Status:
RECRUITING
UNCPM 22314 - Pregnancy, Infant and Maternal Health Outcomes Study
Lead Sponsor:
University of North Carolina, Chapel Hill
Collaborating Sponsors:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
United States President's Emergency Plan for AIDS Relief
Conditions:
Pre-exposure Prophylaxis
HIV Prevention
Eligibility:
FEMALE
15-55 years
Phase:
PHASE4
Brief Summary
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 p...
Detailed Description
For the prospective safety cohort, the study will enroll and follow up eligible women attending antenatal clinic and planning to deliver at Bwaila District Hospital in Lilongwe, Malawi. The primary ob...
Eligibility Criteria
Inclusion
- 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 kg
- Provided informed consent and expressed willingness to participate in study activities with their infants.
- Infant participants: Infant participants will enter the study with their mother as unborn infants. There are no specific eligibility criteria for infant participation otherwise.
Exclusion
- Maternal participants will not be eligible to enter the prospective cohort study if any of the following conditions are identified during the screening process:
- Known to be living with HIV
- Known allergies to CAB-LA, TDF/3TC or FTC/TDF
- Other current significant disease process (active or chronic), substance use, or social circumstances that, in the judgment of the site investigator would make participation in the study unsafe.
- Intention to leave the study site's catchment area of Bwaila before scheduled study exit.
Key Trial Info
Start Date :
April 17 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2027
Estimated Enrollment :
621 Patients enrolled
Trial Details
Trial ID
NCT06158126
Start Date
April 17 2024
End Date
December 1 2027
Last Update
March 14 2025
Active Locations (1)
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1
Bwaila Distict Hospital
Lilongwe, Malawi