Human Papillomavirus VaccinesNCT02358083
Attitudes Toward Human Papillomavirus and Influenza Vaccination Among Mothers of Early Adolescents
A study testing Provider Communication about Vaccination in people with Human Papillomavirus Vaccines and Influenza Vaccines, run by Indiana University.
Trial summary
The purpose of this study was to determine whether messages about 1. relative risk of vaccination vs. other activities and 2. strength of doctor's recommendation influenced parental intention to get own child vaccinated against human papillomavirus (HPV) or Influenza. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Human Papillomavirus Vaccines, Influenza Vaccines, Attitude to Health
- What is being tested?
- Provider Communication about Vaccination
- Type of treatment
- Vaccines, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,165 participants
- Where
- No sites listed yet
- Study dates
- Aug 2014to Aug 2014
- 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
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18 years of age or older
- Lives in United States
- Mother or female legal guardian of at least one child aged 9-13
- Able to understand English
- For HPV condition: Target child must not have received any doses of HPV vaccine
- For Flu condition: Target child must not have received the flu vaccine during the prior flu season
Who cannot join
- Under 18 years of age
- Not mother or female legal guardian of at least one child ages 9-13
- Not living in United States
- Not able to understand English and Spanish
- For HPV condition: Target child had already received at least 1 dose of the HPV vaccine
- For Flu condition: Target child received the influenza vaccine during the previous flu season
About this study
The purpose of this study was to determine whether messages about 1. relative risk of vaccination vs. other activities and 2. strength of doctor's recommendation influenced parental intention to get own child vaccinated against human papillomavirus (HPV) or Influenza.
- Being tested
- Provider Communication about Vaccination
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Provider Communication about VaccinationBehavioural
There are 12 pairs of messages varying in target vaccination, discussion of relative safety of vaccination, and strength of provider recommendation for vaccination.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1. HPV + Control + Control | No intervention | HPV is target vaccine. No message regarding relative safety of vaccine; Provider provides brief routine recommendation for vaccination. |
| Arm 2. HPV + Control + Strong | Experimental | HPV is target vaccine; No message regarding relative safety of vaccine; Provider provides strong recommendation for vaccination. Receives: Behavioral: Provider Communication about Vaccination |
| Arm 3. HPV + Control + Disclosure | Experimental | HPV is target vaccine; No message regarding relative safety of vaccine; Provider provides strong recommendation for vaccination and personal disclosure regarding own child's vaccination history. Receives: Behavioral: Provider Communication about Vaccination |
| Arm 4. HPV + Safety + Control | Experimental | HPV is target vaccine; Provider provides message about relative safety of vaccination compared to other common daily activities; Provider provides brief routine recommendation for vaccination. Receives: Behavioral: Provider Communication about Vaccination |
| Arm 5. HPV + Safety + Strong | Experimental | HPV is target vaccine; Provider provides message about relative safety of vaccination compared to other common daily activities; Provider provides strong recommendation for vaccination. Receives: Behavioral: Provider Communication about Vaccination |
| Arm 6. HPV + Safety + Disclosure | Experimental | HPV is target vaccine; Provider provides message about relative safety of vaccination compared to other common daily activities; Provider provides strong recommendation for vaccination and personal disclosure regarding own child's vaccination history. Receives: Behavioral: Provider Communication about Vaccination |
| Arm 7. Flu + Control + Control | No intervention | Flu is target vaccine. No message regarding relative safety of vaccine; Provider provides brief routine recommendation for vaccination. |
| Arm 8. Flu + Control + Strong | Experimental | Flu is target vaccine; No message regarding relative safety of vaccine; Provider provides strong recommendation for vaccination. Receives: Behavioral: Provider Communication about Vaccination |
| Arm 9. Flu + Control + Disclosure | Experimental | Flu is target vaccine; No message regarding relative safety of vaccine; Provider provides strong recommendation for vaccination and personal disclosure regarding own child's vaccination history. Receives: Behavioral: Provider Communication about Vaccination |
| Arm 10. Flu + Safety + Control | Experimental | Flu is target vaccine; Provider provides message about relative safety of vaccination compared to other common daily activities; Provider provides brief routine recommendation for vaccination. Receives: Behavioral: Provider Communication about Vaccination |
| Arm 11. Flu + Safety + Strong | Experimental | Flu is target vaccine; Provider provides message about relative safety of vaccination compared to other common daily activities; Provider provides strong recommendation for vaccination. Receives: Behavioral: Provider Communication about Vaccination |
| Arm 12. Flu + Safety + Disclosure | Experimental | Flu is target vaccine; Provider provides message about relative safety of vaccination compared to other common daily activities; Provider provides strong recommendation for vaccination and personal disclosure regarding own child's vaccination history. Receives: Behavioral: Provider Communication about Vaccination |
What is being measured
The primary outcome is the main question the study is designed to answer.
Willingness to vaccinate child with target vaccine
Measured: During survey administration, at approximately 15 minutes into the survey.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2015 (estimated)
- Study startAug 2014
- Primary completionAug 2014
- Study completionAug 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Human Papillomavirus VaccinesStudies of the same condition, open and under way.
