Communication Strategies to Increase HPV Vaccinations
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.
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 Overview
Status
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Pennsylvania
-
Philadelphia, Pennsylvania, United States, 19104
- University of Pennsylvania
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 18-45 years old
Exclusion Criteria:
- Under 18 and over 45 years old
- Received HPV vaccine or unsure about receipt
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: HPV Message 1 + Clinic Intervention
|
A patient-directed text-message intervention promoting HPV vaccination, selected from the Aim 1 survey experiment based on its effect on HPV vaccination intentions.
A clinic-level intervention providing primary care providers with a toolkit supporting strong HPV vaccine recommendations.
|
|
Experimental: HPV Message 1 + No Clinic Intervention
|
A patient-directed text-message intervention promoting HPV vaccination, selected from the Aim 1 survey experiment based on its effect on HPV vaccination intentions.
|
|
Experimental: HPV Message 2 + Clinic Intervention
|
A clinic-level intervention providing primary care providers with a toolkit supporting strong HPV vaccine recommendations.
A patient-directed text-message intervention promoting HPV vaccination, selected from the Aim 1 survey experiment based on its effect on HPV vaccination intentions.
|
|
Experimental: HPV Message 2 + No Clinic Intervention
|
A patient-directed text-message intervention promoting HPV vaccination, selected from the Aim 1 survey experiment based on its effect on HPV vaccination intentions.
|
|
Experimental: HPV Message 3 + Clinic Intervention
|
A clinic-level intervention providing primary care providers with a toolkit supporting strong HPV vaccine recommendations.
A patient-directed text-message intervention promoting HPV vaccination, selected from the Aim 1 survey experiment based on its effect on HPV vaccination intentions.
|
|
Experimental: HPV Message 3 + No Clinic Intervention
|
A patient-directed text-message intervention promoting HPV vaccination, selected from the Aim 1 survey experiment based on its effect on HPV vaccination intentions.
|
|
Active Comparator: Control Message + Clinic Intervention
|
A clinic-level intervention providing primary care providers with a toolkit supporting strong HPV vaccine recommendations.
An attention-matched control text-message condition that does not contain the theory-based HPV vaccination messages being evaluated.
|
|
Active Comparator: Control Message + No Clinic Intervention
|
An attention-matched control text-message condition that does not contain the theory-based HPV vaccination messages being evaluated.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Aim 1 - Intention to Vaccinate
Time Frame: Immediately after exposure to the assigned message
|
Validated 3-item likert scale assessing HPV vaccination intention.
|
Immediately after exposure to the assigned message
|
|
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.
|
From intervention initiation through 9 months of follow-up
|
Collaborators and Investigators
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Urogenital Diseases
- Genital Diseases
- Pathologic Processes
- Disease Attributes
- Infections
- Virus Diseases
- Communicable Diseases
- Sexually Transmitted Diseases, Viral
- Sexually Transmitted Diseases
- DNA Virus Infections
- Tumor Virus Infections
- Pathological Conditions, Signs and Symptoms
- Behavior
- Treatment Adherence and Compliance
- Health Behavior
- Treatment Refusal
- Vaccination Refusal
- Papillomavirus Infections
- Communication
- Vaccination Hesitancy
Other Study ID Numbers
- UPCC 02026
- 856892 (Other Identifier: University of Pennsylvania IRB)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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