NIHR Global Health Research on reducing Preterm and Stillbirth (DIPLOMATIC)

Work package 3 Design Hybrid Implementation Study

We anticipate all work packages will begin in Malawi, and will then be undertaken in Zambia as the project progresses.

The DIPLOMATIC project is composed of eight interlocking Work Packages, with cross cutting capacity building in clinical trial methodology, database design and analysis, improvement science, and education in Malawi and Zambia.

Work Package 3

We will style a trial using a rigorous high quality design (adaptive [multi-arm, multi-stage], randomised stepped wedge or interrupted time series, appropriate for the chosen EBP) with a formal sample size calculation to determine health impact, fidelity to the evidence-based practice and barriers and facilitators to implementation. Quality improvement techniques will be used during the trial to continuously improve health outcomes and fidelity to the intervention.

Lead collaborators on this Work Package are: Dr Bridget Freyne and Dr Linda Nyondo in Malawi and Professor Jane Norman in uk.