The STOP-HPV Trial 1: Communication Intervention (STOP-HPV)

Improving HPV Vaccination Delivery in Pediatric Primary Care: The STOP-HPV Trial 1. Comparison of Communication Skills and Standard of Care for Uptake of the HPV Vaccine

Most adolescents who receive human papillomavirus (HPV) vaccine are vaccinated in pediatric practices, yet missed opportunities (MOs) for HPV vaccination occur often and lead to low HPV vaccination rates. This cluster randomized clinical trial (RCT) will test the effectiveness (and cost-effectiveness) of training providers on HPV vaccine communication to reduce MOs and increase HPV vaccination rates.

Study Overview

• Status: Completed
• Conditions: Vaccination; Immunization
• Intervention / Treatment: Behavioral: STOP-HPV communication intervention

Detailed Description

As highlighted by NCI, low HPV vaccination rates represent a major lost opportunity for population-wide cancer prevention. Pediatric primary care office visits are the main site for HPV vaccination, yet many missed opportunities (MOs) for vaccination occur in primary care and contribute to low vaccination rates. MOs are office visits during which a patient is eligible for a vaccine, but does not receive it. Many factors cause MOs - provider factors (e.g., time-constrained visits, lack of communication skills, and giving vaccinations only at preventive visits) and parent factors (e.g., vaccine hesitancy). This cluster randomized clinical trial will test the effectiveness (and cost-effectiveness) of training providers in HPV vaccine communication to reduce MOs and increase HPV vaccination rates. This training will be done through online educational modules (sent via text or email), weekly mini lessons and live office practice sessions.

• Study Type: Interventional
• Enrollment (Actual): 48
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Itasca, Illinois, United States, 60143
      • American Academy of Pediatrics

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 11 years to 17 years (Child)
• Accepts Healthy Volunteers: Yes

Description

Practice Inclusion Criteria:

• The practice provides HPV vaccination services to adolescents.
• The practice is part of Physician's Computer Company (PCC), Office Practicum (OP) or (a) yet-to-be selected health system(s).
• The practice has had the same EHR system in place for a year or more (with special consideration on a case by case basis if they are close to but not do not reach a year).
• The practice agrees to not participate in other HPV-related QI projects or research interventions during the study period (with special consideration on a case by case basis).

Practice Exclusion Criteria:

• The practice plans to change EHR systems in the next three years.
• The practice participated in the last year, is currently engaged in, or plans to participate in an office-based HPV-related quality improvement (QI) project or research intervention during the study period (with special consideration on a case by case basis).
• Estimated 20% or more of adolescents at the practice receive HPV vaccinations at schools or health department clinics (given standard practice and published data, the investigators expect that few to no practices will need to be excluded based on this restriction).

Patient inclusion criteria:

-All patients of participating practices (intervention and comparison) aged 11-17 years who have at least 1 visit to the practice within the past two years.

Patient exclusion criteria:

-None apart from age of patients (above).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control; Arm 2 will receive standard of care
Experimental: Intervention; Arm 1 will receive the STOP-HPV communication intervention	Behavioral: STOP-HPV communication intervention; This intervention will be communication skills training.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in the Rate of Missed Vaccination Opportunities Among All Clinicians	The difference in the missed opportunity rate for HPV vaccination between the baseline period (12 months long) and the feedback period (6 months long) among all the clinicians in the participating practices, regardless of whether they received the training intervention. A missed opportunity is a visit-based measure, with the denominator representing all the visits where an HPV vaccine is due at the time of the visit and the numerator representing the number of visits where an HPV vaccine was not given.	Assessment of rates from 2 time periods- baseline period (assessed outcomes retrospectively from minus 12 months to Time 0), followed by 6 month intervention period (excluding a 4 week ramp-up period).
Change in the Rate of Missed Vaccination Opportunities Among Consenting Clinicians	The difference in the missed opportunity rate for HPV vaccination between the baseline period (12 months long) and the feedback period (6 months long) among all the clinicians in the participating practices who received the training intervention. A missed opportunity is a visit-based measure, with the denominator representing all the visits where an HPV vaccine is due at the time of the visit and the numerator representing the number of visits where an HPV vaccine was not given.	Assessment of rates from 2 time periods- baseline period (assessed outcomes retrospectively from minus 12 months to Time 0), followed by 6 month intervention period (excluding a 4 week ramp-up period).

Collaborators and Investigators

• Sponsor: University of California, Los Angeles
• Collaborators: National Cancer Institute (NCI); Children's Hospital of Philadelphia; University of Pennsylvania; National Institutes of Health (NIH); University of Rochester; American Academy of Pediatrics
• Investigators: Principal Investigator: Peter Szilagyi, MD, University of California, Los Angeles

Publications and helpful links

General Publications

• Fiks AG, Hannan C, Localio R, Kelly MK, Stephens-Shields AJ, Grundmeier RW, Shone LP, Steffes J, Breck A, Wright M, Rand CM, Albertin C, Humiston SG, McFarland G, Abney DE, Szilagyi PG. HPV Vaccinations at Acute Visits and Subsequent Adolescent Preventive Visits. Pediatrics. 2022 Nov 1;150(5):e2022058188. doi: 10.1542/peds.2022-058188. No abstract available.
• Szilagyi PG, Humiston SG, Stephens-Shields AJ, Localio R, Breck A, Kelly MK, Wright M, Grundmeier RW, Albertin C, Shone LP, Steffes J, Rand CM, Hannan C, Abney DE, McFarland G, Kominski GF, Seixas BV, Fiks AG. Effect of Training Pediatric Clinicians in Human Papillomavirus Communication Strategies on Human Papillomavirus Vaccination Rates: A Cluster Randomized Clinical Trial. JAMA Pediatr. 2021 Sep 1;175(9):901-910. doi: 10.1001/jamapediatrics.2021.0766.

Study record dates

Study Major Dates

• Study Start (Actual): August 7, 2018
• Primary Completion (Actual): July 30, 2019
• Study Completion (Actual): October 21, 2019

Study Registration Dates

• First Submitted: June 29, 2018
• First Submitted That Met QC Criteria: July 23, 2018
• First Posted (Actual): July 26, 2018

Study Record Updates

• Last Update Posted (Actual): July 12, 2024
• Last Update Submitted That Met QC Criteria: June 14, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Keywords: Vaccination; HPV; Practice based intervention
• Other Study ID Numbers: 1R01CA202261 (U.S. NIH Grant/Contract); R01CA202261 (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