Human Papillomavirus VirusNCT03000998
Web App Technology for Boys and Parents: Improving HPV Vaccine Uptake
A study testing Web App Intervention Group and Usual Customary Care Group in people with Human Papillomavirus Virus and HPV, run by Klein Buendel, Inc. at 3 sites in United States.
Trial summary
The uptake of vaccines for Human Papillomavirus (HPV) in the U.S. is far below recommended levels, particularly for adolescent boys and especially among minority families. Proposed here is a mobile web application ("mobile web app") for personal computers, smart phones, and tablet computers that will accurately inform… Read more about this study
- Who is it for?
- Ages 11 years and olderHealthy volunteers can take part
- Conditions the study is for
- Human Papillomavirus Virus, HPV
- What is being tested?
- Web App Intervention Group and Usual Customary Care Group
- Type of treatment
- Vaccines, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 432 participants
- Where
- 3 sitesUnited States
- Study dates
- 31 Jan 2017to 30 Jun 2022
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Adolescent boys:
- being male
- being 11-13 years old
- being a patient at a participating University of New Mexico (UNM) Hospital's Envision pediatric practice
- parental consent for testing, and
- child assent for testing
Show all 10Show fewer
- Parents/Guardians:
- being a parent/guardian of an eligible and participating 11-13 year old boy
- demonstrated ability to comprehend study requirements, and
- providing informed consent for oneself and assent for their youth's participation
Who cannot join
- Adolescent boys:
- another immediate family member is participating in the project (i.e., a sibling)
- the participant has already received any or all doses for the HPV vaccine, or
- the participant refuses to assent.
- Parents/Guardians:
- under the age of 18, or
- another immediate family member is participating in the project (i.e., another parent).
Trial locations and contacts
3 sites in 1 country.
United States3 sites
University of New Mexico
Albuquerque, New Mexico, 87131-0001
Klein Buendel, Inc.
Golden, Colorado, 80401
Indiana University
Indianapolis, Indiana, 46202-2915
About this study
The uptake of vaccines for Human Papillomavirus (HPV) in the U.S. is far below recommended levels, particularly for adolescent boys and especially among minority families. Proposed here is a mobile web application ("mobile web app") for personal computers, smart phones, and tablet computers that will accurately inform parents and adolescent boys about the HPV vaccination and address unique concerns about its safety and effectiveness for boys. The BoyVac mobile web app will be evaluated for its ability to improve vaccine outcomes in a randomized efficacy trial with parents and adolescent boys aged 11-13 years.
Read the detailed description
The President's Cancer Advisory Board and the Centers for Disease Control have called for renewed efforts in promoting vaccination for Human Papillomavirus (HPV), including vaccination for adolescent boys, because the uptake of this new vaccine remains alarmingly low. Currently, less than 15% of adolescent boys have received the HPV vaccine; thus, most of this population remains at risk for oropharyngeal, anal, and penile cancers. Many parents remain unconvinced of the safety and effectiveness of HPV vaccines, so effective and accessible messaging to improve decision-making on this vaccine is needed. Parents of adolescent boys also have different concerns about HPV vaccination than for adolescent girls, creating a need for unique health communication interventions to promote vaccine uptake among boys. Interventions also need to address the unique challenges of minority populations and populations for whom English is not the first language. A novel digital intervention will be produced and evaluated for its ability to improve HPV vaccine outcomes. Specifically, a mobile responsive web application ("mobile web app") will be created that performs similar to a mobile app but runs on a variety of computing platforms from personal desktop and laptop computers to the latest smart phones and tablet computers. Mobile web app content will be targeted to parents and adolescent boys aged 11-13 years. The specific aims are to: 1) carefully and systematically develop a mobile web app (BoyVac) for smart phones, tablet computers, and personal computers that will utilize Diffusion of Innovations principles to provide targeted information concerning HPV vaccine adoption to adolescent males and their parents, particularly minority adolescents and parents; 2) implement a comprehensive and rigorous test of the impact of the BoyVac mobile web app intervention on HPV vaccine adoption outcomes via a randomized efficacy trial (BoyVac v. usual and customary care); and 3) examine the dose-response relationships between mobile web app usage and vaccine outcomes within a components analysis. A group-randomized pretest-posttest controlled design will be implemented, recruiting 1800 pairs of parents and adolescent boys from 30 pediatric clinics (n=60 parents and boys per clinic). Parents will be surveyed at baseline, a 3-month follow-up, and a 9-month follow-up and records HPV vaccination adoption for the boys will be obtained from the clinics' medical records at the 9-month follow-up. Analyses will test the hypotheses that 1) more 11-13 year old boys in the intervention group (BoyVac mobile web app) will adopt the HPV vaccine than boys in the usual and customary care comparison group and 2) adoption of HPV vaccine will be mediated by improvements in theoretical mediators among parents in the intervention compared to the usual and customary care comparison group.
