What side effects are associated with this type of intervention?

The most common treatment for Human Papillomavirus (HPV) is vaccination, which is generally safe and effective. Known side effects of the HPV vaccine include pain at the injection site, swelling, redness, and mild fever. Rarely, more serious side effects such as anaphylaxis have been reported, but these are extremely uncommon. For anogenital warts, treatments include patient-applied therapies like imiquimod and podofilox, and clinician-administered therapies such as cryotherapy and surgical removal. Side effects of these treatments can include local skin reactions, pain, and scarring.

What prior FDA approvals exist?

The FDA has approved several vaccines for the prevention of Human Papillomavirus (HPV) infections, which are critical in reducing the incidence of HPV-associated cancers and diseases. Notably, the HPV vaccines Gardasil, Gardasil 9, and Cervarix have been approved to protect against the most common and high-risk HPV types. Additionally, for HPV-associated conditions such as recurrent respiratory papillomatosis and cervical cancer, treatments like Imiquimod 5% cream and Tisotumab vedotin-tftv have been approved. These interventions, along with efforts to improve provider communication through programs like Virtual PCOM, aim to increase vaccination rates and reduce the burden of HPV-related diseases.

What other types of research exist?

Promising alternatives to Virtual PCOM for improving HPV vaccination rates include: 1) Training providers to use presumptive 'announcements' rather than participatory 'conversations,' which has shown effectiveness in a randomized trial. 2) Utilizing social media platforms like Facebook for health promotion interventions, which demonstrated robust engagement and increased awareness in a controlled study. 3) Implementing Virtual Reality (VR) training programs like VICTORI, which significantly increased HPV vaccine initiation rates in a pilot trial.

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Improved Doctor-Patient Communication for HPV Vaccination (PCOM2 Trial)

N/A

Recruiting

Led By Sean O'Leary, MD, MPH

Research Sponsored by University of Colorado, Denver

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be younger than 18 years old

Must not have

Parents: Does not have an adolescent between the ages of 9-17 years old and is not receiving adolescent care at an enrolled clinic

Timeline

Screening 3 weeks

Treatment Varies

Follow Up adolescent vaccination initiation status will be assessed among all "active" (seen in the last 12 months) 13-17-year-old patients at each practice during the last 12 months of the 24 month intervention period

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to test an online training program for healthcare providers to improve how they talk about the HPV vaccine. The goal is to increase vaccination rates among teens, reducing their risk of HPV-related cancers and diseases.

Who is the study for?

This trial is for parents with kids aged 9-17 receiving care at enrolled clinics, and for healthcare providers working at these practices. Parents without children in this age range or not attending the participating clinics, and providers outside these practices cannot join.

What is being tested?

The study is testing two ways of talking to patients about HPV vaccines: a new virtual communication method (PCOM2-virtual) versus the standard approach (PCOM-standard). The goal is to see if the virtual version can improve vaccination rates without needing much help from research teams.

What are the potential side effects?

Since this trial focuses on communication methods rather than medical treatments, there are no direct side effects related to drugs or procedures. However, participants may experience varying levels of satisfaction or effectiveness with each communication strategy.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I do not have a child aged 9-17 nor is my child receiving care at an enrolled clinic.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ adolescent vaccination initiation status will be assessed among all "active" (seen in the last 12 months) 11 to 12-year-old patients at each practice during the last 12 months of the 24 month intervention period

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~adolescent vaccination initiation status will be assessed among all "active" (seen in the last 12 months) 11 to 12-year-old patients at each practice during the last 12 months of the 24 month intervention period

This trial's timeline: 3 weeks for screening, Varies for treatment, and adolescent vaccination initiation status will be assessed among all "active" (seen in the last 12 months) 11 to 12-year-old patients at each practice during the last 12 months of the 24 month intervention period for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

HPV vaccination initiation status in 11-12 year olds

Secondary study objectives

HPV series completion among 11-12 year olds

HPV series completion among 13-17 year olds

HPV vaccination initiation status in 13-17 year olds

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: PCOM2 Virtual ArmExperimental Treatment1 Intervention

Providers participating in the PCOM2-virtual arm will receive training on this communication method through an adapted virtual model of PCOM-standard. PCOM2-Virtual intervention will result in a "shelf ready" intervention and associated "User Manual" that can be easily incorporated into practices broadly to improve the practice's adolescent HPV vaccination rates. PCOM-Virtual arm will then be compared to that of the original PCOM-standard intervention in its efficacy for increasing HPV vaccination among adolescents.

Group II: PCOM Standard ArmActive Control1 Intervention

Providers in participating in the PCOM-standard intervention will be trained on optimizing an in-person provider communication technique about HPV vaccination by training primary care providers in a 2-step verbal communication process: 1) to start the HPV vaccine discussion using a "presumptive" format, and 2) to use motivational interviewing (MI) techniques to address parental vaccine hesitancy.

0 / 1Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Human Papillomavirus (HPV) include vaccination, patient-applied therapies, and clinician-administered therapies. The HPV vaccine works by stimulating the immune system to produce antibodies that prevent future infections with the virus, thereby reducing the risk of HPV-related cancers and diseases. Patient-applied therapies, such as topical treatments, work by directly targeting and eliminating visible warts caused by HPV. Clinician-administered therapies, including cryotherapy and surgical removal, aim to destroy or excise warts and abnormal cells. Improving provider communication, as studied in the Virtual PCOM trial, is crucial because it enhances patient understanding and acceptance of the HPV vaccine, leading to higher vaccination rates and better prevention of HPV-related conditions.

Preliminary efficacy of a tailored narrative intervention to increase human papillomavirus vaccination intention among a multi-ethnic sample of female students.Effect of an IMB Model-Based Education on the Acceptability of HPV Vaccination Among College Girls in Mainland China: A Cluster RCT.The online attention to oral cancer research: An Altmetric analysis.