Educational Program for HPV Vaccination Confidence

Overseen By Anne E Ray, PhD

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Anne E Ray

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 4

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to increase vaccine confidence among hesitant parents regarding the HPV vaccine through educational tools. Participants will use a web app featuring short videos that encourage discussions with healthcare providers and offer personalized feedback to address concerns. The program includes Provider Elaborated Prompts, designed to improve communication with healthcare providers. This trial suits mothers or female guardians of 11-17-year-olds in the U.S. who can read English and are uncertain about the HPV vaccine. Insights gained will guide future efforts to boost vaccination confidence on a larger scale. As an unphased study, this trial provides a unique opportunity to contribute to important research focused on enhancing public health education and vaccine confidence.

Will I have to stop taking my current medications?

The trial does not specify whether you need to stop taking your current medications.

What prior data suggests that this educational program is safe for increasing vaccine confidence?

Previous studies have shown that prompts from healthcare providers to encourage HPV vaccination are well-received. Research indicates these prompts increase vaccination rates without causing problems. These prompts are simple reminders for healthcare providers to discuss the vaccine with parents and have no physical side effects.

For the web application part of the intervention, studies have demonstrated its safety and usefulness. The app offers educational content and feedback to parents, which has been positively received. It enhances understanding of the HPV vaccine without any reported safety concerns.

Overall, both the provider prompts and the web application have proven safe in previous studies, with no significant negative effects reported. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it focuses on boosting confidence in HPV vaccination through innovative communication strategies. Unlike traditional methods that rely solely on direct information delivery from healthcare providers, this approach combines a Parents' Stories Web Application with Provider Elaborated Prompts. The web app features engaging, short narrative videos and personalized feedback tailored to address parents' concerns, making it more interactive and relatable. Meanwhile, healthcare providers use these prompts to enhance conversations with parents, ensuring their specific worries are addressed in a supportive and motivating way. This personalized and interactive approach could lead to higher vaccination rates by directly addressing parental hesitations.

What evidence suggests that this educational program is effective for increasing HPV vaccine confidence?

Research has shown that specific prompts from healthcare providers can increase HPV vaccination rates. For instance, one study found that detailed prompts led to more people starting the vaccine series. Another study demonstrated that these prompts effectively raised vaccination rates across different patient groups.

In this trial, participants will encounter a combination of provider elaborated prompts and a web application. Studies have shown encouraging results with online tools; for example, a mobile app helped parents develop more positive views about the HPV vaccine. Additionally, mobile health (mHealth) tools have significantly increased vaccine uptake. These findings suggest that combining provider prompts with a supportive web application, as tested in this trial, might effectively boost vaccine confidence and uptake among hesitant parents. ^{2 3 6 7 8}

Who Is on the Research Team?

Anne E Ray, PhD

Principal Investigator

University of Kentucky

Michael Hecht, PhD

Principal Investigator

Real Prevention, LLC

Aaron Kruse-Diehr, PhD

Principal Investigator

University of Kentucky

Are You a Good Fit for This Trial?

This trial is for parents who are hesitant about the HPV vaccine and live in rural Kentucky. They must be willing to complete surveys, use a web application, and visit their child's healthcare provider.

Inclusion Criteria

Status as a U.S. resident

Self-reported ability to read English

I am a mother or female guardian of a child aged 11-17.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 week

1 visit (virtual)

Intervention

Participants complete a pre-test survey, view tailored intervention content including Parents' Stories videos, and receive personalized feedback

1 week

1 visit (virtual)

Provider Interaction

During a healthcare provider visit, providers deliver elaborated prompts related to the vaccine

1 day

1 visit (in-person)

Follow-up

Participants receive a link to the post-test survey two weeks following their appointment

2 weeks

1 visit (virtual)

What Are the Treatments Tested in This Trial?

Interventions

• Provider Elaborated Prompts
• Web Application

Trial Overview The study tests if using prompts from providers and a web app can boost parents' confidence in the HPV vaccine. It will compare confidence levels before and after the intervention.

How Is the Trial Designed?

Group I: Parents' Stories Web Application + Provider Elaborated Prompts Experimental Treatment 2 Interventions

Participating parents will be asked to navigate a web application that consists of (a) brief, 90-second narrative videos that encourage parent-provider communication about the vaccine and (b) personalized feedback to parents that is tailored to provide educational content in response to their concerns and be motivational in nature. Providers will provide elaborated prompts related to the vaccine when meeting with parents tailored to their concerns.

Who Is Running the Clinical Trial?

Anne E Ray

Lead Sponsor

Trials

2

Recruited

660+

Merck Institute for Therapeutic Research

Collaborator

Trials

2

Recruited

80,100+

Real Prevention, LLC

Industry Sponsor

Trials

7

Recruited

1,900+

Published Research Related to This Trial

Healthcare providers are less likely to recommend the HPV vaccine if they feel uncomfortable discussing sexual health, perceive parental hesitance, or view patients as low risk, which can negatively impact vaccination rates.

