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GHESKIO Clinical Trials Unit

Award Number: UM1AI069421
ORGANIZATION: NATIONAL INSTITUTE OF ALLERGY & INFECTIOUS DISEASES
OPDIV: NIH
AWARD CLASS: COOPERATIVE AGREEMENT
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 02/01/2007
PERIOD OF PERFORMANCE END DATE: 11/30/2027

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GHESKIO Clinical Trials Unit - PROJECT ABSTRACT: GHESKIO is a Haitian organization dedicated to research, service, and training in HIV/AIDS with a 37 year track record of NIH-funded clinical research. GHESKIO has two clinical sites in Port au Prince, Haiti. The Downtown site has large HIV/TB clinics, a maternal child health center, a cardiovascular center, and programs in adjacent slums. The North site has HIV/TB clinics, an MDR-TB hospital, and a BSL3 TB laboratory. The GHESKIO Clinical Trials Unit (CTU) has two clinical research sites (CRSs) enrolling male and female participants across the lifespan, including pregnant women, infants, children, adolescents and adults. The GHESKIO CTU will continue to participate in two networks: Adult HIV/AIDS Therapeutic Trials (ACTG) and Maternal, Adolescent, Pediatric therapeutics (IMPAACT). We propose the following three aims: 1. Operate a single organization (GHESKIO) CTU with two research sites that is integrated, cohesive, and able to respond rapidly to a breadth of emerging research priorities. The CTU will maximize efficiency by having a single research component for administration, communication, evaluation, community liaison, data management, regulatory assurance, quality management, and training program. Each CRS has its own pharmacy. The main laboratory is at GHESKIO-North and the downtown site has a satellite laboratory. 2. Conduct adult HIV/AIDS therapeutic trials at GHESKIO-Downtown and GHESKIO-North - ACTG: Haiti has the highest HIV prevalence in the hemisphere with 2.0% of adults HIV infected. Both GHESKIO sites (Downtown, North) have large HIV-infected adult ART naïve and ART-experienced cohorts available for recruitment into trials. Haiti also has the highest rates of TB with a prevalence of 1,066/100,000 in Port au Prince. GHESKIO treats ~ 2,000 TB patients annually including patients with MDR-TB who are available for enrollment into TB treatment trials. GHESKIO has established a new cardiovascular disease research unit to study the chronic complications of HIV. 3. Conduct maternal, adolescent, and pediatric HIV/AIDS trials at GHESKIO-Downtown- IMPAACT: GHESKIO-Downtown has the expertise, research capacity, and populations for trials of new antiretroviral drugs in children, adolescents and pregnant women. GHESKIO pediatricians identify and enroll HIV-infected newborns for trials of intensive therapy to induce an ART free remission. GHESKIO investigators are leaders in PK studies of TB drugs in children and pregnant women. We will be leading a trial evaluating one month isoniazid/rifapentine prophylaxis in pregnant women. GHESKIO will introduce studies on nutritional interventions in pregnant women and newborns to improve their growth and neurologic development.


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 = $1,865,917 )
2025	2025	LES CENTRES GHESKIO	33, BOULEVARD HARRY TRUMAN	PORT-AU-PRINCE				HTI	Allergy and Infectious Diseases Research	000	19	11/20/2024	NON-COMPETING CONTINUATION	$932,959
2025	2025	LES CENTRES GHESKIO	33, BOULEVARD HARRY TRUMAN	PORT-AU-PRINCE				HTI	Allergy and Infectious Diseases Research	001	19	3/27/2025	NON-COMPETING CONTINUATION	$932,958
														Subtotal = $1,865,917

Issue Date FY: 2024 ( Subtotal = $1,955,458 )
2024	2024	LES CENTRES GHESKIO	33, BOULEVARD HARRY TRUMAN	PORT-AU-PRINCE				HTI	Allergy and Infectious Diseases Research	001	18	6/4/2024	NON-COMPETING CONTINUATION	$865,799
2024	2024	LES CENTRES GHESKIO	33, BOULEVARD HARRY TRUMAN	PORT-AU-PRINCE				HTI	Allergy and Infectious Diseases Research	002	18	7/17/2024	SUPPLEMENT FOR EXPANSION	$223,859
2024	2024	LES CENTRES GHESKIO	33, BOULEVARD HARRY TRUMAN	PORT-AU-PRINCE				HTI	Allergy and Infectious Diseases Research	000	18	11/1/2023	NON-COMPETING CONTINUATION	$865,800
														Subtotal = $1,955,458

