UNCPM 22314 - Evaluating the Safety of Pregnancy, Infant and Maternal Health Outcomes Among PrEP Users in Malawi

23-2220

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) 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 receiving PrEP at the time of pregnancy diagnosis or initiating 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 at the start of the study 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.

2024-04-17

2026-12-01

2027-12-01

Recruiting

621

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.

{'studyType': 'OBSERVATIONAL', 'patientRegistry': True, 'targetDuration': '36 Months', 'designInfo': {'observationalModel': 'COHORT', 'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'count': 621, 'type': 'ESTIMATED'}}

2024-04-19