Human Papilloma VirusNCT03824093
High and Low Resource Interventions to Promote HPV Vaccines
A study testing AFIX Only and AFIX+ Provider Communication Training in people with Human Papilloma Virus and Tdap - Tetanus, Diphtheria and Acellular Pertussis Vaccination, run by Children's Mercy Hospital Kansas City at 1 site in United States.
Trial summary
Human Papillomavirus (HPV) is a significant public health issue affecting nearly 14 million people in the United States. HPV can lead to cervical, oropharyngeal, anal, and penile cancers as well as genital warts.The purpose of this study is to test the comparative effectiveness of two interventions, AFIX only vs. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Human Papilloma Virus, Tdap - Tetanus, Diphtheria and Acellular Pertussis Vaccination, Meningitis, Meningococcal
- What is being tested?
- AFIX Only and AFIX+ Provider Communication Training
- Type of treatment
- Vaccines, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 225 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2018to 6 May 2020
- 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
- Parent or legal guardian of a child 11-18 years of age or a pediatric health care provider
- Parent or legal guardian of a child being seen for a well-child visit
- Ability to provide informed consent
Who cannot join
- Prior participation in the study
- Unable to read or understand English
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Mercy Hospital Kansas City
Kansas City, Missouri, 64108
About this study
Human Papillomavirus (HPV) is a significant public health issue affecting nearly 14 million people in the United States. HPV can lead to cervical, oropharyngeal, anal, and penile cancers as well as genital warts.The purpose of this study is to test the comparative effectiveness of two interventions, AFIX only vs. AFIX + communication training, to increase Human Papillomavirus (HPV) vaccination rates among adolescent patients in outpatient clinic settings. Providers and staff at four pediatric practices will be randomized to receive an in-person AFIX consultation or an AFIX consultation combined with communication training and commitment poster displays. Provider and parent data will be collected via a tablet computer RedCap survey. Additional practice and provider level HPV vaccination rates will be collected via patient de-identified claims data. The results of this study could contribute to the existing body of literature that suggests provider recommendations and routine vaccination assessments are key to increasing HPV vaccination uptake. This project has the potential to lead to the implementation and dissemination of low resource interventions to increase HPV vaccination rates among children and adolescents.
Read the detailed description
Significance: Human Papillomavirus (HPV) is the most common sexually transmitted infection in the United States with an estimated 14 million new infections each year. While most HPV infections resolve without any symptoms or signs of infection, some HPV infections can lead to genital warts and cancer. Every year, more than 30,000 people are affected by an HPV-related cancer, including cervical, oropharyngeal, vaginal and anal cancers. Because most adults will become infected with HPV at some point in their lives, the CDC recommends routine vaccination for girls aged 11-26 and boys aged 11-21. While vaccines to prevent HPV infection have been widely available for more than a decade nearly 38% of eligible girls and 50% of eligible boys have not initiated the HPV vaccine series and more than 70% of boys and 50% of girls have not completed the full vaccine series. Rates of HPV vaccination are significantly lower than rates for other adolescent recommended vaccines including, tetanus, diptheria, and acellular pertussis (Tdap), and meningococcal conjugate (MenACWY), which range from 81 to 86 percent. There are many factors that contribute to less than optimal HPV vaccination rates but chief among them is lack of a strong provider recommendation to initiate and complete the HPV vaccine series.
Innovation: This study will be the first randomized controlled trial comparing the effectiveness of an AFIX intervention vs. an AFIX intervention combined with a provider "nudge" that includes a brief communication skills training and commitment messaging displays to increase HPV vaccination rates in pediatric outpatient settings.
Approach: 200 eligible parents (or caregivers) of adolescents between the ages of 11 and 18 will be enrolled and exposed to one of the interventions based on their clinic location. Parents will be recruited from the Children's Mercy Hospital Primary Care Clinic (CMH PCC) and Cradle Thru College Care Pediatrics in Kansas City, MO, Preferred Pediatrics in Lee's Summit, MO, and Cass County Pediatrics in Belton,MO. Practices will be randomized to receive either an in-person AFIX assessment or an in-person AFIX assessment combined with a brief, provider communication training and adolescent vaccine commitment poster displays. The primary outcome of this study is HPV vaccination rates. A secondary outcome is parent ratings of satisfaction with their child's visit with the health care provider. Data will be collected via a tablet computer administered RedCap survey in the exam room immediately following the child's visit.
