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Wits HIV Research Group CLINICAL TRIAL UNIT (CTU) reapplication

Award Number: UM1AI069463
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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7. Project Summary/Abstract The Wits HIV Research Group Clinical Trials Unit (WHRG CTU) under the joint PI Leadership of Ian Sanne and Helen Rees, includes four experienced pleuripotent Clinical Research Sites (CRSs), namely the Wits Helen Joseph Hospital CRS (Dr Sharlaa Badal-Faesen), The Wits RHI Shandukani Maternal and Child CRS (Dr Lee Fairlie), Wits RHI Hillbrow Health Precinct Ward 21 CRS (Prof. Sinead Delaney-Moretlwe) and the Wits RHI Research Centre (Dr Thesla Palanee-Phillips). These four CRSs have capacity to conduct clinical trials across all four NIH Networks, the ACTG, IMPAACT, HPTN and VTN. The CTU’s research agenda includes HIV treatment, HIV-associated infections and HIV-related cancers; HIV prevention; TB treatment and prevention (including MDR-TB) and Hepatitis. The CTU conducts research across all key populations, including adolescent girls and young women, men who have sex with men, transgender populations and female sex workers; as well as vulnerable populations such as neonates, infants, older children, pregnant and breastfeeding women. The CTU has capacity to conduct Investigational New Drug (IND) level trials including phase I/II/II trials, blinded and unblinded randomized trials, across a wide range of products including oral products for treatment and prevention; vaccines for infants, children, adolescents, pregnant women and adults; injectable long acting antiretrovirals for treatment and prevention; monoclonal antibody infusions and microbicides. The expertise, facilities and specialized equipment at each CRS results in the sites conducting these studies at a high level of quality and efficiency. The CTU has in-house laboratory capacity and contracts external laboratories to perform testing to the required Network standards. The four sites are situated in Johannesburg, South Africa’s bustling urban centre and populations included in the CTU research are recruited within Johannesburg, using a targeted approach appropriate for each, and ensuring that hard-to-engage people who may be at highest risk are not excluded. This requires facility- and community-based recruitment and the CTU has a formalized approach, for community engagement across all relevant populations based on good participatory practice principles. The CTU has substantial experience and expertise within all components including but Pharmacy, Regulatory Processes, Data Management, Quality Management, Training and Mentoring and although the four CRSs are distinct, the CTU optimizes efficiencies and collaboration across all CRSs. Experience related to specific populations is shared within the CTU, but also externally locally in South Africa, Regionally and Internationally. The CTU has had over 10 successful IND audits and inspections FDA, EMEA and SAHPRA; and numerous successful PPD and sponsor inspections.


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 = $938,678 )
2024	2024	WITS HEALTH CONSORTIUM (PTY) LTD	31 PRINCESS OF WALES TERRACE PARKTOWN	JOHANNESBURG				ZAF	Allergy and Infectious Diseases Research	000	18	11/15/2023	NON-COMPETING CONTINUATION	$938,678
														Subtotal = $938,678

Issue Date FY: 2023 ( Subtotal = $2,492,623 )
2023	2023	WITS HEALTH CONSORTIUM (PTY) LTD	31 PRINCESS OF WALES TERRACE PARKTOWN	JOHANNESBURG				ZAF	Allergy and Infectious Diseases Research	000	17	11/23/2022	NON-COMPETING CONTINUATION	$1,246,312
2023	2023	WITS HEALTH CONSORTIUM (PTY) LTD	31 PRINCESS OF WALES TERRACE PARKTOWN	JOHANNESBURG				ZAF	Allergy and Infectious Diseases Research	001	17	6/28/2023	NON-COMPETING CONTINUATION	$1,246,311
														Subtotal = $2,492,623

Issue Date FY: 2022 ( Subtotal = $2,826,568 )
2022	2022	WITS HEALTH CONSORTIUM (PTY) LTD	31 PRINCESS OF WALES TERRACE PARKTOWN	JOHANNESBURG				ZAF	Allergy and Infectious Diseases Research	000	16	11/23/2021	NON-COMPETING CONTINUATION	$1,724,152
2022	2022	WITS HEALTH CONSORTIUM (PTY) LTD	31 PRINCESS OF WALES TERRACE PARKTOWN	JOHANNESBURG				ZAF	Allergy and Infectious Diseases Research	001	16	7/8/2022	NON-COMPETING CONTINUATION	$1,102,325
2022	2020	WITS HEALTH CONSORTIUM (PTY) LTD	31 PRINCESS OF WALES TERRACE PARKTOWN	JOHANNESBURG				ZAF	Allergy and Infectious Diseases Research	002	14	9/26/2022	NON-COMPETING CONTINUATION	$91
														Subtotal = $2,826,568

