Summary

Eligibility
for females ages 16 years and up (full criteria)
Healthy Volunteers
healthy people welcome
Dates
study started
estimated completion
Principal Investigator
by Dvora Joseph Davey (ucla)

Description

Summary

To reach HIV-uninfected pregnant and breastfeeding women in South Africa, who are at very high risk of HIV, researchers will test a new and innovative package of interventions: 1) pre-exposure prophylaxis (PrEP), which is a daily antiretroviral pill that is both safe and effective for preventing HIV in pregnant and breastfeeding mothers and 2)) enhanced adherence counseling combined with differentiated deliver of community PrEP delivery for women who have difficulties with regular PrEP use. Our study will be among the first ever to evaluate the efficacy and cost-effectiveness of a PrEP intervention among pregnant and postpartum women and will play a key role in informing maternal PrEP interventions to eliminate HIV acquisition and transmission to partners and their infants.

Official Title

Stepped Care to Optimize PrEP Effectiveness in Pregnant and Postpartum Women (SCOPE-PP) in South Africa

Details

HIV incidence doubles during pregnancy and postpartum period compared with non-pregnant women, underscoring the urgent need for prevention interventions tailored to high-risk pregnant and breastfeeding women. Incident maternal HIV infections lead to an estimated one-third of all infant HIV infections. South Africa expects over 90,000 infant HIV cases in the next decade; one-third of those can be prevented by eliminating maternal HIV acquisition. Pre-exposure prophylaxis (PrEP) in pregnancy and breastfeeding is safe and effective at preventing HIV. However, PrEP use remains low in pregnancy, and drop precipitously in the postpartum period. Researchers will 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 PrEP, enhanced adherence counseling combined with community, differentiated delivery of PrEP for women who want to take PrEP but have difficulties with adherence. Our team 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 reducing clinic visit frequency and empowering women to adhere to PrEP. Our team will evaluate SCOPE-PP in a pragmatic RCT of pregnant and postpartum women at risk of HIV acquisition. The study will enroll 650 pregnant women in antenatal care and follow them through 12-months' postpartum. Women in the intervention will be offered rapid PrEP collection with enhanced adherence counseling. Women with poor PrEP continuation and/or adherence who want to continue on PrEP will be offered a differentiated care model of PrEP delivery to de-link PrEP from clinical visits. The primary outcome is PrEP continuation and adherence in postpartum women, measured through drug levels of tenofovir diphosphate. The study aims to: 1) Evaluate the efficacy of the SCOPE-PP intervention on PrEP adherence in pregnant and postpartum women in a RCT; 2) Assess the acceptability and feasibility of integrating SCOPE-PP into ante- and postnatal care using a consolidated framework for implementation research (CFIR); and 3) Estimate the incremental cost effectiveness 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 transmission.

Keywords

Hiv pregnant postpartum prevention of mother to child transmission PrEP pre-exposure prophylaxis HIV prevention breastfeeding PrEP adherence biofeedback

Eligibility

You can join if…

Open to females ages 16 years and up

  1. Age ≥ 16 years
  2. Plans to deliver at the study facility
  3. Documented HIV-negative according to two finger prick rapid tests (per national protocol for routine antenatal care) and confirmed with a 4th generation antigen HIV test
  4. Lives within 20 kilometers of the study facility
  5. Without psychiatric or medical contraindications to PrEP use
  6. >25 weeks pregnant
  7. Able and willing to consent to study participation.

You CAN'T join if...

Individuals not meeting the above criteria will be excluded.

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Lead Scientist at University of California Health

Details

Status
not yet accepting patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, Los Angeles
ID
NCT05322629
Study Type
Interventional
Participants
Expecting 650 study participants
Last Updated