Public Health Impact: This study could have a significant public health impact and contribute to meeting the Healthy People 2020 goals to reduce vaccine preventable infections by increasing vaccination rates in the pediatric population.
- Conditions
- Human Papilloma Virus, Tdap - Tetanus, Diphtheria and Acellular Pertussis Vaccination, Meningitis, Meningococcal, Communication, Satisfaction
- Being tested
- AFIX Only, AFIX+ Provider Communication Training
- Keywords
- Adolescent Vaccines
- Medical subject headings
- Diphtheria, Meningitis, Meningococcal, Communication, Personal Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AFIX OnlyBehavioural
The intervention will include an in-person AFIX assessment of the practice's adolescent vaccination rates.
AFIX+ Provider Communication TrainingBehavioural
The intervention will include an in-person AFIX assessment of the practice's adolescent vaccination rates along with communication training for providers and poster and brochure displays.
| Study group | Role | What they receive |
|---|---|---|
| AFIX Only | Active comparator | Practices enrolled in the AFIX only arm will receive an in-person AFIX consultation that includes assessment of current HPV vaccination rates and feedback on strategies to increase vaccination rates. Receives: Behavioral: AFIX Only |
| AFIX+ Provider Communication Training | Active comparator | Practices enrolled in the AFIX+ Provider Training arm will receive an in-person AFIX consultation along with a brief communication training for providers and poster and brochure displays in clinic waiting and exam rooms. Receives: Behavioral: AFIX+ Provider Communication Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
HPV vaccination rates
Practice and provider level HPV vaccination rates will be collected from patient de-identified claims data.
Measured: 18 months
Secondary outcomes (1)
Parent Satisfaction
Parent satisfaction with visit will be collected using validated measures on tablet computers
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2019
- Study start1 Jul 2018
- Primary completion6 May 2020
- Study completion6 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Human Papilloma VirusStudies 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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 225 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Mercy Hospital Kansas City
- Sponsor type
- University, hospital or other
- Collaborators
- University of Kansas Medical Center, Midwest Cancer Alliance
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03824093
- Sponsor's protocol ID
- ChildrensMHC
- Status last verified
- Jan 2021
- First submitted
- 29 Jan 2019
- Last updated
- 20 Jan 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: We will create a clean, de-identified copy of our final dataset that will be available to other researcher groups, upon request, within 9 months of the end of the study period. Prior to data sharing, we will remove all identifying information. We will make data and associated documentation available to users under a data-sharing agreement.
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High and Low Resource Interventions to Promote HPV Vaccines
- ClinicalTrials.gov ID
- NCT03824093
- Acronym / sponsor ID
- ChildrensMHC
- Conditions
- Human Papilloma Virus, Tdap - Tetanus, Diphtheria and Acellular Pertussis Vaccination, Meningitis, Meningococcal, Communication, Satisfaction
- Keywords
- Adolescent Vaccines
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 225 participants (actual)
- Lead sponsor
- Children's Mercy Hospital Kansas CityUniversity, hospital or other
- Collaborators
- University of Kansas Medical Center, Midwest Cancer Alliance
- Study start
- 1 Jul 2018 (actual)
- Primary completion
- 6 May 2020 (actual)
- Study completion
- 6 May 2020 (actual)
- First posted
- 31 Jan 2019 (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.
Human Papillomavirus (HPV) is a significant public health issue affecting nearly 14 million people in the United States. HPV can lead to cervical, oropharyngeal, anal, and penile cancers as well as genital warts.The purpose of this study is to test the comparative effectiveness of two interventions, AFIX only vs. AFIX + communication training, to increase Human Papillomavirus (HPV) vaccination rates among adolescent patients in outpatient clinic settings. Providers and staff at four pediatric practices will be randomized to receive an in-person AFIX consultation or an AFIX consultation combined with communication training and commitment poster displays. Provider and parent data will be collected via a tablet computer RedCap survey. Additional practice and provider level HPV vaccination rates will be collected via patient de-identified claims data. The results of this study could contribute to the existing body of literature that suggests provider recommendations and routine vaccination assessments are key to increasing HPV vaccination uptake. This project has the potential to lead to the implementation and dissemination of low resource interventions to increase HPV vaccination rates among children and adolescents.
