Results Summary
What was the research about?
Human papillomavirus (HPV) is a sexually transmitted infection that can cause cancer or other health problems. The HPV vaccine protects against this virus. The HPV vaccine requires two or three doses over several months.
HPV vaccination rates in the United States are low. Latinos get HPV infections as often as other racial or ethnic groups. But Latinos are at higher risk for getting cancer and other health problems from HPV.
The research team worked with Latino community members to design a customized website for Latinos about the HPV vaccine. The team wanted to learn if more Latino young adults, ages 18 to 26, and youths, ages 11 to 17, would get the HPV vaccine after they—or in the case of the youths, their parents—viewed this website. The team compared these youths’ and young adults’ vaccination rates with those of young adults and youths who only had a usual doctor visit or looked at a vaccine website that was not created for Latinos.
What were the results?
Compared with a usual doctor visit, neither viewing the customized website nor viewing general websites led to more youths completing the HPV vaccine series. Very few young adults in any group got any doses of the HPV vaccine.
Compared with a usual doctor visit, both websites helped young adults and parents of youths learn more about the risks and benefits of the HPV vaccine.
Who was in the study?
The study included 498 Latino parents of youths and 308 Latino young adults from central Colorado. All young adults were female, and 49 percent of youths were female.
What did the research team do?
The research team asked a group of Latino young adults and parents of Latino youths for feedback on a website that gave information on the HPV vaccine. The group helped customize the content and look of the website for Latino users.
Next, the team assigned young adults and parents of youths to one of three groups by chance. One group of Latino young adults and parents of youths saw the customized website. Another group saw a general website about the HPV vaccine. The third group only had their usual doctor visit.
Using a survey, the team asked the young adults and parents how viewing the website affected their decision about getting the HPV vaccine. The young adults and parents of youths who didn’t see either website answered questions about HPV decision making after their doctor visits.
At the end of the study, 15 months after participants looked at the websites or got usual care, the research team looked at the young adults’ and youths’ vaccination records. The young adults and parents also completed a follow-up survey on HPV vaccine decision making.
What were the limits of the study?
The research team was unable to find vaccination records for many patients in the study. Without those records, the team did not know whether those patients got the vaccine. Young adults and parents reviewed the websites in front of people from the research team. They may have rated the websites higher than if they had reviewed the sites on their own. No males enrolled in the study’s young adult group.
The websites didn’t increase how many youths and young adults got the HPV vaccine. Future studies could find ways to increase the use of HPV vaccination.
How can people use the results?
Although the websites didn’t increase vaccination rates, young adults and parents of youths who reviewed the websites learned about the risks and benefits of the HPV vaccine. Healthcare providers may consider using these websites to help Latino patients learn about the HPV vaccine.
Professional Abstract
Objective
To create a website that provides culturally tailored information about human papillomavirus (HPV) for Latinos and to assess if the website affects HPV vaccine decisions and actions among Latino adolescents and young adults compared with an untailored website and usual care.
Study Design
Design Element | Description |
---|---|
Design | Randomized controlled trial |
Population | 308 Latino young adults and 498 Latino parents of adolescents |
Interventions/ Comparators |
|
Outcomes |
Primary: HPV vaccine use Secondary: vaccination decision quality, vaccination timing |
Timeframe | 15-month follow-up for primary outcome |
The research team conducted a three-group randomized controlled trial to test the effect of a culturally tailored website, called CHICOs, on HPV vaccination among Latinos. One group viewed CHICOs, one group viewed an untailored website, and one group received usual care. CHICOs, which stands for Combatting HPV Infection and Cancer, is a modified version of Youth VaxScene, a website designed to improve adolescent vaccine uptake. The team tailored the content and appearance of CHICOs for Latinos based on feedback from focus groups and a yearlong iterative feedback process with a community advisory board composed of Latino young adults and parents of Latino adolescents.
