The STOP-HPV Trial 1: Communication Intervention

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Immunization, Vaccination

Intervention / Treatment
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* Behavioral: STOP-HPV communication intervention


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 11 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: This study will use a cluster RCT study design to test the impact of the communication intervention to reduce missed opportunities (MOs) and raise HPV vaccine rates
Masking: None (Open Label)


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in the rate of missed vaccination opportunities among all clinicians | Change in the rate of missed vaccination opportunities from baseline through the end of the communication intervention period among all clinicians. | Monthly from months 0 (baseline) to month 6, and also aggregated over the 6-month period from month 0, where month 0 is site specific and depends on completion of site staff training and readiness to proceed. | 
| Change in the rate of missed vaccination opportunities among consenting clinicians | Change in the rate of missed vaccination opportunities from baseline through the end of the communication intervention period among consenting clinicians. | Monthly from months 0 (baseline) to month 6, and also aggregated over the 6-month period from month 0, where month 0 is site specific and depends on completion of site staff training and readiness to proceed. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HPV, Vaccination, Practice based intervention