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NCT06158126RecruitingPhase 4

UNCPM 22314 - Pregnancy, Infant and Maternal Health Outcomes Study

UNCPM 22314 - Evaluating the Safety of Pregnancy, Infant and Maternal Health Outcomes Among PrEP Users in Malawi

Source: ClinicalTrials.gov · Last updated 5 May 2026

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Phase (registry)
Phase 4
Study type
Interventional
Enrollment
621 (estimated)
First submitted
27 Nov 2023
Start date
17 Apr 2024
Primary completion date
Dec 2026
Lead sponsor
University of North Carolina, Chapel Hill
Diseases
HIV
NCT number
NCT06158126

What you commit to

  • Study type: Interventional · Phase 4
  • Planned participants: 621
  • From 17 Apr 2024 to the primary completion date, Dec 2026
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • 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.

Other

  • Intention to leave the study site's catchment area of Bwaila before scheduled study exit.

Who the study is looking for

  • 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.

Age in the registry: 15 years to 55 years · Sex: Female · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Bwaila Distict Hospital
Coordinator of this site? Confirm its status		LilongweMalawiRecruiting

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This page is information, not medical advice. Discuss any trial with your doctor.