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The STOP-HPV Trial 6: Single Arm Evaluation of the Maintenance of the STOP-HPV Bundle

Improving HPV Vaccination Delivery in Pediatric Primary Care: The STOP-HPV Trial 6. Single Arm Evaluation of the Maintenance of the STOP-HPV Bundle

Status
Withdrawn
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03609372
Acronym
STOP-HPV
Enrollment
0
Registered
2018-08-01
Start date
2018-08-07
Completion date
2021-03-31
Last updated
2023-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Immunization, Vaccination

Keywords

HPV, Vaccination, Practice Based Research

Brief summary

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 single arm evaluation (embedded within arm 1 of a 2-arm cluster randomized clinical trial (RCT)) will test the sustainability of improvement made in response to a bundled intervention including HPV vaccine communication, performance feedback and provider prompts to reduce MOs and increase HPV vaccination rates.

Detailed description

HPV vaccine rates remain lower than rates for other adolescent vaccines. Missed opportunities (MOs) are healthcare visits during which a patient is eligible, but does not receive a vaccine. MOs for vaccination contribute strongly to low HPV vaccination rates. This single arm evaluation (embedded within arm 1 of a 2-arm cluster RCT) will test the sustainability of improvement made in repose to a bundled intervention including HPV vaccine communication (done through online educational modules and live office practice sessions), performance feedback reports (that pull from electronic health record (EHR) data, and compare participants performance to their own previous performance and those of others) and provider prompts (via EHR and also office staff prompts, e.g., placing Vaccine Information Statements (VISs) on desk) to reduce MOs and increase HPV vaccination rates.

Interventions

BEHAVIORALThe STOP-HPV Trial 6: Maintenance

In this period, study team support will be withdrawn after previous bundled intervention (including HPV vaccine communication, performance feedback and provider prompts) was given to reduce MOs and increase HPV vaccination rates.

Sponsors

Children's Hospital of Philadelphia
CollaboratorOTHER
American Academy of Pediatrics
CollaboratorOTHER
University of Pennsylvania
CollaboratorOTHER
National Institutes of Health (NIH)
CollaboratorNIH
National Cancer Institute (NCI)
CollaboratorNIH
University of Rochester
CollaboratorOTHER
University of California, Los Angeles
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
11 Years to 17 Years
Healthy volunteers
Yes

Inclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
Change in the rate of missed vaccination opportunities among all cliniciansMonthly from months 0 (baseline) through month 27 (end of maintenance period), 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 from baseline through the end of the maintenance period among all clinicians, with a focus on the contrast between the end of the bundled intervention and the maintenance period.
Change in the rate of missed vaccination opportunities among consenting cliniciansMonthly from months 0 (baseline) through month 27 (end of maintenance period), 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 from baseline through the end of the maintenance period among consenting clinicians, with a focus on the contrast between the end of the bundled intervention and the maintenance period.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026