An interventional study of Protect Me 4 Application + External Quality Improvement Support and Protect Me 4 Application Alone in Human Papillomavirus (HPV) Vaccines, sponsored by University of Florida. Not yet recruiting at 1 site in United States. Open to participants aged 18 Years to 99 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-14.
Sponsored by University of Florida · Not applicable, Interventional, and Health services research
Help build ClinicalTrials.gg — short surveys, remote interviews or testing, in your language. Take part →
Among 166 studies in Papillomavirus Infections with a site in United States — 32 open to participants now, 60 under way, 5 of them phase 3. Papillomavirus Infections · United States.
Among the 166 studies in Papillomavirus Infections with a site in United States, this one is the 18th largest by planned enrollment of the 132 interventional ones that give a count, is one of 2 that started in 2027, is one of 53 with no phase, reaches primary completion later than 48 of the 59 other live ones, and was the 86th registered.
576 studies on the registry are indexed under Papillomavirus Infections; 132 are open to participants now.
Browse Papillomavirus Infections studies →32 of the 166 studies in Papillomavirus Infections with a site in United States are open now. Recruiting first, the newest first:
University of Maryland, Baltimore · Sites in United States
Ages 18+
Daré Bioscience, Inc. · Sites in United States
Ages 22–50 · Women only
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins · Sites in United States
Ages 18+ · Women only
Washington University School of Medicine · Sites in United States
Ages 25+ · Women only · Healthy volunteers
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins · Sites in United States
Ages 18+
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 85 Papillomavirus Infections studies recruiting now, 38 (45%) set no upper age limit and 42 (49%) stop at 75 or younger; 19 take children under 18; 36 take healthy volunteers.
This study: 18 Years to 99 Years · all sexes · healthy volunteers too.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
166 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 11 · Phase 2 48 · Phase 3 18 · Phase 4 8
First in 2003; this study’s year is marked. 2 started in 2027.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 1,296 is above the median of 235 across 402 interventional studies indexed under Papillomavirus Infections.
Median enrollment 128 across the 132 interventional studies, 197 across the 33 observational. Of the 95 that completed or were terminated, 47 (49%) have results posted.
This tab as a report to print or save as PDF → With an account.
45 of 166 have an industry lead sponsor. The 10 most frequent:
University of Florida is the lead sponsor of 1,288 studies on the registry; 200 are open to participants now.
Of its 180 completed or terminated interventional studies of FDA-regulated products, 143 (79%) have results posted.
University of Florida has 1 study filed under Papillomavirus Infections — fewer than ten, so there is no comparison to draw.
28 of the studies in Papillomavirus Infections with a site in United States that are under way reach primary completion within a year, 2 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07217145Phase 3University of UtahPREVENT HPV -Related Cancers Trial | 2026-11 |
| NCT04199689Phase 3Merck Sharp & Dohme LLCEfficacy Against Oral Persistent Infection, Immunogenicity and Safety of the 9-valent Human Papillomavirus Vaccine (9vHPV) in Men Aged 20-45 Years (V503-049) | 2027-01-15 |
| NCT04965792Dana-Farber Cancer InstitutePost-treatment Surveillance in HPV+ Oropharyngeal SCC | 2026-11 |
| NCT04206813Boston Medical CenterAn Exploratory Open-Label Clinical Trial Evaluating the Immunogenicity of the 9-valent 2-dose HPV Vaccination Regimen | 2026-12 |
| NCT05677360H. Lee Moffitt Cancer Center and Research InstituteHPV Multilevel Intervention Strategies Targeting Immunization in Community Settings (HPV MISTICS) | 2026-12 |
Add all 28 to your calendar (.ics) → With an account.
Among the 166 studies in Papillomavirus Infections with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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).
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Parents of 11-12 year old children who visit participating interventional clinics during study period.
Behavioral: Protect Me 4 Application + External Quality Improvement Support · Behavioral: Protect Me 4 Application Alone
Health care providers and clinic staff for 11-12 year old patients at 4 participating pediatric clinics.
Behavioral: Protect Me 4 Application + External Quality Improvement Support · Behavioral: Protect Me 4 Application Alone
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.
Parents of 11-12 year old children who visit participating control clinics during study period.
Health care providers and clinic staff for 11-12 year old patients at 3 participating pediatric control clinics.
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.)
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.
Also known as: Enhanced HIT System Intervention
Reach - Feasibility
Goal will be to have 80% of the parents of 11-12 year olds offered the Protect Me 4 app.
Time frame: 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.
Time frame: 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.
Time frame: 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.)
Time frame: 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
Time frame: Months 7-9
Acceptability - Feasibility
At both the end of the implementation and the maintenance period, providers will complete the Post Intervention Survey.
Time frame: Month 6, Month 9
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.
Time frame: After month 9
Efficacy Measurements
Determination of HPV vaccine initiation using Current Procedural Terminology (CPT) and Current Vaccine Administered (CVX) codes
Time frame: After month 9
Start is estimated for Sep 2027; primary completion for Sep 2028, 12 months later.
Of 106 non-industry interventional studies with no phase under Papillomavirus Infections, half reached primary completion within 26 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 48. This study's planned 12 months is below that.
Counting every sponsor, half of 115 studies reached it within 26 months; a quarter within 12 and three quarters within 51.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.