HPV Immunization StatusNCT02456077
Strengthening Physician Communication About HPV Vaccines
A study testing Multimodal Vaccine Program in people with HPV Immunization Status, run by University of Colorado, Denver at 1 site in United States.
Trial summary
The purpose of this study is to determine if a multimodal Human Papillomavirus (HPV) immunization program carried out in pediatric and family medicine practices would be more effective in improving adolescent patients' HPV immunization rates than the usual care provided to adolescents in pediatric and family medicine… Read more about this study
- Who is it for?
- Ages 9 years and olderHealthy volunteers can take part
- Conditions the study is for
- HPV Immunization Status
- What is being tested?
- Multimodal Vaccine Program
- Type of treatment
- Vaccines, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 93,582 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2015to 31 Jan 2016
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 9 years of age or older when presenting for care
- Patients who present for care one year prior to the start of the intervention and up to two years after the start of the intervention
Who cannot join
- Less than 9 years of age when presenting for care
- Patient is not eligible for HPV immunization
- Provider survey:
- Providers who are working at participating practices during the two times a cross-sectional survey is administered.
- Parent survey:
- Parents of adolescents who presented for care within one 1 year prior to the two times a cross-sectional survey is administration.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Colorado Denver
Aurora, Colorado, 80045
About this study
The purpose of this study is to determine if a multimodal Human Papillomavirus (HPV) immunization program carried out in pediatric and family medicine practices would be more effective in improving adolescent patients' HPV immunization rates than the usual care provided to adolescents in pediatric and family medicine practices.
- Conditions
- HPV Immunization Status
- Being tested
- Multimodal Vaccine Program
- Keywords
- MCV4: Meningococcal Conjugate Vaccine, HPV: Human Papillomavirus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multimodal Vaccine ProgramBehavioural
Efforts will be made to collaborate with pediatric and family medicine offices to utilize a multimodal intervention to improve adolescents' HPV immunization rates. As part of the overall intervention, four intervention strategies will be used: 1) a tailored website, iVac -HPV , 2) Motivational Interview Training for providers, 3) HPV Fact Sheets and 4) The Decision Aid for HPV Vaccines
| Study group | Role | What they receive |
|---|---|---|
| Intervention Practices | Experimental | Intervention offices will adopt a multi-modal vaccine program to increase their patients' vaccine rates. Receives: Behavioral: Multimodal Vaccine Program |
| Control Practices | No intervention | Control offices will offer usual health care related to immunizations throughout the duration of the study. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The percentage of adolescents who initiate the HPV vaccine series
The percent of eligible patients presenting for care at intervention offices who receive one or more HPV vaccines (using administrative, Electronic Medical Records (EMR), and Colorado Immunization Information System (CIIS) immunization data), during the intervention year, compared to the percent in control offices.
Measured: 1 year
Secondary outcomes (4)
The percentage of adolescents who receive MCV4 vaccine
The percent of eligible patients presenting for care at intervention offices who receive MCV4 vaccine (using administrative, EMR and CIIS immunization data) compared to the percent in control offices.
Measured: 1 year
The percentage of adolescents who receive Tdap vaccine
The percentage of eligible patients presenting for care at intervention offices who receive Tetanus, Diphtheria, Pertussis (Tdap) vaccine (using administrative, EMR and CIIS immunization data) during the intervention year compared to the percent in control offices.
Measured: 1 year
Provider HPV vaccine recommendations
The change in intervention providers' HPV vaccine communication practices compared to control providers' as measured by self-report prior to the intervention and after the intervention.
Measured: 1 year
Parents' experiences and preferences regarding provider communication about HPV vaccines
The change in intervention parents' experiences and preferences regarding provider HPV vaccine communication compared to parents of adolescents attending control practices as measured by self report prior to the intervention and after the intervention.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2015 (estimated)
- Study start1 Feb 2015
- Primary completion31 Jan 2016
- Study completion31 Jan 2016
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 Immunization StatusStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 93,582 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Collaborators
- Centers for Disease Control and Prevention
- Responsible party
- Sponsor
- Investigators
- Amanda Dempsey, MD, PhD, MPH, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02456077
- Sponsor's protocol ID
- 13-2785
- Status last verified
- Jun 2019
- First submitted
- 26 May 2015
- Last updated
- 24 Jun 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
Dempsey AF, Pyrznawoski J, Lockhart S, Barnard J, Campagna EJ, Garrett K, Fisher A, Dickinson LM, O'Leary ST. Effect of a Health Care Professional Communication Training Intervention on Adolescent Human Papillomavirus Vaccination: A Cluster Randomized Clinical Trial. JAMA Pediatr. 2018 May 7;172(5):e180016. doi: 10.1001/jamapediatrics.2018.0016. Epub 2018 May 7.
