HPV Vaccination Decision QualityNCT02797054
Educational Intervention to Improve HPV Vaccination Decision Quality
A study testing Tailored educational materials and Untailored educational materials in people with HPV Vaccination Decision Quality, run by University of Colorado, Denver at 1 site in United States.
Trial summary
The purpose of this study is to evaluate an innovative approach to improving HPV vaccination among the Hispanic population. The objectives/aims of this HPV educational intervention project are: 1. To measure the quality of the HPV vaccine decision among participants in different arms of the intervention 2. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- HPV Vaccination Decision Quality
- What is being tested?
- Tailored educational materials and Untailored educational materials
- Type of treatment
- Vaccines, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,205 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2014to Jun 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Parents of an adolescent between the ages of 9-17
- A young adult patient between the ages of 18-26
- Adolescent/young adult who has not yet received all three doses of the HPV vaccine.
- Parent/young adult who can read and converse in either English or Spanish
Who cannot join
- Age <18,
- Prisoners
- Decisionally challenged subjects
- Those who cannot read and converse in either English or Spanish
- Those who have received all 3 doses of the HPV vaccine
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Colorado Denver
Aurora, Colorado, 80045
About this study
Official title: Culturally Tailored Educational Intervention to Improve Decision Quality Around Humanpapillomavirus (HPV) Vaccination
The purpose of this study is to evaluate an innovative approach to improving HPV vaccination among the Hispanic population. The objectives/aims of this HPV educational intervention project are:
- To measure the quality of the HPV vaccine decision among participants in different arms of the intervention
- To determine patterns of intervention utilization among participants in different arms of the intervention, and
The implementation of this educational intervention in clinic waiting rooms is intended to assist primary care providers in communicating HPV vaccine awareness and education to parents and patients in a culturally tailored format.
Read the detailed description
While HPV infection is nearly ubiquitous among the sexually active population, the morbidity and mortality from HPV-related diseases disproportionately affects minorities and the poor. Hispanic women are at particularly high risk as they have the highest rates of invasive cervical cancer when compared to all other racial or ethnic groups in the U.S. Initiating the 3-dose HPV vaccination series is more common among Hispanic adolescents than whites, but series completion has been lowest among Hispanic populations.
To understand barriers to HPV vaccination and to provide insight into ways in which an existing educational intervention should be modified for a Hispanic population, the investigators conducted focus groups among Hispanic parents and Latina young adults. All groups reported vaccine cost, access to insurance, and a general lack of awareness and/or understanding of either HPV or the vaccine as barriers. All groups also wanted substantially more "general" information about both HPV and the vaccine in order to make informed vaccination decisions. The educational intervention was generally well received but there were universal suggestions from all the groups to provide additional basic information about HPV infection, to add information about the vaccine for boys/young men, and to modify the color scheme and logo to make it more eye-catching and pleasing.
This current phase of the project will be comprised of real world testing of an iPad-based educational intervention about HPV, "Combatting HPV Infection and Cancer" (CHICOS) that has been revised and developed per focus group feedback to target the Hispanic population.
By providing information that patients and parents have clearly indicated they want in a way that is culturally sensitive and meaningful and also individually personalized, the investigators hope to improve the HPV vaccination decision-making process.
- Conditions
- HPV Vaccination Decision Quality
- Being tested
- Tailored educational materials, Untailored educational materials, Usual care
- Keywords
- HPV vaccination, Vaccination decision-making, Tailored health messaging, Barriers to vaccination, Attitudes
- Medical subject headings
- Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tailored educational materialsBehavioural
The tailored intervention will use participants' baseline survey responses to generate tailored educational messages about the HPV vaccine. These educational messages will reflect the top concerns indicated by the participant about the HPV vaccine. Additional tailoring will occur in the form of images matched to self-reported race and age, and using participants' first name in the information presented.
Untailored educational materialsBehavioural
The untailored intervention will present educational information on the iPad that is not responsive to participants' baseline questionnaire answers and instead is derived directly from the HPV "Vaccine Information Sheet" that has been created by the Centers for Disease Control and Prevention.
