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OpenTrials
Active, not recruiting

NCT Number: NCT06784960

Communication Strategies to Increase HPV Vaccinations

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.

Active, not recruiting

This study is active but is not currently recruiting participants.

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Key information

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 18-45 years old

Exclusion criteria

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

Treatment and study plan

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 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 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.

Control message

Behavioral

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

Provider Strong-Recommendation Toolkit

Behavioral

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

Primary outcomes

  1. Aim 1 - Intention to Vaccinate

    Time frame: Immediately after exposure to the assigned message

    Validated 3-item likert scale assessing HPV vaccination intention.

  2. 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.

Sponsors and collaborators

Lead sponsor

Abramson Cancer Center at Penn Medicine

Other

Collaborators

  • University of Pennsylvania

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Jan 20, 2025
Registry last updated
Sep 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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