- Conditions
- Human Papillomavirus Virus, HPV
- Being tested
- Web App Intervention Group, Usual Customary Care Group
- Keywords
- HPV, Cancer
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Web App Intervention GroupBehavioural
All baseline and follow-up data collection will be conducted via online surveys and a customized web portal and include parent self-reports and clinic records of vaccination of boys
Usual Customary Care GroupBehavioural
Also called UC
Participants randomized to the usual and customary care (UC) group will receive a website with a pamphlet on HPV vaccination from the Centers for Disease Control and Prevention (CDC) in Portable Document Format (PDF) format.
| Study group | Role | What they receive |
|---|---|---|
| Web App Intervention Group | Experimental | The BoyVac mobile web app will be evaluated in a pair-matched group-randomized pretest-posttest controlled design. In Year 2, 30 clinics in New Mexico will be pair-matched and one member of each pair will be randomized to the intervention (mobile web app) or a usual and customary (UC) HPV vaccine adoption procedures comparison group. Clinics will be paired based on similarities in patient demographic (ethnicity and % Medicaid patients) and location (urban and rural). Receives: Behavioral: Web App Intervention Group |
| Usual Customary Care Group | Active comparator | Currently in pediatric clinics in New Mexico, the HPV vaccines are offered to parents and adolescents as part of annual well-child checkups. Typically for boys aged 11-13, parents initiate this checkup as part of a back-to-school activity. As part of the well-child checkup, clinic staff (physician, physician assistant and/or nurse) talk with parents and adolescents about the recommendation that their sons or daughters receive the HPV vaccination. Well-child pediatric visits to promote good health and development are recommended for all children from infancy through adolescence by the American Academy of Pediatrics. Receives: Behavioral: Usual Customary Care Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vaccine Initiation
Vaccine initiation - whether or not each boy received the HPV vaccine and the date of administration. Number of participants who received at least 1 dose.
Measured: 1 Month
Vaccine Adherence
Vaccine Adherence - whether participants adhered to the three-dose course of the HPV vaccination or not. 2nd dose and date received. Number of participants who received at least 2 doses.
Measured: 2 Months
Vaccine Adherence
Vaccine Adherence - whether participants adhered to the three-dose course of the HPV vaccination or not. 3rd dose and date received. Number of participants who received the 3 doses.
Measured: 4 months
Secondary outcomes (7)
Attitudes towards vaccination in general
Quantitative research in the form of an online survey will be conducted to examine attitudes towards vaccinations in general
Measured: Baseline, 3-month follow-up, and 9-month follow-up
Attitudes towards the HPV vaccine
Quantitative research in the form of an online survey will be conducted to examine attitudes towards the HPV vaccine
Measured: Baseline, 3-month follow-up, and 9-month follow-up
Perception of risk due to HPV and not being vaccinated
Quantitative research in the form of an online survey will be conducted to examine the perception of risk due to HPV and not being vaccinated.
Measured: Baseline, 3-month follow-up, and 9-month follow-up
Perception of negative and positive consequences associated with HPV vaccination
Quantitative research in the form of an online survey will be conducted to examine the perception of negative and positive consequences associated with HPV vaccination.
Measured: Baseline, 3-month follow-up, and 9-month follow-up
Self-efficacy to make informed decisions about HPV vaccination
Quantitative research in the form of an online survey will be conducted to examine the self-efficacy to make informed decisions about HPV vaccination
Measured: Baseline, 3-month follow-up, and 9-month follow-up
HPV knowledge
Quantitative research in the form of an online survey will be conducted to examine the participant's knowledge about HPV
Measured: Baseline, 3-month follow-up, and 9-month follow-up
Spousal support and social normative and cultural perceptions of receiving the HPV vaccination
Quantitative research in the form of an online survey will be conducted to examine the spousal support and social normative and cultural perceptions of receiving the HPV vaccination.