PubMed 29507952
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Strengthening Physician Communication About HPV Vaccines
- ClinicalTrials.gov ID
- NCT02456077
- Acronym / sponsor ID
- 13-2785
- Conditions
- HPV Immunization Status
- Keywords
- MCV4: Meningococcal Conjugate Vaccine, HPV: Human Papillomavirus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 93,582 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- Centers for Disease Control and Prevention
- Study start
- 1 Feb 2015 (actual)
- Primary completion
- 31 Jan 2016 (actual)
- Study completion
- 31 Jan 2016 (actual)
- First posted
- 28 May 2015 (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.
The purpose of this study is to determine if a multimodal Human Papillomavirus (HPV) immunization program carried out in pediatric and family medicine practices would be more effective in improving adolescent patients' HPV immunization rates than the usual care provided to adolescents in pediatric and family medicine practices.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Practices | Experimental | Behavioral: Multimodal Vaccine ProgramIntervention offices will adopt a multi-modal vaccine program to increase their patients' vaccine rates. |
| Control Practices | No intervention | –Control offices will offer usual health care related to immunizations throughout the duration of the study. |
Who may qualify
- Ages
- 9 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- 9 years of age or older when presenting for care
- Patients who present for care one year prior to the start of the intervention and up to two years after the start of the intervention
Key exclusion criteria (6 listed)
- Less than 9 years of age when presenting for care
- Patient is not eligible for HPV immunization
- Providers who are working at participating practices during the two times a cross-sectional survey is administered.
- Parents of adolescents who presented for care within one 1 year prior to the two times a cross-sectional survey is administration.
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 |
|---|---|---|
| Multimodal Vaccine ProgramEfforts will be made to collaborate with pediatric and family medicine offices to utilize a multimodal intervention to improve adolescents' HPV immunization rates. As part of the overall intervention, four intervention strategies will be used: 1) a tailored website, iVac -HPV , 2) Motivational Interview Training for providers, 3) HPV Fact Sheets and 4) The Decision Aid for HPV Vaccines | Behavioural | Intervention Practices |
Primary outcome
The percentage of adolescents who initiate the HPV vaccine series
Time frame: 1 year
The percent of eligible patients presenting for care at intervention offices who receive one or more HPV vaccines (using administrative, Electronic Medical Records (EMR), and Colorado Immunization Information System (CIIS) immunization data), during the intervention year, compared to the percent in control offices.
4 secondary outcomes
The percentage of adolescents who receive MCV4 vaccine
Time frame: 1 year
The percentage of adolescents who receive Tdap vaccine
Time frame: 1 year
Provider HPV vaccine recommendations
Time frame: 1 year
Parents' experiences and preferences regarding provider communication about HPV vaccines
Time frame: 1 year
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 24 Jun 2019.
- Derived from this study: PubMed 29507952Dempsey AF, Pyrznawoski J, Lockhart S, Barnard J, Campagna EJ, Garrett K, Fisher A, Dickinson LM, O'Leary ST. Effect of a Health Care Professional Communication Training Intervention on Adolescent Human Papillomavirus Vaccination: A Cluster Randomized Clinical Trial. JAMA Pediatr. 2018 May 7;172(5):e180016. doi: 10.1001/jamapediatrics.2018.0016. Epub 2018 May 7.
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.
Amanda Dempsey, MD, PhD, MPH principal investigator
University of Colorado, Denver
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multimodal Vaccine Program in people with HPV Immunization Status, run by University of Colorado, Denver 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 2 inclusion and 6 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 24 Jun 2019. 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?
The percentage of adolescents who initiate the HPV vaccine series (time frame: 1 year). 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 NCT02456077, 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 24 Jun 2019; AzTrials last refreshed its copy on 6 Nov 2026.