NCT06158126 UNCPM 22314 - Pregnancy, Infant and Maternal Health Outcomes Study
| NCT ID | NCT06158126 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | University of North Carolina, Chapel Hill |
| Condition | Pre-exposure Prophylaxis |
| Study Type | INTERVENTIONAL |
| Enrollment | 621 participants |
| Start Date | 2024-04-17 |
| Primary Completion | 2026-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 621 participants in total. It began in 2024-04-17 with a primary completion date of 2026-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
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.
Contact & Investigator
Friday Saidi, MBBS, MMED
PRINCIPAL INVESTIGATOR
UNC Project Malawi
Frequently Asked Questions
Who can join the NCT06158126 clinical trial?
This trial is open to female participants only, aged 15 Years or older, up to 55 Years, studying Pre-exposure Prophylaxis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06158126 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT06158126 currently recruiting?
Yes, NCT06158126 is actively recruiting participants. Contact the research team at cnakanga@unclilongwe.org for enrollment information.
Where is the NCT06158126 trial being conducted?
This trial is being conducted at Lilongwe, Malawi.
Who is sponsoring the NCT06158126 clinical trial?
NCT06158126 is sponsored by University of North Carolina, Chapel Hill. The principal investigator is Friday Saidi, MBBS, MMED at UNC Project Malawi. The trial plans to enroll 621 participants.