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Stepped Care to Optimize PrEP Effectiveness in Pregnant and Postpartum Women
Sponsor: University of California, Los Angeles
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
Key Details
Gender
FEMALE
Age Range
16 Years - Any
Study Type
INTERVENTIONAL
Enrollment
650
Start Date
2022-09-07
Completion Date
2025-12-31
Last Updated
2025-11-03
Healthy Volunteers
Yes
Conditions
Interventions
PrEP adherence biofeedback
Services for women in the intervention arm includes bio-feedback adherence counseling based on urine lateral flow assays of tenofovir to measure adherence with rapid PrEP delivery .
Standard of care counseling
Adherence counseling based on self report and following national guidelines
Locations (1)
Gugulethu Midwife Obstetric Unit
Cape Town, South Africa, South Africa