Measured: Baseline, 3-month follow-up, and 9-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2016 (estimated)
- Study start31 Jan 2017
- Primary completion30 Jun 2022
- Study completion30 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Human Papillomavirus 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 432 participants (actual)
Sponsor and investigators
- Lead sponsor
- Klein Buendel, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of New Mexico, Indiana University, National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Gill Woodall, PhD, Principal investigator, Klein Buendel, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03000998
- Sponsor's protocol ID
- 0310
- Other IDs
- 1R01CA210125-01A1
- Status last verified
- Feb 2023
- First submitted
- 21 Nov 2016
- Last updated
- 6 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Web App Technology for Boys and Parents: Improving HPV Vaccine Uptake
- ClinicalTrials.gov ID
- NCT03000998
- Acronym / sponsor ID
- 0310
- Conditions
- Human Papillomavirus Virus, HPV
- Keywords
- HPV, Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 432 participants (actual)
- Lead sponsor
- Klein Buendel, Inc.Industry (pharma, biotech, devices)
- Collaborators
- University of New Mexico, Indiana University, National Cancer Institute (NCI)
- Study start
- 31 Jan 2017 (actual)
- Primary completion
- 30 Jun 2022 (actual)
- Study completion
- 30 Jun 2022 (actual)
- First posted
- 22 Dec 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.
The uptake of vaccines for Human Papillomavirus (HPV) in the U.S. is far below recommended levels, particularly for adolescent boys and especially among minority families. Proposed here is a mobile web application ("mobile web app") for personal computers, smart phones, and tablet computers that will accurately inform parents and adolescent boys about the HPV vaccination and address unique concerns about its safety and effectiveness for boys. The BoyVac mobile web app will be evaluated for its ability to improve vaccine outcomes in a randomized efficacy trial with parents and adolescent boys aged 11-13 years.
Detailed description
The President's Cancer Advisory Board and the Centers for Disease Control have called for renewed efforts in promoting vaccination for Human Papillomavirus (HPV), including vaccination for adolescent boys, because the uptake of this new vaccine remains alarmingly low. Currently, less than 15% of adolescent boys have received the HPV vaccine; thus, most of this population remains at risk for oropharyngeal, anal, and penile cancers. Many parents remain unconvinced of the safety and effectiveness of HPV vaccines, so effective and accessible messaging to improve decision-making on this vaccine is needed. Parents of adolescent boys also have different concerns about HPV vaccination than for adolescent girls, creating a need for unique health communication interventions to promote vaccine uptake among boys. Interventions also need to address the unique challenges of minority populations and populations for whom English is not the first language. A novel digital intervention will be produced and evaluated for its ability to improve HPV vaccine outcomes. Specifically, a mobile responsive web application ("mobile web app") will be created that performs similar to a mobile app but runs on a variety of computing platforms from personal desktop and laptop computers to the latest smart phones and tablet computers. Mobile web app content will be targeted to parents and adolescent boys aged 11-13 years. The specific aims are to: 1) carefully and systematically develop a mobile web app (BoyVac) for smart phones, tablet computers, and personal computers that will utilize Diffusion of Innovations principles to provide targeted information concerning HPV vaccine adoption to adolescent males and their parents, particularly minority adolescents and parents; 2) implement a comprehensive and rigorous test of the impact of the BoyVac mobile web app intervention on HPV vaccine adoption outcomes via a randomized efficacy trial (BoyVac v. usual and customary care); and 3) examine the dose-response relationships between mobile web app usage and vaccine outcomes within a components analysis. A group-randomized pretest-posttest controlled design will be implemented, recruiting 1800 pairs of parents and adolescent boys from 30 pediatric clinics (n=60 parents and boys per clinic). Parents will be surveyed at baseline, a 3-month follow-up, and a 9-month follow-up and records HPV vaccination adoption for the boys will be obtained from the clinics' medical records at the 9-month follow-up. Analyses will test the hypotheses that 1) more 11-13 year old boys in the intervention group (BoyVac mobile web app) will adopt the HPV vaccine than boys in the usual and customary care comparison group and 2) adoption of HPV vaccine will be mediated by improvements in theoretical mediators among parents in the intervention compared to the usual and customary care comparison group.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Web App Intervention Group | Experimental | Behavioral: Web App Intervention GroupThe BoyVac mobile web app will be evaluated in a pair-matched group-randomized pretest-posttest controlled design. In Year 2, 30 clinics in New Mexico will be pair-matched and one member of each pair will be randomized to the intervention (mobile web app) or a usual and customary (UC) HPV vaccine adoption procedures comparison group. Clinics will be paired based on similarities in patient demographic (ethnicity and % Medicaid patients) and location (urban and rural). |
