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Completed

NCT Number: NCT04469569

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

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.

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Key information

Conditions

Papillomavirus Vaccines

Age range

9 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Alabama at Birmingham, Birmingham, Alabama, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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
  • 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

Treatment and study plan

HPV-PROTECT

Behavioral

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

    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"

  2. 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 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.

  3. 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.

    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.

Other outcomes

  1. HPV Vaccine Series Completion Rates

    Time frame: The survivor must have completed the 3-dose HPV vaccine series as of the final day of the study year

    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.

  2. Sustainability of HPV Vaccine Initiation Rates

    Time frame: The survivor must have initiated the HPV vaccine as of the final day of the study year

    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.

Sponsors and collaborators

Lead sponsor

University of Alabama at Birmingham

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study 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

Important dates

Study start
2021
Primary completion
2025
Study completion
2025
First posted
Jul 14, 2020
Registry last updated
Aug 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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