Cervical CancerNCT04905030
Education, Immigration and HPV Vaccination: an Informational Randomized Trial
A study testing Information T1, Information T2 and Information C in people with Cervical Cancer and Vulvar Cancer, run by Karolinska Institutet at 1 site in Sweden.
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. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cervical Cancer, Vulvar Cancer, Anus Cancer
- What is being tested?
- Information T1, Information T2 and Information C
- Type of treatment
- Vaccines, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,500 participants
- Where
- 1 siteSweden
- Study dates
- 28 Apr 2021to 14 Jan 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Karolinska Institutet, Medicinsk epidemiologi och biostatistik
Solna, Stockholm County, 17165
About this study
Official title: Utbildningsnivå, Invandringsstatus Och Viljan Att Vaccinera Mot HPV Som Funktion av Informationsformulering: En Randomiserad Studie
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.
Read the 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.
- Conditions
- Cervical Cancer, Vulvar Cancer, Anus Cancer, Penis Cancer, Mouse Papilloma, Head Cancer
- Being tested
- Information T1, Information T2, Information C
- Keywords
- Human Papilloma Virus, Vaccine
- Medical subject headings
- Uterine Cervical Neoplasms, Vulvar Neoplasms, Anus Neoplasms, Penile Neoplasms, Head and Neck Neoplasms, Condylomata Acuminata
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Information T1Behavioural
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 T2Behavioural
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 CBehavioural
A4 information sheet containing a reminder of the upcoming HPV vaccination, and information on the history and characteristics of the Swedish national vaccination program.
| Study group | Role | What they receive |
|---|---|---|
| Immigrant mother stratum | Experimental | The receiver is an immigrant mother born in Eritrea, Somalia, Syria, Afghanistan, Iran or Iraq. Receives: 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. Receives: 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. Receives: 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 Receives: 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 Receives: Behavioral: Information T1; Behavioral: Information T2; Behavioral: Information C |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 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)
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.
Measured: 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)
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
Measured: 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)
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.
Measured: 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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2021
- Study start28 Apr 2021
- Primary completion14 Jan 2022 (estimated)
- Study completion14 Jan 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical CancerStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 2,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Responsible party
- Principal investigator, Lisen Arnheim Dahlstrom, Karolinska Institutet
- Investigators
- Lisen A. Dahlström, Ph.D., Principal investigator, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04905030
- Sponsor's protocol ID
- HPVRCT01225
- Status last verified
- Jun 2021
- First submitted
- 19 May 2021
- Last updated
- 11 Jun 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Utbildningsnivå, Invandringsstatus Och Viljan Att Vaccinera Mot HPV Som Funktion av Informationsformulering: En Randomiserad Studie
- ClinicalTrials.gov ID
- NCT04905030
- Acronym / sponsor ID
- HPVRCT01225
- Conditions
- Cervical Cancer, Vulvar Cancer, Anus Cancer, Penis Cancer, Mouse Papilloma, Head Cancer
- Keywords
- Human Papilloma Virus, Vaccine
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 2,500 participants (estimated)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- 28 Apr 2021 (actual)
- Primary completion
- 14 Jan 2022 (estimated)
- Study completion
- 14 Jan 2022 (estimated)
- First posted
- 27 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Immigrant mother stratum | Experimental | Behavioral: Information T1, Behavioral: Information T2, Behavioral: Information CThe receiver is an immigrant mother born in Eritrea, Somalia, Syria, Afghanistan, Iran or Iraq. |
| Educ 1 stratum | Experimental | Behavioral: Information T1, Behavioral: Information T2, Behavioral: Information CThe receiver is a mother born in Sweden whose education does not exceed 3 years of high school. |
| Educ 2 stratum | Experimental | Behavioral: Information T1, Behavioral: Information T2, Behavioral: Information CThe receiver is a mother born in Sweden whose education is at least 3 years of high school but no more than high school diploma. |
| Educ 3 stratum | Experimental | Behavioral: Information T1, Behavioral: Information T2, Behavioral: Information CThe receiver is a mother born in Sweden whose education is at least some college (undergrad) but does not exceed an undergraduate degree |
| Educ 4 stratum | Experimental | Behavioral: Information T1, Behavioral: Information T2, Behavioral: Information CThe receiver is a mother born in Sweden whose education is an undergraduate degree plus at least some graduate education |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Information T1A4 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. | Behavioural | Educ 1 stratum, Educ 2 stratum, Educ 3 stratum, Educ 4 stratum, Immigrant mother stratum |
| Information T2A4 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. | Behavioural | Educ 1 stratum, Educ 2 stratum, Educ 3 stratum, Educ 4 stratum, Immigrant mother stratum |
| Information CA4 information sheet containing a reminder of the upcoming HPV vaccination, and information on the history and characteristics of the Swedish national vaccination program. | Behavioural | Educ 1 stratum, Educ 2 stratum, Educ 3 stratum, Educ 4 stratum, Immigrant mother stratum |
Primary outcome
Actual decision to vaccinate child against HPV
Time frame: From treatment administration: 8 to 18 weeks, depending on when the single subject has read the information from the behavioral intervention
Investigators will assess if there are significant differences in the frequency of parents who decide to vaccinate across treatment arms, within each stratum
(Short Term) Posterior beliefs about false risks of the HPV vaccine
Time frame: Same day as treatment in the first survey: ~1 hour post treatment
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
(Long Term) Posterior beliefs about false risks of the HPV vaccine
Time frame: 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
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
3 secondary outcomes
Behavioral mechanisms' analysis (Measurement: questionnaire, likert scale of agreement with statements on the hypothesized beliefs)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lisen A. Dahlström, Ph.D. principal investigator
Karolinska Institutet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Information T1, Information T2 and Information C in people with Cervical Cancer and Vulvar Cancer, run by Karolinska Institutet at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Actual decision to vaccinate child against HPV (time frame: From treatment administration: 8 to 18 weeks, depending on when the single subject has read the information from the behavioral intervention). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2021.