| Usual Customary Care Group | Active comparator | Behavioral: Usual Customary Care GroupCurrently in pediatric clinics in New Mexico, the HPV vaccines are offered to parents and adolescents as part of annual well-child checkups. Typically for boys aged 11-13, parents initiate this checkup as part of a back-to-school activity. As part of the well-child checkup, clinic staff (physician, physician assistant and/or nurse) talk with parents and adolescents about the recommendation that their sons or daughters receive the HPV vaccination. Well-child pediatric visits to promote good health and development are recommended for all children from infancy through adolescence by the American Academy of Pediatrics. |
Who may qualify
- Ages
- 11 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (10 listed)
- being male
- being 11-13 years old
- being a patient at a participating University of New Mexico (UNM) Hospital's Envision pediatric practice
- parental consent for testing, and
- child assent for testing
Key exclusion criteria (7 listed)
- another immediate family member is participating in the project (i.e., a sibling)
- the participant has already received any or all doses for the HPV vaccine, or
- the participant refuses to assent.
- under the age of 18, or
- another immediate family member is participating in the project (i.e., another parent).
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 |
|---|---|---|
| Web App Intervention GroupAll baseline and follow-up data collection will be conducted via online surveys and a customized web portal and include parent self-reports and clinic records of vaccination of boys | Behavioural | Web App Intervention Group |
| Usual Customary Care GroupAlso: UCParticipants randomized to the usual and customary care (UC) group will receive a website with a pamphlet on HPV vaccination from the Centers for Disease Control and Prevention (CDC) in Portable Document Format (PDF) format. | Behavioural | Usual Customary Care Group |
Primary outcome
Vaccine Initiation
Time frame: 1 Month
Vaccine initiation - whether or not each boy received the HPV vaccine and the date of administration. Number of participants who received at least 1 dose.
Vaccine Adherence
Time frame: 2 Months
Vaccine Adherence - whether participants adhered to the three-dose course of the HPV vaccination or not. 2nd dose and date received. Number of participants who received at least 2 doses.
Vaccine Adherence
Time frame: 4 months
Vaccine Adherence - whether participants adhered to the three-dose course of the HPV vaccination or not. 3rd dose and date received. Number of participants who received the 3 doses.
7 secondary outcomes
Attitudes towards vaccination in general
Time frame: Baseline, 3-month follow-up, and 9-month follow-up
Attitudes towards the HPV vaccine
Time frame: Baseline, 3-month follow-up, and 9-month follow-up
Perception of risk due to HPV and not being vaccinated
Time frame: Baseline, 3-month follow-up, and 9-month follow-up
Perception of negative and positive consequences associated with HPV vaccination
Time frame: Baseline, 3-month follow-up, and 9-month follow-up
Self-efficacy to make informed decisions about HPV vaccination
Time frame: Baseline, 3-month follow-up, and 9-month follow-up
HPV knowledge
Time frame: Baseline, 3-month follow-up, and 9-month follow-up
Spousal support and social normative and cultural perceptions of receiving the HPV vaccination
Time frame: Baseline, 3-month follow-up, and 9-month follow-up
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 6 Feb 2023.
- 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.
Gill Woodall, PhD principal investigator
Klein Buendel, Inc.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Web App Intervention Group and Usual Customary Care Group in people with Human Papillomavirus Virus and HPV, run by Klein Buendel, Inc. at 3 sites 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 10 inclusion and 7 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 6 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
Vaccine Initiation (time frame: 1 Month). The study lists 3 primary outcomes in all. 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 6 Feb 2023.