The HPV 9-10 Trial: Early Initiation of HPV Vaccination

NCT ID: NCT04722822

Last Updated: 2025-10-21

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 3100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-12-23
• Study Completion Date: 2027-04-01

Brief Summary

Every year, thousands of Americans die from cancers related to human papillomavirus (HPV). The vast majority of those deaths could be prevented with a safe and effective vaccine, yet many parents choose not have their children vaccinated when it is recommended at age 11 or 12. In this study, we will examine in a randomized trial whether earlier initiation of the vaccine at age 9-10 years will result in less parental refusal and higher rates of full vaccination at younger ages, before early sexual activity begins.

Detailed Description

The burden of Human Papillomavirus (HPV)-related disease in the US is substantial. A safe and effective vaccine has been available for >10 years, yet the current rate of completion for the HPV series is only 49% for U.S.13-17 year olds. The Advisory Committee on Immunization Practices (ACIP) recommends routine HPV vaccination at age 11-12 years (yrs), but states that the vaccine "can be given starting at age 9 years." Currently, the majority of pediatricians begin recommending the vaccine at ages 11-12 yrs, however, a recent retrospective study showed that on-time completion rates for HPV vaccine were much higher when the vaccine series was initiated at ages 9-10 compared to ages 11-12 (adjusted odds ratio, 12.8).

HPV vaccine should be given prior to sexual activity which occurs earlier than 13 yrs for many teens. There are compelling reasons to think that earlier initiation of vaccination at ages 9-10 might result in higher rates of acceptance of the vaccine and earlier series completion. First, many parents refuse HPV vaccine because they have concerns that vaccination could result in higher promiscuity in early adolescents if the vaccine is discussed in the context of sexuality. Initiation at 9-10 yrs, when few providers discuss sex, could put the focus squarely on cancer prevention, decreasing vaccine refusal. Second, three vaccines are recommended at the 11-12 yr visit, but many parents/adolescents are unwilling to receive all three at one visit. When one of the vaccines is delayed, it is almost always HPV vaccine. Initiation at 9-10 yrs when no other vaccines are given could result in less deferral of vaccination to mid-adolescence and higher rates of vaccination prior to early sexual activity. Finally, initiation at age 9-10 years has been shown to be feasible and, in an observational study, to result in higher rates of on-time series completion.

Therefore, we plan to test the effectiveness of shifting initiation of HPV vaccine to 9-10 yrs in a randomized pragmatic trial. Our Specific Aims are to: SA 1: Recruit practices in two states (Colorado and California), randomize in a balanced fashion to recommending HPV vaccine at ages 9-10 yrs or 11-12 yrs and provide standardized training to both arms. SA 2: Conduct a trial to assess effectiveness of early initiation on the primary outcome of age at HPV series completion; secondary outcomes will examine HPV series completion by age 13 and age at HPV series initiation. SA 3: Examine the effect of earlier initiation on length of time for HPV vaccine discussions and on parent/provider communication about HPV vaccine via audio-taping of visits, audio-elicitation interviews with parents and structured interviews with providers and clinic staff.

If earlier HPV initiation is successful in promoting higher HPV series completion by 13 yrs, this intervention could be rapidly disseminated and would have the potential to prevent thousands of cases of HPV-related cancers, their attendant morbidity and mortality as well as the costs of screening, diagnosis and treatment for these cancers yearly.

Conditions

HPV

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: SINGLE

Study Groups

Patients attributed to practices recommending HPV at age 9-10 years of age

Patients attributed to practices routinely recommending HPV vaccine starting at 9-10 years of age.

Group Type: EXPERIMENTAL

(Intervention) Recommending HPV vaccine for patients 9-10 years of age

Intervention Type: BEHAVIORAL

Practices are randomized to receive training on how to recommend HPV vaccine, including both standardized communication strategies and strategies for switching from 11-12 years to 9-10 years including: challenges with 11-12 strategy, long-term immunity, success of other practices and tips to help standardize to age 9-10. Trainings will be a combination of online and in-person or virtual. Annual trainings will be offered and providers will receive Maintenance of Certification credits (MOC) for participating. Providers will routinely recommend HPV starting at age 9 for all patients -- which is already approved for this vaccine but is not routinely recommended at age 9 years.

Patients attributed to practices recommending HPV at age 11-12 years of age

Patients attributed to practices routinely recommending HPV vaccine starting at 11-12 years of age.

Group Type: ACTIVE_COMPARATOR

(Control) Recommending HPV vaccine for patients 11-12 years of age

Intervention Type: BEHAVIORAL

Control practices will receive a training on standardized communication for HPV vaccine including: using strong recommendations, using presumptive recommendation, providing specific phrases to use with parents, answering common questions and, HPV vaccine as a cancer prevention. Annual trainings will be offered and providers will receive professional development credit (MOC).

Interventions

(Intervention) Recommending HPV vaccine for patients 9-10 years of age

Practices are randomized to receive training on how to recommend HPV vaccine, including both standardized communication strategies and strategies for switching from 11-12 years to 9-10 years including: challenges with 11-12 strategy, long-term immunity, success of other practices and tips to help standardize to age 9-10. Trainings will be a combination of online and in-person or virtual. Annual trainings will be offered and providers will receive Maintenance of Certification credits (MOC) for participating. Providers will routinely recommend HPV starting at age 9 for all patients -- which is already approved for this vaccine but is not routinely recommended at age 9 years.

Intervention Type: BEHAVIORAL

(Control) Recommending HPV vaccine for patients 11-12 years of age

Control practices will receive a training on standardized communication for HPV vaccine including: using strong recommendations, using presumptive recommendation, providing specific phrases to use with parents, answering common questions and, HPV vaccine as a cancer prevention. Annual trainings will be offered and providers will receive professional development credit (MOC).

Intervention Type: BEHAVIORAL

Eligibility Criteria

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.

Patient Eligibility Criteria

• Patient age 9-13 years
• Seen at a participating practice in the last 3 years
• Due for at least 1 dose of HPV vaccine

• Minimum Eligible Age: 9 Years
• Maximum Eligible Age: 13 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institutes of Health (NIH)

NIH

Sponsor Role: collaborator

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

University of Colorado, Denver

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Allison Kempe, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

University of Colorado, Denver

Locations

University of California at Los Angeles

Los Angeles, California, United States

Site Status: RECRUITING

University of Colorado

Aurora, Colorado, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Alison Saville, MPH, MSW

Role: CONTACT

alison.saville@cuanschutz.edu

720-257-4406

Facility Contacts

Emma Clark

Role: primary

ejclark@mednet.ucla.edu

ALISON W SAVILLE, MPH, MSW

Role: primary

alison.saville@cuanschutz.edu

7202574406

Provided Documents

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

1R01CA240649-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

19-3006.cc

Identifier Type: -

Identifier Source: org_study_id