UNCPM 22314 - Pregnancy, Infant and Maternal Health Outcomes Study

Launched by UNIVERSITY OF NORTH CAROLINA, CHAPEL HILL · Nov 27, 2023

Keywords

ClinConnect Summary

The UNCPM 22314 trial is studying the safety of two different HIV prevention methods during pregnancy and breastfeeding: an injectable medication called cabotegravir (CAB-LA) and an oral medication known as PrEP (FTC/TDF or 3TC/TDF). The goal is to find out if there are any differences in negative effects on pregnancy, maternal health, or infant health between women using these two options. Pregnant women in Malawi who are eligible for PrEP will be able to choose which treatment they want to use and will be closely monitored throughout their pregnancy and after giving birth. This study will also help create a registry to track the safety of PrEP during pregnancy across the country.

To participate in the trial, women need to be at least 15 years old, confirmed to be pregnant, HIV-negative, and meet other health criteria. Infants will join the study with their mothers. Participants can expect regular check-ups during and after pregnancy to ensure their health and the health of their babies. It's important to know that the trial is currently recruiting participants, and it aims to provide valuable information to improve health care for pregnant women and their infants in Malawi.

Gender

FEMALE

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 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.