Papilloma Viral InfectionNCT06784960
Communication Strategies to Increase HPV Vaccinations
A study testing HPV Message 1, HPV Message 2 and HPV Message 3 in people with Papilloma Viral Infection and Vaccine Hesitancy, run by Abramson Cancer Center at Penn Medicine at 1 site in United States.
Trial summary
This research aims to identify communication strategies to improve the uptake of vaccines using an experimental design, focusing on the Human Papillomavirus (HPV) vaccine, which is highly effective in preventing HPV-related cancers. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Papilloma Viral Infection, Vaccine Hesitancy, Communication
- What is being tested?
- HPV Message 1, HPV Message 2 and HPV Message 3
- Type of treatment
- Vaccines, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9,002 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Feb 2025to 11 Mar 2027
- 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 18-45 years old
Who cannot join
- Under 18 and over 45 years old
- Received HPV vaccine or unsure about receipt
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
Official title: A Cluster Randomized Controlled Trial Testing Communication Strategies to Increase HPV Vaccination in Primary Care
This research aims to identify communication strategies to improve the uptake of vaccines using an experimental design, focusing on the Human Papillomavirus (HPV) vaccine, which is highly effective in preventing HPV-related cancers. However, low HPV vaccination rates among adults remain a significant public health challenge. Although randomized controlled trials (RCTs) have demonstrated that interventions can increase vaccine uptake in children, few RCTs have been conducted among adults.
To address this gap, a multidisciplinary investigative team with expertise in communication, medicine, nursing, and behavior-change intervention research will conduct a survey experiment and a cluster randomized controlled trial. First, a national sample of adults ages 18 to 45 who have not received the HPV vaccine or are unsure of their vaccination status will participate in a survey experiment to identify the most promising theory-based messages to strengthen HPV vaccine intentions. The two messages associated with the largest increases in vaccination intentions will then be selected for further testing.
Read more
Next, 16 Penn Medicine primary care clinics will participate in a factorial cluster randomized controlled trial to test patient-level and clinic-level interventions designed to increase HPV vaccine uptake. Patient-level interventions will include theory-based text messages and a reminder-only message condition. The clinic-level intervention will provide healthcare providers with feedback on missed opportunities for HPV vaccination and a toolkit to support strong HPV vaccine recommendations.
The study will evaluate whether these interventions increase receipt of the first HPV vaccine among eligible adult patients and whether combining patient-directed messages with the clinic-level intervention further increases HPV vaccination. HPV vaccination will be assessed using Penn Medicine electronic health records and, when needed, patient self-report.
- Conditions
- Papilloma Viral Infection, Vaccine Hesitancy, Communication
- Being tested
- HPV Message 1, HPV Message 2, HPV Message 3, Control Message, Provider Strong-Recommendation Toolkit
- Medical subject headings
- Papillomavirus Infections, Vaccination Hesitancy, Communication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HPV Message 1Behavioural
A patient-directed text-message intervention promoting HPV vaccination, selected from the Aim 1 survey experiment based on its effect on HPV vaccination intentions.
HPV Message 2Behavioural
A patient-directed text-message intervention promoting HPV vaccination, selected from the Aim 1 survey experiment based on its effect on HPV vaccination intentions.
HPV Message 3Behavioural
A patient-directed text-message intervention promoting HPV vaccination, selected from the Aim 1 survey experiment based on its effect on HPV vaccination intentions.
Control MessageBehavioural
An attention-matched control text-message condition that does not contain the theory-based HPV vaccination messages being evaluated.
Provider Strong-Recommendation ToolkitBehavioural
A clinic-level intervention providing primary care providers with a toolkit supporting strong HPV vaccine recommendations.
| Study group | Role | What they receive |
|---|---|---|
| HPV Message 1 + Clinic Intervention | Experimental | Not described Receives: Behavioral: HPV Message 1; Behavioral: Provider Strong-Recommendation Toolkit |
| HPV Message 1 + No Clinic Intervention | Experimental | Not described Receives: Behavioral: HPV Message 1 |
| HPV Message 2 + Clinic Intervention | Experimental | Not described Receives: Behavioral: HPV Message 2; Behavioral: Provider Strong-Recommendation Toolkit |
| HPV Message 2 + No Clinic Intervention | Experimental | Not described Receives: Behavioral: HPV Message 2 |
| HPV Message 3 + Clinic Intervention | Experimental | Not described Receives: Behavioral: HPV Message 3; Behavioral: Provider Strong-Recommendation Toolkit |
| HPV Message 3 + No Clinic Intervention | Experimental | Not described Receives: Behavioral: HPV Message 3 |
| Control Message + Clinic Intervention | Active comparator | Not described Receives: Behavioral: Control Message; Behavioral: Provider Strong-Recommendation Toolkit |
| Control Message + No Clinic Intervention | Active comparator | Not described Receives: Behavioral: Control Message |
What is being measured
The primary outcome is the main question the study is designed to answer.
