The STOP-HPV Scale Up Study
ConditionHuman Papilloma Virus Vaccine
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age9-17
SponsorUniversity of California, Los Angeles
About this trial
Human papillomavirus (HPV) causes 35,900 US cancer cases per year, 4,000 deaths, and $4 billion in can In this study, the investigators will conduct a 3-arm clustered randomized controlled trial (RCT) in an estimated 72 practices from up to 8 health systems to evaluate the effectiveness and cost effectiveness of two potentially scalable implementation strategies (based on prior work) to increase the initiation of HPV vaccine against a usual care (control) arm. The intervention arms are 1) online provider communication training only ("STOP-HPV-Online" and 2) online provider communication training plus a Learning Collaborative, with performance feedback, attended by practice leads ("STOP-HPV-LC).
cer-related costs. It is recommended at ages 11-12 years routinely but can be given starting at ages 9-10 years. Despite having an effective vaccine, HPV vaccine initiation/completion rates in the U.S. were only at 76.8%/61.4% respectively in 2023 among 13-17 year olds; these rates are lower than the other recommended adolescent vaccines. Two key barriers are 1) suboptimal clinician communication to address parental concerns and 2) ineffective office systems causing missed vaccine opportunities.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patient of participating practice
Well child care visit during the 12-month intervention period
No prior dose of HPV vaccine at the time of the well child care visit
Age-eligible
Disqualifiers
Prior dose of HPV vaccine
Trial design
Design model
Parallel
Treatments tested in this trial
STOP-HPV-Online
BehavioralApproximately one third of practices within a participating health system will be randomized to receiving the STOP-HPV-Online intervention.
STOP-HPV-LC
BehavioralApproximately one third of practices within a participating health system will be randomized to receiving the STOP-HPV-LC intervention.
Treatment groups
100,000 Participants
are divided into 3 treatment groupsGroup A: STOP-HPV OnlineExperimental treatment 1 intervention
Group B: STOP-HPV LCExperimental treatment 1 intervention
Group C: Usual CareNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Initiation (first dose) of HPV vaccination among 9-<13 year olds at or following a well care visit with a participating provider during the intervention period.
The percent of children ages 9-\<13 years of age who received their first dose of HPV vaccine at or following a well child care visit with a participating provider during the intervention-period (denominator is children ages 9-\<13 with a well child visit during the study period at which they were due for their first dose).
Time frame
12 months from start of interventionSecondary outcomes
1
Initiation (first dose) of HPV vaccination among 13-17 year olds at or following a well care visit with a participating provider during the intervention period.
The percent of children ages 13-17 years of age who received their first dose of HPV vaccine at or following a well child care visit with a participating provider during the intervention-period (denominator is children ages 13-17 years with a well child visit during the study period at which they were due for their first dose).
Time frame
12 months from start of intervention2
Initiation (first dose) of HPV vaccination among 9-<13 year olds at or following a well care visit with any provider during the intervention period.
The percent of children ages 9-\<13 years of age who received their first dose of HPV vaccine at or following a well child care visit with any provider (participating or not) during the intervention-period (denominator is children ages 9-\<13 with a well child visit during the study period at which they were due for their first dose).
Time frame
12 months from start of intervention3
Initiation (first dose) of HPV vaccination among 13-17 year olds at or following a well care visit with any provider during the intervention period.
The percent of children ages 13-17 years of age who received their first dose of HPV vaccine at or following a well child care visit with any provider (participating or not) during the intervention-period (denominator is children ages 13-17 years with a well child visit during the study period at which they were due for their first dose).
Time frame
12 months from start of intervention4
Total implementation cost
The difference in costs between arms will be used to calculate the incremental cost-effectiveness ratio (ICER)
Time frame
12 months from start of interventionSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of California, Los Angeles
Lead sponsor
American Medical Group Association
Collaborator
National Cancer Institute (NCI)
Collaborator
Source ClinicalTrials.gov