Human Papillomavirus (HPV) VaccinesNCT03429413
Maximizing HPV Vaccination: Real-time Reminders, Guidance, and Recommendations - Part 4: Feasibility Trial
A study testing Protect Me 4 Application + External Quality Improvement Support and Protect Me 4 Application Alone in people with Human Papillomavirus (HPV) Vaccines, run by University of Florida at 1 site in United States.
Trial summary
Human papillomavirus (HPV) vaccines have potential to prevent an average of 26,900 cancer cases each year in the United States, but vaccine coverage rates remain low. The study team has developed an electronic application (app), Protect Me 4, to help parents and providers assess and have more productive conversations… Read more about this study
- Who is it for?
- Ages 18 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Human Papillomavirus (HPV) Vaccines
- What is being tested?
- Protect Me 4 Application + External Quality Improvement Support and Protect Me 4 Application Alone
- Type of treatment
- Vaccines, Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,296 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Sep 2027to 15 Sep 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 to 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Must be parent of an adolescent aged 11-12 years old.
- Providers working with age appropriate for study adolescents at the intervention clinics
- Adolescents/Parents/Providers willing to consent to participation
- Adolescents/Parents that can read and speak English
Who cannot join
- Adolescents out of the age range for participation
- Adolescents/Parents/Providers unwilling to consent to participation
- Adolescents/Parents that can NOT read and speak English
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Marta Hansen contact
About this study
Human papillomavirus (HPV) vaccines have potential to prevent an average of 26,900 cancer cases each year in the United States, but vaccine coverage rates remain low. The study team has developed an electronic application (app), Protect Me 4, to help parents and providers assess and have more productive conversations about needed vaccines.
The specific aims of this study are to: (1) evaluate the feasibility of implementing Protect Me 4, and (2) estimate preliminary efficacy of Protect Me 4 to increase HPV vaccine initiation (receipt of first dose).
Read the detailed description
Human papillomavirus (HPV) vaccines have potential to prevent an average of 26,900 cancer cases each year in the United States, but vaccine coverage rates remain low. The study team has developed a health information technology (HIT) electronic application (app), Protect Me 4, to help parents and providers assess and have more productive conversations about needed vaccines.
In past studies, Protect Me 4 users have demonstrated three times higher chances of initiating the HPV vaccine. Despite this promise, Protect Me 4 system implementation suffered from very low reach within clinics. In this phase of the project, the investigators will assess the feasibility of implementing Protect Me 4 in community clinics, as well as test vaccination rate data collection strategies and estimate the preliminary efficacy of Protect Me 4 to increase HPV vaccine initiation. Seven clinics will participate in the study, and three will be randomly assigned the use of Protect Me 4. Three of the clinics will act as controls and will not receive Protect Me 4. The final clinic will receive the intervention (but has not participated in any of the intervention development. This clinic will s as a demonstration clinic for the subsequent R01.
For evaluation, vaccination records will be grouped in three-month periods [initial (months 1-3), implementation (months 4-6) and maintenance (months 7-9)] from Medicaid and CHIP (Children's Health Insurance Program) claims and Florida Immunization Registry data. During the implementation period (months 4-6), intervention clinics will receive the Protect Me 4 app and External Quality Improvement Support (practice facilitation and external and internal provider peer opinion leaders and provider incentives). During the maintenance period (months 7-9), intervention clinics will receive Protect Me 4 without external support (practice facilitation and external provider peer opinion leaders).
To evaluate effectiveness at the individual-level, the study team will compare vaccination rates between eligible adolescents who visited intervention and control clinics across the three time periods.
