Assessing HIV prevention methods during pregnancy and breastfeeding

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.