HPV Vaccination Status
Conditions
Keywords
HPV vaccination, Tailored health messaging
Brief 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. The number of young adults and adolescents in each arm who received any dose of the HPV vaccine during the study period, 2. The number of young adults and adolescents in each arm who initiated the HPV vaccine series during the study period, 3. The number of young adults and adolescents in each arm who initiated but did not complete the HPV vaccine series during the study period, 4. The number of young adults and adolescents in each arm, among all eligible, who completed the HPV vaccine series during the study period, 5. 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 6. 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.
Interventions
BEHAVIORALTailored educational materials
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.
BEHAVIORALUntailored educational materials
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.
BEHAVIORALSurvey-only
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.
Sponsors
University of Michigan
University of Colorado, Denver
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes
Inclusion criteria
1. Parents of an adolescent between the ages of 9-17; OR a young adult patient between the ages of 18-26; 2. Adolescent/young adult has not yet received all three doses of the HPV vaccine. 3. Parent/young adult can read and converse in either English or Spanish
Exclusion criteria
1. Age \<18, 2. Prisoners 3. Decisionally challenged subjects 4. Those who cannot read and converse in either English or Spanish 5. Those who have received all 3 doses of the HPV vaccine
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Young Adults Who Received Any Dose of the HPV Vaccine During the Study Period | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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. |
Countries
United States
Participant flow
Recruitment details
Parent and young adult participants were recruited between June of 2014 and September of 2015 from one of five family health care clinics. Enrollment for the study was facilitated by 1) self-referral (passive recruitment), and 2) approach by research assistants (active recruitment).
Pre-assignment details
Eligibility: 1. Parents of an adolescent between the ages of 9-17; OR a young adult patient between the ages of 18-26; 2. Adolescent/young adult has not yet received all three doses of the HPV vaccine; 3. Parent/young adult can read and converse in either English or Spanish
Participants by arm
| Arm | Count |
|---|---|
| Tailored Intervention 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.
Tailored educational materials: 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. | 430 |
| Untailored Intervention Intervention: Untailored educational materials. In this arm, patients will view educational information on the iPad that is not responsive to their baseline questionnaire answers.
Untailored educational materials: 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. | 425 |
| Usual Care Intervention: Survey-only. Participants in the usual care arm will not view any educational materials or complete the baseline survey.
Survey-only: 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. | 439 |
| Total | 1,294 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | No match to vaccination records | 60 | 52 | 41 |
Baseline characteristics
| Characteristic | Tailored Intervention | Untailored Intervention | Usual Care | Total |
|---|---|---|---|---|
| Age, Continuous Adolescents | 12 Years | 12 Years | 12 Years | 12 Years |
| Age, Continuous Young Adults | 22 Years | 23 Years | 23 Years | 22 Years |
| Race/Ethnicity, Customized Other Race Adolescents | 3 Participants | 1 Participants | 1 Participants | 5 Participants |
| Race/Ethnicity, Customized Other Race Young Adults | 3 Participants | 4 Participants | 3 Participants | 10 Participants |
| Race/Ethnicity, Customized Self-Identify Hispanic Adolescents | 266 Participants | 254 Participants | 269 Participants | 789 Participants |
| Race/Ethnicity, Customized Self-Identify Hispanic Young Adults | 123 Participants | 127 Participants | 130 Participants | 380 Participants |
| Race/Ethnicity, Customized White Non-Hispanic Adolescents | 18 Participants | 19 Participants | 17 Participants | 54 Participants |
| Race/Ethnicity, Customized White Non-Hispanic Young Adults | 17 Participants | 20 Participants | 19 Participants | 56 Participants |
| Region of Enrollment United States | 430 participants | 425 participants | 439 participants | 1294 participants |
| Sex/Gender, Customized Female Adolescents | 143 participants | 133 participants | 139 participants | 415 participants |
| Sex/Gender, Customized Female Young Adults | 143 participants | 151 participants | 152 participants | 446 participants |
| Sex/Gender, Customized Male Adolescents | 144 participants | 141 participants | 148 participants | 433 participants |
| Sex/Gender, Customized Male Young Adults | 0 participants | 0 participants | 0 participants | 0 participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 430 | 0 / 425 | 0 / 439 |
| serious Total, serious adverse events | 0 / 430 | 0 / 425 | 0 / 439 |
Outcome results
Primary
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.
