Stepped Care to Optimize PrEP Effectiveness in Pregnant and Postpartum Women

Launched by UNIVERSITY OF CALIFORNIA, LOS ANGELES · Apr 11, 2022

Keywords

ClinConnect Summary

This clinical trial is looking at a new way to help prevent HIV in pregnant and breastfeeding women in South Africa who are at high risk of getting the virus. The study will test a daily pill called pre-exposure prophylaxis (PrEP), which has been shown to be safe and effective for keeping HIV negative. Along with the pill, researchers will provide support to help women take it regularly, especially if they have trouble sticking to the routine. This trial is important because it aims to find out how well this approach works and how much it costs, providing valuable information for future efforts to protect mothers and their babies from HIV.

To participate in this study, women need to be at least 16 years old, plan to deliver at the study facility, and be confirmed as HIV-negative through specific tests. They should be more than 20 weeks pregnant and live within 20 kilometers of the study location. Participants can expect to receive the PrEP pill, along with personalized support to help them use it effectively. This research could significantly help in reducing the risk of HIV for mothers and their infants.

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • 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. \>20 weeks pregnant
• • 7. Able and willing to consent to study participation.
• Exclusion Criteria:
• • Individuals not meeting the above criteria will be excluded.
• • -