ImmunizationSTOP_HPVNCT03609320
The STOP-HPV Trial 5: Single Arm Evaluation of the Bundle
A study testing The STOP-HPV Trial 5: Bundle Intervention in people with Immunization and Vaccination, run by University of California, Los Angeles at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 11 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Immunization, Vaccination
- What is being tested?
- The STOP-HPV Trial 5: Bundle Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Jan 2022to 9 Aug 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 11 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
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 locations and contacts
1 site in 1 country.
United States1 site
American Academy of Pediatrics
Itasca, Illinois, 60143
About this study
Official title: Improving HPV Vaccination Delivery in Pediatric Primary Care: The STOP-HPV Trial 5. Single Arm Evaluation of the Bundle (Communication Skills, Performance Feedback and Prompts)
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 study (embedded within arm 2 of a 2-arm cluster randomized clinical trial (RCT)) will test the effectiveness (and cost-effectiveness) of a bundled intervention (HPV vaccine communication, performance feedback reports and provider prompts), in practices that previously received standard of care, to reduce MOs and increase HPV vaccination rates.
Read the 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 study (embedded within arm 2 of a 2-arm cluster RCT) will implement a 3-component bundle intervention together in practices that previously received standard of care. This study will test the effectiveness (and cost-effectiveness) of the bundled intervention, which trains providers in HPV vaccine communication (done through online educational modules and live office practice sessions), provides performance feedback reports (that pull from electronic health record (EHR) data, and compare participants' performance to their own previous performance and performance 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. Throughout the intervention participants will also receive weekly text message mini-lessons that will remind participants of the project.
- Conditions
- Immunization, Vaccination
- Being tested
- The STOP-HPV Trial 5: Bundle Intervention
- Keywords
- HPV, Vaccination, Practice Based Intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The STOP-HPV Trial 5: Bundle InterventionBehavioural
This intervention will implement a 3-component bundle intervention (communication skills training, performance feedback and prompts) together in practices that previously received standard of care.
| Study group | Role | What they receive |
|---|---|---|
| Single Arm | Experimental | These practices, which previously received standard of care, will receive The STOP-HPV Trial 5: Bundle Intervention Receives: Behavioral: The STOP-HPV Trial 5: Bundle Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the rate of missed vaccination opportunities among all clinicians
Change in the rate of missed vaccination opportunities from the 6 month bundle intervention period versus the 12 month period preceding the bundle period among all clinicians.
Measured: The 12-month period immediately preceding initiation of the bundle and the 6-month bundle period, excluding the 6-week ramp-up
Change in the rate of missed vaccination opportunities among consenting clinicians
Change in the rate of missed vaccination opportunities from the 6 month bundle intervention period versus the 12 month period preceding the bundle period among consenting clinicians.
Measured: The 12-month period immediately preceding initiation of the bundle and the 6-month bundle period, excluding the 6-week ramp-up
Secondary outcomes (1)
Change in the rate of missed vaccination opportunities among all clinicians.
Change in the rate of missed vaccination opportunities among all clinicians.
Measured: From months 0 (baseline) through month 28 of study activities. Study activities were paused for a 15 month period during the pandemic.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2018
- Study start12 Jan 2022
- Primary completion9 Aug 2022 (estimated)
- Study completion9 Aug 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ImmunizationStudies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This single-arm study embedded within a 2-arm cluster RCT will test the difference in the rate of missed opportunities pre- and post-implementation of a 3-component intervention including communication skills, performance feedback, and prompts. These three interventions will be implemented together in practices that previously received standard of care.