Time frame: 16 months
Population: Includes adolescents in the sample who could be matched to vaccination data, who had not received all 3 doses of the HPV vaccine prior to baseline, and who also had 0, 1 or 2 doses of the HPV vaccine at study enrollment and completed the vaccine series during the study period.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Tailored Intervention | Number of Adolescents, Among All Eligible, Who Completed the HPV Vaccine Series During the Study Period | 54 participants |
| Untailored Intervention | Number of Adolescents, Among All Eligible, Who Completed the HPV Vaccine Series During the Study Period | 39 participants |
| Usual Care | Number of Adolescents, Among All Eligible, Who Completed the HPV Vaccine Series During the Study Period | 48 participants |
p-value: 0.39Chi-squared
p-value: 0.51Chi-squared
p-value: 0.49Chi-squared
p-value: 0.14Chi-squared
Primary
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.
Time frame: 16 months
Population: Includes adolescents in the sample who could be matched to vaccination data, who had not received all 3 doses of the HPV vaccine prior to baseline, and who also had 0 doses of the HPV vaccine at study enrollment and completed the vaccine series during the study period.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Tailored Intervention | Number of Adolescents Who Completed the HPV Vaccine Series Among Those Who Initiated the Series During the Study Period | 24 participants |
| Untailored Intervention | Number of Adolescents Who Completed the HPV Vaccine Series Among Those Who Initiated the Series During the Study Period | 13 participants |
| Usual Care | Number of Adolescents Who Completed the HPV Vaccine Series Among Those Who Initiated the Series During the Study Period | 36 participants |
p-value: 0.38Chi-squared
p-value: 0.17Chi-squared
p-value: 0.6Chi-squared
p-value: 0.35Chi-squared
Primary
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.
Time frame: 16 months
Population: Includes adolescents in the sample who could be matched to vaccination data, who had not received all 3 doses of the HPV vaccine prior to baseline, and who also had 1 or 2 doses of the HPV vaccine at study enrollment and completed the vaccine series during the study period.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Tailored Intervention | Number of Adolescents Who Completed the HPV Vaccine Series During the Study Period, Among Those Who Initiated the Series at Study Start | 59 participants |
| Untailored Intervention | Number of Adolescents Who Completed the HPV Vaccine Series During the Study Period, Among Those Who Initiated the Series at Study Start | 41 participants |
| Usual Care | Number of Adolescents Who Completed the HPV Vaccine Series During the Study Period, Among Those Who Initiated the Series at Study Start | 55 participants |
p-value: 0.09Chi-squared
p-value: 0.51Chi-squared
p-value: 0.15Chi-squared
p-value: 0.03Chi-squared
Primary
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.
Time frame: 16 months
Population: Includes adolescents in the sample who could be matched to vaccination data, who had not received all 3 doses of the HPV vaccine prior to baseline, and who also had 0 doses of the HPV vaccine prior to baseline and did not complete the vaccine series during the study period.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Tailored Intervention | Number of Adolescents Who Initiated But Did Not Complete the HPV Vaccine Series During the Study Period | 79 participants |
| Untailored Intervention | Number of Adolescents Who Initiated But Did Not Complete the HPV Vaccine Series During the Study Period | 93 participants |
| Usual Care | Number of Adolescents Who Initiated But Did Not Complete the HPV Vaccine Series During the Study Period | 89 participants |
p-value: 0.38Chi-squared
p-value: 0.17Chi-squared
p-value: 0.6Chi-squared
p-value: 0.35Chi-squared
Primary
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.
Time frame: 16 months
Population: Includes adolescents in the sample who could be matched to vaccination data, who had not received all 3 doses of the HPV vaccine prior to baseline, and who also had 0 doses of the HPV vaccine prior to baseline.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Tailored Intervention | Number of Adolescents Who Initiated the HPV Vaccine Series During the Study Period | 74 participants |
| Untailored Intervention | Number of Adolescents Who Initiated the HPV Vaccine Series During the Study Period | 73 participants |
| Usual Care | Number of Adolescents Who Initiated the HPV Vaccine Series During the Study Period | 75 participants |
p-value: 0.7Chi-squared
p-value: 0.41Chi-squared
p-value: 0.59Chi-squared
p-value: 0.74Chi-squared
Primary
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.
Time frame: 16 months
Population: Includes adolescents in the sample who could be matched to vaccination data and had not received all 3 doses of the HPV vaccine prior to baseline.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Tailored Intervention | Number of Adolescents Who Received Any Dose of the HPV Vaccine During the Study Period | 124 participants |
| Untailored Intervention | Number of Adolescents Who Received Any Dose of the HPV Vaccine During the Study Period | 122 participants |
| Usual Care | Number of Adolescents Who Received Any Dose of the HPV Vaccine During the Study Period | 121 participants |
p-value: 0.87Chi-squared
p-value: 0.62Chi-squared
p-value: 0.81Chi-squared
p-value: 0.76Chi-squared
Primary
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.
