Actively Recruiting
UNCPM 22314 - Pregnancy, Infant and Maternal Health Outcomes Study
Led by University of North Carolina, Chapel Hill · Updated on 2026-05-05
621
Participants Needed
1
Research Sites
189 weeks
Total Duration
On this page
Sponsors
U
University of North Carolina, Chapel Hill
Lead Sponsor
E
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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 infant health outcomes differ between individuals taking oral PrEP and those taking CAB-LA? Women who are already using PrEP at the time of pregnancy diagnosis or those who initiate PrEP during pregnancy will enroll into a Safety Cohort where they will be closely followed up during pregnancy while optimizing their antenatal care (ANC) per the Malawi ANC package. Women will have access to either CAB-LA or oral PrEP and will be given an opportunity to choose one option. Women and their infants will attend a series of follow-up visits through pregnancy, birth, and the postnatal period. In addition, the study will contribute to the development of a national PrEP Pregnancy Registry which will be initially rolled out in Lilongwe and Blantyre -the two most populous cities in Malawi-before a nationwide roll out begins under the guidance of the Malawi Ministry of Health.
CONDITIONS
Official Title
UNCPM 22314 - Pregnancy, Infant and Maternal Health Outcomes Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Confirmed pregnancy by urine pregnancy test or ultrasound
- Aged 15 years or older
- Eligible for PrEP according to Malawi local guidelines
- Confirmed HIV-negative based on local HIV testing
- Hepatitis B surface antigen (HBsAg) negative
- Weight greater than 35 kilograms
- Provided informed consent and willing to participate with their infants
You will not qualify if you...
- Known to be living with HIV
- Known allergies to CAB-LA, TDF/3TC, or FTC/TDF
- Presence of any significant active or chronic disease, substance use, or social conditions deemed unsafe by the investigator
- Planning to leave the study area before scheduled study completion
AI-Screening
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Trial Site Locations
Total: 1 location
1
Bwaila Distict Hospital
Lilongwe, Malawi
Actively Recruiting
Research Team
C
Charity Nakanga, MBBS, MSc
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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