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Stepped care to optimize PrEP effectiveness in pregnant and postpartum women (SCOPE-PP) in South Africa

Award Number: R01HD106862
ORGANIZATION: NATIONAL INSTITUTE OF CHILD HEALTH AND HUMAN DEVELOPMENT
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

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Stepped care to optimize PrEP effectiveness in pregnant and postpartum women (SCOPE-PP) in South Africa - PROJECT ABSTRACT OF PARENT AWARD (R01HD106862) New maternal HIV infections contribute significantly to vertical HIV transmission underscoring the urgent need for primary prevention interventions for high-risk pregnant and breastfeeding women. Pre- exposure prophylaxis (PrEP) in pregnancy and breastfeeding is safe and effective at preventing HIV. However, PrEP adherence and continuation remain low in pregnancy, and drop precipitously in the postpartum period. Our team is made up of experts in epidemiology, behavioral science, health economics and implementation science from University of California Los Angeles and the University of Cape Town. Together we implemented one of the first studies to integrate PrEP into antenatal care in South Africa (“PrEP-PP”; R01MH116771), that will end enrollment in 2022. Leveraging the research findings to date, we propose to test a novel strategy to optimize PrEP in pregnant and postpartum women in South Africa. Our randomized control trial (RCT) is designed to address key barriers to maternal PrEP use and evaluate cost-effectiveness to inform national policy. This trial builds on our earlier work demonstrating the acceptability, feasibility, safety and potential efficacy of a package of interventions including: 1) Rapid PrEP; 2) Enhanced biofeedback counseling; and 3) Choice of community PrEP delivery for women who show poor PrEP continuation (miss 1+ PrEP pick-up, and wish to continue on PrEP). We developed and piloted a novel intervention entitled, Stepped Care to Optimize PrEP Effectiveness in Pregnant and Postpartum women (SCOPE-PP) that addresses barriers to taking daily PrEP by streamlining PrEP access and empowering women to adhere to PrEP. We will evaluate SCOPE-PP in a pragmatic RCT of pregnant and postpartum women at risk of HIV acquisition. We will enroll 500 pregnant women in antenatal care and follow them through 12-months’ postpartum. Women in the intervention will be offered: Step 1: Rapid PrEP collection with enhanced biofeedback counselling using a novel urine assay that measures recent PrEP adherence, and Step 2: Community PrEP delivery for women who miss PrEP pick-up visit, to de-link PrEP from clinical visits. The primary outcome is PrEP adherence in postpartum women, measured through drug levels of tenofovir diphosphate. We aim to: 1) Evaluate the efficacy of the SCOPE-PP intervention on PrEP adherence in pregnant and postpartum women in a RCT; 2) Assess barriers and facilitators to the integration of SCOPE-PP package into ante- and postnatal care using the Consolidated Framework for Implementation Research; and 3) Estimate the cost effectiveness and equity impact of SCOPE- PP vs. standard of care per HIV infection and disability-adjusted life-year averted. This research is critical to inform maternal PrEP interventions to eliminate HIV acquisition and vertical transmission in high HIV burden communities and inform national policies to roll out maternal PrEP services.


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 = $68,535 )
2025	2025	UNIVERSITY OF CALIFORNIA, LOS ANGELES	10889 WILSHIRE BLVD STE 700	LOS ANGELES	CA	90024	LOS ANGELES	USA	Child Health and Human Development Extramural Research	000	4	1/8/2025	SUPPLEMENT FOR EXPANSION	$68,535
														Subtotal = $68,535

Issue Date FY: 2024 ( Subtotal = $460,434 )
2024	2024	UNIVERSITY OF CALIFORNIA, LOS ANGELES	10889 WILSHIRE BLVD STE 700	LOS ANGELES	CA	90024	LOS ANGELES	USA	Child Health and Human Development Extramural Research	000	4	6/27/2024	NON-COMPETING CONTINUATION	$460,434
														Subtotal = $460,434

Issue Date FY: 2023 ( Subtotal = $454,074 )
2023	2023	UNIVERSITY OF CALIFORNIA, LOS ANGELES	10889 WILSHIRE BLVD STE 700	LOS ANGELES	CA	90024	LOS ANGELES	USA	Child Health and Human Development Extramural Research	000	3	5/10/2023	NON-COMPETING CONTINUATION	$454,074
														Subtotal = $454,074

Issue Date FY: 2022 ( Subtotal = $450,762 )
2022	2022	UNIVERSITY OF CALIFORNIA, LOS ANGELES	10889 WILSHIRE BLVD STE 700	LOS ANGELES	CA	90024	LOS ANGELES	USA	Child Health and Human Development Extramural Research	003	2	7/11/2022	NON-COMPETING CONTINUATION	$512,000
2022	2021	UNIVERSITY OF CALIFORNIA, LOS ANGELES	10889 WILSHIRE BLVD STE 700	LOS ANGELES	CA	90024	LOS ANGELES	USA	Child Health and Human Development Extramural Research	002	1	7/11/2022	NEW	-$61,238
2022	2021	UNIVERSITY OF CALIFORNIA, LOS ANGELES	10889 WILSHIRE BLVD STE 700	LOS ANGELES	CA	90024	LOS ANGELES	USA	Child Health and Human Development Extramural Research	001	1	3/8/2022	NEW	$0
2022	2021	UNIVERSITY OF CALIFORNIA, LOS ANGELES	10889 WILSHIRE BLVD STE 700	LOS ANGELES	CA	90024	LOS ANGELES	USA	Child Health and Human Development Extramural Research	000	1	12/7/2021	NEW	$0
														Subtotal = $450,762

Issue Date FY: 2021 ( Subtotal = $639,880 )
2021	2021	UNIVERSITY OF CALIFORNIA, LOS ANGELES	10889 WILSHIRE BLVD STE 700	LOS ANGELES	CA	90024	LOS ANGELES	USA	Child Health and Human Development Extramural Research	000	1	9/20/2021	NEW	$639,880
														Subtotal = $639,880

Grand Total All Awards = $2,073,685

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Stepped care to optimize PrEP effectiveness in pregnant and postpartum women (SCOPE-PP) in South Africa

Award Number: R01HD106862

ORGANIZATION: NATIONAL INSTITUTE OF CHILD HEALTH AND HUMAN DEVELOPMENT

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

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

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