Usual careBehavioural
Those in the usual care arm will be provided with a paper version of the Post Intervention Survey. This will be provided to participants after their clinic visit is completed.
| Study group | Role | What they receive |
|---|---|---|
| Tailored Intervention | Experimental | Intervention: tailored educational materials. In this arm, participants will complete a baseline survey on an iPad, view a series of educational webpages on the iPad, and complete a brief post intervention survey. Receives: Behavioral: Tailored educational materials |
| Untailored Intervention | Other | Intervention: untailored educational materials. In this arm, patients will view educational information on the iPad that is not responsive to their baseline questionnaire answers. Receives: Behavioral: Untailored educational materials |
| Usual Care | Other | Intervention: usual care as experienced during appointment with primary care provider. Participants in the usual care arm will not view any educational materials or complete the baseline survey. Receives: Behavioral: Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent of Participants - Who Agreed They Felt Sure About the Best Choice Regarding the HPV Vaccine at Post-intervention
Measured: 1 day
Percent of Participants Who Agreed They Knew Enough About the Risks and Benefits of the HPV Vaccine at Post-intervention
Measured: 1 day
Percent of Participants Who Agreed They Felt Clear About Which Risks and Benefits of the HPV Vaccine Mattered Most to Them at Post-intervention
Measured: 1 day
Percent of Participants Who Agreed They Felt They Had Enough Support to Make a Decision About Getting the HPV Vaccine at Post-intervention
Measured: 1 day
Percent of Participants Who Agreed They Felt Sure About the Best Choice Regarding the HPV Vaccine at Follow-up
Measured: 2 Months
Percent of Participants Who Agreed They Knew Enough About the Risks and Benefits of the HPV Vaccine at Follow-up
Measured: 2 Months
Percent of Participants Who Agreed They Felt Clear About Which Risks and Benefits of the HPV Vaccine Mattered Most to Them at Follow-up
Measured: 2 Months
Percent of Participants Who Agreed They Felt They Had Enough Support to Make a Decision About Getting the HPV Vaccine at Follow-up
Measured: 2 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2016 (estimated)
- Study startJun 2014
- Primary completionDec 2015
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for HPV Vaccination Decision QualityStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 1,205 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Collaborators
- University of Michigan
- Responsible party
- Sponsor
- Investigators
- Amanda F Dempsey, MD, PhD, MPH, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02797054
- Sponsor's protocol ID
- 14-0402-1
- Status last verified
- Aug 2018
- First submitted
- 31 May 2016
- Last updated
- 21 Sep 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Culturally Tailored Educational Intervention to Improve Decision Quality Around Humanpapillomavirus (HPV) Vaccination
- ClinicalTrials.gov ID
- NCT02797054
- Acronym / sponsor ID
- 14-0402-1
- Conditions
- HPV Vaccination Decision Quality
- Keywords
- HPV vaccination, Vaccination decision-making, Tailored health messaging, Barriers to vaccination, Attitudes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,205 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- University of Michigan
- Study start
- Jun 2014 (actual)
- Primary completion
- Dec 2015 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 13 Jun 2016 (estimated)
- Results
- Posted 24 Aug 2018
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 is to evaluate an innovative approach to improving HPV vaccination among the Hispanic population. The objectives/aims of this HPV educational intervention project are:
- To measure the quality of the HPV vaccine decision among participants in different arms of the intervention
- To determine patterns of intervention utilization among participants in different arms of the intervention, and
The implementation of this educational intervention in clinic waiting rooms is intended to assist primary care providers in communicating HPV vaccine awareness and education to parents and patients in a culturally tailored format.
Detailed description
While HPV infection is nearly ubiquitous among the sexually active population, the morbidity and mortality from HPV-related diseases disproportionately affects minorities and the poor. Hispanic women are at particularly high risk as they have the highest rates of invasive cervical cancer when compared to all other racial or ethnic groups in the U.S. Initiating the 3-dose HPV vaccination series is more common among Hispanic adolescents than whites, but series completion has been lowest among Hispanic populations.
To understand barriers to HPV vaccination and to provide insight into ways in which an existing educational intervention should be modified for a Hispanic population, the investigators conducted focus groups among Hispanic parents and Latina young adults. All groups reported vaccine cost, access to insurance, and a general lack of awareness and/or understanding of either HPV or the vaccine as barriers. All groups also wanted substantially more "general" information about both HPV and the vaccine in order to make informed vaccination decisions. The educational intervention was generally well received but there were universal suggestions from all the groups to provide additional basic information about HPV infection, to add information about the vaccine for boys/young men, and to modify the color scheme and logo to make it more eye-catching and pleasing.
