UNCPM 22314 - Pregnancy, Infant and Maternal Health Outcomes Study

Recruiting now · Phase 4

Conditions studied: Pre-exposure Prophylaxis, HIV Prevention, Pregnancy Related

In brief

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.

Key facts

Study ID: NCT06158126
Run by: University of North Carolina, Chapel Hill
People needed: 621
Starts: 2024-04-17
Expected to finish: 2027-12-01
Last updated by the study team: 2026-05-05

Who can join

Age: 15 and older, up to 55. Sex: female. Healthy volunteers: accepted.

You may qualify if…

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.

You may not qualify if…

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

Bwaila Distict Hospital — Lilongwe, Malawi (enrolling)

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.