Papillomavirus VaccinesNCT04469569
Provider-Focused Intervention for Maximizing HPV Vaccine Uptake in Young Cancer Survivors
A study testing HPV-PROTECT in people with Papillomavirus Vaccines, run by University of Alabama at Birmingham at 6 sites in United States.
Trial summary
The focus of this research is on increasing the uptake of the human papillomavirus (HPV) vaccine in young cancer survivors, a vulnerable population at high risk for developing new cancers (such as cervical and anal cancer) caused by persistent HPV infection. Read more about this study
- Who is it for?
- Ages 9 years and older
- Conditions the study is for
- Papillomavirus Vaccines
- What is being tested?
- HPV-PROTECT
- Type of treatment
- Vaccines, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8,120 participants
- Where
- 6 sitesUnited States
- Study dates
- 1 Feb 2021to 15 Dec 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- HEALTHCARE PROVIDERS (ONCOLOGISTS, ADVANCED PRACTICE PROVIDERS)
- ≥18y of age
- Care for cancer survivors seen in the targeted clinic who are age 9-17y, ≥1y off-therapy, and reside in the state where clinic is located
- Licensed to order vaccines
- Willing to complete surveys and/or interviews
- CHILDHOOD CANCER SURVIVORS
Show all 10Show fewer
- 9-17y of age
- ≥1y following completion of cancer therapy
- Reside in the state where clinic is located
- Receive follow-up care (in person or via telehealth) at the participating sites
Who cannot join
- N/A
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Emory University
Atlanta, Georgia, 30322
University of Alabama at Birmingham
Birmingham, Alabama, 35233
Baylor College of Medicine
Houston, Texas, 77030-3411
University of Minnesota
Minneapolis, Minnesota, 55455-0341
Oregon Health and Science University
Portland, Oregon, 97239-3098
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157-0001
About this study
Official title: Implementation of a Provider-Focused Intervention for Maximizing HPV Vaccine Uptake in Young Cancer Survivors Receiving Follow-Up Care in Pediatric Oncology Practices: A Cluster-Randomized Trial
The focus of this research is on increasing the uptake of the human papillomavirus (HPV) vaccine in young cancer survivors, a vulnerable population at high risk for developing new cancers (such as cervical and anal cancer) caused by persistent HPV infection. An effective vaccine exists that can prevent these cancers, but HPV vaccine uptake is low among young cancer survivors. This research will evaluate the effectiveness and implementation of an evidence-based intervention, adapted for use by healthcare providers in pediatric oncology clinics, to increase the uptake of HPV vaccine among young cancer survivors 9-17 years of age. Results of this research will provide important information that can be used to implement new strategies to increase the uptake of the HPV vaccine among young cancer survivors.
Read the detailed description
Childhood cancer survivors are at high risk for developing new cancers (such as cervical and anal cancer) caused by persistent infection with the human papillomavirus (HPV). Compared with the age- and sex-matched general population, female and male cancer survivors have a 1.4- to 2.5-fold excess risk, respectively, of developing HPV-related malignancies. Fortunately, HPV-related malignancies are largely preventable due to availability of the nonavalent HPV vaccine, which offers protection against ~90% of oncogenic HPV subtypes. We have previously shown that uptake of the HPV vaccine is significantly lower in cancer survivors compared with general population peers (22.0% vs 42.5% in those age 13-17yrs), and that lack of healthcare provider recommendation is the strongest predictor of HPV vaccine non-initiation in cancer survivors. Strategies that are most successful in increasing HPV vaccine uptake in the general population focus on improving healthcare provider knowledge about the HPV vaccine, enhancing the skills that healthcare providers need to effectively recommend the vaccine to young people and their parents, and reducing barriers to receiving the vaccine.
This study will evaluate the effectiveness and implementation of an evidence-based intervention (HPV-PROTECT), adapted for use by healthcare providers in pediatric oncology clinics, to increase the uptake of HPV vaccine among young cancer survivors (9 to 17 years of age and at least one year following completion of cancer therapy). The HPV-PROTECT intervention has three components: i) Provider Communication Training; ii) Assessment and Peer Feedback/Coaching; and iii) Provider Toolkit, and is designed to increase provider knowledge regarding use of the HPV vaccine in the cancer survivor population, enhance provider skills in delivering brief, compelling HPV vaccine recommendations to parents of young cancer survivors, present ongoing feedback to providers regarding clinic- and provider-level survivor HPV vaccination rates, and decrease barriers to receipt of vaccine by survivors through the provision of Vaccine Action Plans. If the intervention is effective in improving and sustaining increased uptake of the HPV vaccine in young cancer survivors, this study will contribute important information needed to move forward with testing the widespread use of the intervention in pediatric oncology practices.
