Communication Strategies to Increase HPV Vaccinations

NCT06784960 | Active Not Recruiting

• 2 other identifiers: UPCC 02026856892
• Study Type: interventional
• Target: 9,002
• Locations: 1 country
• Sites: 1

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.

Conditions

Papilloma Viral Infection; Vaccine Hesitancy; Communication

Outcome Measures

Primary Outcomes (2)

• 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).

  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.

  From intervention initiation through 9 months of follow-up

Study Arms (8)

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

Interventions

HPV Message 1 BEHAVIORAL

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 1 + Clinic Intervention; HPV Message 1 + No Clinic Intervention

HPV Message 3 BEHAVIORAL

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 3 + Clinic Intervention; HPV Message 3 + No Clinic Intervention

HPV Message 2 BEHAVIORAL

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 2 + Clinic Intervention; HPV Message 2 + No Clinic Intervention

Control Message BEHAVIORAL

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

Control Message + Clinic Intervention; Control Message + No Clinic Intervention

Provider Strong-Recommendation Toolkit BEHAVIORAL

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

Control Message + Clinic Intervention; HPV Message 1 + Clinic Intervention; HPV Message 2 + Clinic Intervention; HPV Message 3 + Clinic Intervention

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• years old

You may not qualify if:

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

Sponsors & Collaborators

• Abramson Cancer Center at Penn Medicine: lead
• University of Pennsylvania: collaborator

Study Sites (1)

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Papillomavirus Infections; Vaccination Hesitancy; Communication

Condition Hierarchy (Ancestors)

Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Communicable Diseases; Infections; DNA Virus Infections; Virus Diseases; Tumor Virus Infections; Genital Diseases; Urogenital Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Vaccination Refusal; Treatment Refusal; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: 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.

Study Record Dates

• First Submitted: December 12, 2024
• First Posted: January 20, 2025
• Study Start: February 6, 2025
• Primary Completion (Estimated): March 11, 2027
• Study Completion (Estimated): March 11, 2027
• Last Updated: September 24, 2026

Record last verified: 2026-09

Locations

US (1)