Issue Date FY: 2023 ( Subtotal = $1,993,512 )
2023	2023	LES CENTRES GHESKIO	33 BOULEVARD HARRY TRUMAN	PORT AU PRINCE	QUEST			HTI	Allergy and Infectious Diseases Research	001	17	5/26/2023	NON-COMPETING CONTINUATION	$1,052,560
2023	2023	LES CENTRES GHESKIO	33 BOULEVARD HARRY TRUMAN	PORT AU PRINCE	QUEST			HTI	Allergy and Infectious Diseases Research	000	17	11/10/2022	NON-COMPETING CONTINUATION	$940,952
														Subtotal = $1,993,512

Issue Date FY: 2022 ( Subtotal = $2,004,533 )
2022	2022	LES CENTRES GHESKIO	33 BOULEVARD HARRY TRUMAN	PORT AU PRINCE	QUEST			HTI	Allergy and Infectious Diseases Research	002	16	6/3/2022	NON-COMPETING CONTINUATION	$725,999
2022	2022	LES CENTRES GHESKIO	33 BOULEVARD HARRY TRUMAN	PORT AU PRINCE	QUEST			HTI	Allergy and Infectious Diseases Research	001	16	11/23/2021	NON-COMPETING CONTINUATION	$1,135,536
2022	2022	LES CENTRES GHESKIO	33 BOULEVARD HARRY TRUMAN	PORT AU PRINCE	QUEST			HTI	Allergy and Infectious Diseases Research	003	16	7/8/2022	NON-COMPETING CONTINUATION	$142,998
2022	2020	LES CENTRES GHESKIO	33 BOULEVARD HARRY TRUMAN	PORT AU PRINCE	QUEST			HTI	Allergy and Infectious Diseases Research	000	14	11/1/2021	NON-COMPETING CONTINUATION	$0
														Subtotal = $2,004,533

Issue Date FY: 2021 ( Subtotal = $1,835,823 )
2021	2021	LES CENTRES GHESKIO	33 BOULEVARD HARRY TRUMAN	PORT AU PRINCE	QUEST			HTI	Allergy and Infectious Diseases Research	001	15	6/8/2021	COMPETING CONTINUATION	$917,911
2021	2021	LES CENTRES GHESKIO	33 BOULEVARD HARRY TRUMAN	PORT AU PRINCE	QUEST			HTI	Allergy and Infectious Diseases Research	000	15	11/17/2020	COMPETING CONTINUATION	$917,912
														Subtotal = $1,835,823

Issue Date FY: 2020 ( Subtotal = $1,801,235 )
2020	2020	LES CENTRES GHESKIO	33 BOULEVARD HARRY TRUMAN	PORT AU PRINCE	QUEST			HTI	Allergy and Infectious Diseases Research	002	14	6/19/2020	NON-COMPETING CONTINUATION	$203,000
2020	2020	LES CENTRES GHESKIO	33 BOULEVARD HARRY TRUMAN	PORT AU PRINCE	QUEST			HTI	Allergy and Infectious Diseases Research	001	14	5/29/2020	NON-COMPETING CONTINUATION	$799,117
2020	2020	LES CENTRES GHESKIO	33 BOULEVARD HARRY TRUMAN	PORT AU PRINCE	QUEST			HTI	Allergy and Infectious Diseases Research	003	14	6/24/2020	NON-COMPETING CONTINUATION	$0
2020	2020	LES CENTRES GHESKIO	33 BOULEVARD HARRY TRUMAN	PORT AU PRINCE	QUEST			HTI	Allergy and Infectious Diseases Research	000	14	11/21/2019	NON-COMPETING CONTINUATION	$799,118
														Subtotal = $1,801,235

Issue Date FY: 2019 ( Subtotal = $1,883,418 )
2019	2019	REDACTED DUE TO PII		PORT AU PRINCE	QUEST			HTI	Allergy and Infectious Diseases Research	001	13	5/9/2019	NON-COMPETING CONTINUATION	$941,708
2019	2019	REDACTED DUE TO PII		PORT AU PRINCE	QUEST			HTI	Allergy and Infectious Diseases Research	000	13	11/9/2018	NON-COMPETING CONTINUATION	$941,710
														Subtotal = $1,883,418

Issue Date FY: 2018 ( Subtotal = $1,037,231 )
2018	2018	LES CENTRES GHESKIO	33 BOULEVARD HARRY TRUMAN	PORT AU PRINCE	QUEST			HTI	Allergy and Infectious Diseases Research	003	12	8/2/2018	NON-COMPETING CONTINUATION	$6,561
2018	2018	LES CENTRES GHESKIO	33 BOULEVARD HARRY TRUMAN	PORT AU PRINCE	QUEST			HTI	Allergy and Infectious Diseases Research	000	12	11/23/2017	NON-COMPETING CONTINUATION	$343,557
2018	2018	LES CENTRES GHESKIO	33 BOULEVARD HARRY TRUMAN	PORT AU PRINCE	QUEST			HTI	Allergy and Infectious Diseases Research	002	12	5/18/2018	NON-COMPETING CONTINUATION	$515,335
2018	2018	LES CENTRES GHESKIO	33 BOULEVARD HARRY TRUMAN	PORT AU PRINCE	QUEST			HTI	Allergy and Infectious Diseases Research	001	12	2/16/2018	NON-COMPETING CONTINUATION	$171,778
														Subtotal = $1,037,231

