HPV Vaccination StatusHPVNCT02145156
Educational Intervention to Minimize Disparities in Humanpapillomavirus Vaccination
A study testing Tailored educational materials, Untailored educational materials and Survey-only in people with HPV Vaccination Status, 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 clinical objectives/aims of this HPV educational intervention project are to determine: 1. 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 Status
- What is being tested?
- Tailored educational materials, Untailored educational materials and Survey-only
- Type of treatment
- Vaccines, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,294 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; OR a young adult patient between the ages of 18-26;
- Adolescent/young adult has not yet received all three doses of the HPV vaccine.
- Parent/young adult 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: Educational Intervention to Minimize Disparities in HPV Vaccination
The purpose of this study is to evaluate an innovative approach to improving HPV vaccination among the Hispanic population. The clinical objectives/aims of this HPV educational intervention project are to determine:
- The number of young adults and adolescents in each arm who received any dose of the HPV vaccine during the study period,
- The number of young adults and adolescents in each arm who initiated the HPV vaccine series during the study period,
- The number of young adults and adolescents in each arm who initiated but did not complete the HPV vaccine series during the study period,
- The number of young adults and adolescents in each arm, among all eligible, who completed the HPV vaccine series during the study period,
- The number of young adults and adolescents in each arm who completed the HPV vaccine series during the study period, among those who initiated the series at study start, and
- The number of young adults and adolescents in each arm who completed the HPV vaccine series among those who initiated the series during the study period.
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 HPV vaccination rates.
- Conditions
- HPV Vaccination Status
- Being tested
- Tailored educational materials, Untailored educational materials, Survey-only
- Keywords
- HPV vaccination, Tailored health messaging
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.
Survey-onlyBehavioural
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: survey-only. Participants in the usual care arm will not view any educational materials or complete the baseline survey. Receives: Behavioral: Survey-only |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Young Adults Who Received Any Dose of the HPV Vaccine During the Study Period
This outcome describes the number of young adult participants between the ages of 18-26 who received any dose of the HPV vaccine during the study period.
Measured: 16 months
Number of Young Adults Who Initiated the HPV Vaccine Series During the Study Period
This outcome describes the number of young adult participants between the ages of 18-26 who had 0 doses of the HPV vaccine at study enrollment and received at least one dose during the study period.
Measured: 16 months
Number of Young Adults Who Initiated But Did Not Complete the HPV Vaccine Series During the Study Period
This outcome describes the number of young adult participants between the ages of 18-26 who had 0 doses of the HPV vaccine at study enrollment and did not complete the vaccine series during the study period.
Measured: 16 months
Number of Young Adults, Among All Eligible, Who Completed the HPV Vaccine Series During the Study Period
This outcome describes the number of young adult participants between the ages of 18-26 who had 0, 1 or 2 doses of the HPV vaccine at study enrollment and completed the vaccine series during the study period.
Measured: 16 months
Number of Young Adults Who Completed the HPV Vaccine Series During the Study Period, Among Those Who Initiated the Series at Study Start
This outcome describes the number of young adult participants between the ages of 18-26 who had 1 or 2 doses of the HPV vaccine at study enrollment and completed the vaccine series during the study period.
Measured: 16 months
Number of Young Adults Who Completed the HPV Vaccine Series Among Those Who Initiated the Series During the Study Period
This outcome describes the number of young adult participants between the ages of 18-26 who had 0 doses of the HPV vaccine at study enrollment and completed the vaccine series during the study period.
Measured: 16 months
Number of Adolescents Who Received Any Dose of the HPV Vaccine During the Study Period
This outcome describes the number of adolescent participants between the ages of 9-17 who received any dose of the HPV vaccine during the study period.
Measured: 16 months
Number of Adolescents Who Initiated the HPV Vaccine Series During the Study Period
This outcome describes the number of adolescent participants between the ages of 9-17 who had 0 doses of the HPV vaccine at study enrollment and received at least one dose during the study period.
Measured: 16 months
Number of Adolescents Who Initiated But Did Not Complete the HPV Vaccine Series During the Study Period
This outcome describes the number of adolescent participants between the ages of 9-17 who had 0 doses of the HPV vaccine at study enrollment and did not complete the vaccine series during the study period.
Measured: 16 months
Number of Adolescents, Among All Eligible, Who Completed the HPV Vaccine Series During the Study Period
This outcome describes the number of adolescent participants between the ages of 9-17 who had 0, 1 or 2 doses of the HPV vaccine at study enrollment and completed the vaccine series during the study period.
Measured: 16 months
Number of Adolescents Who Completed the HPV Vaccine Series During the Study Period, Among Those Who Initiated the Series at Study Start
This outcome describes the number of adolescent participants between the ages of 9-17 who had 1 or 2 doses of the HPV vaccine at study enrollment and completed the vaccine series during the study period.
Measured: 16 months
Number of Adolescents Who Completed the HPV Vaccine Series Among Those Who Initiated the Series During the Study Period
This outcome describes the number of adolescent participants between the ages of 9-17 who had 0 doses of the HPV vaccine at study enrollment and completed the vaccine series during the study period.
Measured: 16 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2014 (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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HPV Vaccination StatusStudies 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
- 1,294 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
- NCT02145156
- Sponsor's protocol ID
- 14-0402
- Other IDs
- PCORI 1455
- Acronym
- HPV
- Status last verified
- May 2017
- First submitted
- 20 May 2014
- Last updated
- 26 Jun 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Dempsey AF, Maertens J, Sevick C, Jimenez-Zambrano A, Juarez-Colunga E. A randomized, controlled, pragmatic trial of an iPad-based, tailored messaging intervention to increase human papillomavirus vaccination among Latinos. Hum Vaccin Immunother. 2019;15(7-8):1577-1584. doi: 10.1080/21645515.2018.1559685. Epub 2019 Feb 20.
