Maternal and infant HIV research

PREGART

Comparing dolutegravir and low-dose efavirenz during pregnancy and breastfeeding, with follow-up of mothers and their children.

Study overview

Evidence for mothers and babies

PREGART is a multicentre, randomised Phase 4 non-inferiority trial in Ethiopia and Uganda. It compares dolutegravir-based and EFV400-based antiretroviral regimens in women living with HIV. Mildmay Hospital Uganda is listed among the Ugandan study sites.

Phase 4Randomised non-inferiority trial
1,156 pairsPlanned mother-infant sample across the trial, not a Mildmay-only count
96 weeksPlanned follow-up after birth

Research questions

Three primary areas of assessment

Maternal viral suppression

Compare viral suppression at delivery between the treatment groups.

Infant HIV prevention

Compare mother-to-child transmission outcomes through the infant's first year.

Pregnancy and neonatal safety

Compare adverse pregnancy, maternal and neonatal outcomes.

The continuing programme

PREGART 2

The consortium launched PREGART 2 in Kampala in February 2026. Karolinska Institutet coordinates the programme under Prof. Eleni Aklillu, with partners in Uganda, Ethiopia, Sweden and Italy.

The launch included a visit to Mildmay Hospital and highlighted investment in laboratory and research capacity.

Read the consortium's launch update

Collaboration and support

The consortium includes Karolinska Institutet, Hawassa University, Makerere University and Istituto Superiore di Sanità. The programme began with EDCTP2 support and continues with Global Health EDCTP3 funding.

Use the official project website for consortium contacts and the latest study updates.

Official PREGART website

Research at Mildmay

Connect with our clinical research team