HPV VaccineNCT05105711
Mobile Coaching to Improve HPV Vaccine Delivery
A study testing QI coaching intervention in people with HPV Vaccine and Provider Communication Practices, run by UNC Lineberger Comprehensive Cancer Center at 1 site in United States.
Trial summary
The purpose of this study is to examine the feasibility of using Checkup Coach, a mobile coaching intervention, to improve the way that primary care providers recommend HPV vaccination to adolescent patients and their parents. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- HPV Vaccine, Provider Communication Practices, Vaccine Recommendation Practices
- What is being tested?
- QI coaching intervention
- Type of treatment
- Vaccines, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Jun 2021to 14 Jan 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Primary care providers who treat 11-12 year old adolescent patients in participating Kaiser Permanente Washington pediatric and family medicine practices
Who cannot join
- Primary care providers who do not treat adolescent patients
Trial locations and contacts
1 site in 1 country.
United States1 site
Kaiser Permanente Washington Health Research Institute
Seattle, Washington, 98101
About this study
Official title: Evaluating the Feasibility of a Mobile Coaching Intervention to Improve HPV Vaccine Delivery
The purpose of this study is to examine the feasibility of using Checkup Coach, a mobile coaching intervention, to improve the way that primary care providers recommend HPV vaccination to adolescent patients and their parents. To conduct this feasibility study, the investigators will deliver the Checkup Coach intervention to 20 Kaiser Permanente Washington primary care providers who routinely recommend HPV vaccine to adolescent patients. The investigators will use a single-arm, pre-post design. Participating primary care providers will attend a 1-hour virtual communication workshop and then use a mobile phone app to receive additional coaching for 12 weeks. Providers will complete surveys at three time points: before the communication workshop, immediately after the workshop, and at 12-week follow-up. Surveys will assess changes in providers' self-reported HPV vaccine recommendation practices and beliefs about HPV vaccine and also acceptability of the intervention. The investigators hypothesizes that providers' HPV vaccine communication will improve between baseline and 12-week follow-up.
- Being tested
- QI coaching intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QI coaching interventionBehavioural
The intervention consists of two main components: a webinar communication workshop and use of the Checkup Coach mobile app. The Checkup Coach intervention begins with a brief (<1 hour), communication training workshop that reviews evidence on HPV vaccination, models guideline-consistent recommendations, trains providers to address parent concerns, and facilitates discussion of shared goals for improving. Next, providers are invited to download and use the Checkup coach mobile app at their discretion for the 12-week study period. Providers complete in-app self-assessments and receive tailored feedback about their HPV vaccine recommendation quality, progress toward improving recommendation practices, a dashboard of aggregate HPV vaccination coverage for patients in their clinic, and tips for addressing parents' concerns about HPV vaccination every time they use the app.
| Study group | Role | What they receive |
|---|---|---|
| Primary care providers | Experimental | Providers who treat 11-12 year old adolescent patients in participating Kaiser Permanente Washington pediatric and family medicine practices. Receives: Behavioral: QI coaching intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in HPV Vaccine Recommendation Quality Score
The change in providers' mean composite score on a 5-item index of self-reported use of HPV vaccine communication practices with scores ranging from 5-25 (5 indicating the lowest quality score to 25 indicating the highest quality score).
Measured: Baseline, 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2021
- Study start21 Jun 2021
- Primary completion14 Jan 2022
- Study completion14 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for HPV VaccineStudies of the same condition, open and under way.
- More trials run by UNC Lineberger Comprehensive Cancer CenterThe 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
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- UNC Lineberger Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Melissa B Gilkey, PhD, Principal investigator, University of North Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05105711
- Sponsor's protocol ID
- 20-0810
- Other IDs
- 1R21CA241518-01
- Status last verified
- Jul 2022
- First submitted
- 21 Oct 2021
- Last updated
- 25 Jul 2022
- Results posted
- Yes, on ClinicalTrials.gov
- 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 25 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Feasibility of a Mobile Coaching Intervention to Improve HPV Vaccine Delivery
- ClinicalTrials.gov ID
- NCT05105711
- Acronym / sponsor ID
- 20-0810
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- UNC Lineberger Comprehensive Cancer CenterUniversity, hospital or other
- Collaborators
- Kaiser Permanente, University of Minnesota, National Cancer Institute (NCI)
- Study start
- 21 Jun 2021 (actual)
- Primary completion
- 14 Jan 2022 (actual)
- Study completion
- 14 Jan 2022 (actual)
- First posted
- 3 Nov 2021 (actual)
- Results
- Posted 25 Jul 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to examine the feasibility of using Checkup Coach, a mobile coaching intervention, to improve the way that primary care providers recommend HPV vaccination to adolescent patients and their parents. To conduct this feasibility study, the investigators will deliver the Checkup Coach intervention to 20 Kaiser Permanente Washington primary care providers who routinely recommend HPV vaccine to adolescent patients. The investigators will use a single-arm, pre-post design. Participating primary care providers will attend a 1-hour virtual communication workshop and then use a mobile phone app to receive additional coaching for 12 weeks. Providers will complete surveys at three time points: before the communication workshop, immediately after the workshop, and at 12-week follow-up. Surveys will assess changes in providers' self-reported HPV vaccine recommendation practices and beliefs about HPV vaccine and also acceptability of the intervention. The investigators hypothesizes that providers' HPV vaccine communication will improve between baseline and 12-week follow-up.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Primary care providers | Experimental | Behavioral: QI coaching interventionProviders who treat 11-12 year old adolescent patients in participating Kaiser Permanente Washington pediatric and family medicine practices. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Primary care providers who treat 11-12 year old adolescent patients in participating Kaiser Permanente Washington pediatric and family medicine practices
Key exclusion criteria (1 listed)
- Primary care providers who do not treat adolescent patients
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 |
|---|---|---|
| QI coaching interventionThe intervention consists of two main components: a webinar communication workshop and use of the Checkup Coach mobile app. The Checkup Coach intervention begins with a brief (<1 hour), communication training workshop that reviews evidence on HPV vaccination, models guideline-consistent recommendations, trains providers to address parent concerns, and facilitates discussion of shared goals for improving. Next, providers are invited to download and use the Checkup coach mobile app at their discretion for the 12-week study period. Providers complete in-app self-assessments and receive tailored feedback about their HPV vaccine recommendation quality, progress toward improving recommendation practices, a dashboard of aggregate HPV vaccination coverage for patients in their clinic, and tips for addressing parents' concerns about HPV vaccination every time they use the app. | Behavioural | Primary care providers |
Primary outcome
Change in HPV Vaccine Recommendation Quality Score
Time frame: Baseline, 12 weeks
The change in providers' mean composite score on a 5-item index of self-reported use of HPV vaccine communication practices with scores ranging from 5-25 (5 indicating the lowest quality score to 25 indicating the highest quality score).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Melissa B Gilkey, PhD principal investigator
University of North Carolina
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing QI coaching intervention in people with HPV Vaccine and Provider Communication Practices, run by UNC Lineberger Comprehensive Cancer Center 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?
The sponsor lists 1 inclusion and 1 exclusion criteria. 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: finished, as of the sponsor's last update on 25 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?
Yes. Results are posted in the registry (first posted 25 Jul 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 HPV Vaccine Recommendation Quality Score (time frame: Baseline, 12 weeks). 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 25 Jul 2022; AzTrials last refreshed its copy on 6 Nov 2026.