Introduction of the Ellavi uterine balloon tamponade into the Kenyan and Ghanaian maternal healthcare package for improved postpartum haemorrhage management: an implementation research study.

OBJECTIVES: Use of intrauterine balloon tamponades for refractory postpartum haemorrhage (PPH) management has triggered recent debate since effectiveness studies have yielded conflicting results. Implementation research is needed to identify factors influencing successful integration into maternal healthcare packages. The Ellavi uterine balloon tamponade (UBT) (Ellavi) is a new low-cost, preassembled device for treating refractory PPH. DESIGN: A mixed-methods, prospective, implementation research study examining the adoption, sustainability, fidelity, acceptability and feasibility of introducing a newly registered UBT. Cross-sectional surveys were administered post-training and post-use over 10 months. SETTING: Three Ghanaian (district, regional) and three Kenyan (levels 4-6) healthcare facilities. PARTICIPANTS: Obstetric staff (n=451) working within participating facilities. INTERVENTION: PPH management training courses were conducted with obstetric staff. PRIMARY AND SECONDARY OUTCOME MEASURES: Facility measures of adoption, sustainability and fidelity and individual measures of acceptability and feasibility. RESULTS: All participating hospitals adopted the device during the study period and the majority (52%-62%) of the employed obstetric staff were trained on the Ellavi; sustainability and fidelity to training content were moderate. The Ellavi was suited for this context due to high delivery and PPH burden. Dynamic training curriculums led by local UBT champions and clear instructions on the packaging yielded positive attitudes and perceptions, and high user confidence, resulting in overall high acceptability. Post-training and post-use, ≥79% of the trainees reported that the Ellavi was easy to use. Potential barriers to use included the lack of adjustable drip stands and difficulties calculating bag height according to blood pressure. Overall, the Ellavi can be feasibly integrated into PPH care and was preferred over condom catheters. CONCLUSIONS: The training package and time saving Ellavi design facilitated its adoption, acceptability and feasibility. The Ellavi is appropriate and feasible for use among obstetric staff and can be successfully integrated into the Kenyan and Ghanaian maternal healthcare package. TRIAL REGISTRATION NUMBERS: NCT04502173; NCT05340777.

Exploring Shigella vaccine priorities and preferences: Results from a mixed-methods study in low- and middle-income settings.

Background: Shigella is the leading bacterial cause of diarrheal mortality in children and can cause long-term effects on growth and development. No licensed Shigella vaccines currently exist but several promising candidates are in development and could be available in the next five years. Despite Shigella being a well-known public health target of the World Health Organization for decades, given current burden estimates and competing preventable disease priorities in low-income settings, whether the availability of an effective Shigella vaccine will lead to its prioritization and widespread introduction among countries at highest risk is unknown. Methods: We conducted a mixed-methods study of national stakeholders and healthcare providers in five countries in Asia and Africa and regional stakeholders in the Pan American Health Organization to identify preferences and priorities for forthcoming Shigella vaccines. Results: In our study of 89 individuals, diarrhea was the most frequently mentioned serious health concern for children under five years. Antimicrobial resistance (AMR) was more often considered very concerning than diarrhea or stunting. Shigella awareness was high but not considered a serious health concern by most stakeholders. Most participants were willing to consider adding a new vaccine to the routine immunization schedule but expressed reservations about a Shigella vaccine because of lower perceived burden relative to other preventable diseases and an already crowded schedule; interest was highest among national stakeholders in countries receiving more financial support for immunization. The priority of a Shigella vaccine rose when participants considered vaccine impacts on reducing stunting and AMR. Participants strongly preferred oral and combination vaccines compared to injectable and a single-antigen presentations, citing greater perceived community acceptability. Conclusions: This study provides a critical opportunity to hear directly from country and regional stakeholders about health priorities and preferences around new vaccines. These findings should inform ongoing Shigella vaccine development efforts and eventual vaccine introduction and implementation planning.