Time frame: 16 months
Population: Includes young adults in the sample who could be matched to vaccination data, who had not received all 3 doses of the HPV vaccine prior to baseline, and who also had 0, 1 or 2 doses of the HPV vaccine at study enrollment and completed the vaccine series during the study period.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Tailored Intervention | Number of Young Adults, Among All Eligible, Who Completed the HPV Vaccine Series During the Study Period | 1 participants |
| Untailored Intervention | Number of Young Adults, Among All Eligible, Who Completed the HPV Vaccine Series During the Study Period | 4 participants |
| Usual Care | Number of Young Adults, Among All Eligible, Who Completed the HPV Vaccine Series During the Study Period | 2 participants |
p-value: 0.59Fisher Exact
p-value: 0.52Fisher Exact
p-value: 0.71Fisher Exact
p-value: 0.34Fisher Exact
Primary
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.
Time frame: 16 months
Population: Includes young adults in the sample who could be matched to vaccination data, who had not received all 3 doses of the HPV vaccine prior to baseline, and who also had 0 doses of the HPV vaccine at study enrollment and completed the vaccine series during the study period.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Tailored Intervention | Number of Young Adults Who Completed the HPV Vaccine Series Among Those Who Initiated the Series During the Study Period | 2 participants |
| Untailored Intervention | Number of Young Adults Who Completed the HPV Vaccine Series Among Those Who Initiated the Series During the Study Period | 0 participants |
| Usual Care | Number of Young Adults Who Completed the HPV Vaccine Series Among Those Who Initiated the Series During the Study Period | 5 participants |
p-value: 0.37Fisher Exact
p-value: 0.23Fisher Exact
p-value: 0.25Fisher Exact
p-value: 0.7Fisher Exact
Primary
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.
Time frame: 16 months
Population: Includes young adults in the sample who could be matched to vaccination data, who had not received all 3 doses of the HPV vaccine prior to baseline, and who also had 1 or 2 doses of the HPV vaccine at study enrollment and completed the vaccine series during the study period.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Tailored Intervention | Number of Young Adults Who Completed the HPV Vaccine Series During the Study Period, Among Those Who Initiated the Series at Study Start | 0 participants |
| Untailored Intervention | Number of Young Adults Who Completed the HPV Vaccine Series During the Study Period, Among Those Who Initiated the Series at Study Start | 4 participants |
| Usual Care | Number of Young Adults Who Completed the HPV Vaccine Series During the Study Period, Among Those Who Initiated the Series at Study Start | 0 participants |
p-value: 0.16Fisher Exact
p-value: 0.15Fisher Exact
p-value: 0.98Fisher Exact
p-value: 0.34Fisher Exact
Primary
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.
Time frame: 16 months
Population: Includes young adults in the sample who could be matched to vaccination data, who had not received all 3 doses of the HPV vaccine prior to baseline, and who also had 0 doses of the HPV vaccine prior to baseline and did not complete the vaccine series during the study period.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Tailored Intervention | Number of Young Adults Who Initiated But Did Not Complete the HPV Vaccine Series During the Study Period | 9 participants |
| Untailored Intervention | Number of Young Adults Who Initiated But Did Not Complete the HPV Vaccine Series During the Study Period | 12 participants |
| Usual Care | Number of Young Adults Who Initiated But Did Not Complete the HPV Vaccine Series During the Study Period | 6 participants |
p-value: 0.37Fisher Exact
p-value: 0.23Fisher Exact
p-value: 0.25Fisher Exact
p-value: 0.7Fisher Exact
Primary
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.
Time frame: 16 months
Population: Includes young adults in the sample who could be matched to vaccination data, who had not received all 3 doses of the HPV vaccine prior to baseline, and who also had 0 doses of the HPV vaccine prior to baseline.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Tailored Intervention | Number of Young Adults Who Initiated the HPV Vaccine Series During the Study Period | 7 participants |
| Untailored Intervention | Number of Young Adults Who Initiated the HPV Vaccine Series During the Study Period | 4 participants |
| Usual Care | Number of Young Adults Who Initiated the HPV Vaccine Series During the Study Period | 3 participants |
p-value: 0.35Fisher Exact
p-value: 1Fisher Exact
p-value: 0.23Fisher Exact
p-value: 0.23Fisher Exact
Primary
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.
Time frame: 16 months
Population: Includes young adults in the sample who could be matched to vaccination data and had not received all 3 doses of the HPV vaccine prior to baseline.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Tailored Intervention | Number of Young Adults Who Received Any Dose of the HPV Vaccine During the Study Period | 8 participants |
| Untailored Intervention | Number of Young Adults Who Received Any Dose of the HPV Vaccine During the Study Period | 9 participants |
| Usual Care | Number of Young Adults Who Received Any Dose of the HPV Vaccine During the Study Period | 3 participants |
p-value: 0.36Fisher Exact
p-value: 0.18Fisher Exact
p-value: 0.22Fisher Exact
p-value: 0.88Fisher Exact