Education, Immigration and HPV Vaccination: an Informational Randomized Trial

NCT04905030 | Unknown

• 1 other identifier: HPVRCT01225
• Study Type: interventional
• Target: 2,500
• Locations: 1 country
• Sites: 1

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.

Conditions

Cervical Cancer; Vulvar Cancer; Anus Cancer; Penis Cancer; Mouse Papilloma; Head Cancer; Genital Wart; Neck Cancer

Keywords

Human Papilloma Virus; Vaccine

Outcome Measures

Primary Outcomes (3)

• Actual decision to vaccinate child against HPV

  Investigators will assess if there are significant differences in the frequency of parents who decide to vaccinate across treatment arms, within each stratum

  From treatment administration: 8 to 18 weeks, depending on when the single subject has read the information from the behavioral intervention

• (Short Term) Posterior beliefs about false risks of the HPV vaccine

  The investigators will examine whether across treatment groups, within strata, parents show different degrees of agreement with false statements concerning the risks of HPV, after reading the information sheet corresponding to their treatment arm

  Same day as treatment in the first survey: ~1 hour post treatment

• (Long Term) Posterior beliefs about false risks of the HPV vaccine

  The investigators will examine whether across treatment groups, within strata, parents show different degrees of agreement with false statements concerning the risks of HPV, after they have already decided whether to vaccinate their child and vaccination has taken place

  Assessed in the endline survey: from treatment, 8 to 18 weeks, depending on when the single subject has read the information from the behavioral intervention

Secondary Outcomes (3)

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

  These beliefs are elicited after treatment and after the vaccination choice has taken place, in the endline survey (from treatment, 8 to 18 weeks, depending on when the single subject has read the information from the behavioral intervention )

• Heterogeneity analysis (ANCOVA regressions including baseline covariates' interaction with treatment binary indicators)

  All indicators are observed at baseline (observed by investigators on the day of treatment: these covariates are either recorded before treatment in the form of administrative data, or elicited with survey questions on the day of treatment)

• Subjective vs Objective vaccination measure (binary indicators)

  All indicators are observed at endline (i.e. 8 to 18 weeks after treatment, depending on when the single subject has read the information from the behavioral intervention)

Study Arms (5)

Immigrant mother stratum

EXPERIMENTAL

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

Behavioral: Information T1; Behavioral: Information T2; Behavioral: Information C

Educ 1 stratum

EXPERIMENTAL

The receiver is a mother born in Sweden whose education does not exceed 3 years of high school.

Behavioral: Information T1; Behavioral: Information T2; Behavioral: Information C

Educ 2 stratum

EXPERIMENTAL

The receiver is a mother born in Sweden whose education is at least 3 years of high school but no more than high school diploma.

Behavioral: Information T1; Behavioral: Information T2; Behavioral: Information C

Educ 3 stratum

EXPERIMENTAL

The receiver is a mother born in Sweden whose education is at least some college (undergrad) but does not exceed an undergraduate degree

Behavioral: Information T1; Behavioral: Information T2; Behavioral: Information C

Educ 4 stratum

EXPERIMENTAL

The receiver is a mother born in Sweden whose education is an undergraduate degree plus at least some graduate education

Behavioral: Information T1; Behavioral: Information T2; Behavioral: Information C

Interventions

Information T1 BEHAVIORAL

A4 information sheet on HPV vaccine containing a reminder of the upcoming HPV vaccination, and information on: (i) its safety and efficacy in preventing a number of cancerous diseases, affecting both women and men; (ii) what is HPV and how contagion happens; (iii) the consequences of cervical cancer for women, in terms of invasive medical treatments and temporary or permanent loss of fertility. The information is framed in non-scientific, non-statistical terms and is emotionally charged: the consequences of cervical cancers are portrayed by testimonies of cancer survivors from Sweden.

Educ 1 stratum; Educ 2 stratum; Educ 3 stratum; Educ 4 stratum; Immigrant mother stratum

Information T2 BEHAVIORAL

A4 information sheet on HPV vaccine containing a reminder of the upcoming HPV vaccination, and information on: (i) its safety and efficacy in preventing a number of cancerous diseases, affecting both women and men; (ii) what is HPV and how contagion happens; (iii) the consequences of cervical cancer for women, in terms of invasive medical treatments and temporary or permanent loss of fertility. The information is framed in scientific terms and incidence and mortality statistics are reported. The information is not emotionally charged but rather aseptic.

Educ 1 stratum; Educ 2 stratum; Educ 3 stratum; Educ 4 stratum; Immigrant mother stratum

Information C BEHAVIORAL

A4 information sheet containing a reminder of the upcoming HPV vaccination, and information on the history and characteristics of the Swedish national vaccination program.

Educ 1 stratum; Educ 2 stratum; Educ 3 stratum; Educ 4 stratum; Immigrant mother stratum

Eligibility Criteria

• Gender Eligibility Details: We are randomly sampling mothers of children who are due for HPV immunization in fall 2021 according to the Swedish national vaccination program. Only for children who do not have a female guardian we invite a male guardian to participate (N=73).
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Karolinska Institutet: lead
• Merck Sharp & Dohme LLC: collaborator

Study Sites (1)

Karolinska Institutet, Medicinsk epidemiologi och biostatistik

Solna, Stockholm County, 17165, Sweden

Location

MeSH Terms

Conditions

Uterine Cervical Neoplasms; Vulvar Neoplasms; Anus Neoplasms; Penile Neoplasms; Head and Neck Neoplasms; Condylomata Acuminata

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Vulvar Diseases; Rectal Neoplasms; Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Anus Diseases; Rectal Diseases; Genital Neoplasms, Male; Genital Diseases, Male; Penile Diseases; Male Urogenital Diseases; Papillomavirus Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Communicable Diseases; Infections; DNA Virus Infections; Virus Diseases; Warts; Skin Diseases, Viral; Tumor Virus Infections; Skin Diseases, Infectious; Skin Diseases; Skin and Connective Tissue Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Lisen A. Dahlström, Ph.D.

  Karolinska Institutet

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Affiliated to Research

Study Record Dates

• First Submitted: May 19, 2021
• First Posted: May 27, 2021
• Study Start: April 28, 2021
• Primary Completion: January 14, 2022
• Study Completion: January 14, 2022
• Last Updated: June 11, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)