Education, Immigration and HPV Vaccination: an Informational Randomized Trial

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Brief Title

Education, Immigration and HPV Vaccination: an Informational Randomized Trial

Official Title

Utbildningsnivå, Invandringsstatus Och Viljan Att Vaccinera Mot HPV Som Funktion av Informationsformulering: En Randomiserad Studie

Brief Summary

      Counteracting misinformation on childhood vaccines remains a priority for public health in
      industrialized countries. Previous research showed that misinformation-induced vaccine
      hesitancy particularly concerns very highly or very lowly educated parents, and, especially
      in Europe, specific groups of immigrants. Misinformation framing directly targets specific
      sub-population of parents by exploiting different cognitive biases, and specific concerns
      based on cultural norms: this project aims at testing the effectiveness of similar framing
      techniques applied to positive information on the HPV vaccine by conducting a Randomized
      Controlled Trial in Stockholm, Sweden. It randomizes emotionally and
      scientifically/statistically framed information addressing the specific concerns reported by
      previous literature.
    

Detailed Description

      In Europe, non-European immigrants display lower vaccination take-up than natives, a higher
      prevalence of STDs, and lower usage of publicly-funded treatments. Therefore, migrants (and
      especially women) face worse preventable health issues. Qualitative research suggests that
      migrants' lower take-up might be due to culturally founded concerns, which are then exploited
      and targeted by anti-vax information. These are adverse effects on fertility and, in the case
      of the HPV vaccine, which is administered at a very young age to prevent a
      sexually-transmissible infection, on reputational concerns related to incentivizing
      pre-marital sexual activity. Existing literature also investigates parental education as an
      alternative explanation to vaccines' mistrust, finding mixed evidence which suggests a
      non-linear relationship between education level and willingness to vaccinate children. In
      particular, qualitative research highlights that targeted misinformation addresses
      emotionally charged contents to lowly educated parents, and pseudo-scientific content to
      highly educated parents.

      In this study, 7500 mothers of children (girls and boys) who are due to be offered the HPV
      vaccine in fall 2021 within the Swedish national vaccination program are randomly sampled.
      Mothers are stratified according to immigration status, and are sampled from the entire
      relevant population through Swedish population registers. There are 5 strata: (i) Mothers
      were born in Iran, Iraq, Afghanistan, Somalia, Eritrea (irrespective of education) (N=2500);
      (ii) Mothers born in Sweden and have attended at most 3 years of high school (N=1600); (iii)
      Mothers born in Sweden and have attended more than 3 years of high school and have not
      attended any university (N=1400); (iv) Mothers born in Sweden and have achieved at most
      undergraduate education (N=1000); (v) Mothers born in Sweden with graduate education after
      obtaining an undergraduate degree (N=1000). Sample sizes are chosen with the expectation of
      having 500 actual participants per stratum, based on participation rate estimates from the
      implementer (Statistics Sweden, SCB).

      Within each stratum, the investigators randomize 3 types of information sheets on the HPV
      vaccine: emotionally-framed (T1), scientifically and statistically framed (T2) and
      uninformative placebo (C). Along the information sheet, all mothers receive a first survey
      covering their beliefs on vaccines (henceforth defined "baseline survey" for simplicity,
      despite being administered along the treatment), which does not vary across treatment arms.
      The information sheet and the baseline survey invitation are sent by ordinary post in June
      2021 to the mother's address, and the survey can be compiled both on paper and online. In
      July and August, mothers who have still not compiled the baseline survey will receive 3
      reminders: each reminders contains the information sheet, which depending on the specific
      reminder can be printed or accessible in digital format when accessing the online survey.
      Between September and October, all mothers will have to decide whether to authorize HPV
      vaccination for their child, which takes places directly at school and free of charge. In
      November, mothers who have responded to the baseline survey receive an invitation to an
      endline survey. All information sheets and surveys are available in Swedish, English, Arabic
      and Farsi. Informed consent is obtained in the baseline survey. For mothers who choose to
      participate, investigators will obtain, from population registers, background variables
      concerning the mother herself, the other parent and the child who is due to immunization.
      These cover specific information on parents' education, income, wealth and occupation,
      marital status, number of total children, gender of the child due to HPV vaccination, and if
      she/he received the previous vaccine in the national program's schedule (3 to 4 years before
      our intervention), order of the child among siblings.
    


Study Type

Interventional


Primary Outcome

Actual decision to vaccinate child against HPV

Secondary Outcome

 Behavioral mechanisms' analysis (Measurement: questionnaire, likert scale of agreement with statements on the hypothesized beliefs)

Condition

Cervical Cancer

Intervention

Information T1

Study Arms / Comparison Groups

 Immigrant mother stratum
Description:  The receiver is an immigrant mother born in Eritrea, Somalia, Syria, Afghanistan, Iran or Iraq.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Behavioral

Estimated Enrollment

2500

Start Date

April 28, 2021

Completion Date

January 14, 2022

Primary Completion Date

January 14, 2022

Eligibility Criteria

        Inclusion Criteria:- Resident in Stockholm County, Sweden

          -  Child attending 5th grade in a school located in the Stockholm County, Sweden

          -  Mother born in one of the following countries: Sweden, Eritrea, Somalia, Syria,
             Afghanistan, Iran, Iraq

          -  Gender: female (sampling among mothers, though we observe also information on their
             partner, even if male). No gender requirement on the child

        Exclusion Criteria:

          -  Mother born outside of Sweden and outside of one of the following countries: Eritrea,
             Somalia, Syria, Afghanistan, Iran, Iraq

          -  Mother already sampled for another child (i.e. excluding children born from the same
             mother)
      

Gender

Female

Ages

N/A - N/A

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

Lisen A. Dahlström, Ph.D., , 

Location Countries

Sweden

Location Countries

Sweden

Administrative Informations


NCT ID

NCT04905030

Organization ID

HPVRCT01225


Responsible Party

Principal Investigator

Study Sponsor

Karolinska Institutet

Collaborators

 Merck Sharp & Dohme Corp.

Study Sponsor

Lisen A. Dahlström, Ph.D., Principal Investigator, Karolinska Institutet


Verification Date

June 2021