- More trials run by Indiana 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 1,165 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gregory Zimet, Indiana University
- Investigators
- Gregory D Zimet, PhD, Principal investigator, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02358083
- Sponsor's protocol ID
- 8645194
- Status last verified
- Oct 2023
- First submitted
- 3 Feb 2015
- Last updated
- 31 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Attitudes Toward Human Papillomavirus and Influenza Vaccination Among Mothers of Early Adolescents
- ClinicalTrials.gov ID
- NCT02358083
- Acronym / sponsor ID
- 8645194
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,165 participants (actual)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Study start
- Aug 2014
- Primary completion
- Aug 2014 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 6 Feb 2015 (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.
The purpose of this study was to determine whether messages about 1. relative risk of vaccination vs. other activities and 2. strength of doctor's recommendation influenced parental intention to get own child vaccinated against human papillomavirus (HPV) or Influenza.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (participant, investigator)
- Number of arms
- 12
| Arm | Type | Receives |
|---|---|---|
| Arm 1. HPV + Control + Control | No intervention | –HPV is target vaccine. No message regarding relative safety of vaccine; Provider provides brief routine recommendation for vaccination. |
| Arm 2. HPV + Control + Strong | Experimental | Behavioral: Provider Communication about VaccinationHPV is target vaccine; No message regarding relative safety of vaccine; Provider provides strong recommendation for vaccination. |
| Arm 3. HPV + Control + Disclosure | Experimental | Behavioral: Provider Communication about VaccinationHPV is target vaccine; No message regarding relative safety of vaccine; Provider provides strong recommendation for vaccination and personal disclosure regarding own child's vaccination history. |
| Arm 4. HPV + Safety + Control | Experimental | Behavioral: Provider Communication about VaccinationHPV is target vaccine; Provider provides message about relative safety of vaccination compared to other common daily activities; Provider provides brief routine recommendation for vaccination. |
| Arm 5. HPV + Safety + Strong | Experimental | Behavioral: Provider Communication about VaccinationHPV is target vaccine; Provider provides message about relative safety of vaccination compared to other common daily activities; Provider provides strong recommendation for vaccination. |
| Arm 6. HPV + Safety + Disclosure | Experimental | Behavioral: Provider Communication about VaccinationHPV is target vaccine; Provider provides message about relative safety of vaccination compared to other common daily activities; Provider provides strong recommendation for vaccination and personal disclosure regarding own child's vaccination history. |
| Arm 7. Flu + Control + Control | No intervention | –Flu is target vaccine. No message regarding relative safety of vaccine; Provider provides brief routine recommendation for vaccination. |
| Arm 8. Flu + Control + Strong | Experimental | Behavioral: Provider Communication about VaccinationFlu is target vaccine; No message regarding relative safety of vaccine; Provider provides strong recommendation for vaccination. |
| Arm 9. Flu + Control + Disclosure | Experimental | Behavioral: Provider Communication about VaccinationFlu is target vaccine; No message regarding relative safety of vaccine; Provider provides strong recommendation for vaccination and personal disclosure regarding own child's vaccination history. |
| Arm 10. Flu + Safety + Control | Experimental | Behavioral: Provider Communication about VaccinationFlu is target vaccine; Provider provides message about relative safety of vaccination compared to other common daily activities; Provider provides brief routine recommendation for vaccination. |
| Arm 11. Flu + Safety + Strong | Experimental | Behavioral: Provider Communication about VaccinationFlu is target vaccine; Provider provides message about relative safety of vaccination compared to other common daily activities; Provider provides strong recommendation for vaccination. |
| Arm 12. Flu + Safety + Disclosure | Experimental | Behavioral: Provider Communication about VaccinationFlu is target vaccine; Provider provides message about relative safety of vaccination compared to other common daily activities; Provider provides strong recommendation for vaccination and personal disclosure regarding own child's vaccination history. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 18 years of age or older
- Lives in United States
- Mother or female legal guardian of at least one child aged 9-13
- Able to understand English
- For HPV condition: Target child must not have received any doses of HPV vaccine
Key exclusion criteria (6 listed)
- Under 18 years of age
- Not mother or female legal guardian of at least one child ages 9-13
- Not living in United States
- Not able to understand English and Spanish
- For HPV condition: Target child had already received at least 1 dose of the HPV vaccine
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 |
|---|---|---|
| Provider Communication about VaccinationThere are 12 pairs of messages varying in target vaccination, discussion of relative safety of vaccination, and strength of provider recommendation for vaccination. | Behavioural | Arm 10. Flu + Safety + Control, Arm 11. Flu + Safety + Strong, Arm 12. Flu + Safety + Disclosure, Arm 2. HPV + Control + Strong, Arm 3. HPV + Control + Disclosure, Arm 4. HPV + Safety + Control, Arm 5. HPV + Safety + Strong, Arm 6. HPV + Safety + Disclosure, Arm 8. Flu + Control + Strong, Arm 9. Flu + Control + Disclosure |
Primary outcome
Willingness to vaccinate child with target vaccine
Time frame: During survey administration, at approximately 15 minutes into the survey.
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 31 Oct 2023.
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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.
Gregory D Zimet, PhD principal investigator
Indiana University
Questions about this trial
What is this clinical trial studying?
A study testing Provider Communication about Vaccination in people with Human Papillomavirus Vaccines and Influenza Vaccines, run by Indiana University.
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 6 inclusion and 6 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 31 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
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?
Willingness to vaccinate child with target vaccine (time frame: During survey administration, at approximately 15 minutes into the survey.). 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 31 Oct 2023.