The STOP-HPV Trial 1: Communication Intervention

University of California, Los Angeles (UCLA)

Status: Completed

Conditions: Immunization; Vaccination

Treatments: Behavioral: STOP-HPV communication intervention

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03599557

R01CA202261 (U.S. NIH Grant/Contract)

1R01CA202261

Details and patient eligibility

About

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.

Full 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.

Enrollment: 48 patients

Sex: All

Ages: 11 to 17 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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 exclusion criteria:

-None apart from age of patients (above).

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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48 participants in 2 patient groups

Intervention

Experimental group

Description:

Arm 1 will receive the STOP-HPV communication intervention

Treatment:

Behavioral: STOP-HPV communication intervention

Control

No Intervention group

Description:

Arm 2 will receive standard of care