Human PapillomavirusNCT03002324
Tailoring of Vaccine-Focused Messages: Disease Salience
A study testing Baseline Survey, Current CDC Message and Cervical Cancer Message in people with Human Papillomavirus, run by Emory University at 1 site in United States.
Trial summary
This study is the second phase of a trial examining decision making about vaccines. For this phase of this study, the researchers will conduct a 3-arm randomized trial to compare the current Centers for Disease Control and Prevention (CDC) human papillomavirus (HPV) message, a new cervical cancer focused message… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Human Papillomavirus
- What is being tested?
- Baseline Survey, Current CDC Message and Cervical Cancer Message
- Type of treatment
- Vaccines, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,320 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2017to 1 May 2017
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Have at least one daughter between 9 and 17 years of age (inclusive)
- Reside in the United States
Who cannot join
- Have previously participated in the disease salience phase of this study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Tailoring of Vaccine-Focused Messages: Moral Foundations and Disease Salience - Part 2
This study is the second phase of a trial examining decision making about vaccines. For this phase of this study, the researchers will conduct a 3-arm randomized trial to compare the current Centers for Disease Control and Prevention (CDC) human papillomavirus (HPV) message, a new cervical cancer focused message developed by the study team, and a non-vaccine related control passage among parents of adolescent females. The goal of the trial will be to determine if the new cervical cancer framed message has an increased impact on intent to have daughters receive the HPV vaccine over the trial period as compared to the current CDC message used in the field. Additionally, the researchers will examine the impact both the CDC message and the new message individually have on intent to vaccinate when compared to the non-vaccine related control message.
The participant's vaccine beliefs and intent to vaccinate will be assessed through an online survey at baseline. Two weeks later, participants will be randomized to view one of the three messages: the current CDC message, the cervical cancer framed message, or a non-vaccine related control message. Immediately afterwards, vaccine beliefs and intent to vaccinate will be assessed to determine the impact of the message.
Read the detailed description
Genital human papillomavirus (HPV) is the most common sexually transmitted infection in the United States. Most HPV infections are asymptomatic and clear on their own within 2 years but persistent infections can lead to diseases, including several cancers. Cervical cancer is the most common cancer caused by HPV infection, and virtually all cervical cancers can be attributed to HPV infection. There is no cure for HPV, but HPV can be prevented through vaccination. Current recommendations from the Advisory Committee on Immunization Practices (ACIP) state that the HPV vaccine may be given starting at 11-12 years of age for boys and girls, through age 26. Despite the safety and efficacy of this vaccine, the coverage among adolescents aged 11-17 years old remains low. Attaining high vaccination rates among adolescents is essential to decreasing the burden of disease due to cervical cancer, and other cancers caused by HPV.
Parental decision to vaccinate their children, specifically with the HPV vaccine, can be tied to multiple constructs of the Health Belief Model. These include perceived susceptibility of HPV infection (is my child at risk of infection), perceived benefit, and perceived severity (of disease, and of vaccine related adverse events). This would suggest that messaging surrounding the HPV vaccination should be highly salient within these constructs. The current message tied to the HPV vaccine presented by the Centers for Disease Control (CDC) has a focus on HPV as an infection and is clinical in nature. In a randomized trial, parents given information about HPV were no more likely to be accepting of an HPV vaccine and no more likely to get their child vaccinated. Based on this literature, the researchers hypothesize that reframing the message to promote HPV vaccination as a means of protection against cervical cancer will impact intent to vaccinate among parents of adolescent females (aged 11-17 years old).
In the first phase of this study the researchers assessed how appealing to different moral foundations impacted attitudes towards vaccination and intent to vaccinate. For this phase of this study, the researchers will conduct a 3-arm randomized trial to compare the current CDC HPV, a cervical cancer focused message developed by the study team, and a non-vaccine related control passage among parents of adolescent females. The goal of the trial will be to determine if the new cervical cancer framed message has an increased impact on intent to have daughters receive the HPV vaccine over the trial period as compared to the current CDC message. Additionally, the researchers will examine the impact both the CDC message and the new message have on intent to vaccinate when compared to the non-vaccine related control message.
The participant's vaccine beliefs and intent to vaccinate will be assessed through an online survey at baseline. Two weeks later, participants will be randomized to view one of the three messages: the current CDC message, the cervical cancer framed message, or a non-vaccine related control message. Immediately afterwards, vaccine beliefs and intent to vaccinate will be assessed to determine the impact of the message.
- Conditions
- Human Papillomavirus
- Being tested
- Baseline Survey, Current CDC Message, Cervical Cancer Message, Control Message, Post-Intervention Survey
- Keywords
- Vaccines, Childhood Vaccination, Decision Making, Health Belief Model
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Baseline SurveyBehavioural
The baseline survey is a combination of the Vaccine Confidence Scale, and a short form of the Parents' Attitudes about Childhood Vaccines (PACV) Scale. Participants will be asked an additional 10 questions developed as a part of a behavioral phenotyping questionnaire to assess behavioral biases at baseline within the study population. Demographic information and intent to vaccinate will also be collected.
