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Communication Strategies to Increase HPV Vaccinations

A Cluster Randomized Controlled Trial Testing Communication Strategies to Increase HPV Vaccination in Primary Care

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06784960
Enrollment
9002
Registered
2025-01-20
Start date
2025-02-06
Completion date
2027-03-11
Last updated
2026-09-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Vaccine Hesitancy, Communication, Papilloma Viral Infection

Brief 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. 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.

Interventions

BEHAVIORALHPV Message 1

A patient-directed text-message intervention promoting HPV vaccination, selected from the Aim 1 survey experiment based on its effect on HPV vaccination intentions.

BEHAVIORALHPV Message 2

A patient-directed text-message intervention promoting HPV vaccination, selected from the Aim 1 survey experiment based on its effect on HPV vaccination intentions.

BEHAVIORALHPV Message 3

A patient-directed text-message intervention promoting HPV vaccination, selected from the Aim 1 survey experiment based on its effect on HPV vaccination intentions.

BEHAVIORALControl Message

An attention-matched control text-message condition that does not contain the theory-based HPV vaccination messages being evaluated.

BEHAVIORALProvider Strong-Recommendation Toolkit

A clinic-level intervention providing primary care providers with a toolkit supporting strong HPV vaccine recommendations.

Sponsors

Abramson Cancer Center at Penn Medicine
Lead SponsorOTHER
University of Pennsylvania
CollaboratorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Intervention 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.

Eligibility

Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes

Inclusion criteria

* 18-45 years old

Exclusion criteria

* Under 18 and over 45 years old * Received HPV vaccine or unsure about receipt

Design outcomes

Primary

MeasureTime frameDescription
Aim 1 - Intention to VaccinateImmediately after exposure to the assigned messageValidated 3-item likert scale assessing HPV vaccination intention.
Aim 2 - Receipt of HPV VaccineFrom intervention initiation through 9 months of follow-upReceipt of HPV vaccine during the follow-up period, determined from HPV vaccination documentation in the electronic health record or patient self-report.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 10, 2026