- Conditions
- Papillomavirus Vaccines
- Being tested
- HPV-PROTECT
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HPV-PROTECTBehavioural
HPV-PROTECT is a multicomponent provider-focused intervention specifically tailored for use in pediatric oncology settings, addressing important survivor-specific vaccine issues. The intervention is comprised of three components, i) Provider Communication Training; ii) Assessment and Peer Feedback/ Coaching; and iii) Provider Toolkit. The HPV-PROTECT intervention is designed to increase provider knowledge regarding use of the HPV vaccine in the cancer survivor population, enhance provider skills in delivering brief, compelling HPV vaccine recommendations to parents of young cancer survivors, present ongoing feedback to providers regarding clinic- and provider-level survivor HPV vaccination rates, and decrease barriers to receipt of vaccine by survivors through the provision of Vaccine Action Plans, tailored to local context.
| Study group | Role | What they receive |
|---|---|---|
| Delayed Intervention | Other | Sites randomized to the Delayed Intervention Arm (Sites A, B, C) will be assigned to the control condition in Years 1 and 2, to the HPV-PROTECT intervention in Year 3, and to the sustainability condition in Year 4 Receives: Behavioral: HPV-PROTECT |
| Early Intervention | Other | Sites randomized to the Early Intervention Arm (Sites D, E, F) will be assigned to the control condition in Year 1, to the HPV-PROTECT intervention in Year 2, and to the sustainability condition in Years 3 and 4 Receives: Behavioral: HPV-PROTECT |
What is being measured
The primary outcome is the main question the study is designed to answer.
HPV Vaccine Initiation Rates
The primary outcome was the percentage of cancer survivors, age 9-17y and ≥1y post-completion of cancer therapy, who completed a clinic visit (in-person or via telehealth) at one of the participating sites during the study year, and who had initiated the HPV vaccine series as of the final day of the study year, as measured via state vaccine registry records.
Measured: The survivor must have initiated the HPV vaccine as of the final day of the study year
Secondary outcomes (3)
Provider Perspectives Regarding Intervention Feasibility, Acceptability, Appropriateness, Fidelity
Descriptive statistics summarizing provider survey data and qualititatively coded provider interview data were integrated to evaluate the feasability, acceptability, and appropriateness of the HPV-PROTECT intervention to the pediatric oncology setting, and provider adherence (fidelity) to intervention components. Quantitative item: Change in healthcare provider practice of recommending HPV vaccine to their patients (item 13c): Percentage of participants reporting "often/always"
Measured: Qualitative interviews: Months 11-12 of the Intervention Year (i.e., Year 2 for sites D, E, F, and Year 3 for sites A, B, C); Quantitative survey: Administered to providers at end of pre-intervention, intervention, and sustainability phases of the study.
Change in Provider HPV Vaccine-related Knowledge
Change in healthcare provider HPV and HPV vaccine-related knowledge, as measured quantitatively via 16 survey items, and reported as a combined mean score of proportion of items answered correctly (lowest possible mean score: 0; highest possible mean score: 1.0). A higher score indicates more HPV vaccine-related knowledge.
Measured: Quantitative survey administered to providers at end of pre-intervention, intervention, and sustainability phases of the study.
Change in Provider HPV Vaccine-related Practices
Change in HPV vaccine-related practices, as measured by the mean score +/- standard deviation of the healthcare provider survey responses to the following items: (a) "I order the HPV vaccine to be given to my patients in the pediatric oncology clinic" and (b) "I check to make sure that my patients complete the HPV vaccine series." Each of these two items were rated by the providers using a Likert scale with the lowest possible score of 1 ("Never") and the highest possible score of 5 ("Always"). Outcomes are reported as the Mean and Standard Deviation of the Likert scale score for each of these two survey items.
