BehaviorNCT02812732
DOSE HPV: Development of Systems and Education to Improve HPV Vaccination Rates
A study testing DOSE HPV in people with Behavior, run by Boston Medical Center.
Trial summary
After completing over 600 interviews with parents, adolescents, and clinicians to determine reasons why HPV vaccines are used or not used, the investigators recently piloted a communication-based educational intervention with healthcare clinicians to improve communication around HPV vaccination. Read more about this study
- Who is it for?
- Ages 9 to 26 yearsHealthy volunteers can take part
- Conditions the study is for
- Behavior
- What is being tested?
- DOSE HPV
- Type of treatment
- Vaccines, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 382 participants
- Where
- No sites listed yet
- Study dates
- Apr 2016to 15 May 2018
- 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 9 to 26 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Receive primary care at intervention sites
- ages 9-26
Who cannot join
- do not receive primary care
- outside age range
About this study
After completing over 600 interviews with parents, adolescents, and clinicians to determine reasons why HPV vaccines are used or not used, the investigators recently piloted a communication-based educational intervention with healthcare clinicians to improve communication around HPV vaccination. The intervention combined education and quality improvement methods using a mechanism called Performance Improvement Continuing Medical Education. This type of intervention is attractive to clinicians because they improve their cancer prevention practices while fulfilling requirements for maintaining board certification. The intervention consists of seven education and feedback sessions along with baseline and follow-up chart reviews and facilitated group discussions of clinician and practice vaccination rates. The pilot intervention was effective: at the two pilot intervention sites, girls were 60% and boys were 15 times more likely to receive HPV vaccination than at control sites both during and after the intervention period.
The goal of the proposed research is to broadly test the intervention's effectiveness in a diverse group of pediatric and family medicine practices serving low-income and minority patients. First, the investigators will perform a randomized trial in five community health centers to determine the effectiveness of the intervention. Second, the investigators will examine what made the intervention successful and identify barriers to sustainability with the goal of ensuring that the intervention can be successfully replicated in other settings. Third, the investigators will explore the effects of the intervention on parent-clinician communication by surveying parents and clinicians and observing clinical encounters when vaccination is discussed.
The proposed intervention represents an innovative and scalable model for promoting cancer prevention and screening activities by clinicians. Unlike programs that increase administrative burdens on busy clinicians, the proposed intervention allows clinicians to improve cancer prevention practices while simultaneously fulfilling requirements to maintain their board certification and improving the quality of cancer prevention care. It therefore has great potential for widespread dissemination.
Read the detailed description
BACKGROUND
Human Papillomavirus (HPV) causes cervical, vaginal, vulvar, anal, and oral cancers, which disproportionately affect low-income and minority populations. Universal HPV vaccination has the potential to decrease burdens and to reduce disparities in these diseases. However, HPV vaccination rates for U.S. adolescents remain low. Clinician recommendation is the most important factor influencing HPV vaccine uptake; thus enhancing clinician communication about HPV vaccines is a critically important target for interventions to prevent cancer.
OBJECTIVE
In the past six years, the investigators' research has identified factors affecting HPV vaccine communication and utilization. the investigators recently piloted a communication intervention with clinicians, and at the two pilot intervention sites, girls were 60% and boys were 15 times more likely to receive HPV vaccination than at control sites both during and after the intervention period. The investigators aim to demonstrate the effectiveness of this intervention in a randomized trial, and to directly examine its effects on communication.
SPECIFIC AIMS
Aim 1. To evaluate intervention effectiveness on raising HPV vaccination rates using a stepped wedge randomized trial in federally qualified health centers.
Aim 2: To conduct a process evaluation that examines barriers and facilitators to intervention implementation and intervention sustainability, and to assess intervention fidelity.
Aim 3. To describe specific effects of the intervention on clinician-parent communication about HPV vaccination.
STUDY DESIGN
To address Aim 1, the investigators will perform a stepped wedge randomized trial in five community health centers to determine the effectiveness of the intervention. The intervention consists of a seven session Performance Improvement Continuing Medical Education (PI CME) program that employs HPV education and training in motivational interviewing to improve clinicians' HPV vaccine communication, and allows clinicians to improve the quality of vaccine care while fulfilling board certification requirements. To address Aim 2, the investigators will individually interview a selected group of providers and clinical leaders using the Promoting Action on Research Implementation in Health Services (PARiHS) model of process evaluation, and will analyze audio recordings of clinical interactions to measure intervention fidelity. Aim 3, an exploration of the intervention's effects on parent-clinician communication, will be conducted by surveying parents and clinicians and observing clinical encounters.
CANCER RELEVANCE
Rates of HPV related cancers have been increasing, but vaccination rates have remained stagnant since 2011. Recognizing the potential impact of HPV vaccination, the President's Cancer Panel stated in 2014 that raising HPV vaccination rates was a national priority. The proposed intervention represents an innovative and scalable model for promoting cancer prevention and screening activities by clinicians.
- Conditions
- Behavior
- Being tested
- DOSE HPV
- Keywords
- HPV vaccination, provider education
- Medical subject headings
- Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DOSE HPVBehavioural
The primary goals of the DOSE HPV intervention are to 1) change clinician HPV vaccine recommendations and responses to hesitant parents, and 2) support systems changes to improve the vaccination process. The first four sessions follow a standardized curriculum, while the last three sessions include development and implementation of tailored activities designed to meet individual practice needs.
Sessions 1 and 2 generate motivation for the project through feedback of vaccination rates (Session 1) and education on HPV disease (Session 2). Brief Negotiated Interview (BNI) skills are taught in Sessions 3\&4. Action Plans are developed in Session 5. Sessions 6\&7, which follow a standard quality improvement format: plan-do-study-act (PDSA) cycles.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Other | Providers at each clinic will receive the intervention (DOSE HPV) on a rolling basis. Vaccination rates will be compared pre- and post-intervention at each clinic, and changes in rates will be compared across clinics. Receives: Behavioral: DOSE HPV |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intervention effectiveness on increasing HPV vaccination rates using a stepped wedge randomized trial in federally qualified health centers.
Compare pre- and post-intervention rates of HPV vaccination
Measured: Outcomes are assessed up to 36 months from the start of the study.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2016 (estimated)
- Study startApr 2016
- Primary completion15 May 2018
- Study completion15 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for BehaviorStudies of the same condition, open and under way.
- More trials run by Boston Medical 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
- 382 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Boston University, American Cancer Society, Inc.
- Responsible party
- Principal investigator, Rebecca Perkins, Boston Medical Center
- Investigators
- Rebecca Perkins, MD, Principal investigator, Boston Medical Center/ Boston University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02812732
- Sponsor's protocol ID
- H-34561
- Status last verified
- Dec 2019
- First submitted
- 21 Jun 2016
- Last updated
- 2 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Perkins RB, Zisblatt L, Legler A, Trucks E, Hanchate A, Gorin SS. Effectiveness of a provider-focused intervention to improve HPV vaccination rates in boys and girls. Vaccine. 2015 Feb 25;33(9):1223-9. doi: 10.1016/j.vaccine.2014.11.021. Epub 2014 Nov 24.
PubMed 25448095Casey SM, Jansen E, Drainoni ML, Schuch TJ, Leschly KS, Perkins RB. Long-Term Multilevel Intervention Impact on Human Papillomavirus Vaccination Rates Spanning the COVID-19 Pandemic. J Low Genit Tract Dis. 2022 Jan 1;26(1):13-19. doi: 10.1097/LGT.0000000000000648.
PubMed 34928249Perkins RB, Legler A, Jansen E, Bernstein J, Pierre-Joseph N, Eun TJ, Biancarelli DL, Schuch TJ, Leschly K, Fenton ATHR, Adams WG, Clark JA, Drainoni ML, Hanchate A. Improving HPV Vaccination Rates: A Stepped-Wedge Randomized Trial. Pediatrics. 2020 Jul;146(1):e20192737. doi: 10.1542/peds.2019-2737. Epub 2020 Jun 15.
PubMed 32540986Perkins RB, Banigbe B, Fenton AT, O'Grady AK, Jansen EM, Bernstein JL, Joseph NP, Eun TJ, Biancarelli DL, Drainoni ML. Effect of a multi-component intervention on providers' HPV vaccine communication. Hum Vaccin Immunother. 2020 Nov 1;16(11):2736-2743. doi: 10.1080/21645515.2020.1747923. Epub 2020 May 13.
PubMed 32401592
Study at a glance
From the registry record, last updated by the sponsor on 2 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- DOSE HPV: Development of Systems and Education to Improve HPV Vaccination Rates
- ClinicalTrials.gov ID
- NCT02812732
- Acronym / sponsor ID
- H-34561
- Conditions
- Behavior
- Keywords
- HPV vaccination, provider education
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 382 participants (actual)
- Lead sponsor
- Boston Medical CenterUniversity, hospital or other
- Collaborators
- Boston University, American Cancer Society, Inc.
- Study start
- Apr 2016
- Primary completion
- 15 May 2018 (actual)
- Study completion
- 15 May 2018 (actual)
- First posted
- 24 Jun 2016 (estimated)
- 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.
After completing over 600 interviews with parents, adolescents, and clinicians to determine reasons why HPV vaccines are used or not used, the investigators recently piloted a communication-based educational intervention with healthcare clinicians to improve communication around HPV vaccination. The intervention combined education and quality improvement methods using a mechanism called Performance Improvement Continuing Medical Education. This type of intervention is attractive to clinicians because they improve their cancer prevention practices while fulfilling requirements for maintaining board certification. The intervention consists of seven education and feedback sessions along with baseline and follow-up chart reviews and facilitated group discussions of clinician and practice vaccination rates. The pilot intervention was effective: at the two pilot intervention sites, girls were 60% and boys were 15 times more likely to receive HPV vaccination than at control sites both during and after the intervention period.
The goal of the proposed research is to broadly test the intervention's effectiveness in a diverse group of pediatric and family medicine practices serving low-income and minority patients. First, the investigators will perform a randomized trial in five community health centers to determine the effectiveness of the intervention. Second, the investigators will examine what made the intervention successful and identify barriers to sustainability with the goal of ensuring that the intervention can be successfully replicated in other settings. Third, the investigators will explore the effects of the intervention on parent-clinician communication by surveying parents and clinicians and observing clinical encounters when vaccination is discussed.
The proposed intervention represents an innovative and scalable model for promoting cancer prevention and screening activities by clinicians. Unlike programs that increase administrative burdens on busy clinicians, the proposed intervention allows clinicians to improve cancer prevention practices while simultaneously fulfilling requirements to maintain their board certification and improving the quality of cancer prevention care. It therefore has great potential for widespread dissemination.
Detailed description
BACKGROUND
Human Papillomavirus (HPV) causes cervical, vaginal, vulvar, anal, and oral cancers, which disproportionately affect low-income and minority populations. Universal HPV vaccination has the potential to decrease burdens and to reduce disparities in these diseases. However, HPV vaccination rates for U.S. adolescents remain low. Clinician recommendation is the most important factor influencing HPV vaccine uptake; thus enhancing clinician communication about HPV vaccines is a critically important target for interventions to prevent cancer.
OBJECTIVE
In the past six years, the investigators' research has identified factors affecting HPV vaccine communication and utilization. the investigators recently piloted a communication intervention with clinicians, and at the two pilot intervention sites, girls were 60% and boys were 15 times more likely to receive HPV vaccination than at control sites both during and after the intervention period. The investigators aim to demonstrate the effectiveness of this intervention in a randomized trial, and to directly examine its effects on communication.
SPECIFIC AIMS
Aim 1. To evaluate intervention effectiveness on raising HPV vaccination rates using a stepped wedge randomized trial in federally qualified health centers.
Aim 2: To conduct a process evaluation that examines barriers and facilitators to intervention implementation and intervention sustainability, and to assess intervention fidelity.
Aim 3. To describe specific effects of the intervention on clinician-parent communication about HPV vaccination.
STUDY DESIGN
To address Aim 1, the investigators will perform a stepped wedge randomized trial in five community health centers to determine the effectiveness of the intervention. The intervention consists of a seven session Performance Improvement Continuing Medical Education (PI CME) program that employs HPV education and training in motivational interviewing to improve clinicians' HPV vaccine communication, and allows clinicians to improve the quality of vaccine care while fulfilling board certification requirements. To address Aim 2, the investigators will individually interview a selected group of providers and clinical leaders using the Promoting Action on Research Implementation in Health Services (PARiHS) model of process evaluation, and will analyze audio recordings of clinical interactions to measure intervention fidelity. Aim 3, an exploration of the intervention's effects on parent-clinician communication, will be conducted by surveying parents and clinicians and observing clinical encounters.
CANCER RELEVANCE
Rates of HPV related cancers have been increasing, but vaccination rates have remained stagnant since 2011. Recognizing the potential impact of HPV vaccination, the President's Cancer Panel stated in 2014 that raising HPV vaccination rates was a national priority. The proposed intervention represents an innovative and scalable model for promoting cancer prevention and screening activities by clinicians.
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 |
|---|---|---|
| Intervention | Other | Behavioral: DOSE HPVProviders at each clinic will receive the intervention (DOSE HPV) on a rolling basis. Vaccination rates will be compared pre- and post-intervention at each clinic, and changes in rates will be compared across clinics. |
Who may qualify
- Ages
- 9 to 26 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Receive primary care at intervention sites
- ages 9-26
Key exclusion criteria (2 listed)
- do not receive primary care
- outside age range
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 |
|---|---|---|
| DOSE HPVThe primary goals of the DOSE HPV intervention are to 1) change clinician HPV vaccine recommendations and responses to hesitant parents, and 2) support systems changes to improve the vaccination process. The first four sessions follow a standardized curriculum, while the last three sessions include development and implementation of tailored activities designed to meet individual practice needs. Sessions 1 and 2 generate motivation for the project through feedback of vaccination rates (Session 1) and education on HPV disease (Session 2). Brief Negotiated Interview (BNI) skills are taught in Sessions 3\&4. Action Plans are developed in Session 5. Sessions 6\&7, which follow a standard quality improvement format: plan-do-study-act (PDSA) cycles. | Behavioural | Intervention |
Primary outcome
Intervention effectiveness on increasing HPV vaccination rates using a stepped wedge randomized trial in federally qualified health centers.
Time frame: Outcomes are assessed up to 36 months from the start of the study.
Compare pre- and post-intervention rates of HPV vaccination
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 2 Jan 2020.
- Results publication: PubMed 25448095Perkins RB, Zisblatt L, Legler A, Trucks E, Hanchate A, Gorin SS. Effectiveness of a provider-focused intervention to improve HPV vaccination rates in boys and girls. Vaccine. 2015 Feb 25;33(9):1223-9. doi: 10.1016/j.vaccine.2014.11.021. Epub 2014 Nov 24.
- Derived from this study: PubMed 34928249Casey SM, Jansen E, Drainoni ML, Schuch TJ, Leschly KS, Perkins RB. Long-Term Multilevel Intervention Impact on Human Papillomavirus Vaccination Rates Spanning the COVID-19 Pandemic. J Low Genit Tract Dis. 2022 Jan 1;26(1):13-19. doi: 10.1097/LGT.0000000000000648.
- Derived from this study: PubMed 32540986Perkins RB, Legler A, Jansen E, Bernstein J, Pierre-Joseph N, Eun TJ, Biancarelli DL, Schuch TJ, Leschly K, Fenton ATHR, Adams WG, Clark JA, Drainoni ML, Hanchate A. Improving HPV Vaccination Rates: A Stepped-Wedge Randomized Trial. Pediatrics. 2020 Jul;146(1):e20192737. doi: 10.1542/peds.2019-2737. Epub 2020 Jun 15.
- Derived from this study: PubMed 32401592Perkins RB, Banigbe B, Fenton AT, O'Grady AK, Jansen EM, Bernstein JL, Joseph NP, Eun TJ, Biancarelli DL, Drainoni ML. Effect of a multi-component intervention on providers' HPV vaccine communication. Hum Vaccin Immunother. 2020 Nov 1;16(11):2736-2743. doi: 10.1080/21645515.2020.1747923. Epub 2020 May 13.
- 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.
Rebecca Perkins, MD principal investigator
Boston Medical Center/ Boston University School of Medicine
Questions about this trial
What is this clinical trial studying?
A study testing DOSE HPV in people with Behavior, run by Boston Medical Center.
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 2 inclusion and 2 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 2 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
Intervention effectiveness on increasing HPV vaccination rates using a stepped wedge randomized trial in federally qualified health centers. (time frame: Outcomes are assessed up to 36 months from the start of the study.). 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 NCT02812732, which also lists 4 linked publications.
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 2 Jan 2020.