PubMed 30689494
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Educational Intervention to Minimize Disparities in HPV Vaccination
- ClinicalTrials.gov ID
- NCT02145156
- Acronym / sponsor ID
- HPV / 14-0402
- Conditions
- HPV Vaccination Status
- Keywords
- HPV vaccination, Tailored health messaging
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,294 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- University of Michigan
- Study start
- Jun 2014
- Primary completion
- Dec 2015 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 22 May 2014 (estimated)
- Results
- Posted 26 Aug 2016
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 clinical objectives/aims of this HPV educational intervention project are to determine:
- The number of young adults and adolescents in each arm who received any dose of the HPV vaccine during the study period,
- The number of young adults and adolescents in each arm who initiated the HPV vaccine series during the study period,
- The number of young adults and adolescents in each arm who initiated but did not complete the HPV vaccine series during the study period,
- The number of young adults and adolescents in each arm, among all eligible, who completed the HPV vaccine series during the study period,
- The number of young adults and adolescents in each arm who completed the HPV vaccine series during the study period, among those who initiated the series at study start, and
- The number of young adults and adolescents in each arm who completed the HPV vaccine series among those who initiated the series during the study period.
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 HPV vaccination rates.
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: Survey-onlyIntervention: survey-only. 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 (3 listed)
- Parents of an adolescent between the ages of 9-17; OR a young adult patient between the ages of 18-26;
- Adolescent/young adult has not yet received all three doses of the HPV vaccine.
- Parent/young adult 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 |
| Survey-onlyThose 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
Number of Young Adults Who Received Any Dose of the HPV Vaccine During the Study Period
Time frame: 16 months
This outcome describes the number of young adult participants between the ages of 18-26 who received any dose of the HPV vaccine during the study period.
Number of Young Adults Who Initiated the HPV Vaccine Series During the Study Period
Time frame: 16 months
This outcome describes the number of young adult participants between the ages of 18-26 who had 0 doses of the HPV vaccine at study enrollment and received at least one dose during the study period.
Number of Young Adults Who Initiated But Did Not Complete the HPV Vaccine Series During the Study Period
Time frame: 16 months
This outcome describes the number of young adult participants between the ages of 18-26 who had 0 doses of the HPV vaccine at study enrollment and did not complete the vaccine series during the study period.
Number of Young Adults, Among All Eligible, Who Completed the HPV Vaccine Series During the Study Period
Time frame: 16 months
This outcome describes the number of young adult participants between the ages of 18-26 who had 0, 1 or 2 doses of the HPV vaccine at study enrollment and completed the vaccine series during the study period.
Number of Young Adults Who Completed the HPV Vaccine Series During the Study Period, Among Those Who Initiated the Series at Study Start
Time frame: 16 months
This outcome describes the number of young adult participants between the ages of 18-26 who had 1 or 2 doses of the HPV vaccine at study enrollment and completed the vaccine series during the study period.
Number of Young Adults Who Completed the HPV Vaccine Series Among Those Who Initiated the Series During the Study Period
Time frame: 16 months
This outcome describes the number of young adult participants between the ages of 18-26 who had 0 doses of the HPV vaccine at study enrollment and completed the vaccine series during the study period.
Number of Adolescents Who Received Any Dose of the HPV Vaccine During the Study Period
Time frame: 16 months
This outcome describes the number of adolescent participants between the ages of 9-17 who received any dose of the HPV vaccine during the study period.
Number of Adolescents Who Initiated the HPV Vaccine Series During the Study Period
Time frame: 16 months
This outcome describes the number of adolescent participants between the ages of 9-17 who had 0 doses of the HPV vaccine at study enrollment and received at least one dose during the study period.
Number of Adolescents Who Initiated But Did Not Complete the HPV Vaccine Series During the Study Period
Time frame: 16 months
This outcome describes the number of adolescent participants between the ages of 9-17 who had 0 doses of the HPV vaccine at study enrollment and did not complete the vaccine series during the study period.
Number of Adolescents, Among All Eligible, Who Completed the HPV Vaccine Series During the Study Period
Time frame: 16 months
This outcome describes the number of adolescent participants between the ages of 9-17 who had 0, 1 or 2 doses of the HPV vaccine at study enrollment and completed the vaccine series during the study period.
Number of Adolescents Who Completed the HPV Vaccine Series During the Study Period, Among Those Who Initiated the Series at Study Start
Time frame: 16 months
This outcome describes the number of adolescent participants between the ages of 9-17 who had 1 or 2 doses of the HPV vaccine at study enrollment and completed the vaccine series during the study period.
Number of Adolescents Who Completed the HPV Vaccine Series Among Those Who Initiated the Series During the Study Period
Time frame: 16 months
This outcome describes the number of adolescent participants between the ages of 9-17 who had 0 doses of the HPV vaccine at study enrollment and completed the vaccine series during the study period.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 30689494Dempsey AF, Maertens J, Sevick C, Jimenez-Zambrano A, Juarez-Colunga E. A randomized, controlled, pragmatic trial of an iPad-based, tailored messaging intervention to increase human papillomavirus vaccination among Latinos. Hum Vaccin Immunother. 2019;15(7-8):1577-1584. doi: 10.1080/21645515.2018.1559685. Epub 2019 Feb 20.
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, Untailored educational materials and Survey-only in people with HPV Vaccination Status, 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 3 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 26 Jun 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. 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 26 Aug 2016). 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?
Number of Young Adults Who Received Any Dose of the HPV Vaccine During the Study Period (time frame: 16 months). The study lists 12 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 NCT02145156, 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 26 Jun 2017.