Phase 4 HIV and AIDS Trial, Recruiting
Who may be able to join
AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI
Who might be able to join this trial:
(For mothers)
- A confirmed pregnancy, shown by a urine test or ultrasound
- Aged 15 years or older
- Meeting the local Malawi guidelines for PrEP (a type of HIV prevention medication) (confirm with trial site)
- Testing HIV-negative using the local HIV testing process
- Testing negative for Hepatitis B (a liver infection)
- Weighing more than 35 kg
- Having given informed consent and being willing to take part in study activities alongside their baby
(For babies)
- Babies enter the study as unborn infants along with their mother — there are no other specific requirements for the baby to be eligible
Who may not be able to join:
(For mothers)
- People already known to be living with HIV
- People with known allergies to the study medications (CAB-LA, TDF/3TC, or FTC/TDF)
- People with another significant illness (current or ongoing), substance use issues, or personal circumstances that the study investigator considers would make participation unsafe
- People who plan to move away from the Bwaila study area before the scheduled end of their participation in the study
Important: Always verify eligibility with the trial site directly before applying.
Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.
Contact this trial
Principal Investigator: Friday Saidi, MBBS, MMED, UNC Project Malawi
Phone: 265 88 556 5888
Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.
GP referral letter
Print a one-page summary to share with your doctor.
Trial details
Where this trial is recruiting
Primary endpoints
Rate of composite adverse pregnancy outcomes
Can't join this trial?
Data last synced from ClinicalTrials.gov: 26 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.