HPV Vaccination Decision Quality
Conditions
Keywords
HPV vaccination, Vaccination decision-making, Tailored health messaging, Barriers to vaccination, Attitudes
Brief 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. 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.
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.
BEHAVIORALUsual care
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 2. A young adult patient between the ages of 18-26 3. Adolescent/young adult who has not yet received all three doses of the HPV vaccine. 4. Parent/young adult who 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 |
|---|---|
| Percent of Participants - Who Agreed They Felt Sure About the Best Choice Regarding the HPV Vaccine at Post-intervention | 1 day |
| Percent of Participants Who Agreed They Knew Enough About the Risks and Benefits of the HPV Vaccine at Post-intervention | 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 | 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 | 1 day |
| Percent of Participants Who Agreed They Felt Sure About the Best Choice Regarding the HPV Vaccine at Follow-up | 2 Months |
| Percent of Participants Who Agreed They Knew Enough About the Risks and Benefits of the HPV Vaccine at Follow-up | 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 | 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 | 2 Months |
Countries
United States
Participant flow
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. | 387 |
| 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. | 383 |
| Usual Care 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.
Usual care: 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. | 435 |
| Total | 1,205 |
Baseline characteristics
| Characteristic | Tailored Intervention | Untailored Intervention | Usual Care | Total |
|---|---|---|---|---|
| Age, Customized Age | 32.01 Years | 31.18 Years | 31.60 Years | 31.60 Years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 349 Participants | 342 Participants | 392 Participants | 1083 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 36 Participants | 41 Participants | 40 Participants | 117 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 2 Participants | 0 Participants | 3 Participants | 5 Participants |
| Race/Ethnicity, Customized Race African American | 4 Participants | 1 Participants | 2 Participants | 7 Participants |
| Race/Ethnicity, Customized Race American Indian | 6 Participants | 6 Participants | 6 Participants | 18 Participants |
| Race/Ethnicity, Customized Race Asian | 2 Participants | 1 Participants | 0 Participants | 3 Participants |
| Race/Ethnicity, Customized Race Other | 285 Participants | 277 Participants | 319 Participants | 881 Participants |
| Race/Ethnicity, Customized Race Unknown | 2 Participants | 0 Participants | 3 Participants | 5 Participants |
| Race/Ethnicity, Customized Race White | 88 Participants | 98 Participants | 105 Participants | 291 Participants |
| Sex: Female, Male Female | 386 Participants | 382 Participants | 434 Participants | 1202 Participants |
| Sex: Female, Male Male | 1 Participants | 1 Participants | 1 Participants | 3 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 / 387 | 0 / 383 | 0 / 435 |
| serious Total, serious adverse events | 0 / 387 | 0 / 383 | 0 / 435 |
Outcome results
Primary
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
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Tailored Intervention | Percent of Participants Who Agreed They Felt Clear About Which Risks and Benefits of the HPV Vaccine Mattered Most to Them at Follow-up | 78 Percent of participants |
| Untailored Intervention | Percent of Participants Who Agreed They Felt Clear About Which Risks and Benefits of the HPV Vaccine Mattered Most to Them at Follow-up | 78 Percent of participants |
| Usual Care | Percent of Participants Who Agreed They Felt Clear About Which Risks and Benefits of the HPV Vaccine Mattered Most to Them at Follow-up | 65 Percent of participants |
p-value: 0.0056Chi-squared
Primary
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
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Tailored Intervention | Percent of Participants Who Agreed They Felt Clear About Which Risks and Benefits of the HPV Vaccine Mattered Most to Them at Post-intervention | 85 Percent of participants |
| Untailored Intervention | Percent of Participants Who Agreed They Felt Clear About Which Risks and Benefits of the HPV Vaccine Mattered Most to Them at Post-intervention | 87 Percent of participants |