- Conditions
- Human Papillomavirus (HPV) Vaccines
- Being tested
- Protect Me 4 Application + External Quality Improvement Support, Protect Me 4 Application Alone
- Keywords
- Health Information Technology (HIT)
- Medical subject headings
- Papillomavirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Protect Me 4 Application + External Quality Improvement SupportBehavioural
Participants will be asked to interact with the Protect Me 4 application, using an iPad tablet. During the implementation period (months 4-6), intervention clinics will receive the Protect Me 4 app and External Quality Improvement Support (practice facilitation and external and internal provider peer opinion leaders and provider incentives). Providers from intervention clinics will complete audit and feedback reports to assess HPV vaccination rates with the assistance of the practice facilitator. Providers at the intervention clinic will complete a pre-intervention survey to obtain background information (demographics, approximate HPV vaccination rates, comfort with the use of technology etc.)
Protect Me 4 Application AloneBehavioural
Also called Enhanced HIT System Intervention
During the maintenance period (months 7-9), intervention clinics will receive Protect Me 4 without external support (practice facilitation and external provider peer opinion leaders). Providers from intervention clinics will complete audit and feedback reports to assess HPV vaccination rates without the assistance of the practice facilitator. Providers at the intervention clinic will complete a post-intervention survey to gain provider feedback regarding the feasibility of Protect Me 4 and changes in perceptions regarding the use of technology.
| Study group | Role | What they receive |
|---|---|---|
| Parents | Active comparator | Parents of 11-12 year old children who visit participating interventional clinics during study period. Receives: Behavioral: Protect Me 4 Application + External Quality Improvement Support; Behavioral: Protect Me 4 Application Alone |
| Health Care Provider | Active comparator | Health care providers and clinic staff for 11-12 year old patients at 4 participating pediatric clinics. Receives: Behavioral: Protect Me 4 Application + External Quality Improvement Support; Behavioral: Protect Me 4 Application Alone |
| Adolescents at Intervention clinics | No intervention | Adolescents between 11-12 years of age. Adolescent vaccination data is used in the study, adolescents will assent to participate. The parents, however, use the HIT system. |
| Adolescents at Control Clinic | No intervention | Parents of 11-12 year old children who visit participating control clinics during study period. |
| Health Care Provider at Control Clinic | No intervention | Health care providers and clinic staff for 11-12 year old patients at 3 participating pediatric control clinics. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reach - Feasibility
Goal will be to have 80% of the parents of 11-12 year olds offered the Protect Me 4 app.
Measured: After month 9
Adoption - Feasibility
Goal will be to have 70% of parents complete the Protect Me 4 app for each provider. App will be considered feasible of 80% or more of providers use the app during the study.
Measured: After month 9
Provider-level Implementation - Feasibility
Goal will be to have providers report using the discussion tips approximately half the time they are provided and offering HPV vaccine 75% of the time it is due. App will be considered feasible if providers view shot lists for 60% of their patients with screens indicating that shots are due. Will aim for providers to look at specific hesitations reported by parents 60% of the time they login to the app and hesitations are reported.
Measured: After month 9
Parent-level Implementation - Feasibility
Goal will be to have 95% of people who start the app successfully enter the app and 80% agree to participate (consent and assent.)
Measured: After month 9
Maintenance - Feasibility
During months 7-9, the study team will assess clinic and provider maintenance of use of the Protect Me 4 app
Measured: Months 7-9
Acceptability - Feasibility
At both the end of the implementation and the maintenance period, providers will complete the Post Intervention Survey.
Measured: Month 6, Month 9
Secondary outcomes (2)
Data Collection Strategy
Analysis of de-identified participant datasets linked to clinic records, HIT participation date, and vaccinations from the Florida Medicaid and CHIP claims or the Florida Immunization Registry data.
Measured: After month 9
Efficacy Measurements
Determination of HPV vaccine initiation using Current Procedural Terminology (CPT) and Current Vaccine Administered (CVX) codes
Measured: After month 9
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2018
- Study start15 Sep 2027 (estimated)
- Primary completion15 Sep 2028 (estimated)
- Study completion15 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Human Papillomavirus (HPV) VaccinesStudies of the same condition, open and under way.