Current CDC MessageBehavioural
Participants randomized to the current CDC message arm will read a message taken almost directly from the CDC Vaccine Information Sheet (VIS) on HPV. This message was minimally altered for length and clarity.
Cervical Cancer MessageBehavioural
Participants randomized to the cervical cancer messaging arm will receive a message developed by the study team to appeal tenants of the Health Belief Model (self-efficacy, perceived benefit) and on the purity tenant of the moral foundations theory.
Control MessageBehavioural
Participants randomized to the non-vaccine related control arm will read a bird-feeding passage.
Post-Intervention SurveyBehavioural
The immediate post-intervention survey will include questions from the Vaccine Confidence Scale and the PACV short scale. Intent to vaccinate will be assessed.
| Study group | Role | What they receive |
|---|---|---|
| Current CDC Message Arm | Active comparator | Participants randomized to this arm will receive a message developed to directly follow the current message on the CDC's website. Receives: Behavioral: Baseline Survey; Behavioral: Current CDC Message; Behavioral: Post-Intervention Survey |
| Cervical Cancer Message Arm | Experimental | Participants randomized to this arm will receive a message focused on cervical cancer risks and prevention and framed to highlight perceived susceptibility, perceived benefit, and self-efficacy. Receives: Behavioral: Baseline Survey; Behavioral: Cervical Cancer Message; Behavioral: Post-Intervention Survey |
| Control Message | Sham comparator | Participants randomized to the control arm will be provided with a short message about the costs and benefits of bird feeding. Receives: Behavioral: Baseline Survey; Behavioral: Control Message; Behavioral: Post-Intervention Survey |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall change in attitude towards the human papilloma virus (HPV) vaccine
Number of caregivers experiencing a change in attitude towards the HPV vaccine
Measured: Week 2
Intent to have their child vaccinated against HPV
Number of caregivers intending to have their daughter(s) receive the HPV vaccine
Measured: Week 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2016 (estimated)
- Study startJan 2017
- Primary completion1 May 2017
- Study completion1 May 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Human PapillomavirusStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,320 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Saad B. Omer, MBBS, MPH, PhD, Emory University
- Investigators
- Saad B Omer, BBS, MPH, PhD, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03002324
- Sponsor's protocol ID
- IRB00087211a
- Status last verified
- May 2017
- First submitted
- 21 Dec 2016
- Last updated
- 10 May 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Porter RM, Amin AB, Bednarczyk RA, Omer SB. Cancer-salient messaging for Human Papillomavirus vaccine uptake: A randomized controlled trial. Vaccine. 2018 Apr 25;36(18):2494-2500. doi: 10.1016/j.vaccine.2018.01.040. Epub 2018 Mar 26.
PubMed 29599089
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tailoring of Vaccine-Focused Messages: Moral Foundations and Disease Salience - Part 2
- ClinicalTrials.gov ID
- NCT03002324
- Acronym / sponsor ID
- IRB00087211a
- Conditions
- Human Papillomavirus
- Keywords
- Vaccines, Childhood Vaccination, Decision Making, Health Belief Model
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,320 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Study start
- Jan 2017 (actual)
- Primary completion
- 1 May 2017 (actual)
- Study completion
- 1 May 2017 (actual)
- First posted
- 23 Dec 2016 (estimated)
- 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.
This study is the second phase of a trial examining decision making about vaccines. For this phase of this study, the researchers will conduct a 3-arm randomized trial to compare the current Centers for Disease Control and Prevention (CDC) human papillomavirus (HPV) message, a new cervical cancer focused message developed by the study team, and a non-vaccine related control passage among parents of adolescent females. The goal of the trial will be to determine if the new cervical cancer framed message has an increased impact on intent to have daughters receive the HPV vaccine over the trial period as compared to the current CDC message used in the field. Additionally, the researchers will examine the impact both the CDC message and the new message individually have on intent to vaccinate when compared to the non-vaccine related control message.
The participant's vaccine beliefs and intent to vaccinate will be assessed through an online survey at baseline. Two weeks later, participants will be randomized to view one of the three messages: the current CDC message, the cervical cancer framed message, or a non-vaccine related control message. Immediately afterwards, vaccine beliefs and intent to vaccinate will be assessed to determine the impact of the message.
Detailed description
Genital human papillomavirus (HPV) is the most common sexually transmitted infection in the United States. Most HPV infections are asymptomatic and clear on their own within 2 years but persistent infections can lead to diseases, including several cancers. Cervical cancer is the most common cancer caused by HPV infection, and virtually all cervical cancers can be attributed to HPV infection. There is no cure for HPV, but HPV can be prevented through vaccination. Current recommendations from the Advisory Committee on Immunization Practices (ACIP) state that the HPV vaccine may be given starting at 11-12 years of age for boys and girls, through age 26. Despite the safety and efficacy of this vaccine, the coverage among adolescents aged 11-17 years old remains low. Attaining high vaccination rates among adolescents is essential to decreasing the burden of disease due to cervical cancer, and other cancers caused by HPV.
