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

Study Overview
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Brief Summary
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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 among pregnant women and medically at risk children and test the effectiveness of the interventions using randomised controlled trials.

Detailed Description
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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 among pregnant women and medically at risk children by conducting four randomised control trials.

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

Conditions
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Influenza, COVID-19

Intervention / Treatment
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* Behavioral: Nudge


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Pregnant women (COVID RCT) - those who have received 2 or less doses of a recommended COVID-19 vaccine Pregnant women (influenza RCT) - those who have not received the influenza vaccine during pregnancy Medically at risk children (COVID RCT) - those who have received 1 or no dose of a recommended COVID-19 vaccine Medically at risk children(influenza RCT) - those who have not received the annual influenza vaccine Exclusion Criteria: Pregnant women (COVID RCT) - those who have received 3 or more doses of a recommended COVID-19 vaccine Pregnant women (influenza RCT) - those who have received the influenza vaccine during pregnancy Medically at risk children (COVID RCT) - those who have received 2 or more doses of a recommended COVID-19 vaccine Medically at risk children(influenza RCT) - those who have received the annual influenza vaccine

Ages Eligible for Study
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Minimum Age: 6 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pregnant women-COVID-19 vaccine RCT - intervention group<br>Women randomized to the intervention group will receive the nudge (three text messages four weeks apart) to remind them to get the COVID-19 booster vaccine | Behavioral: Nudge<br>* Three text messages that are sent four weeks apart reminding to obtain the vaccines<br>|
| No Intervention: Pregnant women-COVID-19 vaccine RCT - standard care group<br>Women randomized to the standard care group will not receive the nudge (three text messages four weeks apart) to remind them to get the COVID-19 booster vaccine. They will receive normal care at the hospital. | |
| Experimental: Pregnant women-influenza vaccine RCT - intervention group<br>Women randomized to the intervention group will receive the nudge (three text messages four weeks apart) to remind them to get the annual influenza vaccine | Behavioral: Nudge<br>* Three text messages that are sent four weeks apart reminding to obtain the vaccines<br>|
| No Intervention: Pregnant women-influenza vaccine RCT - standard care group<br>Women randomized to the standard care group will not receive the nudge (three text messages four weeks apart) to remind them to get the annual influenza vaccine. They will receive normal care at the hospital. | |
| Experimental: Medically at risk children-COVID-19 vaccine RCT - intervention group<br>Parents of medically at risk children randomized to the intervention group will receive the nudge (three text messages four weeks apart) to remind them to get their child the COVID-19 vaccine | Behavioral: Nudge<br>* Three text messages that are sent four weeks apart reminding to obtain the vaccines<br>|
| No Intervention: Medically at risk children-COVID-19 vaccine RCT - standard care group<br>Parents of medically at risk children randomized to the standard care group will not receive the nudge (three text messages four weeks apart) to remind them to get their child the COVID-19 vaccine. They will receive normal care at the hospital. | |
| Experimental: Medically at risk children-influenza vaccine RCT - intervention group<br>Parents of medically at risk children randomized to the intervention group will receive the nudge (three text messages four weeks apart) to remind them to get their child the annual influenza vaccine | Behavioral: Nudge<br>* Three text messages that are sent four weeks apart reminding to obtain the vaccines<br>|
| No Intervention: Medically at risk children-influenza vaccine RCT - standard care group<br>Parents of medically at risk children randomized to the standard care group will not receive the nudge (three text messages four weeks apart) to remind them to get their child the annual influenza vaccine. They will receive normal care at the hospital. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The proportion of pregnant women who receive one or more doses of a COVID-19 vaccine during pregnancy | confirmed using the Australian Immunisation Register (AIR) | 3 months of receiving the nudge intervention | 
| The proportion of pregnant women who receive one dose of the influenza vaccine during pregnancy | confirmed using the Australian Immunisation Register (AIR) | 3 months of receiving the nudge intervention | 
| The proportion of medically at risk children who receive one or more doses of a COVID-19 vaccine | confirmed using the Australian Immunisation Register (AIR) | 3 months of receiving the nudge intervention | 
| The proportion of medically at risk children who receive one dose of an influenza vaccine | confirmed using the Australian Immunisation Register (AIR) | 3 months of receiving the nudge intervention |