Human Papillomavirus (HPV)NCT03111251
Multi-component Interventions to Increase HPV Vaccination in a Network of Pediatric Clinics
A study testing Provider assessment and feedback, Provider reminders and Provider education in people with Human Papillomavirus (HPV), run by The University of Texas Health Science Center, Houston at 1 site in United States.
Trial summary
The purpose of the study is to determine the comparative effectiveness of a provider-only intervention and a parent plus provider intervention to increase initiation of HPV vaccination among male and female patients ages 11-17 in a large pediatric clinic network in the greater Houston area. Read more about this study
- Who is it for?
- Ages 11 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Human Papillomavirus (HPV)
- What is being tested?
- Provider assessment and feedback, Provider reminders and Provider education
- Type of treatment
- Vaccines, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,000 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2015to 28 Feb 2019
- 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
Who may be able to join
- Patient at a Texas Children's Pediatrics clinic
- Patient had not initiated the HPV vaccination series at baseline
Who cannot join
- Patient had completed the HPV vaccination series at baseline
Trial locations and contacts
1 site in 1 country.
United States1 site
The University of Texas Health Science Center at Houston
Houston, Texas, 77030
About this study
Official title: Multi-component Interventions for Patients and Providers to Increase HPV Vaccination in a Network of Pediatric Clinics in Houston, TX
The purpose of the study is to determine the comparative effectiveness of a provider-only intervention and a parent plus provider intervention to increase initiation of HPV vaccination among male and female patients ages 11-17 in a large pediatric clinic network in the greater Houston area. The hypothesis is that HPV vaccine initiation will be higher in clinics randomized to the parent plus provider intervention compared with clinics randomized to the provider-only intervention.
- Conditions
- Human Papillomavirus (HPV)
- Being tested
- Provider assessment and feedback, Provider reminders, Provider education, Patient reminders, Parent education
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Provider assessment and feedbackBehavioural
Tailored immunization reports highlighting adolescent vaccination rates at the individual, clinic and network levels are distributed by clinic champions every quarter. Reports track vaccination rates over time and allow physicians to compare their rates to the national goal.
Provider remindersBehavioural
An EHR-based reminder system informs providers when patients are due or overdue for HPV vaccination.
Provider educationBehavioural
Provider education is being delivered through a comprehensive online continuing education activity that is tailored specifically to physicians, nurses, and clinical staff at TCP practices. It focuses on HPV vaccination best practices and communicating with parents about the HPV vaccine.
Patient remindersBehavioural
Patient reminders are delivered through MyChart, the clinics' online personal health record system, to inform patients (parents) that they are due or overdue for HPV vaccination.
Parent educationBehavioural
The parent education intervention (currently in development) will employ innovative strategies to identify and overcome barriers to HPV vaccination.
