UNCPM 22314 - Pregnancy, Infant and Maternal Health Outcomes Study
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexFemale
Age15-55
SponsorUniversity of North Carolina, Chapel Hill
About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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.
Trial design
Treatments tested in this trial
- 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
Treatment groups
621 Participants
are divided into 2 treatment groupsSponsors and collaborators
University of North Carolina, Chapel Hill
Lead sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborator
United States President's Emergency Plan for AIDS Relief
Collaborator
Ministry of Health, Malawi
Collaborator
Source ClinicalTrials.gov