Issue Date FY: 2017 ( Subtotal = $1,030,670 )
2017	2017	LES CENTRES GHESKIO	33 BOULEVARD HARRY TRUMAN	PORT AU PRINCE	QUEST			HTI	Allergy and Infectious Diseases Research	000	11	11/8/2016	NON-COMPETING CONTINUATION	$1,030,670
														Subtotal = $1,030,670

Issue Date FY: 2016 ( Subtotal = $1,110,670 )
2016	2016	THE GHESKIO CENTERS	33 BOULEVARD HARRY TRUMAN	PORT-AU-PRINCE				HTI	Allergy and Infectious Diseases Research	000	10	11/13/2015	NON-COMPETING CONTINUATION	$1,030,670
2016	2016	THE GHESKIO CENTERS	33 BOULEVARD HARRY TRUMAN	PORT-AU-PRINCE				HTI	Allergy and Infectious Diseases Research	001	10	8/11/2016	NON-COMPETING CONTINUATION	$80,000
														Subtotal = $1,110,670

Issue Date FY: 2015 ( Subtotal = $919,160 )
2015	2015	THE GHESKIO CENTERS	33 BOULEVARD HARRY TRUMAN	PORT-AU-PRINCE				HTI	Allergy and Infectious Diseases Research	000	9	11/4/2014	NON-COMPETING CONTINUATION	$919,160
														Subtotal = $919,160

Issue Date FY: 2014 ( Subtotal = $1,425,181 )
2014	2014	THE GHESKIO CENTERS	33 BOULEVARD HARRY TRUMAN	PORT-AU-PRINCE				HTI	Allergy and Infectious Diseases Research	002	8	2/14/2014	COMPETING CONTINUATION	$131,828
2014	2014	THE GHESKIO CENTERS	33 BOULEVARD HARRY TRUMAN	PORT-AU-PRINCE				HTI	Allergy and Infectious Diseases Research	000	8	12/10/2013	COMPETING CONTINUATION	$814,446
2014	2014	THE GHESKIO CENTERS	33 BOULEVARD HARRY TRUMAN	PORT-AU-PRINCE				HTI	Allergy and Infectious Diseases Research	004	8	8/20/2014	COMPETING CONTINUATION	$35,730
2014	2014	THE GHESKIO CENTERS	33 BOULEVARD HARRY TRUMAN	PORT-AU-PRINCE				HTI	Allergy and Infectious Diseases Research	001	8	12/23/2013	COMPETING CONTINUATION	$380,047
2014	2014	THE GHESKIO CENTERS	33 BOULEVARD HARRY TRUMAN	PORT-AU-PRINCE				HTI	Allergy and Infectious Diseases Research	003	8	6/6/2014	COMPETING CONTINUATION	$63,130
														Subtotal = $1,425,181

Issue Date FY: 2013 ( Subtotal = $1,374,213 )
2013	2013	THE GHESKIO CENTERS	33 BLVD HARRY TRUMAN	PORT-AU-PRINCE				HTI	Allergy and Infectious Diseases Research	001	7	6/11/2013	EXTENSION WITH OR WITHOUT FUNDS	$137,420
2013	2013	THE GHESKIO CENTERS	33 BLVD HARRY TRUMAN	PORT-AU-PRINCE				HTI	Allergy and Infectious Diseases Research	000	7	11/30/2012	EXTENSION WITH OR WITHOUT FUNDS	$1,236,793
														Subtotal = $1,374,213

Issue Date FY: 2012 ( Subtotal = $1,604,865 ) (Continued on the next page)
2012	2012	THE GHESKIO CENTERS	33 BLVD HARRY TRUMAN	PORT-AU-PRINCE				HTI	Allergy and Infectious Diseases Research	003	6	7/19/2012	NON-COMPETING CONTINUATION	$198,509
2012	2012	THE GHESKIO CENTERS	33 BLVD HARRY TRUMAN	PORT-AU-PRINCE				HTI	Allergy and Infectious Diseases Research	000	6	12/21/2011	NON-COMPETING CONTINUATION	$1,265,720
Grand Total All Awards = $21,841,886

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GHESKIO Clinical Trials Unit

Award Number: UM1AI069421

ORGANIZATION: NATIONAL INSTITUTE OF ALLERGY & INFECTIOUS DISEASES

OPDIV: NIH

AWARD CLASS: COOPERATIVE AGREEMENT

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

PERIOD OF PERFORMANCE START DATE: 02/01/2007

PERIOD OF PERFORMANCE END DATE: 11/30/2027

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