Patients, particularly younger individuals, males, and those from racial/ethnic minorities, are less likely to receive strong recommendations for the HPV vaccine, highlighting the need for clearer communication strategies from providers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Provider communication about HPV vaccination: A systematic review. Gilkey, MB., McRee, AL.[2023]

An evidence-based educational brochure and reminder system significantly increased HPV vaccine uptake among parents of preteen girls, with a 9.4 times higher likelihood of vaccination compared to a historical control group.

The intervention also led to a remarkable 22.5 times increase in dose completion rates, highlighting the effectiveness of structured educational and reminder strategies in improving vaccination outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A quality improvement initiative to increase HPV vaccine rates using an educational and reminder strategy with parents of preteen girls. Cassidy, B., Braxter, B., Charron-Prochownik, D., et al.[2015]

The study aims to create an educational package about the HPV vaccine co-produced with young people to address information gaps and increase vaccine uptake in schools with historically lower rates.

The research will involve a three-phase approach, including a review of existing materials, co-production of communication strategies with adolescents, and testing the educational package in four schools, ensuring that the intervention is tailored to the needs of the target population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Co-production of an educational package for the universal human papillomavirus (HPV) vaccination programme tailored for schools with low uptake: a participatory study protocol. Fisher, H., Audrey, S., Chantler, T., et al.[2021]

A total of 3174 adverse events (AEs) were reported in children and adolescents aged 6-17 after receiving the HPV vaccine, with 191 (6%) classified as serious.

While these serious AEs raise concerns, further research is necessary to establish a direct link between these events and the HPV vaccine.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Human papillomavirus vaccine safety in pediatric patients: an evaluation of the Vaccine Adverse Event Reporting System. Borja-Hart, NL., Benavides, S., Christensen, C.[2019]

A structured 30-minute presentation significantly improved HPV vaccine knowledge among 427 healthcare providers, including physicians, medical students, and nurses, with average scores rising from 8 to 15 out of 16 (P < .001).

Younger participants and non-physician healthcare workers showed the greatest improvement in knowledge, highlighting the effectiveness of targeted educational interventions to address knowledge gaps in HPV vaccination.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A brief educational intervention increases providers' human papillomavirus vaccine knowledge. Berenson, AB., Rahman, M., Hirth, JM., et al.[2022]

The electronic medical record (EMR)-based HPV vaccine decision support intervention was well-received by parents, with 46% recalling the reminder call, which encouraged them to seek more information and discuss the vaccine with others.

Parents whose daughters attended practices using the clinician-focused intervention were more likely to have discussions about the HPV vaccine during preventive visits, indicating that the intervention positively influenced clinician engagement and communication about vaccination.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The implementation and acceptability of an HPV vaccination decision support system directed at both clinicians and families. Mayne, S., Karavite, D., Grundmeier, RW., et al.[2021]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10901897/

Effectiveness of provider communication training for ... Our provider feedback intervention had minimal effect on increasing prevalence of HPV vaccination in seven family medicine and pediatric clinics.

2. sciencedirect.com sciencedirect.com/science/article/pii/S0264410X25006565

Review Effective strategies in human papillomavirus (HPV) ... Around 70 % of these studies (n = 7) yielded statistically significant results with an increase in HPV vaccination from 12.5 to 65.5 % [33,40,42 ...

3. scholarworks.indianapolis.iu.edu scholarworks.indianapolis.iu.edu/bitstreams/fa5e01f6-579a-4998-b413-0debbf2999f3/download

Simple and elaborated clinician reminder prompts for HPV ... However, this trial adds evidence that provider-targeted. CDS prompts can be effective at increasing vaccine uptake in diverse patient populations.

4. publications.aap.org publications.aap.org/pediatrics/article/151/5/e2022058029/191043/Provider-Based-HPV-Vaccine-Promotion-Interventions

Provider-Based HPV Vaccine Promotion Interventions The HPV vaccine uptake rate increased from 1.2% at baseline to 26.5% after the intervention.28 However, in a study evaluating 2 provider ...

5. academicpedsjnl.net academicpedsjnl.net/article/S1876-2859(17)30563-6/fulltext

Simple and Elaborated Clinician Reminder Prompts for ... Results suggest that an elaborated HCP-targeted reminder prompt, with suggested recommendation language, might improve rates of HPV vaccine initiation.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11056302/

Clinician Prompts for Human Papillomavirus Vaccination We assessed the impact of an online intervention using clinician prompts for human papillomavirus (HPV) vaccination with a cluster randomized controlled trial.

7. sciencedirect.com sciencedirect.com/science/article/pii/S2211335524000755

Effectiveness of provider communication training for ... Our overall results suggest a modest decrease in HPV vaccination prevalence immediately after a brief provider communication training with clinic-level audit ...

8. clinicaltrials.gov clinicaltrials.gov/study/NCT02551887

HPV Vaccination: An Investigation of Physician Reminders ... The primary outcome of interest, HPV vaccination, will be evaluated as a patient outcome nested within provider. Physician acceptance of the recommendations, ...