| Study group | Role | What they receive |
|---|---|---|
| Provider-only intervention | Experimental | New provider- and system-level evidence-based strategies for increasing HPV vaccination rates are being implemented throughout the entire clinic network. This includes provider assessment and feedback, provider reminders, provider education, and patient reminders. Receives: Behavioral: Provider assessment and feedback; Behavioral: Provider reminders; Behavioral: Provider education; Behavioral: Patient reminders |
| Provider plus parent intervention | Experimental | Clinics randomized to the provider plus parent intervention will receive both the provider intervention and the parent education intervention. Receives: Behavioral: Provider assessment and feedback; Behavioral: Provider reminders; Behavioral: Provider education; Behavioral: Patient reminders; Behavioral: Parent education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in percent of HPV vaccination initiation
Measured: baseline, 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2017
- Study start1 Mar 2015
- Primary completion28 Feb 2019
- Study completion28 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Human Papillomavirus (HPV)Studies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University of Texas Health Science Center, Houston
- Sponsor type
- University, hospital or other
- Collaborators
- Cancer Prevention Research Institute of Texas, Baylor College of Medicine
- Responsible party
- Principal investigator, Sally Vernon, The University of Texas Health Science Center, Houston
- Investigators
- Sally W Vernon, PhD, Principal investigator, The University of Texas Health Science Center, Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03111251
- Sponsor's protocol ID
- HSC-SPH-15-0202
- Status last verified
- May 2020
- First submitted
- 6 Apr 2017
- Last updated
- 21 May 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-component Interventions for Patients and Providers to Increase HPV Vaccination in a Network of Pediatric Clinics in Houston, TX
- ClinicalTrials.gov ID
- NCT03111251
- Acronym / sponsor ID
- HSC-SPH-15-0202
- Conditions
- Human Papillomavirus (HPV)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Collaborators
- Cancer Prevention Research Institute of Texas, Baylor College of Medicine
- Study start
- 1 Mar 2015 (actual)
- Primary completion
- 28 Feb 2019 (actual)
- Study completion
- 28 Feb 2019 (actual)
- First posted
- 12 Apr 2017 (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 purpose of the study is to determine the comparative effectiveness of a provider-only intervention and a parent plus provider intervention to increase initiation of HPV vaccination among male and female patients ages 11-17 in a large pediatric clinic network in the greater Houston area. The hypothesis is that HPV vaccine initiation will be higher in clinics randomized to the parent plus provider intervention compared with clinics randomized to the provider-only intervention.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Provider-only intervention | Experimental | Behavioral: Provider assessment and feedback, Behavioral: Provider reminders, Behavioral: Provider education, Behavioral: Patient remindersNew provider- and system-level evidence-based strategies for increasing HPV vaccination rates are being implemented throughout the entire clinic network. This includes provider assessment and feedback, provider reminders, provider education, and patient reminders. |
| Provider plus parent intervention | Experimental | Behavioral: Provider assessment and feedback, Behavioral: Provider reminders, Behavioral: Provider education, Behavioral: Patient reminders, Behavioral: Parent educationClinics randomized to the provider plus parent intervention will receive both the provider intervention and the parent education intervention. |
Who may qualify
- Ages
- 11 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Patient at a Texas Children's Pediatrics clinic
- Patient had not initiated the HPV vaccination series at baseline
Key exclusion criteria (1 listed)
- Patient had completed the HPV vaccination series at baseline
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 |
|---|---|---|
| Provider assessment and feedbackTailored immunization reports highlighting adolescent vaccination rates at the individual, clinic and network levels are distributed by clinic champions every quarter. Reports track vaccination rates over time and allow physicians to compare their rates to the national goal. | Behavioural | Provider plus parent intervention, Provider-only intervention |
| Provider remindersAn EHR-based reminder system informs providers when patients are due or overdue for HPV vaccination. | Behavioural | Provider plus parent intervention, Provider-only intervention |
| Provider educationProvider education is being delivered through a comprehensive online continuing education activity that is tailored specifically to physicians, nurses, and clinical staff at TCP practices. It focuses on HPV vaccination best practices and communicating with parents about the HPV vaccine. | Behavioural | Provider plus parent intervention, Provider-only intervention |
| Patient remindersPatient reminders are delivered through MyChart, the clinics' online personal health record system, to inform patients (parents) that they are due or overdue for HPV vaccination. | Behavioural | Provider plus parent intervention, Provider-only intervention |
| Parent educationThe parent education intervention (currently in development) will employ innovative strategies to identify and overcome barriers to HPV vaccination. | Behavioural | Provider plus parent intervention |
Primary outcome
Change in percent of HPV vaccination initiation
Time frame: baseline, 3 years
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 21 May 2020.
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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.
Sally W Vernon, PhD principal investigator
The University of Texas Health Science Center, Houston
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Provider assessment and feedback, Provider reminders and Provider education in people with Human Papillomavirus (HPV), run by The University of Texas Health Science Center, Houston 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 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 21 May 2020. 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?
Change in percent of HPV vaccination initiation (time frame: baseline, 3 years). 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 21 May 2020.