Status:
ACTIVE_NOT_RECRUITING
Stepped Care to Optimize PrEP Effectiveness in Pregnant and Postpartum Women
Lead Sponsor:
University of California, Los Angeles
Collaborating Sponsors:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
University of Cape Town
Conditions:
Hiv
Eligibility:
FEMALE
16+ years
Phase:
NA
Brief 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 prophyl...
Detailed Description
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 breastfeedin...
Eligibility Criteria
Inclusion
- Age ≥ 16 years
- Plans to deliver at the study facility
- 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
- Lives within 20 kilometers of the study facility
- Without psychiatric or medical contraindications to PrEP use
- \>20 weeks pregnant
- Able and willing to consent to study participation.
Exclusion
- Individuals not meeting the above criteria will be excluded.
- \-
Key Trial Info
Start Date :
September 7 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2025
Estimated Enrollment :
650 Patients enrolled
Trial Details
Trial ID
NCT05322629
Start Date
September 7 2022
End Date
December 31 2025
Last Update
November 3 2025
Active Locations (1)
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1
Gugulethu Midwife Obstetric Unit
Cape Town, South Africa, South Africa