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UNCPM 22314 - Pregnancy, Infant and Maternal Health Outcomes Study

RecruitingPhase 4Ages 15 Years - 55 YearsFemaleUniversity of North Carolina, Chapel Hill
NCT06158126 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 wi

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📋 Eligibility rules (as published)
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.
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What it tests

  • 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
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Where

1 site
Bwaila Distict Hospital
Lilongwe, Malawi
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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