Provider-Focused Intervention for Maximizing HPV Vaccine Uptake in Young Cancer Survivors

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.

Study Overview

• Status: Completed
• Conditions: Papillomavirus Vaccines
• Intervention / Treatment: Behavioral: HPV-PROTECT

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 Type: Interventional
• Enrollment (Actual): 8120
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35233
      • University of Alabama at Birmingham
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • Emory University
  • Minnesota
    • Minneapolis, Minnesota, United States, 55455-0341
      • University of Minnesota
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27157-0001
      • Wake Forest University Health Sciences
  • Oregon
    • Portland, Oregon, United States, 97239-3098
      • Oregon Health and Science University
  • Texas
    • Houston, Texas, United States, 77030-3411
      • Baylor College of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 9 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. 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

2. CHILDHOOD CANCER SURVIVORS

   • 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

Exclusion Criteria:

N/A

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Delayed Intervention; 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	Behavioral: HPV-PROTECT; 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.
Other: Early Intervention; 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	Behavioral: HPV-PROTECT; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	The survivor must have initiated the HPV vaccine as of the final day of the study year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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"	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.	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.	Quantitative survey administered to providers at end of pre-intervention, intervention, and sustainability phases of the study.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
HPV Vaccine Series Completion Rates	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 completed the 3-dose HPV vaccine series as of the final day of the study year, as measured via state vaccine registry records.	The survivor must have completed the 3-dose HPV vaccine series as of the final day of the study year
Sustainability of HPV Vaccine Initiation Rates	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. Applies only to the Sustainability condition.	The survivor must have initiated the HPV vaccine as of the final day of the study year

Collaborators and Investigators

• Sponsor: University of Alabama at Birmingham
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Wendy Landier, PhD, University of Alabama at Birmingham

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2021
• Primary Completion (Actual): January 26, 2025
• Study Completion (Actual): December 15, 2025

Study Registration Dates

• First Submitted: July 9, 2020
• First Submitted That Met QC Criteria: July 13, 2020
• First Posted (Actual): July 14, 2020

Study Record Updates

• Last Update Posted (Actual): August 3, 2026
• Last Update Submitted That Met QC Criteria: July 30, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: IRB-300005305; 1U01CA246567-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No