Measured: Quantitative survey administered to providers at end of pre-intervention, intervention, and sustainability phases of the study.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2020
- Study start1 Feb 2021
- Primary completion26 Jan 2025
- Study completion15 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Papillomavirus VaccinesStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- Cluster-randomized stepped-wedge design with 6 clusters
- Masking
- None (open label)
- Enrolment
- 8,120 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Wendy Landier, PhD, University of Alabama at Birmingham
- Investigators
- Wendy Landier, PhD, Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04469569
- Sponsor's protocol ID
- IRB-300005305
- Other IDs
- 1U01CA246567-01A1
- Status last verified
- Jul 2026
- First submitted
- 9 Jul 2020
- Last updated
- 3 Aug 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Landier W, Bhatia S, Richman JS, Campos Gonzalez PD, Cherven B, Chollette V, Aye J, Castellino SM, Gramatges MM, Lindemulder S, Russell TB, Turcotte LM, Colditz GA, Gilkey MB, Klosky JL. Implementation of a provider-focused intervention for maximizing human papillomavirus (HPV) vaccine uptake in young cancer survivors receiving follow-up care in pediatric oncology practices: protocol for a cluster-randomized trial of the HPV PROTECT intervention. BMC Pediatr. 2022 Sep 12;22(1):541. doi: 10.1186/s12887-022-03562-1.
PubMed 36096775
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementation of a Provider-Focused Intervention for Maximizing HPV Vaccine Uptake in Young Cancer Survivors Receiving Follow-Up Care in Pediatric Oncology Practices: A Cluster-Randomized Trial
- ClinicalTrials.gov ID
- NCT04469569
- Acronym / sponsor ID
- IRB-300005305
- Conditions
- Papillomavirus Vaccines
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8,120 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 1 Feb 2021 (actual)
- Primary completion
- 26 Jan 2025 (actual)
- Study completion
- 15 Dec 2025 (actual)
- First posted
- 14 Jul 2020 (actual)
- Results
- Posted 3 Aug 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The focus of this research is on increasing the uptake of the human papillomavirus (HPV) vaccine in young cancer survivors, a vulnerable population at high risk for developing new cancers (such as cervical and anal cancer) caused by persistent HPV infection. An effective vaccine exists that can prevent these cancers, but HPV vaccine uptake is low among young cancer survivors. This research will evaluate the effectiveness and implementation of an evidence-based intervention, adapted for use by healthcare providers in pediatric oncology clinics, to increase the uptake of HPV vaccine among young cancer survivors 9-17 years of age. Results of this research will provide important information that can be used to implement new strategies to increase the uptake of the HPV vaccine among young cancer survivors.
Detailed description
Childhood cancer survivors are at high risk for developing new cancers (such as cervical and anal cancer) caused by persistent infection with the human papillomavirus (HPV). Compared with the age- and sex-matched general population, female and male cancer survivors have a 1.4- to 2.5-fold excess risk, respectively, of developing HPV-related malignancies. Fortunately, HPV-related malignancies are largely preventable due to availability of the nonavalent HPV vaccine, which offers protection against ~90% of oncogenic HPV subtypes. We have previously shown that uptake of the HPV vaccine is significantly lower in cancer survivors compared with general population peers (22.0% vs 42.5% in those age 13-17yrs), and that lack of healthcare provider recommendation is the strongest predictor of HPV vaccine non-initiation in cancer survivors. Strategies that are most successful in increasing HPV vaccine uptake in the general population focus on improving healthcare provider knowledge about the HPV vaccine, enhancing the skills that healthcare providers need to effectively recommend the vaccine to young people and their parents, and reducing barriers to receiving the vaccine.
This study will evaluate the effectiveness and implementation of an evidence-based intervention (HPV-PROTECT), adapted for use by healthcare providers in pediatric oncology clinics, to increase the uptake of HPV vaccine among young cancer survivors (9 to 17 years of age and at least one year following completion of cancer therapy). The HPV-PROTECT intervention has three components: i) Provider Communication Training; ii) Assessment and Peer Feedback/Coaching; and iii) Provider Toolkit, and is designed to increase provider knowledge regarding use of the HPV vaccine in the cancer survivor population, enhance provider skills in delivering brief, compelling HPV vaccine recommendations to parents of young cancer survivors, present ongoing feedback to providers regarding clinic- and provider-level survivor HPV vaccination rates, and decrease barriers to receipt of vaccine by survivors through the provision of Vaccine Action Plans. If the intervention is effective in improving and sustaining increased uptake of the HPV vaccine in young cancer survivors, this study will contribute important information needed to move forward with testing the widespread use of the intervention in pediatric oncology practices.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Cluster-randomized stepped-wedge design with 6 clusters
| Arm | Type | Receives |
|---|---|---|
| Delayed Intervention | Other | Behavioral: HPV-PROTECTSites randomized to the Delayed Intervention Arm (Sites A, B, C) will be assigned to the control condition in Years 1 and 2, to the HPV-PROTECT intervention in Year 3, and to the sustainability condition in Year 4 |
| Early Intervention | Other | Behavioral: HPV-PROTECTSites randomized to the Early Intervention Arm (Sites D, E, F) will be assigned to the control condition in Year 1, to the HPV-PROTECT intervention in Year 2, and to the sustainability condition in Years 3 and 4 |
Who may qualify
- Ages
- 9 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (10 listed)
- HEALTHCARE PROVIDERS (ONCOLOGISTS, ADVANCED PRACTICE PROVIDERS)
- CHILDHOOD CANCER SURVIVORS
Key exclusion criteria (1 listed)
- N/A
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 |
|---|---|---|
| HPV-PROTECTHPV-PROTECT is a multicomponent provider-focused intervention specifically tailored for use in pediatric oncology settings, addressing important survivor-specific vaccine issues. The intervention is comprised of three components, i) Provider Communication Training; ii) Assessment and Peer Feedback/ Coaching; and iii) Provider Toolkit. The HPV-PROTECT intervention is designed to increase provider knowledge regarding use of the HPV vaccine in the cancer survivor population, enhance provider skills in delivering brief, compelling HPV vaccine recommendations to parents of young cancer survivors, present ongoing feedback to providers regarding clinic- and provider-level survivor HPV vaccination rates, and decrease barriers to receipt of vaccine by survivors through the provision of Vaccine Action Plans, tailored to local context. | Behavioural | Delayed Intervention, Early Intervention |
Primary outcome
HPV Vaccine Initiation Rates
Time frame: The survivor must have initiated the HPV vaccine as of the final day of the study year
The primary outcome was the percentage of cancer survivors, age 9-17y and ≥1y post-completion of cancer therapy, who completed a clinic visit (in-person or via telehealth) at one of the participating sites during the study year, and who had initiated the HPV vaccine series as of the final day of the study year, as measured via state vaccine registry records.
3 secondary outcomes
Provider Perspectives Regarding Intervention Feasibility, Acceptability, Appropriateness, Fidelity
Time frame: Qualitative interviews: Months 11-12 of the Intervention Year (i.e., Year 2 for sites D, E, F, and Year 3 for sites A, B, C); Quantitative survey: Administered to providers at end of pre-intervention, intervention, and sustainability phases of the study.
Change in Provider HPV Vaccine-related Knowledge
Time frame: Quantitative survey administered to providers at end of pre-intervention, intervention, and sustainability phases of the study.
Change in Provider HPV Vaccine-related Practices
Time frame: Quantitative survey administered to providers at end of pre-intervention, intervention, and sustainability phases of the study.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 36096775Landier W, Bhatia S, Richman JS, Campos Gonzalez PD, Cherven B, Chollette V, Aye J, Castellino SM, Gramatges MM, Lindemulder S, Russell TB, Turcotte LM, Colditz GA, Gilkey MB, Klosky JL. Implementation of a provider-focused intervention for maximizing human papillomavirus (HPV) vaccine uptake in young cancer survivors receiving follow-up care in pediatric oncology practices: protocol for a cluster-randomized trial of the HPV PROTECT intervention. BMC Pediatr. 2022 Sep 12;22(1):541. doi: 10.1186/s12887-022-03562-1.
- Individual participant dataSharing planned: No
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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.
Wendy Landier, PhD principal investigator
University of Alabama at Birmingham
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HPV-PROTECT in people with Papillomavirus Vaccines, run by University of Alabama at Birmingham at 6 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 10 inclusion and 1 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 3 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 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?
Yes. Results are posted in the registry (first posted 3 Aug 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
HPV Vaccine Initiation Rates (time frame: The survivor must have initiated the HPV vaccine as of the final day of the study year). 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 NCT04469569, 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 3 Aug 2026.