Issue Date FY: 2021 ( Subtotal = $1,877,496 )
2021	2021	WITS HEALTH CONSORTIUM (PTY) LTD	31 PRINCESS OF WALES TERRACE PARKTOWN	JOHANNESBURG				ZAF	Allergy and Infectious Diseases Research	001	15	12/2/2020	COMPETING CONTINUATION	$0
2021	2021	WITS HEALTH CONSORTIUM (PTY) LTD	31 PRINCESS OF WALES TERRACE PARKTOWN	JOHANNESBURG				ZAF	Allergy and Infectious Diseases Research	004	15	8/17/2021	COMPETING CONTINUATION	$91
2021	2021	WITS HEALTH CONSORTIUM (PTY) LTD	31 PRINCESS OF WALES TERRACE PARKTOWN	JOHANNESBURG				ZAF	Allergy and Infectious Diseases Research	002	15	3/2/2021	COMPETING CONTINUATION	$938,748
2021	2021	WITS HEALTH CONSORTIUM (PTY) LTD	31 PRINCESS OF WALES TERRACE PARKTOWN	JOHANNESBURG				ZAF	Allergy and Infectious Diseases Research	000	15	11/19/2020	COMPETING CONTINUATION	$938,748
2021	2020	WITS HEALTH CONSORTIUM (PTY) LTD	31 PRINCESS OF WALES TERRACE PARKTOWN	JOHANNESBURG				ZAF	Allergy and Infectious Diseases Research	003	14	8/17/2021	NON-COMPETING CONTINUATION	-$91
														Subtotal = $1,877,496

Issue Date FY: 2020 ( Subtotal = $3,411,797 )
2020	2020	WITS HEALTH CONSORTIUM (PTY) LTD	31 PRINCESS OF WALES TERRACE PARKTOWN	JOHANNESBURG		2193		ZAF	Allergy and Infectious Diseases Research	000	14	11/19/2019	NON-COMPETING CONTINUATION	$1,705,899
2020	2020	WITS HEALTH CONSORTIUM (PTY) LTD	31 PRINCESS OF WALES TERRACE PARKTOWN	JOHANNESBURG		2193		ZAF	Allergy and Infectious Diseases Research	001	14	6/1/2020	NON-COMPETING CONTINUATION	$1,705,898
														Subtotal = $3,411,797

Issue Date FY: 2019 ( Subtotal = $4,132,035 )
2019	2019	WITS HEALTH CONSORTIUM (PTY) LTD	8 BLACKWOOD AVENUE	JOHANNESBURG		2193		ZAF	Allergy and Infectious Diseases Research	000	13	11/19/2018	NON-COMPETING CONTINUATION	$2,042,318
2019	2019	WITS HEALTH CONSORTIUM (PTY) LTD	31 PRINCESS OF WALES TERRACE PARKTOWN	JOHANNESBURG		2193		ZAF	Allergy and Infectious Diseases Research	002	13	8/13/2019	NON-COMPETING CONTINUATION	$47,399
2019	2019	WITS HEALTH CONSORTIUM (PTY) LTD	31 PRINCESS OF WALES TERRACE PARKTOWN	JOHANNESBURG		2193		ZAF	Allergy and Infectious Diseases Research	001	13	5/17/2019	NON-COMPETING CONTINUATION	$2,042,318
														Subtotal = $4,132,035

Issue Date FY: 2018 ( Subtotal = $1,084,670 )
2018	2018	WITS HEALTH CONSORTIUM (PTY) LTD	8 BLACKWOOD AVENUE	JOHANNESBURG		2193		ZAF	Allergy and Infectious Diseases Research	000	12	12/5/2017	NON-COMPETING CONTINUATION	$361,557
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	$542,335
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	$180,778
														Subtotal = $1,084,670

Issue Date FY: 2017 ( Subtotal = $1,051,232 )
2017	2017	WITS HEALTH CONSORTIUM (PTY) LTD	8 BLACKWOOD AVENUE	JOHANNESBURG		2193		ZAF	Allergy and Infectious Diseases Research	000	11	11/11/2016	NON-COMPETING CONTINUATION	$1,051,232
														Subtotal = $1,051,232

Issue Date FY: 2016 ( Subtotal = $1,084,670 )
2016	2016	WITS HEALTH CONSORTIUM	8 BLACKWOOD AVENUE	PARKTOWN				ZAF	Allergy and Infectious Diseases Research	000	10	11/24/2015	NON-COMPETING CONTINUATION	$1,084,670
														Subtotal = $1,084,670

