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UNCPM 22314 - Pregnancy, Infant and Maternal Health Outcomes Study

Study acronym: PrIMO
StatusRecruiting
PhasePhase 4
Started
View on ClinicalTrials.gov ↗

Record History

  1. Re-verified, no change to tracked fieldsv6
  2. Phase: Not specified to Phase 4 Study description revised · Study arms: 1 to 2v5 Show 2 more changesShow less
    • Study description revised
    • Study arms: 1 to 2

    See this version in full on ClinicalTrials.gov ↗

  3. Trial status: Not Yet Recruiting to Recruiting Start date changed from estimate of Apr 1, 2024 to Apr 17, 2024 · Site details revisedv4 Show 2 more changesShow less
    • Start date changed from estimate of Apr 1, 2024 to Apr 17, 2024
    • Site details revised
  4. Re-verified, no change to tracked fieldsv3
  5. Start date: Jan 1, 2024 to Apr 1, 2024 Primary endpoint revised · Secondary endpoints: 11 to 14 · Collaborators: 2 to 3v2 Show 3 more changesShow less
    • Primary endpoint revised
    • Secondary endpoints: 11 to 14
    • Collaborators: 2 to 3

    See this version in full on ClinicalTrials.gov ↗

  6. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06158126
Lead Sponsor University of North Carolina, Chapel Hill
Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), United States President's Emergency Plan for AIDS Relief, Ministry of Health, Malawi
Conditions Pre-exposure Prophylaxis, HIV Prevention, Pregnancy Related
Enrollment 621 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov