HPV VaccinesNCT03399396
Increasing HPV Vaccination in Community-Based Pediatric Practices
A study testing Practice facilitation for HPV vaccine in people with HPV Vaccines, run by Pamela Hull at 1 site in United States.
Trial summary
The central goal of this study is to identify the optimal approach to implementing an evidence-based practice facilitation (PF) intervention for the uptake and completion of HPV vaccine among adolescents receiving care in the community, guided by implementation science theory. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- HPV Vaccines
- What is being tested?
- Practice facilitation for HPV vaccine
- Type of treatment
- Vaccines, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 420 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Feb 2018to 28 Feb 2021
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- All providers and staff at each practice
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
United States1 site
Vanderbilt University Medical Center
Nashville, Tennessee, 37203
About this study
The central goal of this study is to identify the optimal approach to implementing an evidence-based practice facilitation (PF) intervention for the uptake and completion of HPV vaccine among adolescents receiving care in the community, guided by implementation science theory.
AIM 1: Determine the clinical effectiveness and cost-effectiveness of two modalities for delivering a multi-component PF intervention to increase HPV vaccination initiation and completion in community-based pediatric practices. The investigators will compare the traditional In-person Coaching PF modality to a lower-resource Web-Based Coaching PF modality. The primary patient outcome is HPV vaccination. The investigators will also examine and compare the sustainability of practice changes on vaccination rates and the effects over time for each intervention modality.
AIM 2. Understand mechanisms of why the PF intervention may work better for some pediatric practices than others for HPV vaccination. The investigators will examine theory-based determinants at the organizational, provider, and patient levels that may mediate (explain) or moderate (change) the effects of the PF intervention on vaccination outcomes.
Read the detailed description
Background:
The human papillomavirus (HPV) vaccine offers the unprecedented opportunity to prevent nearly all cervical and anal cancers and a high proportion of vaginal, oropharyngeal, vulvar and penile cancers, where HPV is the etiologic agent. HPV vaccination is recommended for all children ages 11-12, with catch up for females to age 26 and males to age 21. However, despite clear and indisputable value in cancer prevention, uptake and completion of the HPV vaccine series has lagged far behind the goal of 80%. Provider recommendation is the strongest determinant of HPV vaccination, but slow translation of guidelines for preventive services, such as immunizations, into practice is a known challenge. Practice Facilitation (PF), also called quality improvement coaching, is a multicomponent quality improvement intervention approach that has well-established efficacy, in which external support and resources are provided to build the internal capacity of practices to improve quality of care and patient outcomes.
Objectives:
The central goal of the study is to identify the optimal approach to implementing an evidence-based intervention for the uptake and completion of HPV vaccine among adolescents receiving care in the community, guided by implementation science theory.
AIM 1: Determine the clinical effectiveness and cost-effectiveness of two modalities for delivering a multi-component PF intervention to increase HPV vaccination initiation and completion in community-based pediatric practices.
The investigators will compare the traditional In-person Coaching modality to a lower-resource Web-Based Coaching modality. The primary patient outcome is HPV vaccination. The investigators will also examine and compare the sustainability of practice changes on vaccination rates and the effects over time for each intervention modality.
H1: Both interventions will result in significant increases in HPV vaccination from baseline over time.
H2: Increases in the rate of HPV vaccination will be higher and sustained for a longer period of time in the In-person Coaching PF Arm as compared with the Web-Based Coaching Arm.
H3: The Web-Based Coaching Arm will be more cost-effective than the In-person Coaching Arm.
AIM 2. Understand mechanisms of why the PF intervention may work better for some pediatric practices than others for HPV vaccination.
The investigators will examine theory-based determinants at the organizational, provider, and patient levels that may mediate (explain) or moderate (change) the effects of the PF intervention on vaccination outcomes.
H4: Adoption of changes (process variables) and patient factors will mediate effects of the intervention on HPV vaccination outcomes.
H5: Organizational factors, provider attitudes, and intervention characteristics will moderate intervention effects on HPV vaccination outcomes.
Implications:
The findings will inform organizations about which PF modality to use among their constituent practices to improve HPV vaccination rates, with potential for future national dissemination.
- Conditions
- HPV Vaccines
- Being tested
- Practice facilitation for HPV vaccine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Practice facilitation for HPV vaccineBehavioural
The practice facilitation intervention provides coaching support to pediatric practices to guide them through quality improvement projects to increase HPV vaccination rates.
| Study group | Role | What they receive |
|---|---|---|
| Web-Based Coaching | Experimental | Web-based delivery of practice facilitation for HPV vaccine Receives: Behavioral: Practice facilitation for HPV vaccine |
| In-Person Coaching | Experimental | In-person delivery of practice facilitation for HPV vaccine Receives: Behavioral: Practice facilitation for HPV vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Age-appropriate completion rate (ages 13-17)
Percentage of active patients ages 13-17 who completed the HPV vaccine series before 13th birthday
Measured: Annually, up to 3 years post baseline
Secondary outcomes (9)
Age-appropriate initiation rate (ages 13-17)
Percentage of active patients ages 13-17 who received at least one dose of HPV vaccine before 13th birthday
Measured: Monthly, up to 36 months post baseline
Age-appropriate completion rate (at age 13)
Percentage of active patients who turned age 13 who completed the HPV vaccine series before 13th birthday
Measured: Monthly, up to 36 months post baseline
Age-appropriate initiation rate (at age 13)
Percentage of active patients who turned age 13 who received at least one dose of HPV vaccine before 13th birthday
Measured: Monthly, up to 36 months post baseline
Overall completion rate (ages 13-17)
Percentage of active patients ages 13-17 who completed the HPV vaccine series at any age
Measured: Monthly, up to 36 months post baseline
Overall initiation rate (ages 13-17)
Percentage of active patients ages 13-17 who received at least one dose of HPV vaccine at any age
Measured: Monthly, up to 36 months post baseline
Dose received rate (well visits)
Percentage of well visits in which a dose of HPV vaccine was administered (1st, 2nd, or 3rd dose), among all well visits for active vaccine-eligible patients ages 11-17
Measured: Monthly, up to 36 months post baseline
Dose received rate (all visits)
Percentage of visits in which a dose of HPV vaccine was administered (1st, 2nd, or 3rd dose), among all visits for active vaccine-eligible patients ages 11-17
Measured: Monthly, up to 36 months post baseline
Age at vaccination
Average age at receipt of first HPV vaccine dose, among active patients ages 13-17 who received 1st dose
Measured: Monthly, up to 36 months post baseline
Time to series completion
Average number of months from 1st dose to last dose of HPV vaccine, among active patients ages 13-17 who completed the series
Measured: Monthly, up to 36 months post baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2018
- Study start21 Feb 2018
- Primary completion28 Feb 2021
- Study completion28 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HPV VaccinesStudies of the same condition, open and under way.
- 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Using a two-group, cluster randomized control trial (RCT) design, with the clusters being pediatric practices, practices will be randomized to two study arms representing two delivery modalities of the intervention: In-Person Coaching Arm and Web-Based Coaching Arm. The intervention targets the providers and staff in the pediatric practices to make changes aimed to improve their quality of care, and the study participants are the providers and staff (not patients). Individual patients will not be recruited or enrolled in the study, since the intervention is focused on QI and all patient vaccination outcome data will be collected via aggregated reports from the EHR or other clinical data systems (no individual patient-level private health information (PHI)). The study practices include approximately 190 providers (physicians, nurse practitioners, physician assistants) and 275 other staff (nurses, clinical support staff, administrative staff).
- Masking
- None (open label)
- Enrolment
- 420 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pamela Hull
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor-investigator, Pamela Hull, University of Kentucky
- Investigators
- Pamela C Hull, PhD, Principal investigator, Vanderbilt University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03399396
- Sponsor's protocol ID
- 171793
- Other IDs
- 1R01CA207401-01A1
- Status last verified
- Dec 2023
- First submitted
- 20 Dec 2017
- Last updated
- 5 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data collected from providers and staff (surveys and interviews) will be made available to other researchers upon request. All individual identifiers will be stripped to ensure confidentiality and privacy of study participants.
Publications
Chang RS, Shing JZ, Erves JC, Du L, Koyama T, Deppen S, Rentuza AB, McAfee C, Stroebel C, Cates J, Harnack L, Andrews D, Bramblett R, Hull PC. Measurement of provider fidelity to immunization guidelines: a mixed-methods study on the feasibility of documenting patient refusals of the human papillomavirus vaccine. BMC Med Inform Decis Mak. 2022 Dec 22;22(1):339. doi: 10.1186/s12911-022-02083-2.
PubMed 36550466
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Increasing HPV Vaccination in Community-Based Pediatric Practices
- ClinicalTrials.gov ID
- NCT03399396
- Acronym / sponsor ID
- 171793
- Conditions
- HPV Vaccines
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 420 participants (actual)
- Lead sponsor
- Pamela HullUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 21 Feb 2018 (actual)
- Primary completion
- 28 Feb 2021 (actual)
- Study completion
- 28 Feb 2021 (actual)
- First posted
- 16 Jan 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.
The central goal of this study is to identify the optimal approach to implementing an evidence-based practice facilitation (PF) intervention for the uptake and completion of HPV vaccine among adolescents receiving care in the community, guided by implementation science theory.
AIM 1: Determine the clinical effectiveness and cost-effectiveness of two modalities for delivering a multi-component PF intervention to increase HPV vaccination initiation and completion in community-based pediatric practices. The investigators will compare the traditional In-person Coaching PF modality to a lower-resource Web-Based Coaching PF modality. The primary patient outcome is HPV vaccination. The investigators will also examine and compare the sustainability of practice changes on vaccination rates and the effects over time for each intervention modality.
AIM 2. Understand mechanisms of why the PF intervention may work better for some pediatric practices than others for HPV vaccination. The investigators will examine theory-based determinants at the organizational, provider, and patient levels that may mediate (explain) or moderate (change) the effects of the PF intervention on vaccination outcomes.
Detailed description
Background:
The human papillomavirus (HPV) vaccine offers the unprecedented opportunity to prevent nearly all cervical and anal cancers and a high proportion of vaginal, oropharyngeal, vulvar and penile cancers, where HPV is the etiologic agent. HPV vaccination is recommended for all children ages 11-12, with catch up for females to age 26 and males to age 21. However, despite clear and indisputable value in cancer prevention, uptake and completion of the HPV vaccine series has lagged far behind the goal of 80%. Provider recommendation is the strongest determinant of HPV vaccination, but slow translation of guidelines for preventive services, such as immunizations, into practice is a known challenge. Practice Facilitation (PF), also called quality improvement coaching, is a multicomponent quality improvement intervention approach that has well-established efficacy, in which external support and resources are provided to build the internal capacity of practices to improve quality of care and patient outcomes.
Objectives:
The central goal of the study is to identify the optimal approach to implementing an evidence-based intervention for the uptake and completion of HPV vaccine among adolescents receiving care in the community, guided by implementation science theory.
AIM 1: Determine the clinical effectiveness and cost-effectiveness of two modalities for delivering a multi-component PF intervention to increase HPV vaccination initiation and completion in community-based pediatric practices.
The investigators will compare the traditional In-person Coaching modality to a lower-resource Web-Based Coaching modality. The primary patient outcome is HPV vaccination. The investigators will also examine and compare the sustainability of practice changes on vaccination rates and the effects over time for each intervention modality.
H1: Both interventions will result in significant increases in HPV vaccination from baseline over time.
H2: Increases in the rate of HPV vaccination will be higher and sustained for a longer period of time in the In-person Coaching PF Arm as compared with the Web-Based Coaching Arm.
H3: The Web-Based Coaching Arm will be more cost-effective than the In-person Coaching Arm.
AIM 2. Understand mechanisms of why the PF intervention may work better for some pediatric practices than others for HPV vaccination.
The investigators will examine theory-based determinants at the organizational, provider, and patient levels that may mediate (explain) or moderate (change) the effects of the PF intervention on vaccination outcomes.
H4: Adoption of changes (process variables) and patient factors will mediate effects of the intervention on HPV vaccination outcomes.
H5: Organizational factors, provider attitudes, and intervention characteristics will moderate intervention effects on HPV vaccination outcomes.
Implications:
The findings will inform organizations about which PF modality to use among their constituent practices to improve HPV vaccination rates, with potential for future national dissemination.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Using a two-group, cluster randomized control trial (RCT) design, with the clusters being pediatric practices, practices will be randomized to two study arms representing two delivery modalities of the intervention: In-Person Coaching Arm and Web-Based Coaching Arm. The intervention targets the providers and staff in the pediatric practices to make changes aimed to improve their quality of care, and the study participants are the providers and staff (not patients). Individual patients will not be recruited or enrolled in the study, since the intervention is focused on QI and all patient vaccination outcome data will be collected via aggregated reports from the EHR or other clinical data systems (no individual patient-level private health information (PHI)). The study practices include approximately 190 providers (physicians, nurse practitioners, physician assistants) and 275 other staff (nurses, clinical support staff, administrative staff).
| Arm | Type | Receives |
|---|---|---|
| Web-Based Coaching | Experimental | Behavioral: Practice facilitation for HPV vaccineWeb-based delivery of practice facilitation for HPV vaccine |
| In-Person Coaching | Experimental | Behavioral: Practice facilitation for HPV vaccineIn-person delivery of practice facilitation for HPV vaccine |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All providers and staff at each practice
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| Practice facilitation for HPV vaccineThe practice facilitation intervention provides coaching support to pediatric practices to guide them through quality improvement projects to increase HPV vaccination rates. | Behavioural | In-Person Coaching, Web-Based Coaching |
Primary outcome
Age-appropriate completion rate (ages 13-17)
Time frame: Annually, up to 3 years post baseline
Percentage of active patients ages 13-17 who completed the HPV vaccine series before 13th birthday
9 secondary outcomes
Age-appropriate initiation rate (ages 13-17)
Time frame: Monthly, up to 36 months post baseline
Age-appropriate completion rate (at age 13)
Time frame: Monthly, up to 36 months post baseline
Age-appropriate initiation rate (at age 13)
Time frame: Monthly, up to 36 months post baseline
Overall completion rate (ages 13-17)
Time frame: Monthly, up to 36 months post baseline
Overall initiation rate (ages 13-17)
Time frame: Monthly, up to 36 months post baseline
Dose received rate (well visits)
Time frame: Monthly, up to 36 months post baseline
Dose received rate (all visits)
Time frame: Monthly, up to 36 months post baseline
Age at vaccination
Time frame: Monthly, up to 36 months post baseline
Time to series completion
Time frame: Monthly, up to 36 months post baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2023.
- Derived from this study: PubMed 36550466Chang RS, Shing JZ, Erves JC, Du L, Koyama T, Deppen S, Rentuza AB, McAfee C, Stroebel C, Cates J, Harnack L, Andrews D, Bramblett R, Hull PC. Measurement of provider fidelity to immunization guidelines: a mixed-methods study on the feasibility of documenting patient refusals of the human papillomavirus vaccine. BMC Med Inform Decis Mak. 2022 Dec 22;22(1):339. doi: 10.1186/s12911-022-02083-2.
- Individual participant dataSharing planned: Yes. Data collected from providers and staff (surveys and interviews) will be made available to other researchers upon request. All individual identifiers will be stripped to ensure confidentiality and privacy of study participants.
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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.
Pamela C Hull, PhD principal investigator
Vanderbilt University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Practice facilitation for HPV vaccine in people with HPV Vaccines, run by Pamela Hull 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 5 Dec 2023. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Age-appropriate completion rate (ages 13-17) (time frame: Annually, up to 3 years post baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03399396, which also lists 1 linked publication.
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 Dec 2023.