UNCPM 22314 - Pregnancy, Infant and Maternal Health Outcomes Study — Stella

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UNCPM 22314 - Pregnancy, Infant and Maternal Health Outcomes Study — Stella

Home/Pre-exposure Prophylaxis/

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Phase 4 — Post-approval study. The treatment has been approved, but researchers continue monitoring it in a large population over time.

Trial locations(1 site)

Malawi

Bwaila Distict Hospital, Lilongwe

Key details

Phase

Post-approval study

Sponsor

University of North Carolina, Chapel Hill

Collaborators

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), United States President's Emergency Plan for AIDS Relief

Enrollment target

~621 participants

Started

April 2024

Primary completion

December 2026

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Age range

15 Years – 55 Years

Sex

Female only

Last updated March 2025