- More trials run by University of FloridaThe 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
- Model description
- Clinics are randomly assigned to use the intervention app or not. A 5th clinic, will use the app, but has not been involved in the app development.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 1,296 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI), Patient-Centered Outcomes Research Institute
- Responsible party
- Sponsor
- Investigators
- Stephanie Staras, PhD, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03429413
- Sponsor's protocol ID
- IRB201701537 -N
- Other IDs
- R21CA202011, OCR19940
- Status last verified
- Sep 2026
- First submitted
- 5 Feb 2018
- Last updated
- 14 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Maximizing HPV Vaccination: Real-time Reminders, Guidance, and Recommendations - Part 4: Feasibility Trial
- ClinicalTrials.gov ID
- NCT03429413
- Acronym / sponsor ID
- IRB201701537 -N
- Conditions
- Human Papillomavirus (HPV) Vaccines
- Keywords
- Health Information Technology (HIT)
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,296 participants (estimated)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI), Patient-Centered Outcomes Research Institute
- Study start
- 15 Sep 2027 (estimated)
- Primary completion
- 15 Sep 2028 (estimated)
- Study completion
- 15 Sep 2028 (estimated)
- First posted
- 12 Feb 2018 (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) vaccines have potential to prevent an average of 26,900 cancer cases each year in the United States, but vaccine coverage rates remain low. The study team has developed an electronic application (app), Protect Me 4, to help parents and providers assess and have more productive conversations about needed vaccines.
The specific aims of this study are to: (1) evaluate the feasibility of implementing Protect Me 4, and (2) estimate preliminary efficacy of Protect Me 4 to increase HPV vaccine initiation (receipt of first dose).
Detailed description
Human papillomavirus (HPV) vaccines have potential to prevent an average of 26,900 cancer cases each year in the United States, but vaccine coverage rates remain low. The study team has developed a health information technology (HIT) electronic application (app), Protect Me 4, to help parents and providers assess and have more productive conversations about needed vaccines.
In past studies, Protect Me 4 users have demonstrated three times higher chances of initiating the HPV vaccine. Despite this promise, Protect Me 4 system implementation suffered from very low reach within clinics. In this phase of the project, the investigators will assess the feasibility of implementing Protect Me 4 in community clinics, as well as test vaccination rate data collection strategies and estimate the preliminary efficacy of Protect Me 4 to increase HPV vaccine initiation. Seven clinics will participate in the study, and three will be randomly assigned the use of Protect Me 4. Three of the clinics will act as controls and will not receive Protect Me 4. The final clinic will receive the intervention (but has not participated in any of the intervention development. This clinic will s as a demonstration clinic for the subsequent R01.
For evaluation, vaccination records will be grouped in three-month periods [initial (months 1-3), implementation (months 4-6) and maintenance (months 7-9)] from Medicaid and CHIP (Children's Health Insurance Program) claims and Florida Immunization Registry data. During the implementation period (months 4-6), intervention clinics will receive the Protect Me 4 app and External Quality Improvement Support (practice facilitation and external and internal provider peer opinion leaders and provider incentives). During the maintenance period (months 7-9), intervention clinics will receive Protect Me 4 without external support (practice facilitation and external provider peer opinion leaders).
To evaluate effectiveness at the individual-level, the study team will compare vaccination rates between eligible adolescents who visited intervention and control clinics across the three time periods.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 5
- Model description
- Clinics are randomly assigned to use the intervention app or not. A 5th clinic, will use the app, but has not been involved in the app development.
| Arm | Type | Receives |
|---|---|---|
| Parents | Active comparator | Behavioral: Protect Me 4 Application + External Quality Improvement Support, Behavioral: Protect Me 4 Application AloneParents of 11-12 year old children who visit participating interventional clinics during study period. |
| Health Care Provider | Active comparator | Behavioral: Protect Me 4 Application + External Quality Improvement Support, Behavioral: Protect Me 4 Application AloneHealth care providers and clinic staff for 11-12 year old patients at 4 participating pediatric clinics. |
| Adolescents at Intervention clinics | No intervention | –Adolescents between 11-12 years of age. Adolescent vaccination data is used in the study, adolescents will assent to participate. The parents, however, use the HIT system. |
| Adolescents at Control Clinic | No intervention | –Parents of 11-12 year old children who visit participating control clinics during study period. |
| Health Care Provider at Control Clinic | No intervention | –Health care providers and clinic staff for 11-12 year old patients at 3 participating pediatric control clinics. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Must be parent of an adolescent aged 11-12 years old.
