Early HPV vaccination for children aged 9-10
The HPV 9-10 Trial: Early Initiation of HPV Vaccination
This study tests if giving the HPV vaccine to kids at ages 9-10 can help more children get vaccinated compared to starting at ages 11-12.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 660 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Colorado, Denver Academic / other |
| Locations | 2 sites (Los Angeles, California and 1 other locations) |
| Trial ID | NCT04722822 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates whether initiating the HPV vaccination at ages 9-10 can lead to higher vaccination rates compared to the current recommendation of starting at ages 11-12. The study will randomly assign practices in Metro Denver and Metro Los Angeles to either recommend the vaccine at the earlier age or the standard age. By focusing on cancer prevention rather than sexual activity, the trial aims to reduce parental refusal rates and improve completion of the vaccination series before adolescents become sexually active. The study will involve practices that do not currently recommend early vaccination and have a sufficient number of eligible patients.
Who should consider this trial
Good fit: Ideal candidates for this study are children aged 9-13 years whose healthcare practices do not currently recommend HPV vaccination at ages 9-10.
Not a fit: Patients who are already receiving HPV vaccinations at ages 9-10 or those whose practices routinely recommend this vaccination will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly increase HPV vaccination rates and reduce the incidence of HPV-related cancers.
How similar studies have performed: Previous studies have indicated that earlier initiation of the HPV vaccine can lead to higher completion rates, suggesting that this approach may be effective.
Eligibility criteria
Show full inclusion / exclusion criteria
Practices: Inclusion Criteria: * Practices in Metro Denver, Colorado and Metro Los Angeles, California (specifically UCLA medical clinics and clinics affiliated with Children's Hospital of Orange County) * Practices that have at least 60% of providers agree to participate * Practices do not currently recommend HPV at 9-10 years. * Practice must have at least 100 eligible patients age 9-13 years Exclusion Criteria: * Practices with less than 100 eligible patients age 9-13 years * Practices currently routinely recommend HPV vaccine at 9-10 years. * Practices where less than 60% of providers agree to participate in the study. Patients whose data will be used to assess the outcomes of the intervention will be age 9-13 years old.
Where this trial is running
Los Angeles, California and 1 other locations
- University of California at Los Angeles — Los Angeles, California, United States (Recruiting)
- University of Colorado — Aurora, Colorado, United States (Recruiting)
Study contacts
- Principal investigator: Allison Kempe, MD, MPH — University of Colorado, Denver
- Study coordinator: Alison Saville, MPH, MSW
- Email: alison.saville@cuanschutz.edu
- Phone: 720-257-4406
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.