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

University Of California Los Angeles, Los Angeles CA

Investigators

Linked publications & trials

Abstract

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.