| Usual Care | Percent of Participants Who Agreed They Felt Clear About Which Risks and Benefits of the HPV Vaccine Mattered Most to Them at Post-intervention | 71 Percent of participants |
p-value: 0.001Chi-squared
Primary
Percent of Participants Who Agreed They Felt Sure About the Best Choice Regarding the HPV Vaccine at Follow-up
Time frame: 2 Months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Tailored Intervention | Percent of Participants Who Agreed They Felt Sure About the Best Choice Regarding the HPV Vaccine at Follow-up | 96 percent of participants |
| Untailored Intervention | Percent of Participants Who Agreed They Felt Sure About the Best Choice Regarding the HPV Vaccine at Follow-up | 95 percent of participants |
| Usual Care | Percent of Participants Who Agreed They Felt Sure About the Best Choice Regarding the HPV Vaccine at Follow-up | 94 percent of participants |
p-value: 0.58Chi-squared
Primary
Percent of Participants - Who Agreed They Felt Sure About the Best Choice Regarding the HPV Vaccine at Post-intervention
Time frame: 1 day
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Tailored Intervention | Percent of Participants - Who Agreed They Felt Sure About the Best Choice Regarding the HPV Vaccine at Post-intervention | 94 Percent of participants |
| Untailored Intervention | Percent of Participants - Who Agreed They Felt Sure About the Best Choice Regarding the HPV Vaccine at Post-intervention | 95 Percent of participants |
| Usual Care | Percent of Participants - Who Agreed They Felt Sure About the Best Choice Regarding the HPV Vaccine at Post-intervention | 89 Percent of participants |
p-value: 0.069Chi-squared
Primary
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
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Tailored Intervention | Percent of Participants Who Agreed They Felt They Had Enough Support to Make a Decision About Getting the HPV Vaccine at Follow-up | 85 Percent of participants |
| Untailored Intervention | Percent of Participants Who Agreed They Felt They Had Enough Support to Make a Decision About Getting the HPV Vaccine at Follow-up | 84 Percent of participants |
| Usual Care | Percent of Participants Who Agreed They Felt They Had Enough Support to Make a Decision About Getting the HPV Vaccine at Follow-up | 77 Percent of participants |
p-value: 0.21Chi-squared
Primary
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
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Tailored Intervention | Percent of Participants Who Agreed They Felt They Had Enough Support to Make a Decision About Getting the HPV Vaccine at Post-intervention | 86 Percent of participants |
| Untailored Intervention | Percent of Participants Who Agreed They Felt They Had Enough Support to Make a Decision About Getting the HPV Vaccine at Post-intervention | 87 Percent of participants |
| Usual Care | Percent of Participants Who Agreed They Felt They Had Enough Support to Make a Decision About Getting the HPV Vaccine at Post-intervention | 86 Percent of participants |
p-value: 0.895Chi-squared
Primary
Percent of Participants Who Agreed They Knew Enough About the Risks and Benefits of the HPV Vaccine at Follow-up
Time frame: 2 Months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Tailored Intervention | Percent of Participants Who Agreed They Knew Enough About the Risks and Benefits of the HPV Vaccine at Follow-up | 76 Percent of participants |
| Untailored Intervention | Percent of Participants Who Agreed They Knew Enough About the Risks and Benefits of the HPV Vaccine at Follow-up | 73 Percent of participants |
| Usual Care | Percent of Participants Who Agreed They Knew Enough About the Risks and Benefits of the HPV Vaccine at Follow-up | 60 Percent of participants |
p-value: 0.0015Chi-squared
Primary
Percent of Participants Who Agreed They Knew Enough About the Risks and Benefits of the HPV Vaccine at Post-intervention
Time frame: 1 day
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Tailored Intervention | Percent of Participants Who Agreed They Knew Enough About the Risks and Benefits of the HPV Vaccine at Post-intervention | 75 Percent of participants |
| Untailored Intervention | Percent of Participants Who Agreed They Knew Enough About the Risks and Benefits of the HPV Vaccine at Post-intervention | 77 Percent of participants |
| Usual Care | Percent of Participants Who Agreed They Knew Enough About the Risks and Benefits of the HPV Vaccine at Post-intervention | 69 Percent of participants |
p-value: 0.303Chi-squared