HPVNCT04722822
The HPV 9-10 Trial: Early Initiation of HPV Vaccination
A study testing (Intervention) Recommending HPV vaccine for patients 9-10 years of age in people with HPV, run by University of Colorado, Denver at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 9 to 13 years
- Conditions the study is for
- HPV
- What is being tested?
- (Intervention) Recommending HPV vaccine for patients 9-10 years of age
- Type of treatment
- Vaccines, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62,272 participants
- Where
- 2 sitesUnited States
- Study dates
- 4 Oct 2021to 1 Jun 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 9 to 13 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Colorado
Aurora, Colorado, 80045
University of California at Los Angeles
Los Angeles, California, 90095
About this study
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.
Read the 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
- Being tested
- (Intervention) Recommending HPV vaccine for patients 9-10 years of age, (Control) Recommending HPV vaccine for patients 11-12 years of age
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
(Intervention) Recommending HPV vaccine for patients 9-10 years of ageBehavioural
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.
(Control) Recommending HPV vaccine for patients 11-12 years of ageBehavioural
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).
| Study group | Role | What they receive |
|---|---|---|
| Patients attributed to practices recommending HPV at age 9-10 years of age | Experimental | Patients attributed to practices routinely recommending HPV vaccine starting at 9-10 years of age. Receives: Behavioral: (Intervention) Recommending HPV vaccine for patients 9-10 years of age |
| Patients attributed to practices recommending HPV at age 11-12 years of age | Active comparator | Patients attributed to practices routinely recommending HPV vaccine starting at 11-12 years of age. Receives: Behavioral: (Control) Recommending HPV vaccine for patients 11-12 years of age |
What is being measured
The primary outcome is the main question the study is designed to answer.
Age at completion of two dose HPV series
The primary outcome will be age at completion of the two dose HPV series. This is a time-to-event outcome, with the event of interest being vaccine completion. Comparisons between the intervention practices and control practices will be made. Practice electronic health records will be used to assess this outcome.
Measured: post-intervention assessed in year 5 of study, year 4 of trial
Secondary outcomes (2)
HPV completion by age 13 years
Secondary outcome will be HPV series completion rates by age 13. This will be a binary outcome. Comparisons between the intervention practices and control practices will be made. Practice electronic health records will be used to assess this outcome.
Measured: post-intervention assessed in year 5 of study, year 4 of trial
Age at initiation of the HPV series
This is a time-to-event outcome, with the event of interest being vaccine initiation. Comparisons between the intervention practices and control practices will be made. Practice electronic health records will be used to assess this outcome.
Measured: post-intervention assessed in year 5 of study, year 4 of trial
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2021
- Study start4 Oct 2021
- Primary completion30 Apr 2026
- Study completion1 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HPVStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 62,272 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Allison Kempe, MD, MPH, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04722822
- Sponsor's protocol ID
- 19-3006.cc
- Other IDs
- 1R01CA240649-01A1
- Status last verified
- Jul 2026
- First submitted
- 20 Jan 2021
- Last updated
- 16 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The study team guarantees that any and all data collected as part of this project will be released in accordance with standard data sharing policies and procedures to validate research findings if requested. Data will be made available in a timely manner to the broader scientific community, and will be complete, and as accurate as possible. All data released will be de-identified, with no information that could be linked to any study subjects, or participating study practices in order to ensure the confidentiality of all subjects and practices. If necessary, a data use agreement will be established.
Publications
Kempe A, Vangala S, Albertin C, O'Leary S, Beaty B, Saville AW, Gurfinkel D, Humiston S, Nagel S, Singh J, Golden C, Woo H, Clark E, Szilagyi PG. Effect of HPV Vaccine Introduction at 9-10 years: A Randomized Clinical Trial. medRxiv [Preprint]. 2026 Sep 27:2026.09.24.26363898. doi: 10.64898/2026.09.24.26363898.
PubMed 42818472
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The HPV 9-10 Trial: Early Initiation of HPV Vaccination
- ClinicalTrials.gov ID
- NCT04722822
- Acronym / sponsor ID
- 19-3006.cc
- Conditions
- HPV
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62,272 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Cancer Institute (NCI)
- Study start
- 4 Oct 2021 (actual)
- Primary completion
- 30 Apr 2026 (actual)
- Study completion
- 1 Jun 2026 (actual)
- First posted
- 25 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients attributed to practices recommending HPV at age 9-10 years of age | Experimental | Behavioral: (Intervention) Recommending HPV vaccine for patients 9-10 years of agePatients attributed to practices routinely recommending HPV vaccine starting at 9-10 years of age. |
| Patients attributed to practices recommending HPV at age 11-12 years of age | Active comparator | Behavioral: (Control) Recommending HPV vaccine for patients 11-12 years of agePatients attributed to practices routinely recommending HPV vaccine starting at 11-12 years of age. |
Who may qualify
- Ages
- 9 to 13 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| (Intervention) Recommending HPV vaccine for patients 9-10 years of agePractices 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. | Behavioural | Patients attributed to practices recommending HPV at age 9-10 years of age |
| (Control) Recommending HPV vaccine for patients 11-12 years of ageControl 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). | Behavioural | Patients attributed to practices recommending HPV at age 11-12 years of age |
Primary outcome
Age at completion of two dose HPV series
Time frame: post-intervention assessed in year 5 of study, year 4 of trial
The primary outcome will be age at completion of the two dose HPV series. This is a time-to-event outcome, with the event of interest being vaccine completion. Comparisons between the intervention practices and control practices will be made. Practice electronic health records will be used to assess this outcome.
2 secondary outcomes
HPV completion by age 13 years
Time frame: post-intervention assessed in year 5 of study, year 4 of trial
Age at initiation of the HPV series
Time frame: post-intervention assessed in year 5 of study, year 4 of trial
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2026.
- Derived from this study: PubMed 42818472Kempe A, Vangala S, Albertin C, O'Leary S, Beaty B, Saville AW, Gurfinkel D, Humiston S, Nagel S, Singh J, Golden C, Woo H, Clark E, Szilagyi PG. Effect of HPV Vaccine Introduction at 9-10 years: A Randomized Clinical Trial. medRxiv [Preprint]. 2026 Sep 27:2026.09.24.26363898. doi: 10.64898/2026.09.24.26363898.
- Individual participant dataSharing planned: Yes. The study team guarantees that any and all data collected as part of this project will be released in accordance with standard data sharing policies and procedures to validate research findings if requested. Data will be made available in a timely manner to the broader scientific community, and will be complete, and as accurate as possible. All data released will be de-identified, with no information that could be linked to any study subjects, or participating study practices in order to ensure the confidentiality of all subjects and practices. If necessary, a data use agreement will be established.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Allison Kempe, MD, MPH principal investigator
University of Colorado, Denver
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing (Intervention) Recommending HPV vaccine for patients 9-10 years of age in people with HPV, run by University of Colorado, Denver at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Age at completion of two dose HPV series (time frame: post-intervention assessed in year 5 of study, year 4 of trial). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04722822, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2026; AzTrials last refreshed its copy on 8 Nov 2026.