Herd Immunity and Influenza Vaccine Uptake (HIIVU)

• ClinicalTrials.gov Identifier: NCT03748160
• Recruitment Status: Completed
• First Posted: November 20, 2018
• Last Update Posted: February 27, 2020
• Sponsor: Finnish Institute for Health and Welfare
• Collaborators: RWTH Aachen University; University of Erfurt
• Information provided by (Responsible Party): Finnish Institute for Health and Welfare

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.

Condition or disease	Intervention/treatment	Phase
Influenza, Human	Other: Letter	Not Applicable

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

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 48125 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Cluster (household) RCT with three treatment arms
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Prevention
• Official Title: Herd Immunity Communication and Influenza Vaccine Uptake
• Actual Study Start Date: October 1, 2018
• Actual Primary Completion Date: June 1, 2019
• Actual Study Completion Date: December 31, 2019

Arms and Interventions

Arm	Intervention/treatment
No Intervention: Control; 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.
Active Comparator: Mailing; 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.	Other: Letter; 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
Active Comparator: Herd; 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.	Other: Letter; 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

Outcome Measures

Primary Outcome Measures :

1. Vaccine uptake [ Time Frame: up to six months (beginning from November 1 / until April 30) ]
   Number of influenza vaccinations in study population

Other Outcome Measures:

1. Heterogeneity [ Time Frame: up to six months (beginning from November 1 / until April 30) ]
   We run the statistical analysis by municipality to study ATE in areas with low/high historical vaccine uptake

Eligibility Criteria

• Ages Eligible for Study: 65 Years and older (Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

-

Contacts and Locations

Locations

Finland

National Institute for Health and Welfare

Helsinki, Finland, 00271

Sponsors and Collaborators

Finnish Institute for Health and Welfare

RWTH Aachen University

University of Erfurt

Investigators

• Principal Investigator: Cornelia Betsch, PhD; University of Erfurt
• Principal Investigator: Robert Böhm, PhD; RTWH Aachen University
• Principal Investigator: Hanna Nohynek, PhD; Finnish Institute for Health and Welfare
• Principal Investigator: Saila Pitkänen, MSc; Finnish Institute for Health and Welfare
• Principal Investigator: Heini Salo, PhD; Finnish Institute for Health and Welfare
• Study Director: Lauri Sääksvuori, PhD; Finnish Institute for Health and Welfare
• Principal Investigator: Jonas Sivelä, PhD; Finnish Institute for Health and Welfare

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Sääksvuori L, Betsch C, Nohynek H, Salo H, Sivelä J, Böhm 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.

• Responsible Party: Finnish Institute for Health and Welfare
• ClinicalTrials.gov Identifier: NCT03748160
• Other Study ID Numbers: 240317
• First Posted: November 20, 2018
• Last Update Posted: February 27, 2020
• Last Verified: February 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided
• Plan Description: This study is based in administrative register follow-up. We will share pseudonymized data according to current data availability regulations.

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Influenza, Human; Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases