Skip to main content
Clinical Trials/NCT04469569
NCT04469569
Active, not recruiting
Not Applicable

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

University of Alabama at Birmingham6 sites in 1 country5,196 target enrollmentFebruary 1, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Papillomavirus Vaccines
Sponsor
University of Alabama at Birmingham
Enrollment
5196
Locations
6
Primary Endpoint
HPV vaccine initiation rates
Status
Active, not recruiting
Last Updated
last year

Overview

Brief 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. 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.

Registry
clinicaltrials.gov
Start Date
February 1, 2021
End Date
January 31, 2026
Last Updated
last year
Study Type
Interventional
Study Design
Sequential
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Wendy Landier, PhD

Professor

University of Alabama at Birmingham

Eligibility Criteria

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

  • Not provided

Outcomes

Primary Outcomes

HPV vaccine initiation rates

Time Frame: 12 months following implementation of the HPV-PROTECT Intervention.

Proportion 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 intervention year, and who have initiated the HPV vaccine series, as measured via state vaccine registry data

Secondary Outcomes

  • Change in provider HPV vaccine-related knowledge and practices(12 and 24 months [all sites], and 36 months [sites D, E, F only] following implementation of the HPV-PROTECT Intervention))
  • Provider perspectives regarding intervention feasibility, acceptability, appropriateness, fidelity(Months 11-12 of the Intervention Year (i.e., Year 2 for sites D, E, F and Year 3 for sites A, B, C)])

Study Sites (6)

Loading locations...

Similar Trials