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Collaborators
- Children's Hospital of Philadelphia, American Academy of Pediatrics, University of Pennsylvania, National Institutes of Health (NIH), National Cancer Institute (NCI), University of Rochester
- Responsible party
- Principal investigator, Peter G Szilagyi, MD MPH, University of California, Los Angeles
- Investigators
- Peter Szilagyi, MD, Principal investigator, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03609320
- Sponsor's protocol ID
- 5R01CA202261
- Other IDs
- R01CA202261
- Acronym
- STOP_HPV
- Status last verified
- Jun 2022
- First submitted
- 29 Jun 2018
- Last updated
- 5 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving HPV Vaccination Delivery in Pediatric Primary Care: The STOP-HPV Trial 5. Single Arm Evaluation of the Bundle (Communication Skills, Performance Feedback and Prompts)
- ClinicalTrials.gov ID
- NCT03609320
- Acronym / sponsor ID
- STOP_HPV / 5R01CA202261
- Conditions
- Immunization, Vaccination
- Keywords
- HPV, Vaccination, Practice Based Intervention
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Collaborators
- Children's Hospital of Philadelphia, American Academy of Pediatrics, University of Pennsylvania, National Institutes of Health (NIH), National Cancer Institute (NCI), University of Rochester
- Study start
- 12 Jan 2022 (actual)
- Primary completion
- 9 Aug 2022 (estimated)
- Study completion
- 9 Aug 2022 (estimated)
- First posted
- 1 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 study (embedded within arm 2 of a 2-arm cluster randomized clinical trial (RCT)) will test the effectiveness (and cost-effectiveness) of a bundled intervention (HPV vaccine communication, performance feedback reports and provider prompts), in practices that previously received standard of care, 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 study (embedded within arm 2 of a 2-arm cluster RCT) will implement a 3-component bundle intervention together in practices that previously received standard of care. This study will test the effectiveness (and cost-effectiveness) of the bundled intervention, which trains providers in HPV vaccine communication (done through online educational modules and live office practice sessions), provides performance feedback reports (that pull from electronic health record (EHR) data, and compare participants' performance to their own previous performance and performance 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. Throughout the intervention participants will also receive weekly text message mini-lessons that will remind participants of the project.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This single-arm study embedded within a 2-arm cluster RCT will test the difference in the rate of missed opportunities pre- and post-implementation of a 3-component intervention including communication skills, performance feedback, and prompts. These three interventions will be implemented together in practices that previously received standard of care.
| Arm | Type | Receives |
|---|---|---|
| Single Arm | Experimental | Behavioral: The STOP-HPV Trial 5: Bundle InterventionThese practices, which previously received standard of care, will receive The STOP-HPV Trial 5: Bundle Intervention |
Who may qualify
- Ages
- 11 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| The STOP-HPV Trial 5: Bundle InterventionThis intervention will implement a 3-component bundle intervention (communication skills training, performance feedback and prompts) together in practices that previously received standard of care. | Behavioural | Single Arm |
Primary outcome
Change in the rate of missed vaccination opportunities among all clinicians
Time frame: The 12-month period immediately preceding initiation of the bundle and the 6-month bundle period, excluding the 6-week ramp-up
Change in the rate of missed vaccination opportunities from the 6 month bundle intervention period versus the 12 month period preceding the bundle period among all clinicians.
Change in the rate of missed vaccination opportunities among consenting clinicians
Time frame: The 12-month period immediately preceding initiation of the bundle and the 6-month bundle period, excluding the 6-week ramp-up
Change in the rate of missed vaccination opportunities from the 6 month bundle intervention period versus the 12 month period preceding the bundle period among consenting clinicians.
1 secondary outcome
Change in the rate of missed vaccination opportunities among all clinicians.
Time frame: From months 0 (baseline) through month 28 of study activities. Study activities were paused for a 15 month period during the pandemic.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jul 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peter Szilagyi, MD principal investigator
University of California, Los Angeles
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The STOP-HPV Trial 5: Bundle Intervention in people with Immunization and Vaccination, run by University of California, Los Angeles at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the rate of missed vaccination opportunities among all clinicians (time frame: The 12-month period immediately preceding initiation of the bundle and the 6-month bundle period, excluding the 6-week ramp-up). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jul 2022.