONSORTIUM (PTY) LTD	31 PRINCESS OF WALES TERRACE PARKTOWN	JOHANNESBURG				ZAF	Allergy and Infectious Diseases Research	000	15	11/23/2020	COMPETING CONTINUATION	$1,438,427
2021	2021	WITS HEALTH CONSORTIUM (PTY) LTD	31 PRINCESS OF WALES TERRACE PARKTOWN	JOHANNESBURG				ZAF	Allergy and Infectious Diseases Research	001	15	3/10/2021	COMPETING CONTINUATION	$2,094,569
2021	2020	WITS HEALTH CONSORTIUM (PTY) LTD	31 PRINCESS OF WALES TERRACE PARKTOWN	JOHANNESBURG				ZAF	Allergy and Infectious Diseases Research	002	14	8/10/2021	NON-COMPETING CONTINUATION	-$619,012
														Subtotal = $3,532,996

Issue Date FY: 2020 ( Subtotal = $6,186,290 )
2020	2020	WITS HEALTH CONSORTIUM (PTY) LTD	31 PRINCESS OF WALES TERRACE PARKTOWN	JOHANNESBURG		2193		ZAF	Allergy and Infectious Diseases Research	000	14	11/21/2019	NON-COMPETING CONTINUATION	$3,159,552
2020	2020	WITS HEALTH CONSORTIUM (PTY) LTD	31 PRINCESS OF WALES TERRACE PARKTOWN	JOHANNESBURG		2193		ZAF	Allergy and Infectious Diseases Research	001	14	2/14/2020	NON-COMPETING CONTINUATION	$0
2020	2020	WITS HEALTH CONSORTIUM (PTY) LTD	31 PRINCESS OF WALES TERRACE PARKTOWN	JOHANNESBURG		2193		ZAF	Allergy and Infectious Diseases Research	002	14	6/1/2020	NON-COMPETING CONTINUATION	$3,026,738
														Subtotal = $6,186,290

Issue Date FY: 2019 ( Subtotal = $3,987,535 )
2019	2019	WITS HEALTH CONSORTIUM (PTY) LTD	31 PRINCESS OF WALES TERRACE PARKTOWN	JOHANNESBURG		2193		ZAF	Allergy and Infectious Diseases Research	003	13	8/13/2019	NON-COMPETING CONTINUATION	$100,147
2019	2019	WITS HEALTH CONSORTIUM (PTY) LTD	31 PRINCESS OF WALES TERRACE PARKTOWN	JOHANNESBURG		2193		ZAF	Allergy and Infectious Diseases Research	001	13	2/15/2019	NON-COMPETING CONTINUATION	$0
2019	2019	WITS HEALTH CONSORTIUM (PTY) LTD	8 BLACKWOOD AVENUE	JOHANNESBURG		2193		ZAF	Allergy and Infectious Diseases Research	000	13	11/21/2018	NON-COMPETING CONTINUATION	$1,943,694
2019	2019	WITS HEALTH CONSORTIUM (PTY) LTD	31 PRINCESS OF WALES TERRACE PARKTOWN	JOHANNESBURG		2193		ZAF	Allergy and Infectious Diseases Research	002	13	5/17/2019	NON-COMPETING CONTINUATION	$1,943,694
														Subtotal = $3,987,535

Issue Date FY: 2018 ( Subtotal = $1,741,539 )
2018	2018	WITS HEALTH CONSORTIUM (PTY) LTD	8 BLACKWOOD AVENUE	JOHANNESBURG		2193		ZAF	Allergy and Infectious Diseases Research	003	12	8/14/2018	NON-COMPETING CONTINUATION	$119,315
2018	2018	WITS HEALTH CONSORTIUM (PTY) LTD	8 BLACKWOOD AVENUE	JOHANNESBURG		2193		ZAF	Allergy and Infectious Diseases Research	002	12	5/16/2018	NON-COMPETING CONTINUATION	$670,869
2018	2018	WITS HEALTH CONSORTIUM (PTY) LTD	8 BLACKWOOD AVENUE	JOHANNESBURG		2193		ZAF	Allergy and Infectious Diseases Research	000	12	12/1/2017	NON-COMPETING CONTINUATION	$540,741
2018	2018	WITS HEALTH CONSORTIUM (PTY) LTD	8 BLACKWOOD AVENUE	JOHANNESBURG		2193		ZAF	Allergy and Infectious Diseases Research	001	12	2/9/2018	NON-COMPETING CONTINUATION	$410,614
														Subtotal = $1,741,539

