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UNCPM 22314 - Pregnancy, Infant and Maternal Health Outcomes Study
Sponsor: University of North Carolina, Chapel Hill
Summary
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.
Official title: UNCPM 22314 - Evaluating the Safety of Pregnancy, Infant and Maternal Health Outcomes Among PrEP Users in Malawi
Key Details
Gender
FEMALE
Age Range
15 Years - 55 Years
Study Type
INTERVENTIONAL
Enrollment
621
Start Date
2024-04-17
Completion Date
2027-12
Last Updated
2025-03-14
Healthy Volunteers
Yes
Interventions
Initiating daily oral PrEP during pregnancy
Group 1a will include pregnant women who initiate oral PrEP when already pregnant, at enrollment into the study.
Already using daily oral PrEP at the time of pregnancy diagnosis
Group 1b will include women already using daily oral PrEP at the time of pregnancy diagnosis and enrollment in the study.
Initiating injectable PrEP during pregnancy
Group 2a will include pregnant women who initiate injectable PrEP (CAB-LA) when already pregnant, at enrollment into the study.
Already using injectable PrEP (CAB-LA) at the time of pregnancy diagnosis
Group 2b will include women using injectable PrEP (CAB-LA) at the time of pregnancy diagnosis and enrollment into the study.
Locations (1)
Bwaila Distict Hospital
Lilongwe, Malawi