Parental decision to vaccinate their children, specifically with the HPV vaccine, can be tied to multiple constructs of the Health Belief Model. These include perceived susceptibility of HPV infection (is my child at risk of infection), perceived benefit, and perceived severity (of disease, and of vaccine related adverse events). This would suggest that messaging surrounding the HPV vaccination should be highly salient within these constructs. The current message tied to the HPV vaccine presented by the Centers for Disease Control (CDC) has a focus on HPV as an infection and is clinical in nature. In a randomized trial, parents given information about HPV were no more likely to be accepting of an HPV vaccine and no more likely to get their child vaccinated. Based on this literature, the researchers hypothesize that reframing the message to promote HPV vaccination as a means of protection against cervical cancer will impact intent to vaccinate among parents of adolescent females (aged 11-17 years old).
In the first phase of this study the researchers assessed how appealing to different moral foundations impacted attitudes towards vaccination and intent to vaccinate. For this phase of this study, the researchers will conduct a 3-arm randomized trial to compare the current CDC HPV, a cervical cancer focused message developed by the study team, and a non-vaccine related control passage among parents of adolescent females. The goal of the trial will be to determine if the new cervical cancer framed message has an increased impact on intent to have daughters receive the HPV vaccine over the trial period as compared to the current CDC message. Additionally, the researchers will examine the impact both the CDC message and the new message have on intent to vaccinate when compared to the non-vaccine related control message.
The participant's vaccine beliefs and intent to vaccinate will be assessed through an online survey at baseline. Two weeks later, participants will be randomized to view one of the three messages: the current CDC message, the cervical cancer framed message, or a non-vaccine related control message. Immediately afterwards, vaccine beliefs and intent to vaccinate will be assessed to determine the impact of the message.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Current CDC Message Arm | Active comparator | Behavioral: Baseline Survey, Behavioral: Current CDC Message, Behavioral: Post-Intervention SurveyParticipants randomized to this arm will receive a message developed to directly follow the current message on the CDC's website. |
| Cervical Cancer Message Arm | Experimental | Behavioral: Baseline Survey, Behavioral: Cervical Cancer Message, Behavioral: Post-Intervention SurveyParticipants randomized to this arm will receive a message focused on cervical cancer risks and prevention and framed to highlight perceived susceptibility, perceived benefit, and self-efficacy. |
| Control Message | Sham comparator | Behavioral: Baseline Survey, Behavioral: Control Message, Behavioral: Post-Intervention SurveyParticipants randomized to the control arm will be provided with a short message about the costs and benefits of bird feeding. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Have at least one daughter between 9 and 17 years of age (inclusive)
- Reside in the United States
Key exclusion criteria (1 listed)
- Have previously participated in the disease salience phase of this study
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 |
|---|---|---|
| Baseline SurveyThe baseline survey is a combination of the Vaccine Confidence Scale, and a short form of the Parents' Attitudes about Childhood Vaccines (PACV) Scale. Participants will be asked an additional 10 questions developed as a part of a behavioral phenotyping questionnaire to assess behavioral biases at baseline within the study population. Demographic information and intent to vaccinate will also be collected. | Behavioural | Cervical Cancer Message Arm, Control Message, Current CDC Message Arm |
| Current CDC MessageParticipants randomized to the current CDC message arm will read a message taken almost directly from the CDC Vaccine Information Sheet (VIS) on HPV. This message was minimally altered for length and clarity. | Behavioural | Current CDC Message Arm |
| Cervical Cancer MessageParticipants randomized to the cervical cancer messaging arm will receive a message developed by the study team to appeal tenants of the Health Belief Model (self-efficacy, perceived benefit) and on the purity tenant of the moral foundations theory. | Behavioural | Cervical Cancer Message Arm |
| Control MessageParticipants randomized to the non-vaccine related control arm will read a bird-feeding passage. | Behavioural | Control Message |
| Post-Intervention SurveyThe immediate post-intervention survey will include questions from the Vaccine Confidence Scale and the PACV short scale. Intent to vaccinate will be assessed. | Behavioural | Cervical Cancer Message Arm, Control Message, Current CDC Message Arm |
Primary outcome
Overall change in attitude towards the human papilloma virus (HPV) vaccine
Time frame: Week 2
Number of caregivers experiencing a change in attitude towards the HPV vaccine
Intent to have their child vaccinated against HPV
Time frame: Week 2
Number of caregivers intending to have their daughter(s) receive the HPV vaccine
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2017.
- Derived from this study: PubMed 29599089Porter RM, Amin AB, Bednarczyk RA, Omer SB. Cancer-salient messaging for Human Papillomavirus vaccine uptake: A randomized controlled trial. Vaccine. 2018 Apr 25;36(18):2494-2500. doi: 10.1016/j.vaccine.2018.01.040. Epub 2018 Mar 26.
- 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.
Saad B Omer, BBS, MPH, PhD principal investigator
Emory University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Baseline Survey, Current CDC Message and Cervical Cancer Message in people with Human Papillomavirus, run by Emory University at 1 site in United States.
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 2 inclusion and 1 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: finished, as of the sponsor's last update on 10 May 2017. 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 United States. 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Overall change in attitude towards the human papilloma virus (HPV) vaccine (time frame: Week 2). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03002324, which also lists 1 linked publication.
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 10 May 2017.