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

Sponsor
University of Adelaide (Other)
Overall Status
Recruiting
CT.gov ID
NCT05613751
Collaborator
(none)
4,152
7
8
26.2
593.1
22.7

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Nudge
N/A

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

Study Design

Study Type:
Interventional
Anticipated Enrollment :
4152 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Outcomes Assessor)
Primary Purpose:
Health Services Research
Official Title:
Enhancing Protection Against Influenza and COVID-19 for Pregnant Women and Medically at Risk Children (EPIC Study)
Actual Study Start Date :
Oct 26, 2022
Anticipated Primary Completion Date :
Dec 31, 2023
Anticipated Study Completion Date :
Dec 31, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Pregnant women-COVID-19 vaccine RCT - intervention group

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
Three text messages that are sent four weeks apart reminding to obtain the vaccines

No Intervention: Pregnant women-COVID-19 vaccine RCT - standard care group

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

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
Three text messages that are sent four weeks apart reminding to obtain the vaccines

No Intervention: Pregnant women-influenza vaccine RCT - standard care group

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

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
Three text messages that are sent four weeks apart reminding to obtain the vaccines

No Intervention: Medically at risk children-COVID-19 vaccine RCT - standard care group

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

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
Three text messages that are sent four weeks apart reminding to obtain the vaccines

No Intervention: Medically at risk children-influenza vaccine RCT - standard care group

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.

Outcome Measures

Primary Outcome Measures

  1. The proportion of pregnant women who receive one or more doses of a COVID-19 vaccine during pregnancy [3 months of receiving the nudge intervention]

    confirmed using the Australian Immunisation Register (AIR)

  2. The proportion of pregnant women who receive one dose of the influenza vaccine during pregnancy [3 months of receiving the nudge intervention]

    confirmed using the Australian Immunisation Register (AIR)

  3. The proportion of medically at risk children who receive one or more doses of a COVID-19 vaccine [3 months of receiving the nudge intervention]

    confirmed using the Australian Immunisation Register (AIR)

  4. The proportion of medically at risk children who receive one dose of an influenza vaccine [3 months of receiving the nudge intervention]

    confirmed using the Australian Immunisation Register (AIR)

Eligibility Criteria

Criteria

Ages Eligible for Study:
6 Months and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Women's and Children's Hospital Adelaide South Australia Australia 5006
2 Flinders Medical Centre Bedford Park South Australia Australia 5042
3 Lyell McEwin Hospital Elizabeth Vale South Australia Australia 5112
4 Mercy Hospital For Women Heidelberg Victoria Australia 3084
5 The Royal Children's Hospital Parkville Victoria Australia 3052
6 Perth Children's Hospital Nedlands Western Australia Australia 6009
7 King Edward Memorial Hospital Subiaco Western Australia Australia 6008

Sponsors and Collaborators

  • University of Adelaide

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Helen Marshall, Clinical Research Director, Women's and Children's Health Network Consultant in Vaccinology and Medical Director, Vaccinology and Immunology Research Trials Unit, Women's and Children's Health Network, University of Adelaide
ClinicalTrials.gov Identifier:
NCT05613751
Other Study ID Numbers:
  • WCHN HREC/2022/HREC00082
First Posted:
Nov 14, 2022
Last Update Posted:
Nov 14, 2022
Last Verified:
Nov 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 14, 2022