NCT05613751

Enhancing Protection Against Influenza and COVID-19 for Pregnant Women and Medically at Risk Children

Enhancing Protection Against Influenza and COVID-19 for Pregnant Women and Medically at Risk Children (EPIC Study)

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,038 (estimated)
• Sponsor: University of Adelaide · Academic / Other
• Sex: All
• Age: 6 Months
• Healthy volunteers: Not accepted

Summary

Pregnant women and children with chronic medical conditions are at increased risk of hospitalisation, intensive care admission and death from influenza and COVID-19 infections. However, there appears to be a high level of vaccine hesitancy among women of reproductive age. We will develop "nudge" interventions to improve influenza and COVID vaccine uptake and test the effectiveness of the interventions using randomised controlled trials in * pregnant women * medically at risk children.

Detailed description

Pregnant women and children with chronic medical conditions are at an unacceptable risk of hospitalisation and death from influenza and COVID-19 infections. Pregnant women are 3 times more likely to die from COVID-19 and over 7 times more likely to be admitted to an intensive care unit (ICU) with influenza compared to non-pregnant women. Children with chronic disease are already compromised with a higher risk of hospitalisation from influenza and requirement for ICU management and long term disability following COVID-19. Uptake of the recommended influenza vaccine among pregnant women and medically at risk children in Australia is only \~50%. Based on recent surveys, the predicted uptake of COVID-19 vaccine among both groups is also likely to be \~50%. These two groups preferentially receive care from medical specialists (obstetricians and paediatricians) and specialist nursing staff in hospitals, and are less likely to engage with primary care, the usual providers of immunisation. The aim of this project is to develop a nudge (i.e. small changes in the environment that alter people's behaviour) and evaluate the effectiveness of the nudge intervention in improving the uptake of COVID and influenza vaccine by conducting four randomised control trials in * pregnant women * medically at risk children.

Conditions

• Influenza
• COVID-19

Interventions

Type	Name	Description
BEHAVIORAL	Nudge	Three text messages that are sent four weeks apart reminding to obtain the vaccines

Timeline

• Start date: 2022-10-26
• Primary completion: 2024-06-30
• Completion: 2024-12-31
• First posted: 2022-11-14
• Last updated: 2024-01-17

Locations

7 sites across 1 country: Australia