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Herd Immunity and Influenza Vaccine Uptake (HIIVU)

Primary Purpose

Influenza, Human

Status
Completed
Phase
Not Applicable
Locations
Finland
Study Type
Interventional
Intervention
Letter
Sponsored by
Finnish Institute for Health and Welfare
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Influenza, Human

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • At least 65 year old citizens in the municipalities of Espoo, Maalahti, Korsnäs, Kristiinankaupunki, Kaskinen and Närpiö

Exclusion Criteria:

-

Sites / Locations

  • National Institute for Health and Welfare

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Active Comparator

Active Comparator

Arm Label

Control

Mailing

Herd

Arm Description

There is no intervention (letter) in the control arm. There is no control arm in the city of Espoo. 1/3 of subjects in all other municipalities are assigned to the control arm.

This treatment arm consists of a standard letter reminding elderly citizens (65 years and above) about influenza vaccines that are available free of charge from the local health centers.

This treatment arm consists of a letter that highlights the herd immunity effects of vaccination and reminds elderly citizens (65 years and above) about influenza vaccines that are available free of charge from the local health centers.

Outcomes

Primary Outcome Measures

Vaccine uptake
Number of influenza vaccinations in study population

Secondary Outcome Measures

Full Information

First Posted
November 1, 2018
Last Updated
February 26, 2020
Sponsor
Finnish Institute for Health and Welfare
Collaborators
RWTH Aachen University, University of Erfurt
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1. Study Identification

Unique Protocol Identification Number
NCT03748160
Brief Title
Herd Immunity and Influenza Vaccine Uptake
Acronym
HIIVU
Official Title
Herd Immunity Communication and Influenza Vaccine Uptake
Study Type
Interventional

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
October 1, 2018 (Actual)
Primary Completion Date
June 1, 2019 (Actual)
Study Completion Date
December 31, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Finnish Institute for Health and Welfare
Collaborators
RWTH Aachen University, University of Erfurt

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The aim of this study is to test the effectiveness of communicating the concept of herd immunity on actual influenza vaccine uptake using a randomized controlled trial.
Detailed Description
The investigators run a large-scale randomized controlled trial (RCT) to understand behavioural processes that guide decisions to vaccinate and test alternative strategies to communicate the concept of herd immunity. The experiment varies the text of postal letters send to individuals eligible for free influenza vaccines. The experiment is run in collaboration with the municipal health authorities. The investigators identify from the Population Register all individuals who are born in year 1953 or before and resided in the participating municipality on October 01, 2018. The investigators will obtain the postal addresses of these individuals using the Population Register and randomly assign individuals to treatment conditions that differ in the wording of the information material and reception of a text message. Importantly, the extract from the Population Register will also include an individual identifier (social security number) that can be used to match the received type of letter (treatment) with the actual vaccination decision recorded in the Care Register for Health Care to objectively evaluate the impact of received information on vaccine uptake. The matching of postal addresses and vaccination data will be conducted using pseudonymized identifiers. The pseudonymization of individual identifiers will be performed separately for both datasets by professional data management and data security staff of the National Institute for Health and Welfare. The investigators conducting the data analysis will be able to access only pseudonymous data without a possibility to directly identify individuals from the data set. The data will be stored according to the data protection legislation and regulations of the National Institute for Health and Welfare during the research project. The investigators randomly assign individuals to treatment conditions that differ in the wording of the letters. The authority's standard letter serves as the baseline condition (T1). This letter is extended by communicating the concept of herd immunity and appealing to pro-social preferences by highlighting the fact that vaccinations may effectively prevent infections among people who are not able to vaccinate themselves (especially babies) (T2). To summarize, this study includes a control treatment (T0, no letter) and two active treatment arms with the following contents: T1 (Mailing) - Standard letter T2 (Herd) - Herd immunity letter

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Influenza, Human

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Cluster (household) RCT with three treatment arms
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
48125 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
No Intervention
Arm Description
There is no intervention (letter) in the control arm. There is no control arm in the city of Espoo. 1/3 of subjects in all other municipalities are assigned to the control arm.
Arm Title
Mailing
Arm Type
Active Comparator
Arm Description
This treatment arm consists of a standard letter reminding elderly citizens (65 years and above) about influenza vaccines that are available free of charge from the local health centers.
Arm Title
Herd
Arm Type
Active Comparator
Arm Description
This treatment arm consists of a letter that highlights the herd immunity effects of vaccination and reminds elderly citizens (65 years and above) about influenza vaccines that are available free of charge from the local health centers.
Intervention Type
Other
Intervention Name(s)
Letter
Intervention Description
Intervention consists of two different types of postal letters reminding elderly citizens (65 years and above) about influenza vaccines that are available free of charge from the local health centers
Primary Outcome Measure Information:
Title
Vaccine uptake
Description
Number of influenza vaccinations in study population
Time Frame
up to six months (beginning from November 1 / until April 30)
Other Pre-specified Outcome Measures:
Title
Heterogeneity
Description
We run the statistical analysis by municipality to study ATE in areas with low/high historical vaccine uptake
Time Frame
up to six months (beginning from November 1 / until April 30)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: At least 65 year old citizens in the municipalities of Espoo, Maalahti, Korsnäs, Kristiinankaupunki, Kaskinen and Närpiö Exclusion Criteria: -
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cornelia Betsch, PhD
Organizational Affiliation
University of Erfurt
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Robert Böhm, PhD
Organizational Affiliation
RTWH Aachen University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Hanna Nohynek, PhD
Organizational Affiliation
Finnish Institute for Health and Welfare
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Saila Pitkänen, MSc
Organizational Affiliation
Finnish Institute for Health and Welfare
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Heini Salo, PhD
Organizational Affiliation
Finnish Institute for Health and Welfare
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Lauri Sääksvuori, PhD
Organizational Affiliation
Finnish Institute for Health and Welfare
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Jonas Sivelä, PhD
Organizational Affiliation
Finnish Institute for Health and Welfare
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Institute for Health and Welfare
City
Helsinki
ZIP/Postal Code
00271
Country
Finland

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
This study is based in administrative register follow-up. We will share pseudonymized data according to current data availability regulations.
Citations:
PubMed Identifier
35139082
Citation
Saaksvuori L, Betsch C, Nohynek H, Salo H, Sivela J, Bohm R. Information nudges for influenza vaccination: Evidence from a large-scale cluster-randomized controlled trial in Finland. PLoS Med. 2022 Feb 9;19(2):e1003919. doi: 10.1371/journal.pmed.1003919. eCollection 2022 Feb.
Results Reference
derived

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Herd Immunity and Influenza Vaccine Uptake

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