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UNCPM 22314 - Evaluating the Safety of Pregnancy, Infant and Maternal Health Outcomes Among PrEP Users in Malawi (PrIMO)
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.
Details
| Lead sponsor | University of North Carolina, Chapel Hill |
|---|---|
| Phase | Phase 4 |
| Status | RECRUITING |
| Enrolment | 621 |
| Start date | 2024-04-17 |
| Completion | 2027-12 |
Conditions
- Pre-exposure Prophylaxis
- HIV Prevention
- Pregnancy Related
Interventions
- Initiating daily oral PrEP during pregnancy
- Already using daily oral PrEP at the time of pregnancy diagnosis
- Initiating injectable PrEP during pregnancy
- Already using injectable PrEP (CAB-LA) at the time of pregnancy diagnosis
Primary outcomes
- Rate of composite adverse pregnancy outcomes — Enrollment through birth
Rate will be calculated as the number of women with an adverse pregnancy outcome, defined as the occurrence of any one of the following events: spontaneous miscarriage (pregnancy lost before 28 weeks gestation), stillbirth (fetal death at or after 28 weeks gestation), preterm birth (delivery before 37 weeks gestation), infant born small for gestational age (birth weight of less than 10th percentile for gestational age) over the accumulated person time from enrollment through birth.
Countries
Malawi