Detailed description
Significance: Human Papillomavirus (HPV) is the most common sexually transmitted infection in the United States with an estimated 14 million new infections each year. While most HPV infections resolve without any symptoms or signs of infection, some HPV infections can lead to genital warts and cancer. Every year, more than 30,000 people are affected by an HPV-related cancer, including cervical, oropharyngeal, vaginal and anal cancers. Because most adults will become infected with HPV at some point in their lives, the CDC recommends routine vaccination for girls aged 11-26 and boys aged 11-21. While vaccines to prevent HPV infection have been widely available for more than a decade nearly 38% of eligible girls and 50% of eligible boys have not initiated the HPV vaccine series and more than 70% of boys and 50% of girls have not completed the full vaccine series. Rates of HPV vaccination are significantly lower than rates for other adolescent recommended vaccines including, tetanus, diptheria, and acellular pertussis (Tdap), and meningococcal conjugate (MenACWY), which range from 81 to 86 percent. There are many factors that contribute to less than optimal HPV vaccination rates but chief among them is lack of a strong provider recommendation to initiate and complete the HPV vaccine series.
Innovation: This study will be the first randomized controlled trial comparing the effectiveness of an AFIX intervention vs. an AFIX intervention combined with a provider "nudge" that includes a brief communication skills training and commitment messaging displays to increase HPV vaccination rates in pediatric outpatient settings.
Approach: 200 eligible parents (or caregivers) of adolescents between the ages of 11 and 18 will be enrolled and exposed to one of the interventions based on their clinic location. Parents will be recruited from the Children's Mercy Hospital Primary Care Clinic (CMH PCC) and Cradle Thru College Care Pediatrics in Kansas City, MO, Preferred Pediatrics in Lee's Summit, MO, and Cass County Pediatrics in Belton,MO. Practices will be randomized to receive either an in-person AFIX assessment or an in-person AFIX assessment combined with a brief, provider communication training and adolescent vaccine commitment poster displays. The primary outcome of this study is HPV vaccination rates. A secondary outcome is parent ratings of satisfaction with their child's visit with the health care provider. Data will be collected via a tablet computer administered RedCap survey in the exam room immediately following the child's visit.
Public Health Impact: This study could have a significant public health impact and contribute to meeting the Healthy People 2020 goals to reduce vaccine preventable infections by increasing vaccination rates in the pediatric population.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AFIX Only | Active comparator | Behavioral: AFIX OnlyPractices enrolled in the AFIX only arm will receive an in-person AFIX consultation that includes assessment of current HPV vaccination rates and feedback on strategies to increase vaccination rates. |
| AFIX+ Provider Communication Training | Active comparator | Behavioral: AFIX+ Provider Communication TrainingPractices enrolled in the AFIX+ Provider Training arm will receive an in-person AFIX consultation along with a brief communication training for providers and poster and brochure displays in clinic waiting and exam rooms. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Parent or legal guardian of a child 11-18 years of age or a pediatric health care provider
- Parent or legal guardian of a child being seen for a well-child visit
- Ability to provide informed consent
Key exclusion criteria (2 listed)
- Prior participation in the study
- Unable to read or understand English
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 |
|---|---|---|
| AFIX OnlyThe intervention will include an in-person AFIX assessment of the practice's adolescent vaccination rates. | Behavioural | AFIX Only |
| AFIX+ Provider Communication TrainingThe intervention will include an in-person AFIX assessment of the practice's adolescent vaccination rates along with communication training for providers and poster and brochure displays. | Behavioural | AFIX+ Provider Communication Training |
Primary outcome
HPV vaccination rates
Time frame: 18 months
Practice and provider level HPV vaccination rates will be collected from patient de-identified claims data.
1 secondary outcome
Parent Satisfaction
Time frame: 18 months
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 20 Jan 2021.
- Individual participant dataSharing planned: Yes. We will create a clean, de-identified copy of our final dataset that will be available to other researcher groups, upon request, within 9 months of the end of the study period. Prior to data sharing, we will remove all identifying information. We will make data and associated documentation available to users under a data-sharing agreement.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AFIX Only and AFIX+ Provider Communication Training in people with Human Papilloma Virus and Tdap - Tetanus, Diphtheria and Acellular Pertussis Vaccination, run by Children's Mercy Hospital Kansas City 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 3 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 20 Jan 2021. 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?
HPV vaccination rates (time frame: 18 months). 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 20 Jan 2021.