Work Packages
WP 1 – Coordination and Support of PREGART
Lead: Karolinska Institutet (KI), Sweden
The main objective of WP1 is to ensure the efficient day-to-day management of PREGART and the successful implementation of the project Work Plan. KI, as project coordinator, facilitates communication between all partner institutions and with the Global Health EDCTP3 Joint Undertaking, and is responsible for financial and administrative oversight across all WPs.
Key activities include:
• Coordination of overall project implementation and monitoring
• Management of consortium collaborations and joint activities
• Internal communication across all partners
• Financial and administrative management
• Evaluation of project progress against milestones and deliverables
A highlight of WP1 is the organisation of the PREGART Closure Symposium (Month 36), a public event dedicated to the dissemination of the trial’s final results to the scientific community and broader stakeholders. WP1 also oversees the development of a Global Access Plan, ensuring that the knowledge generated by PREGART is accessible and actionable for health authorities, guideline developers, and communities in sub-Saharan Africa.
WP 2 – Trial Management – Ethiopia
Lead: Hawassa University (HU), Ethiopia
WP2 covers the execution and completion of the PREGART clinical trial across 20 sites in Ethiopia, spanning three regions: the Southern Nations, Nationalities and Peoples Region (SNNPR)/Sidama, the Oromia Region, and Addis Ababa City Administration.
Its objectives are to ensure that the trial is conducted rigorously, in compliance with the study protocol and Good Clinical Practice (GCP) standards, and that all ethical and regulatory approvals are renewed annually. WP2 encompasses the full cycle of trial activities in Ethiopia: participant enrolment (to be completed by Month 15), longitudinal follow-up through delivery and up to 33 months post-enrolment, laboratory testing (viral load, immunological,haematological, metabolic, pharmacokinetic, pharmacogenetic, and drug resistance analyses), adverse event monitoring and reporting, data management, and the preparation of the final clinical trial report in accordance with ICH E3 guidelines.
HU leads all Ethiopian trial activities, in close collaboration with KI and ISS for monitoring, analysis, and dissemination.
WP 3 – Trial Management – Uganda
Lead: Makerere University (MU), Uganda
WP3 mirrors WP2 in scope and objectives, adapted to the Ugandan context. MU oversees the clinical trial across sites in Kampala and Entebbe — including Mildmay Hospital Uganda, TASO Entebbe, China-Uganda Partnership Hospital (Kisenyi), and Kawaala Health Centres — ensuring that procedures are harmonised with those applied in Ethiopia and that the highest standards of clinical practice are maintained.
In addition to the activities described under WP2, WP3 includes specific requirements arising from the Ugandan regulatory and healthcare context: ensuring compliance with Uganda national guidelines on antenatal and postnatal care for HIV-infected mothers, and developing Stewardship Plans on antiretroviral therapy use, to support evidence-based and sustainable mplementation of trial findings at the national level.
A Kick-off meeting bringing together all consortium partners will be held in Uganda in Month 3 of the project.
WP 4 – Data Management and Statistical Analysis
Lead: Makerere University (MU), Uganda
The main aim of WP4 is to ensure the quality, consistency, and long-term accessibility of all data collected in the PREGART trial. A dedicated data management team, reporting to the Trial Management Office and the Trial Steering Committee, is established at both trial implementation sites.
Key activities include the preparation and regular updating of a Data Management Plan; ongoing data monitoring, cleaning, validation, and query resolution across both countries; interim analyses to support Data Safety Monitoring Board (DSMB) reviews; final database lock (Month 34); and facilitation of data access and sharing in line with Horizon Europe’s open data policy.
All data from Ethiopian and Ugandan sites are regularly merged into a unified PREGART electronic database, with restricted access managed through password-protected accounts.
WP 5 – Capacity Building
Lead: Karolinska Institutet (KI), Sweden
WP5 is dedicated to strengthening sustainable clinical trial research capacity in Ethiopia and Uganda, with an impact intended to extend well beyond the PREGART trial itself.
The centrepiece of WP5 is a PhD training programme for four doctoral students — two from Ethiopia and two from Uganda — enrolled at Karolinska Institutet through a sandwich model combining periods of study in Sweden and in their home institutions. Each student works on a research question embedded within the trial:
1. Optimisation of ART regimens for pregnant and breastfeeding women: maternal and infant safety, efficacy, and drug resistance (PhD student, Ethiopia)
2. Safety, pharmacokinetics, and pharmacogenetics of DTG- and EFV400-based ART in pregnant and breastfeeding women (PhD student, Ethiopia)
3. Effect of efavirenz and dolutegravir on neuropsychiatric disorders in mothers and infants (PhD student, Uganda)
4. Safety, pharmacokinetics, and pharmacogenetics of ART in pregnant and breastfeeding women (PhD student, Uganda)
All four PhD students are expected to complete and defend their theses by December 2028. In parallel, WP5 supports the preparation and submission of scientific manuscripts for peer-reviewed publications, contributing to the open-access dissemination of PREGART results.
WP 6 – Communication and Dissemination
Lead: Istituto Superiore di Sanità (ISS), Italy
The main aim of WP6 is to communicate PREGART’s objectives, activities, and results to a wide range of audiences — including researchers, clinicians, health authorities, Ministries of Health (Ethiopia and Uganda), international organisations such as WHO, NGOs, industry, and the general public.
Communication channels include the project website (www.pregart.eu), the project’s X and IN accounts, peer-reviewed open-access publications, participation in national and international conferences, and the production of videos, flyers, and other public engagement materials.
A particular aim of WP6 is to promote the uptake of PREGART findings in the development and revision of HIV treatment guidelines for pregnant and breastfeeding women at the national and international level. A Plan for the Exploitation and Dissemination of Results will be published at Month 6 and updated at Month 18, and at least four open-access publications are planned for submission by Month 36.
WP 7 – Scientific Project Leadership
Lead: Hawassa University (HU), Ethiopia
WP7 is a new work package introduced in the EDCTP3 phase of PREGART, reflecting the expanded governance structure of the project. Its objective is to provide overarching scientific leadership and to ensure that all scientific activities are implemented with rigour, consistency, and accountability across both countries.
HU, as Scientific Project Leader, acts as the primary scientific contact for the Global Health EDCTP3 Joint Undertaking and oversees compliance with budgets, timelines, deliverables, and scientific quality standards across all beneficiaries. Key activities include scientific leadership and coordination, information management, support to the coordinator on monitoring and compliance, and oversight of scientific task implementation by all partners.