Aim 1 - Intention to Vaccinate
Assessed using a three-item validated HPV Vaccination Intention Scale. The three items evaluate the participant's intent, plan, and likelihood to receive the HPV vaccine within the next 6 months. Responses for each item were recorded on a 5-point Likert scale. A composite intention score was calculated as the mean of the three items, with total scores ranging from 1 to 5. Higher scores indicate a better outcome (a greater intention to receive the HPV vaccine).
Measured: Immediately after exposure to the assigned message
Aim 2 - Receipt of HPV Vaccine
Receipt of HPV vaccine during the follow-up period, determined from HPV vaccination documentation in the electronic health record or patient self-report.
Measured: From intervention initiation through 9 months of follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2025
- Study start6 Feb 2025
- Primary completion11 Mar 2027 (estimated)
- Study completion11 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Papilloma Viral InfectionStudies of the same condition, open and under way.
- More trials run by Abramson Cancer Center at Penn MedicineThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The study consists of two randomized components. In Aim 1, participants are randomly assigned to one of five theory-based HPV vaccine message conditions or an attention-matched control condition. The messages associated with the largest increases in HPV vaccination intentions are then selected for testing in Aim 2. In Aim 2, 16 primary care clinics are randomized in a 4 × 2 factorial design to one of four patient-level conditions (three patient-directed intervention text-message conditions or a control text-message condition) and, independently, to either receive or not receive a clinic-level provider intervention.
- Masking
- None (open label)
- Enrolment
- 9,002 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abramson Cancer Center at Penn Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- University of Pennsylvania
- Responsible party
- Principal investigator, Florence Momplaisir, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06784960
- Sponsor's protocol ID
- UPCC 02026
- Other IDs
- 856892
- Status last verified
- Sep 2026
- First submitted
- 12 Dec 2024
- Last updated
- 24 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 24 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Cluster Randomized Controlled Trial Testing Communication Strategies to Increase HPV Vaccination in Primary Care
- ClinicalTrials.gov ID
- NCT06784960
- Acronym / sponsor ID
- UPCC 02026
- Conditions
- Papilloma Viral Infection, Vaccine Hesitancy, Communication
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 9,002 participants (actual)
- Lead sponsor
- Abramson Cancer Center at Penn MedicineUniversity, hospital or other
- Collaborators
- University of Pennsylvania
- Study start
- 6 Feb 2025 (actual)
- Primary completion
- 11 Mar 2027 (estimated)
- Study completion
- 11 Mar 2027 (estimated)
- First posted
- 20 Jan 2025 (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.
This research aims to identify communication strategies to improve the uptake of vaccines using an experimental design, focusing on the Human Papillomavirus (HPV) vaccine, which is highly effective in preventing HPV-related cancers. However, low HPV vaccination rates among adults remain a significant public health challenge. Although randomized controlled trials (RCTs) have demonstrated that interventions can increase vaccine uptake in children, few RCTs have been conducted among adults.
To address this gap, a multidisciplinary investigative team with expertise in communication, medicine, nursing, and behavior-change intervention research will conduct a survey experiment and a cluster randomized controlled trial. First, a national sample of adults ages 18 to 45 who have not received the HPV vaccine or are unsure of their vaccination status will participate in a survey experiment to identify the most promising theory-based messages to strengthen HPV vaccine intentions. The two messages associated with the largest increases in vaccination intentions will then be selected for further testing.
Next, 16 Penn Medicine primary care clinics will participate in a factorial cluster randomized controlled trial to test patient-level and clinic-level interventions designed to increase HPV vaccine uptake. Patient-level interventions will include theory-based text messages and a reminder-only message condition. The clinic-level intervention will provide healthcare providers with feedback on missed opportunities for HPV vaccination and a toolkit to support strong HPV vaccine recommendations.