The research team based the untailored website on the Centers for Disease Control and Prevention’s Vaccine Information Statement (VIS) for HPV. Usual care refers to providers’ usual practice regarding HPV vaccine education for patients. Interviews before the study indicated that usual care consisted of providing a paper version of the VIS for HPV, discussing the vaccine, or not discussing the vaccine.
The study outcomes were HPV vaccine use, vaccination decision quality, and vaccination timing.
The study included 308 Latino young adults ages 18 to 26 and 498 Latino parents of adolescents ages 11 to 17. Participants lived in central Colorado. All young adults in the study were female, and 49% of the adolescents were female. The study took place in family healthcare clinics that primarily serve Latino patients with low incomes.
Participants in the CHICOs and untailored groups responded to questions about their HPV vaccination intentions before and after viewing the websites. These participants also completed a four-question survey on HPV vaccination decision making after viewing the websites. Participants in the usual-care group took the postintervention survey after completing doctor visits.
After 15 months, the research team collected data on participant vaccination status using health records and a statewide vaccination registry. Participants also completed a follow-up survey on HPV decision making.
Results
HPV vaccine utilization. The study found no difference in HPV vaccination among the three groups. Among all adolescents in the study, 42–45% received at least one needed dose of the vaccine during the study. Among the young adults in the study, only 3–6% received at least one dose of the vaccine during the study. Subgroup analyses were limited due to the low vaccination rates for young adults.
Both CHICOs and the untailored intervention increased participants’ intentions to get the HPV vaccine (p<0.0001); the increase was about the same in the two groups.
HPV vaccination decision quality. Parents and young adults in the CHICOs and untailored groups understood the benefits and risks of the vaccine better than parents and young adults in the usual-care group immediately after the intervention (p=0.001) and at the 15-month follow-up (p=0.006). In addition, at the 15-month follow-up, more parents and young adults in the CHICOs group said they knew the benefits and risks of getting the vaccine than did parents and young adults in the untailored or usual-care groups (p=0.002).
Vaccination timing. The study did not find statistically significant differences in vaccination timing.
Limitations
The research team was unable to link a high proportion of study participant names with electronic health records or the state vaccination database because of name discrepancies and other problems in initial enrollment. The team used imputation to account for the missing data, which led to high uncertainty in the study analyses. Reviewing the websites with the research team present may have made participants more likely to give the websites high ratings or masked any usability issues. In addition, no males chose to enroll in the young adult group.
Conclusions and Relevance
Among Latino young adults and adolescents, the CHICOs website did not increase HPV vaccination series completion compared with the untailored intervention or usual care. Both CHICOs and the untailored intervention did increase the intent to get the HPV vaccine among young adults and parents of adolescents.
Future Research Needs
Future studies could continue to examine how to increase HPV vaccination rates among Latino youths.
Final Research Report
View this project's final research report.
Journal Citations
Results of This Project
Related Journal Citations
Peer-Review Summary
Peer review of PCORI-funded research helps make sure the report presents complete, balanced, and useful information about the research. It also confirms that the research has followed PCORI’s Methodology Standards. During peer review, experts who were not members of the research team read a draft report of the research. These experts may include a scientist focused on the research topic, a specialist in research methods, a patient or caregiver, and a healthcare professional. Reviewers do not have conflicts of interest with the study.
The peer reviewers point out where the draft report may need revision. For example, they may suggest ways to improve how the research team analyzed its results or reported its conclusions. Learn more about PCORI’s peer-review process here.
In response to peer review, Dempsey made changes including
- Conducting an intent-to-treat analysis with imputed missing data so that the results included data for all randomized participants
- Including a participant flow diagram per CONSORT guidelines
- Expanding the description of engagement with patients and stakeholders throughout this study
- Revising the report conclusions to de-emphasize the significant changes within treatment groups, and acknowledge the lack of significant difference between the two treatment groups, which was the primary aim
- Clarifying that the age stratification presented in the report was prespecified, and also correcting information in ClinicalTrials.gov to reflect the changes made to the report after peer review