UNCPM 22314 - Pregnancy, Infant and Maternal Health Outcomes Study
Recruiting · NCT06158126 · Interventional (participants receive a specific treatment) · Lead sponsor: University of North Carolina, Chapel Hill
View the official record on ClinicalTrials.gov →Interventions studied
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.
Who can take part
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 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 criteria
- 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.
Where it is running
1 location listed.
- Bwaila Distict Hospital - Lilongwe, Malawi