This current phase of the project will be comprised of real world testing of an iPad-based educational intervention about HPV, "Combatting HPV Infection and Cancer" (CHICOS) that has been revised and developed per focus group feedback to target the Hispanic population.
By providing information that patients and parents have clearly indicated they want in a way that is culturally sensitive and meaningful and also individually personalized, the investigators hope to improve the HPV vaccination decision-making process.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Tailored Intervention | Experimental | Behavioral: Tailored educational materialsIntervention: tailored educational materials. In this arm, participants will complete a baseline survey on an iPad, view a series of educational webpages on the iPad, and complete a brief post intervention survey. |
| Untailored Intervention | Other | Behavioral: Untailored educational materialsIntervention: untailored educational materials. In this arm, patients will view educational information on the iPad that is not responsive to their baseline questionnaire answers. |
| Usual Care | Other | Behavioral: Usual careIntervention: usual care as experienced during appointment with primary care provider. Participants in the usual care arm will not view any educational materials or complete the baseline survey. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Parents of an adolescent between the ages of 9-17
- A young adult patient between the ages of 18-26
- Adolescent/young adult who has not yet received all three doses of the HPV vaccine.
- Parent/young adult who can read and converse in either English or Spanish
Key exclusion criteria (5 listed)
- Age <18,
- Prisoners
- Decisionally challenged subjects
- Those who cannot read and converse in either English or Spanish
- Those who have received all 3 doses 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 |
|---|---|---|
| Tailored educational materialsThe tailored intervention will use participants' baseline survey responses to generate tailored educational messages about the HPV vaccine. These educational messages will reflect the top concerns indicated by the participant about the HPV vaccine. Additional tailoring will occur in the form of images matched to self-reported race and age, and using participants' first name in the information presented. | Behavioural | Tailored Intervention |
| Untailored educational materialsThe untailored intervention will present educational information on the iPad that is not responsive to participants' baseline questionnaire answers and instead is derived directly from the HPV "Vaccine Information Sheet" that has been created by the Centers for Disease Control and Prevention. | Behavioural | Untailored Intervention |
| Usual careThose in the usual care arm will be provided with a paper version of the Post Intervention Survey. This will be provided to participants after their clinic visit is completed. | Behavioural | Usual Care |
Primary outcome
Percent of Participants - Who Agreed They Felt Sure About the Best Choice Regarding the HPV Vaccine at Post-intervention
Time frame: 1 day
Percent of Participants Who Agreed They Knew Enough About the Risks and Benefits of the HPV Vaccine at Post-intervention
Time frame: 1 day
Percent of Participants Who Agreed They Felt Clear About Which Risks and Benefits of the HPV Vaccine Mattered Most to Them at Post-intervention
Time frame: 1 day
Percent of Participants Who Agreed They Felt They Had Enough Support to Make a Decision About Getting the HPV Vaccine at Post-intervention
Time frame: 1 day
Percent of Participants Who Agreed They Felt Sure About the Best Choice Regarding the HPV Vaccine at Follow-up
Time frame: 2 Months
Percent of Participants Who Agreed They Knew Enough About the Risks and Benefits of the HPV Vaccine at Follow-up
Time frame: 2 Months
Percent of Participants Who Agreed They Felt Clear About Which Risks and Benefits of the HPV Vaccine Mattered Most to Them at Follow-up
Time frame: 2 Months
Percent of Participants Who Agreed They Felt They Had Enough Support to Make a Decision About Getting the HPV Vaccine at Follow-up
Time frame: 2 Months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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.
Amanda F Dempsey, MD, PhD, MPH principal investigator
University of Colorado, Denver
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tailored educational materials and Untailored educational materials in people with HPV Vaccination Decision Quality, run by University of Colorado, Denver 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 4 inclusion and 5 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 21 Sep 2018. 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. 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?
Yes. Results are posted in the registry (first posted 24 Aug 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Percent of Participants - Who Agreed They Felt Sure About the Best Choice Regarding the HPV Vaccine at Post-intervention (time frame: 1 day). The study lists 8 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 21 Sep 2018.