UNCPM 22314 - Pregnancy, Infant and Maternal Health Outcomes Study
Recruiting
Phase 4
Interventional Study
Pre-exposure Prophylaxis
HIV Prevention
Pregnancy Related
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Healthy Volunteers Welcome
You do not need to have the condition being studied to take part.
At a Glance
- Age
- 15 – 55
- Sex
- Female
- Trial phase
- Phase 4
- Study type
- Interventional
- Purpose
- Prevention
- Participants needed
- 621 (estimated)
- Sponsor
- University of North Carolina, Chapel Hill · Other
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About This Trial
The primary purpose of this study is to assess the safety of long-acting injectable cabotegravir (CAB-LA) and oral pre-expose prophylaxis (PrEP) (FTC/TDF or 3TC/TDF) for the prevention of HIV during pregnancy and breastfeeding among pregnant women and their infants in Malawi. The main question the study aims to answer is:
\- Do composite adverse pregnancy events, maternal health outcomes, and/or …
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
Maternal participants:
* Confirmed pregnancy by urine pregnancy test or ultrasound.
* Aged 15 years or older
* PrEP-eligible by Malawi local guidelines
* Confirmed HIV-negative based on the local HIV testing algorithm
* Hepatitis B surface antigen (HBsAg) negative
* Weight \>35…
Contacts