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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT04905030
Other study ID # HPVRCT01225
Secondary ID
Status Enrolling by invitation
Phase N/A
First received
Last updated
Start date April 28, 2021
Est. completion date January 14, 2022

Study information

Verified date June 2021
Source Karolinska Institutet
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

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Study Design


Intervention

Behavioral:
Information T1
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.
Information T2
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.
Information C
A4 information sheet containing a reminder of the upcoming HPV vaccination, and information on the history and characteristics of the Swedish national vaccination program.

Locations

Country Name City State
Sweden Karolinska Institutet, Medicinsk epidemiologi och biostatistik Solna Stockholm

Sponsors (2)

Lead Sponsor Collaborator
Karolinska Institutet Merck Sharp & Dohme Corp.

Country where clinical trial is conducted

Sweden, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary (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
Primary (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 Behavioral mechanisms' analysis (Measurement: questionnaire, likert scale of agreement with statements on the hypothesized beliefs) Investigators will assess, within strata and across treatment arms, whether individual treatments affected common beliefs about the benefits and risks of the HPV vaccine, which are observed more often among specific group of parents and which are believed to drive vaccine hesitancy. These beliefs are directly addressed by the informational intervention. They concern the perceived benefits/risks of the HPV vaccine relative to fertility, cancer and other illnesses' incidence and sexual behavior, such as whether the HPV vaccine incentivizes sexual activity of teenagers, or if it changes the probability that the teenager develops a cancer in the future. In the second case, the vaccine actually decreases that probability, but anti-vax information would postulate the opposite: we test whether across treatment arms there are significant differences in the degree of agreement with statements on these 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 )
Secondary Heterogeneity analysis (ANCOVA regressions including baseline covariates' interaction with treatment binary indicators) Investigators will assess whether the treatment effect has a significant interaction with the following variables which, unless specified otherwise, are extracted from population registers based on administrative data: -Field of education (medical vs non-medical and quantitative vs non-quantitative) -Presence of a medical doctor in the close network of the parent[from baseline survey] and other parent being a health worker -Self-declared percentage of the information sheet they actually read [from baseline survey] -Preferred source of information on vaccines [from baseline survey] - Household and mother's wealth - Previous knowledge of HPV and HPV vaccine [from baseline survey] -Marital status of the mother - Child being the firstborn - Child being female 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)
Secondary Subjective vs Objective vaccination measure (binary indicators) Investigators will test, within each stratum, whether the self-reported intention to vaccinate [post-treatment baseline survey] and the objective measure of vaccination [from vaccination registers] are statistically different. While the objective vaccination indicator is by definition a binary variable, the subjective indicator is initially reported on a Likert scale by subjects, and then reduced to a binary indicator by investigators for immediate comparison. 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)
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