The study will evaluate whether these interventions increase receipt of the first HPV vaccine among eligible adult patients and whether combining patient-directed messages with the clinic-level intervention further increases HPV vaccination. HPV vaccination will be assessed using Penn Medicine electronic health records and, when needed, patient self-report.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 8
- Model description
- The study consists of two randomized components. In Aim 1, participants are randomly assigned to one of five theory-based HPV vaccine message conditions or an attention-matched control condition. The messages associated with the largest increases in HPV vaccination intentions are then selected for testing in Aim 2. In Aim 2, 16 primary care clinics are randomized in a 4 × 2 factorial design to one of four patient-level conditions (three patient-directed intervention text-message conditions or a control text-message condition) and, independently, to either receive or not receive a clinic-level provider intervention.
| Arm | Type | Receives |
|---|---|---|
| HPV Message 1 + Clinic Intervention | Experimental | Behavioral: HPV Message 1, Behavioral: Provider Strong-Recommendation Toolkit |
| HPV Message 1 + No Clinic Intervention | Experimental | Behavioral: HPV Message 1 |
| HPV Message 2 + Clinic Intervention | Experimental | Behavioral: HPV Message 2, Behavioral: Provider Strong-Recommendation Toolkit |
| HPV Message 2 + No Clinic Intervention | Experimental | Behavioral: HPV Message 2 |
| HPV Message 3 + Clinic Intervention | Experimental | Behavioral: HPV Message 3, Behavioral: Provider Strong-Recommendation Toolkit |
| HPV Message 3 + No Clinic Intervention | Experimental | Behavioral: HPV Message 3 |
| Control Message + Clinic Intervention | Active comparator | Behavioral: Control Message, Behavioral: Provider Strong-Recommendation Toolkit |
| Control Message + No Clinic Intervention | Active comparator | Behavioral: Control Message |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 18-45 years old
Key exclusion criteria (2 listed)
- Under 18 and over 45 years old
- Received HPV vaccine or unsure about receipt
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 |
|---|---|---|
| HPV Message 1A patient-directed text-message intervention promoting HPV vaccination, selected from the Aim 1 survey experiment based on its effect on HPV vaccination intentions. | Behavioural | HPV Message 1 + Clinic Intervention, HPV Message 1 + No Clinic Intervention |
| HPV Message 2A patient-directed text-message intervention promoting HPV vaccination, selected from the Aim 1 survey experiment based on its effect on HPV vaccination intentions. | Behavioural | HPV Message 2 + Clinic Intervention, HPV Message 2 + No Clinic Intervention |
| HPV Message 3A patient-directed text-message intervention promoting HPV vaccination, selected from the Aim 1 survey experiment based on its effect on HPV vaccination intentions. | Behavioural | HPV Message 3 + Clinic Intervention, HPV Message 3 + No Clinic Intervention |
| Control MessageAn attention-matched control text-message condition that does not contain the theory-based HPV vaccination messages being evaluated. | Behavioural | Control Message + Clinic Intervention, Control Message + No Clinic Intervention |
| Provider Strong-Recommendation ToolkitA clinic-level intervention providing primary care providers with a toolkit supporting strong HPV vaccine recommendations. | Behavioural | Control Message + Clinic Intervention, HPV Message 1 + Clinic Intervention, HPV Message 2 + Clinic Intervention, HPV Message 3 + Clinic Intervention |
Primary outcome
Aim 1 - Intention to Vaccinate
Time frame: Immediately after exposure to the assigned message
Assessed using a three-item validated HPV Vaccination Intention Scale. The three items evaluate the participant's intent, plan, and likelihood to receive the HPV vaccine within the next 6 months. Responses for each item were recorded on a 5-point Likert scale. A composite intention score was calculated as the mean of the three items, with total scores ranging from 1 to 5. Higher scores indicate a better outcome (a greater intention to receive the HPV vaccine).
Aim 2 - Receipt of HPV Vaccine
Time frame: From intervention initiation through 9 months of follow-up
Receipt of HPV vaccine during the follow-up period, determined from HPV vaccination documentation in the electronic health record or patient self-report.
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 24 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. 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 HPV Message 1, HPV Message 2 and HPV Message 3 in people with Papilloma Viral Infection and Vaccine Hesitancy, run by Abramson Cancer Center at Penn Medicine 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 1 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: under way, not looking for participants, as of the sponsor's last update on 24 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?
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?
Aim 1 - Intention to Vaccinate (time frame: Immediately after exposure to the assigned message). The study lists 2 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 24 Sep 2026.