- Providers working with age appropriate for study adolescents at the intervention clinics
- Adolescents/Parents/Providers willing to consent to participation
- Adolescents/Parents that can read and speak English
Key exclusion criteria (3 listed)
- Adolescents out of the age range for participation
- Adolescents/Parents/Providers unwilling to consent to participation
- Adolescents/Parents that can NOT read and speak 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 |
|---|---|---|
| Protect Me 4 Application + External Quality Improvement SupportParticipants will be asked to interact with the Protect Me 4 application, using an iPad tablet. During the implementation period (months 4-6), intervention clinics will receive the Protect Me 4 app and External Quality Improvement Support (practice facilitation and external and internal provider peer opinion leaders and provider incentives). Providers from intervention clinics will complete audit and feedback reports to assess HPV vaccination rates with the assistance of the practice facilitator. Providers at the intervention clinic will complete a pre-intervention survey to obtain background information (demographics, approximate HPV vaccination rates, comfort with the use of technology etc.) | Behavioural | Health Care Provider, Parents |
| Protect Me 4 Application AloneAlso: Enhanced HIT System InterventionDuring the maintenance period (months 7-9), intervention clinics will receive Protect Me 4 without external support (practice facilitation and external provider peer opinion leaders). Providers from intervention clinics will complete audit and feedback reports to assess HPV vaccination rates without the assistance of the practice facilitator. Providers at the intervention clinic will complete a post-intervention survey to gain provider feedback regarding the feasibility of Protect Me 4 and changes in perceptions regarding the use of technology. | Behavioural | Health Care Provider, Parents |
Primary outcome
Reach - Feasibility
Time frame: After month 9
Goal will be to have 80% of the parents of 11-12 year olds offered the Protect Me 4 app.
Adoption - Feasibility
Time frame: After month 9
Goal will be to have 70% of parents complete the Protect Me 4 app for each provider. App will be considered feasible of 80% or more of providers use the app during the study.
Provider-level Implementation - Feasibility
Time frame: After month 9
Goal will be to have providers report using the discussion tips approximately half the time they are provided and offering HPV vaccine 75% of the time it is due. App will be considered feasible if providers view shot lists for 60% of their patients with screens indicating that shots are due. Will aim for providers to look at specific hesitations reported by parents 60% of the time they login to the app and hesitations are reported.
Parent-level Implementation - Feasibility
Time frame: After month 9
Goal will be to have 95% of people who start the app successfully enter the app and 80% agree to participate (consent and assent.)
Maintenance - Feasibility
Time frame: Months 7-9
During months 7-9, the study team will assess clinic and provider maintenance of use of the Protect Me 4 app
Acceptability - Feasibility
Time frame: Month 6, Month 9
At both the end of the implementation and the maintenance period, providers will complete the Post Intervention Survey.
2 secondary outcomes
Data Collection Strategy
Time frame: After month 9
Efficacy Measurements
Time frame: After month 9
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2026.
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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.
Marta Hansen contact
Stephanie Staras, PhD principal investigator
University of Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Protect Me 4 Application + External Quality Improvement Support and Protect Me 4 Application Alone in people with Human Papillomavirus (HPV) Vaccines, run by University of Florida 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 4 inclusion and 3 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: opening soon, as of the sponsor's last update on 14 Sep 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Stephanie Staras, PhD (352-294 8299, sstaras@ufl.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reach - Feasibility (time frame: After month 9). The study lists 6 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 14 Sep 2026.