Plain-English translation of NCT04405700 on ClinicalTrials.gov ↗ · Source last updated · Translation generated · How we translate trials
This research study is following pregnant women—both those with HIV and those without—to understand how HIV treatment affects pregnancy outcomes and newborn health. Researchers will collect medical records and birth information from women who receive care at participating health clinics in Kenya and South Africa. The goal is to create a shared system for tracking pregnancy and birth outcomes across multiple clinics so doctors can better understand the safety and effects of HIV medications during pregnancy.
Doctors need better information about how HIV medications affect pregnant women and their babies across different parts of the world. By combining data from multiple clinics, researchers can spot patterns and help ensure that pregnant women with HIV receive the safest, most effective care.
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If you join this study as a pregnant woman, researchers will collect information from your medical records during pregnancy and after delivery. If you deliver at the participating clinic, your records will be included automatically. If you deliver elsewhere, researchers may contact you by phone or visit you to learn about your pregnancy and baby's health. If your baby has any birth abnormalities, photos or videos may be taken for expert review. The study is designed to fit into your regular prenatal and delivery care, with no extra visits required.
AI-generated summary from trial data · Jun 17, 2026 · Not medical advice
Kenya
Sponsor
Indiana University
Enrollment target
~2,800 participants
Started
September 2020
Primary completion
May 2026
This trial's estimated completion date has passed — the record may not be fully up to date.
Sex
Female only
Last updated on clinicaltrials.gov in August 2025.
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