Issue Date FY: 2015 ( Subtotal = $1,022,484 )
2015	2015	WITS HEALTH CONSORTIUM	8 BLACKWOOD AVENUE	PARKTOWN				ZAF	Allergy and Infectious Diseases Research	000	9	11/19/2014	NON-COMPETING CONTINUATION	$1,022,484
														Subtotal = $1,022,484

Issue Date FY: 2014 ( Subtotal = $2,952,539 )
2014	2014	WITS HEALTH CONSORTIUM	8 BLACKWOOD AVENUE	PARKTOWN				ZAF	Allergy and Infectious Diseases Research	002	8	12/23/2013	COMPETING CONTINUATION	$1,827,512
2014	2014	WITS HEALTH CONSORTIUM	8 BLACKWOOD AVENUE	PARKTOWN				ZAF	Allergy and Infectious Diseases Research	003	8	2/12/2014	COMPETING CONTINUATION	$304,956
2014	2014	WITS HEALTH CONSORTIUM	8 BLACKWOOD AVENUE	PARKTOWN				ZAF	Allergy and Infectious Diseases Research	001	8	12/10/2013	COMPETING CONTINUATION	$820,071
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 = $2,952,539

Issue Date FY: 2013 ( Subtotal = $3,619,097 )
2013	2013	WITS HEALTH CONSORTIUM	8 BLACKWOOD AVENUE	PARKTOWN				ZAF	Allergy and Infectious Diseases Research	002	7	2/18/2013	EXTENSION WITH OR WITHOUT FUNDS	-$3,171,048
2013	2013	WITS HEALTH CONSORTIUM	8 BLACKWOOD AVENUE	PARKTOWN				ZAF	Allergy and Infectious Diseases Research	003	7	2/22/2013	EXTENSION WITH OR WITHOUT FUNDS	$3,171,048
2013	2013	WITS HEALTH CONSORTIUM	8 BLACKWOOD AVENUE	PARKTOWN				ZAF	Allergy and Infectious Diseases Research	005	7	12/9/2013	EXTENSION WITH OR WITHOUT FUNDS	$0
2013	2013	WITS HEALTH CONSORTIUM	8 BLACKWOOD AVENUE	PARKTOWN				ZAF	Allergy and Infectious Diseases Research	001	7	1/18/2013	EXTENSION WITH OR WITHOUT FUNDS	$3,171,048
2013	2013	WITS HEALTH CONSORTIUM	8 BLACKWOOD AVENUE	PARKTOWN				ZAF	Allergy and Infectious Diseases Research	004	7	7/16/2013	EXTENSION WITH OR WITHOUT FUNDS	$448,049
2013	2012	UNIVERSITY OF THE WITWATERSRAND	MILNER PARK	JOHANNESBURG		00000		ZAF	Allergy and Infectious Diseases Research	000	6	11/2/2012	NON-COMPETING CONTINUATION	$0
														Subtotal = $3,619,097

Issue Date FY: 2012 ( Subtotal = $2,250,104 ) (Continued on the next page)
2012	2012	UNIVERSITY OF THE WITWATERSRAND	MILNER PARK	JOHANNESBURG		00000		ZAF	Allergy and Infectious Diseases Research	006	6	9/7/2012	NON-COMPETING CONTINUATION	$0
2012	2012	UNIVERSITY OF THE WITWATERSRAND	8 BLACKWOOD AVE PARKTOWN	JOHANNESBURG				ZAF	Allergy and Infectious Diseases Research	003	6	8/10/2012	NON-COMPETING CONTINUATION	$54,000
2012	2012	UNIVERSITY OF THE WITWATERSRAND	MILNER PARK	JOHANNESBURG		00000		ZAF	Allergy and Infectious Diseases Research	002	6	3/28/2012	NON-COMPETING CONTINUATION	$0
2012	2012	UNIVERSITY OF THE WITWATERSRAND	MILNER PARK	JOHANNESBURG		00000		ZAF	Allergy and Infectious Diseases Research	004	6	8/29/2012	NON-COMPETING CONTINUATION	$0
2012	2012	UNIVERSITY OF THE WITWATERSRAND	MILNER PARK	JOHANNESBURG		00000		ZAF	Allergy and Infectious Diseases Research	005	6	9/5/2012	NON-COMPETING CONTINUATION	$0
Grand Total All Awards = $28,743,993

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Wits HIV Research Group CLINICAL TRIAL UNIT (CTU) reapplication

Award Number: UM1AI069463

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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