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Improving influenza vaccine uptake in pregnant women

Improving influenza vaccine uptake in Hong Kong pregnant women: a randomised controlled trial

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12623000753651
Enrollment
522
Registered
2023-07-11
Start date
2023-07-18
Completion date
2023-11-08
Last updated
2026-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

This randomised controlled trial primarily aims to determine whether influenza vaccine uptake in pregnant women can be increased with a multiple component intervention package (a concise information on influenza and its vaccination, and contact details of nearby clinics offering subsidised influenza vaccines, and vaccination reminders) and with influenza vaccine offered as part of routine antenatal care at no charge. It is hypothesised that the uptake of seasonal influenza vaccine in pregnant women can be improved by providing mothers with either a multicomponent intervention package to encourage influenza vaccine through the Vaccine Subsidy Scheme or to offer free influenza vaccine as part of routine antenatal care.

Interventions

Subjects in the control group will receive the standard information about the VSS that is available from the CHP through text message in smart phones (https://www.chp.gov.hk/en/features/46107.html) Subjects in intervention group 1 will receive an intervention package through text messages containing the following: 1. the same standard information about the VSS by CHP (https://www.chp.gov.hk/en/features/46107.html) as the control-subjects and 2. additional interventions which include: a concise

Subjects in the control group will receive the standard information about the VSS that is available from the CHP through text message in smart phones (https://www.chp.gov.hk/en/features/46107.html) Subjects in intervention group 1 will receive an intervention package through text messages containing the following: 1. the same standard information about the VSS by CHP (https://www.chp.gov.hk/en/features/46107.html) as the control-subjects and 2. additional interventions which include: a concise information sheet designed by our research team specifically for this study including (i) highlight of the risks of influenza in pregnant women and infants and the benefits of influenza vaccination to them, (ii) a hyperlink to the forms required for the VSS, if necessary, with guidelines to complete, and (iii) a hyperlink of Department of Health (DH)’s website to search for VSS registered clinics that do not charge additional fees for influenza vaccination above the subsidy. When vaccination is possible, they will receive text message reminders for vaccination (also contain the concise information sheet), with a further reminder one to two months later. Subjects in intervention group 2 will receive the same standard information about the VSS by CHP (https://www.chp.gov.hk/en/features/46107.html) as the control-subjects and the same multiple interventions as the intervention group 1 through text message. In addition the subjects will be informed that should they prefer they can receive free influenza vaccine during future antenatal follow-up visit once the vaccine is available. Participants will be asked whether they have read the information provided by the research team in questionnaire distributed at three to four weeks after the expected date of delivery.

Sponsors

Li Man Chim, Albert Martin
Lead SponsorIndividual

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Educational / counselling / training
Masking
Blinded (masking used) (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

The inclusion criteria to subject selection includes: pregnant women in any trimester; at least 18 years old; Cantonese speaking and able to read Chinese; no serious obstetrical complications; no mental or psychosocial problem that might affect their interpretation of study questionnaires; not yet received influenza vaccine during this pregnancy; have plans to continue most antenatal follow-up at the study hospital; have plans to remain in Hong Kong after delivery for at least one month; have smart phones; and can provide signed informed consent.

Exclusion criteria

under 18 years old; received influenza vaccine already during this pregnancy;

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026