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Botswana Birth Outcomes Surveillance Extension

Award Number: R01HD095766
ORGANIZATION: NATIONAL INSTITUTE OF CHILD HEALTH AND HUMAN DEVELOPMENT
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 08/03/2018
PERIOD OF PERFORMANCE END DATE: 06/30/2025

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Botswana Birth Outcomes Surveillance Extension - Abstract Antiretroviral treatment (ART) guidelines depend upon safety data in pregnancy. Although developed countries have moved to dolutegravir (DTG)-based first-line ART for non-pregnant adults, the World Health Organization (WHO) still recommends efavirenz (EFV)/emtricitabine (FTC)/tenofovir (TDF) while awaiting safety data for DTG that may harmonize guidelines for pregnant and non-pregnant adults. In June 2016, Botswana became the first country in Africa to switch to DTG/TDF/FTC as first-line ART for adults, including pregnant women. This change occurred in the setting of ongoing NIH-supported birth outcomes surveillance at 8 sites throughout Botswana (R01HD080471), which was designed to evaluate adverse birth outcomes by ART regimen and neural tube defects by EFV exposure status. This surveillance system has already provided initial safety data for the DTG roll-out, and has raised concerns about the safety of specific nevirapine- and lopinavir/ritonavir- based “legacy” ART regimens in pregnancy. Botswana's change to DTG/TDF/FTC, combined with the government's plan to switch women off “legacy” ART starting in 2018, opens new scientific opportunities for this surveillance system. We are therefore applying for a new R01 to continue (and enhance) birth outcomes surveillance in Botswana. Our proposal has the following primary aims: 1) to perform the first large analysis of adverse birth outcomes and congenital abnormalities following DTG exposure from the time of conception, and 2) to evaluate birth outcomes among women who either continue “legacy” ART or switch to DTG/TDF/FTC prior to (or during) pregnancy. These novel aims take advantage of the unique ART landscape in Botswana (including an upcoming plan to switch women off legacy ART regimens), and build on the emerging scientific findings from our highly productive surveillance system. Data generated from this study will be critical for updating WHO (and US) guidelines for the use of ART among pregnant women, and for women who may become pregnant.


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: 2026 ( Subtotal = -$5,530 )
2026	2022	PRESIDENT AND FELLOWS OF HARVARD COLLEGE	1033 MASSACHUSETTS AVE STE 3	CAMBRIDGE	MA	02138	MIDDLESEX	USA	Child Health and Human Development Extramural Research	000	5	12/16/2025	NON-COMPETING CONTINUATION	-$5,530
														Subtotal = -$5,530

Issue Date FY: 2025 ( Subtotal = $0 )
2025	2022	PRESIDENT AND FELLOWS OF HARVARD COLLEGE	1033 MASSACHUSETTS AVE STE 3	CAMBRIDGE	MA	02138	MIDDLESEX	USA	Child Health and Human Development Extramural Research	001	5	9/10/2025	NON-COMPETING CONTINUATION	$0
2025	2022	PRESIDENT AND FELLOWS OF HARVARD COLLEGE	1033 MASSACHUSETTS AVE STE 3	CAMBRIDGE	MA	02138	MIDDLESEX	USA	Child Health and Human Development Extramural Research	000	5	5/19/2025	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2024 ( Subtotal = $0 )
2024	2022	HARVARD COLLEGE PRESIDENT & FELLOWS OF	677 HUNTINGTON AVE	BOSTON	MA	02115	SUFFOLK	USA	Child Health and Human Development Extramural Research	001	5	6/26/2024	NON-COMPETING CONTINUATION	$0
2024	2022	HARVARD COLLEGE PRESIDENT & FELLOWS OF	677 HUNTINGTON AVE	BOSTON	MA	02115	SUFFOLK	USA	Child Health and Human Development Extramural Research	000	5	6/13/2024	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2022 ( Subtotal = $577,763 )
2022	2022	HARVARD COLLEGE PRESIDENT & FELLOWS OF	677 HUNTINGTON AVE	BOSTON	MA	02115	SUFFOLK	USA	Child Health and Human Development Extramural Research	000	5	6/13/2022	NON-COMPETING CONTINUATION	$577,763
														Subtotal = $577,763

Issue Date FY: 2021 ( Subtotal = $584,759 )
2021	2021	PRESIDENT AND FELLOWS OF HARVARD COLLEGE	677 HUNTINGTON AVE	BOSTON	MA	02115	SUFFOLK	USA	Child Health and Human Development Extramural Research	000	4	6/18/2021	NON-COMPETING CONTINUATION	$584,759
														Subtotal = $584,759

Issue Date FY: 2020 ( Subtotal = $795,344 )
2020	2020	PRESIDENT AND FELLOWS OF HARVARD COLLEGE	677 HUNTINGTON AVE	BOSTON	MA	02115	SUFFOLK	USA	Child Health and Human Development Extramural Research	002	3	6/19/2020	NON-COMPETING CONTINUATION	$604,783
2020	2020	PRESIDENT AND FELLOWS OF HARVARD COLLEGE	677 HUNTINGTON AVE	BOSTON	MA	02115	SUFFOLK	USA	Child Health and Human Development Extramural Research	001	2	3/17/2020	SUPPLEMENT FOR EXPANSION	$190,561
2020	2019	PRESIDENT AND FELLOWS OF HARVARD COLLEGE	677 HUNTINGTON AVE	BOSTON	MA	02115	SUFFOLK	USA	Child Health and Human Development Extramural Research	000	2	2/26/2020	NON-COMPETING CONTINUATION	$0
														Subtotal = $795,344

Issue Date FY: 2019 ( Subtotal = $623,767 )
2019	2019	PRESIDENT AND FELLOWS OF HARVARD COLLEGE	677 HUNTINGTON AVE	BOSTON	MA	02115	SUFFOLK	USA	Child Health and Human Development Extramural Research	000	2	6/25/2019	NON-COMPETING CONTINUATION	$623,767
														Subtotal = $623,767

Issue Date FY: 2018 ( Subtotal = $765,202 )
2018	2018	PRESIDENT AND FELLOWS OF HARVARD COLLEGE	677 HUNTINGTON AVE	BOSTON	MA	02115	SUFFOLK	USA	Child Health and Human Development Extramural Research	000	1	8/1/2018	NEW	$667,378
2018	2018	PRESIDENT AND FELLOWS OF HARVARD COLLEGE	677 HUNTINGTON AVE	BOSTON	MA	02115	SUFFOLK	USA	Child Health and Human Development Extramural Research	003	1	9/13/2018	SUPPLEMENT FOR EXPANSION	$0
2018	2018	PRESIDENT AND FELLOWS OF HARVARD COLLEGE	677 HUNTINGTON AVE	BOSTON	MA	02115	SUFFOLK	USA	Child Health and Human Development Extramural Research	002	1	9/12/2018	SUPPLEMENT FOR EXPANSION	$97,824
2018	2018	PRESIDENT AND FELLOWS OF HARVARD COLLEGE	677 HUNTINGTON AVE	BOSTON	MA	02115	SUFFOLK	USA	Child Health and Human Development Extramural Research	001	1	9/6/2018	NEW	$0
														Subtotal = $765,202

Grand Total All Awards = $3,341,306

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Botswana Birth Outcomes Surveillance Extension

Award Number: R01HD095766

ORGANIZATION: NATIONAL INSTITUTE OF CHILD HEALTH AND HUMAN DEVELOPMENT

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

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

PERIOD OF PERFORMANCE START DATE: 08/03/2018

PERIOD OF PERFORMANCE END DATE: 06/30/2025

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