Issue Date FY: 2017 ( Subtotal = $1,634,670 )
2017	2017	WITS HEALTH CONSORTIUM (PTY) LTD	8 BLACKWOOD AVENUE	JOHANNESBURG		2193		ZAF	Allergy and Infectious Diseases Research	003	11	7/31/2017	NON-COMPETING CONTINUATION	$0
2017	2017	WITS HEALTH CONSORTIUM (PTY) LTD	8 BLACKWOOD AVENUE	JOHANNESBURG		2193		ZAF	Allergy and Infectious Diseases Research	002	11	7/25/2017	NON-COMPETING CONTINUATION	$26,603
2017	2017	WITS HEALTH CONSORTIUM (PTY) LTD	8 BLACKWOOD AVENUE	JOHANNESBURG		2193		ZAF	Allergy and Infectious Diseases Research	001	11	2/1/2017	NON-COMPETING CONTINUATION	$0
2017	2017	WITS HEALTH CONSORTIUM (PTY) LTD	8 BLACKWOOD AVENUE	JOHANNESBURG		2193		ZAF	Allergy and Infectious Diseases Research	000	11	11/23/2016	NON-COMPETING CONTINUATION	$1,608,067
														Subtotal = $1,634,670

Issue Date FY: 2016 ( Subtotal = $918,589 )
2016	2016	WITS HEALTH CONSORTIUM	8 BLACKWOOD AVENUE	PARKTOWN				ZAF	Allergy and Infectious Diseases Research	000	10	11/23/2015	NON-COMPETING CONTINUATION	$918,589
														Subtotal = $918,589

Issue Date FY: 2015 ( Subtotal = $1 )
2015	2015	WITS HEALTH CONSORTIUM	8 BLACKWOOD AVENUE	PARKTOWN				ZAF	Allergy and Infectious Diseases Research	000	9	12/5/2014	NON-COMPETING CONTINUATION	$1
														Subtotal = $1

Issue Date FY: 2014 ( Subtotal = $2,693,563 )
2014	2014	WITS HEALTH CONSORTIUM	8 BLACKWOOD AVENUE	PARKTOWN				ZAF	Allergy and Infectious Diseases Research	002	8	12/23/2013	COMPETING CONTINUATION	$1,592,634
2014	2014	WITS HEALTH CONSORTIUM	8 BLACKWOOD AVENUE	PARKTOWN				ZAF	Allergy and Infectious Diseases Research	003	8	2/12/2014	COMPETING CONTINUATION	$278,846
2014	2014	WITS HEALTH CONSORTIUM	8 BLACKWOOD AVENUE	PARKTOWN				ZAF	Allergy and Infectious Diseases Research	001	8	12/10/2013	COMPETING CONTINUATION	$822,083
2014	2013	WITS HEALTH CONSORTIUM	8 BLACKWOOD AVENUE	PARKTOWN				ZAF	Allergy and Infectious Diseases Research	000	7	12/9/2013	EXTENSION WITH OR WITHOUT FUNDS	$0
														Subtotal = $2,693,563

Issue Date FY: 2013 ( Subtotal = $2,591,933 ) (Continued on the next page)
2013	2013	WITS HEALTH CONSORTIUM	8 BLACKWOOD AVENUE	PARKTOWN				ZAF	Allergy and Infectious Diseases Research	005	7	6/24/2013	EXTENSION WITH OR WITHOUT FUNDS	$402,825
2013	2013	WITS HEALTH CONSORTIUM	8 BLACKWOOD AVENUE	PARKTOWN				ZAF	Allergy and Infectious Diseases Research	002	7	2/4/2013	EXTENSION WITH OR WITHOUT FUNDS	$2,189,108
Grand Total All Awards = $34,351,728

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PHRU-Setshaba Clinical Trials Unit

Award Number: UM1AI069453

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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