Assessing HIV prevention methods during pregnancy and breastfeeding
UNCPM 22314 - Evaluating the Safety of Pregnancy, Infant and Maternal Health Outcomes Among PrEP Users in Malawi
This study is testing whether a long-acting injectable HIV prevention method is safer than a daily pill for pregnant women and their babies in Malawi.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 621 (estimated) |
| Ages | 15 Years to 55 Years |
| Sex | Female |
| Sponsor | University of North Carolina, Chapel Hill Academic / other |
| Locations | 1 site (Lilongwe) |
| Trial ID | NCT06158126 on ClinicalTrials.gov |
What this trial studies
This study evaluates the safety of long-acting injectable cabotegravir (CAB-LA) and oral pre-exposure prophylaxis (PrEP) for preventing HIV in pregnant women and their infants in Malawi. Women who are either already using PrEP or initiate it during pregnancy will be enrolled in a Safety Cohort and monitored throughout their pregnancy and postpartum period. The study aims to compare adverse pregnancy events and health outcomes between those using CAB-LA and those using oral PrEP. Participants will have access to both treatment options and will be followed up through a series of visits aligned with standard antenatal care protocols.
Who should consider this trial
Good fit: Ideal candidates include pregnant women aged 15 years or older who are HIV-negative and eligible for PrEP according to Malawi's guidelines.
Not a fit: Patients living with HIV or those with known allergies to the study medications will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide safer HIV prevention options for pregnant women and improve maternal and infant health outcomes.
How similar studies have performed: Other studies have shown promise in evaluating PrEP safety during pregnancy, but this specific approach is novel in the Malawian context.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Lilongwe
- Bwaila Distict Hospital — Lilongwe, Malawi (Recruiting)
Study contacts
- Principal investigator: Friday Saidi, MBBS, MMED — UNC Project Malawi
- Study coordinator: Charity Nakanga, MBBS, MSc
- Email: cnakanga@unclilongwe.org
- Phone: 265 88 556 5888
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.